FATE THERAPEUTICS INC Management’s Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) – Marketscreener.com

The following discussion and analysis should be read in conjunction with ourfinancial statements and accompanying notes included in this Quarterly Report onForm 10-Q and the financial statements and accompanying notes thereto for thefiscal year ended December 31, 2022 and the related Management's Discussion andAnalysis of Financial Condition and Results of Operations, which are containedin our Annual Report on Form 10-K filed with the Securities and ExchangeCommission on February 28, 2023.

This Quarterly Report on Form 10-Q contains "forward-looking statements" withinthe meaning of Section 27A of the Securities Act and Section 21E of theSecurities Exchange Act of 1934, as amended (the Exchange Act). Suchforward-looking statements, which represent our intent, belief, or currentexpectations, involve risks and uncertainties and other factors that could causeactual results and the timing of certain events to differ materially from futureresults expressed or implied by such forward-looking statements. In some casesyou can identify forward-looking statements by terms such as "may," "will,""expect," "anticipate," "estimate," "intend," "plan," "predict," "potential,""believe," "should" and similar expressions. Factors that could cause orcontribute to differences in results include, but are not limited to, those setforth under "Risk Factors" under Item 1A of Part II below. Except as required bylaw, we undertake no obligation to update these forward-looking statements toreflect events or circumstances after the date of this report or to reflectactual outcomes.

Overview

We are a clinical-stage biopharmaceutical company dedicated to bringing afirst-in-class pipeline of programmed cellular immunotherapies to patients withcancer and autoimmune disorders. Our development of first-in-class cell therapyproduct candidates is based on a simple notion: we believe that better celltherapies start with better cells.

To create better cell therapies, we have pioneered a therapeutic approach thatwe generally refer to as cell programming: we create and engineer human inducedpluripotent stem cells (iPSCs) to incorporate novel synthetic controls of cellfunction; we generate a clonal master iPSC line for use as a renewable source ofcell manufacture; and we direct the fate of the clonal master iPSC line toproduce our first-in-class cell therapy product candidate. Analogous to mastercell lines used to manufacture biopharmaceutical drug products such asmonoclonal antibodies, we believe clonal master iPSC lines can be used to massproduce multiplexed-engineered cellular immunotherapies which are well-definedand uniform in composition, can be stored in inventory for off-the-shelfavailability, can be combined and administered with other therapies, and canhave broader patient reach.

Utilizing this therapeutic approach, we are advancing a cell therapy pipelinecomprised of off-the-shelf, multiplexed-engineered, iPSC-derived natural killer(NK) and T-cell product candidates that are selectively designed, incorporatenovel synthetic controls of cell function, and are intended to deliver multiplemechanisms of therapeutic importance to patients for the treatment of cancer andautoimmune diseases.

We have entered into a research collaboration and license agreement with theRegents of the University of Minnesota to develop off-the-shelf, engineeredNK-cell cancer immunotherapies derived from clonal master iPSC lines.Additionally, we have entered into a research collaboration and licenseagreement with Memorial Sloan Kettering Cancer Center (MSK) to developoff-the-shelf, engineered T-cell cancer immunotherapies derived from clonalmaster iPSC lines.

In September 2018, we entered into a collaboration and option agreement (OnoAgreement) with Ono Pharmaceutical Co. Ltd. (Ono) for the joint development andcommercialization of off-the-shelf, iPSC-derived CAR T-cell product candidatesfor the treatment of cancer. In June 2022, we entered into an amendment (OnoAmendment) to the Ono Agreement to expand the collaboration to include theresearch and development of off-the-shelf, iPSC-derived CAR NK-cell productcandidates, and pursuant to the Ono Agreement, Ono agreed to provide novelbinding domains targeting a second solid tumor antigen under the collaboration.

In April 2020, we entered into a collaboration and option agreement with JanssenBiotech, Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson& Johnson (Janssen Agreement), for the development and commercialization ofoff-the-shelf, iPSC-derived CAR NK and CAR T-cell product candidates for thetreatment of cancer. Through the period ending December 31, 2022, Janssen hadexercised a commercial option for two collaboration candidates: an iPSC-derived,CAR-targeted NK cell product candidate for the treatment of B-cell lymphoma, forwhich the U.S. Food and Drug Administration (FDA) allowed an Investigational NewDrug (IND) application in December 2022; and an iPSC-derived, CAR-targeted NKcell product candidate for the treatment of multiple myeloma, for which thecompanies were preparing to submit an IND application to the FDA in early 2023.On January 3, 2023, we received notice of termination from Janssen of theJanssen Agreement. The termination of the Janssen Agreement took effect on April3, 2023, and during the three months ended March 31, 2023, we performed winddown activities, including discontinuing development of all collaborationproduct candidates, including two product candidates that were expected to enterthe clinic in 2023.

In January 2023, we announced the discontinuation of our FT516, FT596, FT538,and FT536 NK cell programs to focus our resources on advancing our mostinnovative and differentiated programs.

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We were incorporated in Delaware in 2007, and are headquartered in San Diego,CA. Since our inception in 2007, we have devoted substantially all of ourresources to our cell programming approach and the research and development ofour product candidates, the creation, licensing and protection of relatedintellectual property, and the provision of general and administrative supportfor these activities. To date, we have funded our operations primarily throughthe public and private sale of common stock, the private placement of preferredstock and convertible notes, commercial bank debt and revenues fromcollaboration activities and grants.

We have never been profitable and have incurred net losses in each year sinceinception. Substantially all of our net losses resulted from costs incurred inconnection with our research and development programs and from general andadministrative costs associated with our operations. We expect to continue toincur operating losses for at least the foreseeable future. Our net losses mayfluctuate significantly from quarter to quarter and year to year. We expect ourexpenses will increase substantially in connection with our ongoing and plannedactivities as we:

conduct our ongoing and planned clinical trials of our product candidates, whichmay include higher clinical trial expenses associated with arrangements we mayenter into with clinical research organizations (CROs) for the execution andmanagement of certain clinical trials, including trials outside of the UnitedStates;

conduct Good Manufacturing Practice (GMP) production, including through the useof contract manufacturing organizations (CMOs) for the conduct of some or all ofthe activities required for manufacturing our iPSC-derived cell productcandidates, process and scale-up development and technology transfer activitiesfor the manufacture of our product candidates, including those undergoingclinical investigation and IND-enabling preclinical development;

procure laboratory equipment, materials and supplies for the manufacture of ourproduct candidates and the conduct of our research activities;

conduct preclinical and clinical research to investigate the therapeuticactivity of our product candidates;

continue our research, development and manufacturing activities, including underour sponsored research and collaboration agreement with Ono;

maintain, prosecute, protect, expand and enforce our intellectual propertyportfolio;

engage with regulatory authorities for the development of, and seek regulatoryapprovals for, our product candidates;

build out business operations at our corporate headquarters, including internalGMP production capabilities;

continue to implement the corporate restructuring and reduction in force that weannounced in January 2023; and

continue operating as a public company and support our operations and developcommercial infrastructure for potential commercialization of our productcandidates.

We do not expect to generate any meaningful revenues from product sales,royalties, or sales milestones unless and until we successfully completedevelopment and obtain regulatory approval for one or more of our productcandidates, which we expect will take a number of years. If we obtain regulatoryapproval for any of our product candidates, we expect to incur significantcommercialization expenses related to product sales, marketing, manufacturingand distribution. Accordingly, we will seek to fund our operations throughpublic or private equity or debt financings, collaboration arrangements, orother sources. However, we may be unable to raise additional funds or enter intosuch other arrangements when needed on favorable terms or at all. Our failure toraise capital or enter into such other arrangements when needed would have anegative effect on our financial condition and ability to develop our productcandidates.

Financial Operations Overview

We conduct substantially all of our activities through Fate Therapeutics, Inc.,a Delaware corporation, at our facilities headquartered in San Diego,California. The results of operations include the operations of the Company andits subsidiaries. To date, the aggregate operations of our subsidiaries have notbeen significant and all intercompany transactions and balances have beeneliminated in consolidation.

Collaboration Revenue

To date, we have not generated any revenues from therapeutic product sales orroyalties. Our revenues have been derived from collaboration agreements andgovernment grants.

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Agreement with Janssen Biotech, Inc.

On April 2, 2020 (the Janssen Agreement Effective Date), we entered into aCollaboration and Option Agreement (the Janssen Agreement) with Janssen Biotech,Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson &Johnson. Additionally, on the Janssen Agreement Effective Date, we entered intoa Stock Purchase Agreement (the Stock Purchase Agreement) with Johnson & JohnsonInnovation - JJDC, Inc. (JJDC). Under the terms of the Janssen Agreement and theStock Purchase Agreement taken together, we received $100.0 million, of which$50.0 million was an upfront cash payment and $50.0 million was in the form ofan equity investment by JJDC. Additionally, we are entitled to receive fees forthe conduct of all research, preclinical development and IND-enabling activitiesperformed by us under the Janssen Agreement.

We determined the common stock purchase by JJDC represented a premium of $9.93per share, or $16.0 million in aggregate (the Equity Premium), and the remaining$34.0 million was recorded as issuance of common stock in shareholders' equity.

On January 3, 2023, we received notice of termination from Janssen of theJanssen Agreement. The termination will take effect on April 3, 2023, and duringthe three months ending March 31, 2023, we performed wind down activities,including discontinuing development of all collaboration product candidatesunder the Janssen Agreement. We expect to be reimbursed for all wind downactivities associated with the termination of the Janssen Agreement in thesecond quarter of this year. Under the terms of the Janssen Agreement, inconnection with the termination, (i) all licenses and other rights granted toeither party pursuant to the Janssen Agreement have terminated, subject tolimited exceptions set forth in the Janssen Agreement; (ii) both parties havewound down all development, commercialization and manufacturing activities underthe Janssen Agreement; (iii) neither party has any right to continue to develop,manufacture or commercialize any collaboration candidate or collaborationproduct or use the other party's materials; and (iv) neither party is restrictedfrom independently developing, manufacturing, or commercializing any product,including any products directed to the same antigens as those of anycollaboration candidate or collaboration product.

During the three months ended March 31, 2023, we recognized $52.3 million ofcollaboration revenue under the Janssen Agreement, of which $41.2 million waspreviously deferred. During the three months ended March 31, 2022, we recognized$15.9 million of collaboration revenue under the Janssen Agreement.

Agreement with Ono Pharmaceutical Co., Ltd.

On September 14, 2018, we entered into a Collaboration and Option Agreement (theOno Agreement) with Ono for the joint development and commercialization of twooff-the-shelf iPSC-derived CAR T-cell product candidates (Candidate 1 andCandidate 2). Pursuant to the terms of the Ono Agreement, we received anupfront, non-refundable and non-creditable payment of $10.0 million.Additionally, we are entitled to receive fees for the conduct of research anddevelopment under a joint development plan, which fees were estimated to be$20.0 million in aggregate.

We concluded that certain units of account within the Ono Agreement representeda customer relationship and in accordance with ASC 606, we determined that theinitial transaction price under the Ono Agreement equals $30.0 million,consisting of the upfront, non-refundable and non-creditable payment of $10.0million and the aggregate estimated research and development fees of $20.0million. In addition, we identified our performance obligations under the OnoAgreement, including our grant to Ono of a license to certain of ourintellectual property subject to certain conditions, our conduct of researchservices, and our participation in a joint steering committee. We determinedthat all performance obligations should be accounted for as one combinedperformance obligation since no individual performance obligation is distinct,and that the combined performance obligation is transferred over the expectedterm of the conduct of the research services, which is estimated to be fouryears.

In December 2020, we entered into a letter agreement with Ono pursuant to whichOno delivered proprietary antigen binding domains targeting an antigen expressedon certain solid tumors for incorporation into Candidate 2 and paid the Companya milestone fee of $10.0 million for further research and development ofCandidate 2. In addition, Ono terminated all further research and developmentwith respect to Candidate 1, and we retained all rights to research, develop andcommercialize Candidate 1 throughout the world without any obligation to Ono.

In June 2022, we entered into an amendment with Ono to the Ono Agreement (theOno Amendment). Pursuant to the Ono Amendment, the companies agreed to designatean additional antigen expressed on certain solid tumors for research andpreclinical development, and Ono agreed to contribute proprietary antigenbinding domains targeting such additional solid tumor antigen (Candidate 3). Inaddition, for both Candidate 2 and Candidate 3, the companies expanded the scopeof the collaboration to include the research and development of iPSC-derived CARNK cell product candidates (in addition to iPSC-derived CAR T-cell productcandidates) targeting the designated solid tumor antigens. Similar to Candidate2, we granted to Ono, during a specified period of time, a preclinical option toobtain an exclusive license under certain intellectual property rights, subjectto payment of an option exercise fee to us by Ono, to develop and commercializeCandidate 3 in all territories of the world, where we retain rights toco-develop and co-commercialize Candidate 3 in the United States and Europeunder a joint arrangement with Ono under which we are eligible to share at least50% of the profits and losses. We maintained worldwide rights of manufacture forCandidate 3. The preclinical option expires upon the earlier of: (a) September30, 2024, or (b) the achievement of the pre-defined preclinical milestone underthe joint development plan for Candidate 3. Subject to payment of an extensionfee by Ono, Ono may choose to defer its

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decision to exercise the preclinical option until no later than June 2026. Underthe Ono Amendment, aggregate estimated research and development fees have beenincreased by approximately $9.3 million, for a total estimated $29.3 million inaggregate research and development fees over the course of the joint developmentplan.

In November 2022, Ono exercised its preclinical option to Candidate 2, and weexercised our preclinical option to co-develop and co-commercialize (CDCCOption) in the United States and Europe under a joint arrangement with Ono. As aresult, we received an option exercise fee of $12.5 million from Ono.

During the three months ended March 31, 2023, we recognized $6.7 million ofcollaboration revenue and $1.0 million of contra-research and developmentexpense under the Ono Agreement. During the three months ended March 31, 2022,we recognized $2.5 million of collaboration revenue under the Ono Agreement.

Research and Development Expenses

Research and development expenses consist of costs associated with the research,preclinical development, process and scale-up development, manufacture andclinical development of our product candidates, the research and development ofour cell programming technology including our iPSC product platform, and theperformance of research and development activities under our collaborationagreements. These costs are expensed as incurred and include:

salaries and employee-related costs, including stock-based compensation;

costs incurred under clinical trial agreements with investigative sites;

costs to acquire, develop and manufacture preclinical study and clinical trialmaterials, including our product candidates;

costs associated with conducting our preclinical, process and scale-updevelopment, manufacturing, clinical and regulatory activities, including feespaid to third-party professional consultants, service providers and suppliers;

costs incurred for our research, development and manufacturing activities,including under our collaboration agreements;

costs for laboratory equipment, materials and supplies for the manufacture ofour product candidates and the conduct of our research activities;

costs incurred to license and maintain intellectual property; and

facilities, depreciation and other expenses including allocated expenses forrent and maintenance of facilities.

We plan to increase our current level of research and development expenses forthe foreseeable future as we continue the clinical and preclinical developmentand manufacture of our product candidates, research and develop our iPSC productplatform, and perform our obligations under collaboration agreements includingunder our agreements with Ono, University of Minnesota and MSK. Our currentplanned research and development activities over the next twelve months consistprimarily of the following:

conducting clinical trials of our product candidates, including through theengagement of CROs to manage various aspects of our clinical trials;

conducting GMP production, including through the use of CMOs for the conduct ofsome or all of the activities required for manufacturing our iPSC-derived cellproduct candidates, process and scale-up development and technology transferactivities for the manufacture of our product candidates, including thoseundergoing clinical investigation and IND-enabling preclinical development;

procuring laboratory equipment, materials and supplies for the manufacture ofour product candidates and the conduct of our research activities;

conducting preclinical and clinical research to investigate the therapeuticactivity of our product candidates; and

conducting research, development and manufacturing activities, including underour sponsored research and collaboration agreement with Ono.

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Due to the inherently unpredictable nature of preclinical and clinicaldevelopment and manufacture, and given our novel therapeutic approach and thecurrent stage of development of our product candidates, we cannot determine andare unable to estimate with certainty the timelines we will require and thecosts we will incur for the development and manufacture of our productcandidates. Clinical and preclinical development and manufacturing timelines andcosts, and the potential of development and manufacturing success, can differmaterially from expectations. In addition, we cannot forecast which productcandidates may be subject to future collaborations, when such arrangements willbe secured, if at all, and to what degree such arrangements would affect ourdevelopment and manufacturing plans and capital requirements. We cannot predictthe effects of the impact of global economic and market conditions, the COVID-19pandemic and the ongoing conflict in Ukraine on our business and operations, andour expenditures may be increased by delays or disruptions due to these or otherfactors, including as a result of actions we take in the near term to ensurebusiness continuity and protect against possible supply chain shortages.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries andemployee-related costs, including stock-based compensation, for our employees inexecutive, operational, finance and human resource functions; professional feesfor accounting, legal and tax services; costs for obtaining, prosecuting,maintaining, and enforcing our intellectual property; and other costs and fees,including director and officer insurance premiums, to support our operations asa public company. We anticipate that our general and administrative expenseswill increase in the future as we increase our research and developmentactivities, maintain compliance with exchange listing and SEC requirements,protect and enforce our intellectual property, and continue to operate as apublic company.

Other Income (Expense)

Other income (expense) consists of changes in the fair value of stock priceappreciation milestones associated with the Amended and Restated ExclusiveLicense Agreement dated May 15, 2018 (Amended MSK License) with Memorial SloanKettering Cancer Center (MSK), interest income earned on cash and cashequivalents and interest income from investments (including the amortization ofdiscounts and premiums).

California Institute for Regenerative Medicine Award

On April 5, 2018, we executed an award agreement with the California Institutefor Regenerative Medicine (CIRM) pursuant to which CIRM awarded us $4.0 millionto advance our FT516 product candidate into a first-in-human clinical trial (theAward). In November 2019, we submitted an IND application for FT516 in advancedsolid tumors. As of March 31, 2023, we have received aggregate disbursementsunder the Award in the amount of $4.0 million.

Pursuant to the terms of the Award, we, in our sole discretion, have the optionto treat the Award either as a loan or as a grant. In connection with ourdecision to discontinue our FT516 program during the first quarter of 2023, wereversed the liability associated with the Award, and recorded such amount inother income during the three months ended March 31, 2023.

Critical Accounting Policies and Significant Judgments and Estimates

Our management's discussion and analysis of our financial condition and resultsof operations are based on our unaudited condensed consolidated financialstatements, which have been prepared in accordance with United States generallyaccepted accounting principles. The preparation of these unaudited condensedconsolidated financial statements requires us to make estimates and judgmentsthat affect the reported amounts of assets, liabilities, revenues, and expensesand the disclosure of contingent assets and liabilities in our financialstatements. On an ongoing basis, we evaluate our estimates and judgments,including those related to the fair value of the stock price appreciationmilestones for the Amended MSK License, contracts containing leases, accruedexpenses, stock-based compensation, and the estimated total costs expected to beincurred under our collaboration agreements. We base our estimates on historicalexperience, known trends and events, financial models, and various other factorsthat are believed to be reasonable under the circumstances, the results of whichform the basis for making judgments about the carrying values of assets andliabilities that are not readily apparent from other sources. Actual results maydiffer from these estimates under different assumptions or conditions.

The estimates and judgments involved in our accounting policies as described inItem 7 of our Annual Report on Form 10-K for the year ended December 31, 2022,continue to be our critical accounting policies and there have been no othermaterial changes to our critical accounting policies during the three monthsended March 31, 2023.

See Note 1 to the unaudited condensed consolidated financial statements for asummary of critical accounting policies and information related to recentaccounting pronouncements.

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Results of Operations

Comparison of the Three Months Ended March 31, 2023 and 2022

The following table summarizes the results of our operations for the threemonths ended March 31, 2023 and 2022 (in thousands):

Collaboration Revenue. During the three months ended March 31, 2023 and 2022, werecognized revenue of $59.0 million and $18.4 million, respectively, under ourcollaboration agreements with Janssen and Ono. The increase in collaborationrevenue was attributable to recognition of deferred revenue balances associatedto the Janssen contract termination.

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FATE THERAPEUTICS INC Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) - Marketscreener.com

Ocean Biomedical (NASDAQ: OCEA) Announces 70% Increase in … – InvestorsObserver

Ocean Biomedical (NASDAQ: OCEA) Announces 70% Increase in Price Target by EF Hutton from $10 to $17 on New Glioblastoma Results Validating Profound Tumor Suppression with Anti-Chi3L1 Antibody

Providence, RI, May 01, 2023 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. ( NASDAQ: OCEA ), a biopharma company working to accelerate the development and commercialization of scientifically compelling assets from research universities and medical centers, announced today that an equity analyst coverage report issued by EF Hutton has increased that firms price target by 70%, now targeting $17 per share, up from their initial target of $10 per share. This increase was attributed in part to the publication in Cancer Research of findings suggesting compelling activity of Chi3L1 in animal models of glioblastoma.

The animal models cited in the studies used mice implanted with human glioblastoma to test the efficacy of Ocean Biomedicals anti-Chi3L1 therapeutic candidate, and showed tumor reduction of greater than 60% in 2 different study approaches. The groundbreaking research uncovers in detail how the suppression of Chi3L1 works to keep glioma stem cells from differentiating into the most aggressive forms of glioblastoma. This data provides further evidence of the therapeutic potential of Oceans anti-Chi3L1 for solid tumors.

From the EF Hutton The publication elucidates the mechanism by which Chi3L1 licenses the proliferation of GBM in animal models, and the role by which antibodies against Chi3L1 play in limiting their growth, the EF Hutton report notes, Further, the publication speaks to the effect of OCEA's antibodies on the GBM stem cell niche. Dr. Elias' previous work has demonstrated the multifaceted role that Chi3L1 plays in other solid tumor types such as melanoma and lung cancer.

Dr. Elias work is the foundation of both the oncology and fibrosis programs at Ocean, the report additionally notes, adding that, the key takeaway message from Dr. Tapinos work is that if the reversion of GBM cells to a less mature state (also known as a mesenchymal phenotype) is prevented, one may be able to provide meaningful benefit to patients with this challenging condition, which is uniformly fatal.

From Ocean Biomedical We are honored to see independent institutional research analyst coverage recognizing our core programs in oncology, fibrosis, and infectious diseases that we believe have the potential to save thousands of lives, commented Dr. Chirinjeev Kathuria co-founder and Chairman of OCEA.

We appreciate EF Huttons close attention to our research news and long-term analytics, said Gurinder Kalra, Oceans Chief Financial Officer,

Our team of experienced biopharma executives and top-tier scientists are working to move our research programs forward step by step towards IND filings on each of them as efficiently as possible, said Elizabeth Ng, CEO of Ocean Biomedical.

Oceans core assets in oncology, fibrosis, and infectious diseases, all based on new target discoveries enabling first-in-class drug and vaccine candidates, were developed through past and ongoing grants totaling $123.9 million.

A copy of EF Huttons full analyst report can be obtained directly from EFHutton.

All reports on OCEA prepared by analysts represent the views of such analysts and are not necessarily those of OCEA. OCEA is not responsible for the content, accuracy, or timelines provided by analysts. OCEA does not expressly or by implication warrant or assume any legal liability or responsibility for the accuracy, completeness, or usefulness of any information, assumption, data, forecast, price target, estimate, or projection contained in the reports or industry notes provided by analysts, and the dissemination of such reports or industry notes does not necessarily constitute or imply OCEAs endorsement or recommendation.

About Ocean Biomedical

Ocean Biomedical, Inc. (Ocean Biomedical or the Company) is a Providence, Rhode Island-based biopharma company with an innovative business model that accelerates the development and commercialization of scientifically compelling assets from research universities and medical centers. Ocean Biomedical deploys the funding and expertise to move new therapeutic candidates efficiently from the laboratory to the clinic, to the world. Ocean Biomedical is currently developing five promising discoveries that have the potential to achieve life-changing outcomes in lung cancer, brain cancer, pulmonary fibrosis, and the prevention and treatment of malaria. The Ocean Biomedical team is working on solving some of the worlds toughest problems, for the people who need it most.

To learn more, visit http://www.oceanbiomedical.com .

Forward-Looking Statements

The information included herein and in any oral statements made in connection herewith include forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as estimate, plan, project, forecast, intend, will, expect, anticipate, believe, seek, target or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of financial and performance metrics and expectations. These statements are based on various assumptions, whether or not identified herein, and on the current expectations of the Companys management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions.

Any discoveries announced by the Company are based solely on laboratory and animal studies. Ocean Biomedical has not conducted any studies that show similar efficacy or safety in humans. There can be no assurances that this treatment will prove safe or effective in humans, and any clinical benefits of this treatment is subject to clinical trials and ultimate approval of its use in patients by the FDA. Such approval, if granted, could be years away.

Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of the Company that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include but are not limited to: (i) the outcome of any legal proceedings that may be instituted against the Company; (ii) changes in the markets in which the Company competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; (iii) changes in domestic and global general economic conditions; (iv) the risk that the Company may not be able to execute its growth strategies; (v) risks related to the ongoing COVID-19 pandemic and response, including supply chain disruptions; (vi) the risk that the Company may not be able to develop and maintain effective internal controls; (vii) the risk that the Company may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; (viii) the ability to develop, license or acquire new therapeutics; (ix) the risk that the Company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (x) the risk that the Company experiences difficulties in managing its growth and expanding operations; (xi) the risk of product liability or regulatory lawsuits or proceedings relating to the Companys business; (xii) the risk of cyber security or foreign exchange losses; or (xiii) the risk that the Company is unable to secure or protect its intellectual property.

The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that are described in the Companys Annual Report on Form 10-K for the year ended December 31, 2021 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and which are described in the Risk Factors section of the Companys definitive proxy statement filed by the Company on January 12, 2023, and other documents to be filed by the Company from time to time with the SEC and which are and will be available at http://www.sec.gov . These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements. These forward-looking statements should not be relied upon as representing the Companys assessments as of any date subsequent to the date of this filing. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Ocean Biomedical Investor Relations OCEANIR@westwicke.com

Ocean Biomedical Media Relations OCEANPR@westwicke.com

Kevin Kertscher Communications Director

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LifeSouth Stem Cells Headed to Space – Free Press of Jacksonville – Jacksonville Free Press

JACKSONVILLE, Fla. April 26, 2023 LifeSouth Community Blood Centers, headquartered in Gainesville, Fla., was selected to provide CD-34 cells (stem cells) to Dr. Abba Zubair of Mayo Clinic in Florida for his research study aboard the International Space Station. This is a collaborative research study that includes BioServe Space Technologies, University of Colorado Boulder and ClinImmune, University of Colorado Anschutz Medical Campus, Denver and Mayo Clinic.

Dr. Zubair and others are studying how these stem cells will divide or expand in space versus how the same cells expand on Earth with the ultimate goal that these cells could be used for cancer treatment.

It is an honor for LifeSouth to be selected by Dr. Zubair to provide stem cells for this important research, said LifeSouth President and CEO, Kimberly Kinsell. By partnering with medical researchers like Dr. Zubair, with their incredibly important work, we are helping to advance lifesaving medical research. This aligns with LifeSouths core mission of saving lives.

A Northrup Grumman Cygnus spacecraft is scheduled to launch from Kennedy Space Center in May 2023 and will carry the cryogenically preserved cells provided by LifeSouth to the International Space Station. Crew members on board will thaw the cells and seed them into specialized hardware to allow them to expand.

Products being used for this study are produced by LifeSouth from umbilical cord blood collected by the LifeSouth Cord Blood Bank that are not eligible for transfusion. Mothers can donate their newborns umbilical cord blood for transplant at hospitals partnering with LifeSouth locally at UF Health and Baptist Medical Center South. The cord blood collected is banked and listed on the Be the Match Registry, making it available for patients needing a stem cell transplant. If the cord blood is not viable for transplant, it can be used for medical research aimed at curing cancers, diseases and genetic disorders.

Luis Hernandez, Director of Cellular Therapies for LifeSouth, emphasizes the importance of cord blood donation to help patients and research programs advancing modern medicine. Our hospital partners and the families that donate their umbilical cord to LifeSouths public cord blood bank provide lifesaving opportunities to patients now and those who will benefit from future scientific breakthroughs.

To learn more about LifeSouth Community Blood Centers and the LifeSouth Cord Blood Bank visit lifesouth.org.

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About LifeSouth:

LifeSouth is a non-profit community blood bank serving more than 125 hospitals in Alabama, Florida and Georgia. LifeSouth is committed to meeting the blood supply needs of hospitals and their patients by providing the highest quality blood components and services. The LifeSouth team is dedicated to making sure the blood is there when a patient is in need. To learn more, visit LifeSouth.org.

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Driving the CAR: The Road Ahead for Cell Therapy – Genetic Engineering & Biotechnology News

Programming human cells to perform desired therapeutic functions is the basis for the growing field of cell therapy. One key example is chimeric antigen receptor (CAR) T cell immunotherapy, in which patient-derived T cells are genetically modified to express artificial antigen-targeting receptors to allow redirection to attack tumors. While cell therapies have shown clinical promise, the field has navigated challenges relating to safety, barriers to activity due to tumor heterogeneity, immune cell exhaustion, and the immune-suppressive tumor microenvironment. In addition, the complex manufacturing of CAR-Ts and other cell-based therapies translates to high costs and places constraints on scale and accessibility.

In this interview (conducted by senior editor Fay Lin), we asked Geulah Livshits, Senior Research Analyst at Chardan, to assess the advances and challenges facing the cell therapy field. Livshits discusses how the field has progressed with advances in tumor-immune interactions, cell engineering technologies, as well as improvements in cell manufacturing and the logistics of cell therapy administration in the clinic.

(This interview has been edited for length and clarity.)

How would you describe the current state of CAR-T therapies? What are the challenges?

Livshits: Its been more than five years since the first approval of CAR-Ts targeting CD19 for B-cell leukemia and lymphoma. The field has learned a lot since then, both with respect to science and what it takes to make cell therapies work in the commercial setting. While these initial agents were approved in patients who had progressed in standard of care therapies (third-line or later), weve also seen some CAR-Ts outperform standard-of-care chemotherapy in second-line lymphoma over the past year and gain approval in additional lymphoma subsets. This has allowed these advanced therapies to be used in earlier line settings, as well as in larger numbers of patients.

Beyond CD19, there has been a lot of success with CAR-Ts for multiple myeloma, targeting B-cell maturation antigen (BCMA), where some agents have shown response rates of up to 95% and thus far have impressive durability. This has led to interest in developing engineered cell therapies for solid tumors, which account for close to 90% of cancer deaths in the United States.

CAR-T manufacturing is complex as they are living drugs. It involves cell collection, genetic engineering within appropriate specifications such as viability, and then infusion back into the patient. Approved CAR-Ts are autologous, meaning that theyre manufactured individually for each patient. As a result, you cant scale up by making a bigger batch of cells. You have to scale out by making more batches at once and have the equipment to run those batches as patients need them. Theres a lot of logistics involved in ensuring that cancer patients who are eligible to receive CAR-Ts can actually get them manufactured and delivered in a timeframe during which they can still benefit.

CAR-Ts are also not the only modalities that are being developed for their indications. For example, bispecific antibodies (bsAbs) and to some extent, antibody-drug conjugates are also being developed for similar targets. Those are off-the-shelf biologics. Data on cell therapies are being analyzed in the context of durability of response, safety, and convenience relative to what is also emerging on some of these other agents.

In principle, cell therapies can be engineered to have additional functionalities beyond the currently approved CAR-Ts. Some areas of active innovation include a few overlapping buckets. These strategies include expanding the use of cell therapies to solid tumors, enhancing the safety elements of cell therapy so that they could be used in earlier lines and in community and outpatient treatment settings, and addressing some of those logistical challenges that are associated with current cell therapies. Different groups are focusing on the identification of optimal targets and additional cargos that could be incorporated to drive activity, such as different cell sources and cell types that have distinct activity, safety profiles, and manufacturability.

How are currently approved CAR-Ts developed and administered to patients?

The current approved CAR-Ts, such as Kymriah, Yescarta, Abecma, Carvykti, etc. are patient specific. The process involves harvesting immune cells from the patient by apheresis, genetically modifying them with the vector to get the construct, and then expanding them over several days. While doses vary by product, several of them are above 1 million cells per kilogram. The engineered cells are typically frozen down, shipped to the patients hospital, and infused into the patient. The turnaround time is often around three weeks, sometimes more.

Once the cells are infused, they rapidly expand and reach peak levels within two weeks of infusion and then decline. The long-term persistence and kinetics are often variable between products, patients, and indications, but CAR-Ts can persist at detectable levels for months to years due to the long lifespan of T cells.

To promote the expansion and activity of CAR-Ts, patients typically undergo lymphodepletion conditioning, typically with chemo drugs, such as fludarabine and cyclophosphamide. This transiently depletes a patients own lymphocytes and removes the sinks for cytokines to allow them to be available to support CAR-T expansion. Those expanded CAR-Ts then circulate around the body and kill cells with their respective targets, such as CD19, BCMA, and others. That includes both cancer cells as well as normal B cells.

How effective are these CAR-T therapies?

Responses tend to be pretty high for CD19 cancers and multiple myeloma. Many of these patients achieve a complete response or partial clearance within four weeks. In many cases, 40% of lymphoma patients and high numbers of multiple myeloma patients can remain responsive up to two years post-treatment. However, the durability numbers vary.

While thats encouraging, theres still room for improvement, particularly in the third-line setting. The activity has been quite encouraging in these cancer types but the answer is [to be determined] in other indications as we start to look beyond the lowest hanging fruits. Durability, toxicity, and safety are other relevant metrics that people use to evaluate these therapies.

Speaking of toxicity, are there any toxicities associated with these CAR-T therapies?

Years of clinical experience have shown some clear patterns on that front. CAR-Ts have been associated with certain toxicities including cytokine release syndrome, macrophage activation syndrome, immune effector cell-associated neurotoxicity syndrome (ICANS), as well as infections. The infections are often related to the lymphodepletion component because youre eliminating a persons immune cells, but other components arise from different elements of the CAR-T expansion.

Clinicians who have been administrating these therapies over the past several years have been increasingly adept at navigating the safety issues and treating cytokine release syndrome by using tocilizumab, an IL6 antibody. ICANS has been managed using corticosteroids. The field is seeing increasing assessment of CAR-T administration in outpatient settings. It is also important to keep in mind that all of this is learned from blood cancers. The situation could be different in solid tumors, where cell therapy strategies have also been in the clinic for quite a while.

What is the history behind cell therapy in oncology?

Years before CAR-Ts were [developed], there was work from Steve Rosenbergs group back in the 1980s and 1990s at the National Cancer Institute that showed immune cells could be harnessed to mediate rejection of a tumor. Much of that work focused on tumor infiltrating lymphocytes (TILs). TILs could be isolated from a patients tumor and then grown up in culture to doses of billions of cells and then infused back into that patient. That approach led to durable regressions of late-stage solid tumors. The idea behind TILs is that T cells that are found within a tumor might be likely to be enriched for T cells that are reactive to that tumor. Expanding and reinvigorating those cells outside the body can help them mount a more successful attack against that tumor.

Historically in those studies, TILs werent engineered and there was much less understanding about how that worked. Now we know that T cells, via their T-cell receptors (TCRs), can recognize tumor cells and kill them, particularly when theyre expressing proteins that are derived from mutations. That approach has been quite heavily studied, particularly in cancers that have a high number of mutations like melanoma. Companies that are operating in that space, such as Achilles Therapeutics, Instil Bio, Iovance Biotherapeutics, KSQ Therapeutics, and Lyell Immunopharma, are working on professionalizing elements of isolation of the TILs, their expansion, as well as looking at different strategies to boost their activity, either by reducing exhaustion or increasing cell killing capabilities.

How does research in engineered TCRs compare with CAR-T research?

The major difference between CARs and TCRs is that TCRs can recognize protein targets that have been processed into short fragments and then are presented on the cell surface in the context of the major histocompatibility complex (MHC). Both cell-surface and intracellular proteins are presented this way, meaning TCRs can target a wide range of potential targets. However, these MHC complexes vary from person to person. What that functionally means from a therapeutic development standpoint is that separate TCR products do need to be produced to target distinct alleles of the human leukocyte antigen (HLA) system.

The prevalence of different alleles varies across geographies. For example, in the United States, its estimated that around 40% of the Caucasian population has the most common HLA allele. There are other frequencies for less common variants. A series of products would need to cover additional segments of that population. This is distinct from CAR-Ts, where the CAR comprises an antibody-like domain that then recognizes unprocessed protein targets on the surface of tumor cells. Its not restricted by these HLA allele specificities, but they are limited to targeting proteins on the surface of the cell. They have a narrower potential antigen target pool, but a broader potential patient coverage by not being HLA restricted.

The antibody-like binders of CAR-T constructs are restricted to recognizing cell surface proteins. Are they able to distinguish between tumor and normal cells bearing their target? What are some solutions for off-target effects?

The currently approved CAR-Ts cant distinguish between cancer cells and normal cells. They kill cells that have enough of the target, and that can lead to on-target off-tumor toxicity. In the case of B-cell cancers, that translates to depletion of normal B cells along with the cancer cells. While thats not ideal, its an acceptable trade-off given the activity profile, considering that a patient can get by without B cells, especially with supportive treatment. In other tumor types, this can pose a bigger safety risk. For example, a patient died during an early study of CAR-Ts targeting HER2 days after administration, potentially because the T cells recognized low levels of their target in the lung tissue, which led to high inflammation in the lung.

Companies and academic groups are looking at safety switches or regulatable CARs or logic gates to try to reduce those off-tumor toxicities. Theyre focusing on targets that are highly expressed in cancers and have more limited expression in health tissues. This is also where the TCR T cells come into play. Theres a larger target space of intracellular proteins used to select targets that are overexpressed in cancer or neoantigen peptides that arise from mutated proteins. Targets that are overexpressed in cancer, such as NY-ESO-1, MAGE-A4, and PRAME, are being explored by companies like Adaptimmune, Immatics, and Tscan Therapeutics, while others such as Affini-T Therapeutics are targeting neoantigens.

While the TCR T space has lagged behind CAR-Ts, there are several biotech-driven programs that are now in the clinic. Adaptimmune expects to complete a rolling BLA submission for its MAGE-A4 TCR T program for synovial sarcoma in the middle of this year. A key technological area of focus among programs that are either pre-clinical or early development is screening T-cell receptors to have that optimal binding affinity to their target, but also screening to make sure that they dont cross-react with other proteins in healthy cells. There are also strategies to functionalize different types of T cells, for example, not just CD8 cells but also CD4 cells. There are some programs being advanced in conjunction with histological markers to allow their use in patients who express the target and would be more likely to benefit from the treatment.

What are the challenges posed by the tumor microenvironment on the effectiveness of these therapies? How are these challenges addressed?

The tumor microenvironment is definitely seen as a major barrier for cell therapy, particularly in solid tumors. There are several immune suppressive signals from different cell types that can promote T-cell exhaustion or other elements of T-cell dysfunction. Over the past decade, there have been many academic and industry studies teasing out how these tumor microenvironment mechanisms work and what characteristics are associated with functionality vs dysfunctionality (e.g. using CRISPR screens to functionally identify genes whose disruption can promote T-cell activity).

Other approaches identify additional components, such as cytokines or switch receptors, that can convert negative signals into positive or co-stimulatory signals to further boost activity in these immune suppressive microenvironments. These different approaches are expected to move through clinical trials in the coming years. Companies are also looking at combining T-cell therapies with approved checkpoint inhibitors as another way to boost activity.

How can off-the-shelf strategies simplify the manufacturing workflow of these therapies?

An advantage of off-the-shelf approaches is that the complex manufacturing and engineering does not have to be done individually for each patient. As a result, there is no 3-4 week lag to treatment. Also, in some cases, patients who have gone through multiple rounds of therapy may not have immune cells of sufficient quality or quantity to make a great autologous cell product.

The challenge is that immune systems are good at recognizing and eliminating foreign cells. Donor T-cells may attack a patients body (graft-versus-host disease, GvHD) or the bodys own immune cells can recognize donor cells as foreign and attack those. GvHD can be avoided by eliminating the endogenous TCR and T cells using tools such as gene editing, or by using other cell types that dont have this GvHD property. The issue with GvHD seems to be solvable with current technologies, but the immune invasion part is a bit more complicated. There are several strategies that are in development and the optimal approach remains to be seen at present. Companies such as Allogene Therapeutics, Beam Therapeutics, Caribou Biosciences, CRISPR Therapeutics, Precision BioSciences, and Sana Biotechnologies, are using different strategies to evade rejection from the patients T or NK cells.

There are several companies using NK cells, a cell type expected to have a shorter persistence. NK cells can be given at doses of over 1 billion cells in multiple administrations and potentially multiple cycles. One of the other attractive features of NK cells is that there seems to be a lower propensity towards cytokine release syndrome. That, in addition to engineering them with a CAR, can work in conjunction with some therapeutic antibodies to kill by multiple methods.

Different sources of NK cells are being explored by companies in the space. What is the impact of the starting material on the manufacturing process, costs, and attributes of the final product?

For NK cells, there have been a few different cell-sourcing strategies. Some groups, such as Nkarta, are developing donor-derived NK cells that are taken from other people and expanded. Others such as Fate Therapeutics, Century Therapeutics, and Shoreline Biosciences, are advancing NK cells that are derived from induced pluripotent stem cells (iPSCs). Companies like Takeda are advancing NK cells that are isolated from cord blood, which might have distinct properties. Donor-derived processes might yield expansion of NK cells several thousand-fold over a 2-3 week period and generate hundreds to thousands of doses per round. As this isnt bespoke, companies are able to scale up for commercial use. What that translates to in terms of cost per dose will depend on the dose paradigms that might end up being effective. Its still early days for the space, and the optimal dose regimens that would be used in commercial settings are not yet defined.

The difference with iPSC-derived therapies is that they can be expanded theoretically indefinitely and thus could be used to generate a clonally derived cell bank. This means that you can do all of the genetic engineering and have those associated costs upfront, freeze down a working cell bank, run a manufacturing batch, take cells from the bank and adjust culture conditions to differentiate them into NK cells. As its off-the-shelf, a batch can be hundreds or thousands of doses, depending again on manufacturing scale and dose levels and the exact process. Each of these approaches has its advantages and open questions.

What are the prospects for CRISPR, base and prime editing in the CAR-T field?

Various gene editing approaches are being used in cell therapy, particularly in the immune evasion setting. Were also starting to see use in autologous settings. For example, disruption of PD-1 in TILs from Iovance is an example of gene editing being used in cell-based therapies. There is interest in other approaches, such as base and prime editing that dont cause double-strand DNA breaks. Those approaches can make it easier to edit multiple genes at once while avoiding translocations. While current approved CAR-Ts use viral vectors to deliver the CAR construct, there is interest in using other approaches to insert the CAR or TCR construct, or other elements using non-viral approaches to target them in a particular location.

Geulah Livshits, PhD, ([emailprotected]) is a senior research analyst with Chardan in New York City, covering biotech companies.

GEN Biotechnology, published byMary Ann Liebert, Inc., is the new, marquee peer-reviewed journal publishing outstanding original research and perspectives across all facets of the biotech industry. Thisarticlewas originally published in the February 2023 issue of GEN Biotechnology,Volume 2, Issue 1.

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Driving the CAR: The Road Ahead for Cell Therapy - Genetic Engineering & Biotechnology News

R3 Anti-Aging Medicine Launches New Beverly Hills Clinic – EIN News

R3s new Beverly Hills location will provide med spa treatments and stem cell therapies to improve health and wellness, and combat negative effects of aging.

R3 President Kathleen Frankie Francesca will serve as one of the co-owners of this location. While this new location will provide the same procedures as R3s other clinics, it will additionally be adding more exclusive social events: Frankie is eager to host monthly celebrity wellness events to promote anti-aging and overall wellness. The company will also collaborate with celebrity brand ambassadors, such as actor and cold press company owner Andrew Walker, to host these events. Some of R3s other brand ambassadors include All My Children actors Cameron Mathison and Colin Egglesfield; Hallmarks Crystal Lowe; and Days of Our Lives and 90210 actor Trevor Donovan.

Named one of the Top Ten Biotech Startups of 2021, R3 is pioneering the anti-aging industry with its innovative work in stem cell operations research. R3s Scottsdale location provides traveling and in-house training opportunities and ultrasound courses for doctors to get hands-on experience with regenerative aesthetics procedures. The company then uses these IRB-approved protocols in each of its locations.

Roxanne GuzmanNow PR+1 424-245-4004email us here

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R3 Anti-Aging Medicine Launches New Beverly Hills Clinic - EIN News

Young scientist, longevity expert from Poland, at the AMWC 2023 … – The First News

VIMED

Hope for patients with chronic diseases, abdominal obesity and persistent overweight! Innovative anti-aging therapies improving quality of life.

The prestigious 21st World Congress on Aesthetic and Anti-Aging Medicine, held in Monaco from March 30 to April 1, 2023, is a unique annual event attended by more than 12,000 specialists from around the world.

Innovation in anti-aging medicine, treatment of overweight and inflammation

Under the aegis of the Aesthetic Multispecialty Society (AMS), the congress annually promotes aesthetic and anti-aging medicine programs, continuous education, new ideas and the exchange of experiences of the scientific community and anti-aging medicine practitioners.

Congress organizers invite scientists and promising practitioners from around the world. Each presentation is created on the basis of 4 principles: Experience, Excellence, Evidence, Engagement and is structured to allow participants to actively participate and debate.

Pole among 6 most promising aesthetic and anti-aging specialists in the world

Julia Trawinska, Specialist in Functional Medicine and Phenotypic Therapy has been recognized as one of the world's most promising and innovative young professionals in the field of aesthetic and anti-aging medicine.VIMED

Hundreds of contenders from all over the world have applied to be Young Innovators. Only 6 people were selected to present their research results in the Aesthetic Disruptors Young-Career Innovators From Around The World session. Among them, Julia Trawinska from VIMED Medical Center was the only Pole.

Julia Trawinska, Specialist in Functional Medicine and Phenotypic Therapy has been recognized as one of the world's most promising and innovative young professionals in the field of aesthetic and anti-aging medicine.

The Congress Board selected individuals whose research met the criteria of Significance, Coherence, Effectiveness, Originality, and Impact on the development of science and evidence based.

Effective treatment of overweight in people over 40 is possible

Julia Trawinska presented the results of a study involving 62 patients who underwent innovative therapy for the treatment of persistent overweight at the clinic in Warsaw. The topic of the presentation was: Innovative personalized therapy for the treatment of inflammation, persistent overweight and abdominal obesity in people over 40 years of age.

The proprietary method, developed by Julia Trawinska in collaboration with Italian scientists from Unicusano University in Rome, shows proven results. Eliminating inflammation and thus effectiveness in restoring optimal cellular metabolism in patients over 40 that leads to significant weight loss and rejuvenation of the body.

Julia Trawinska is the CEO of the medical facility that has been one of the first in the world to use non-invasive, personalized lifestyle medicine therapies to treat chronic diseases since 2006.

In 2012, the clinic was one of the first in Europe to install monoplace hyperbaric chambers. They are an indispensable part of multifactorial therapies supporting the body's regeneration processes and treating diseases of civilization.

Innovative methodology leads to optimization of metabolic processes and regeneration of all organs.

With comprehensive therapeutic intervention at the level of the epigenome, the body's natural aging processes are slowed down. As a result of optimization of glycation processes, increased production of telomerase enzyme and mobilization of stem cells (Stem Cell).

Modern therapies developed at the Polish clinic among the finalists of the AMWC Awards 2023 in Monaco

TheAMWC AwardsBest Clinical Cases competition, held during the congress, showcases the greatest achievements of specialists from around the world in 12 categories. The goal is to identify the best, most innovative, safe and effective procedures to improve the condition, appearance, quality of life and revitalize the body.

This year, as many as two therapies from Poland were selected for the finals of the AMWC Awards 2023, out of 12 categories. Both therapies were submitted by Julia Trawinska and were based on the patients treated at her clinic.

Innovative treatment method for overweight and abdominal obesity

Effective weight loss - in category 04 Best non-surgical body contouring - therapy for the treatment of persistent overweight and abdominal obesity. The patient lost more than 50 kg of body fat in a year, without losing muscle tissue, without any surgical intervention, without drugs, without removing excess skin, and without intensive exercise. The patient reported feeling 10 years younger with improved physical and mental health, and was able to take on new professional challenges with ease.

Comprehensive rejuvenation combined with treatment of chronic diseases

Comprehensive rejuvenation - in category 12 Best results of integrative medicine, improving quality of life - therapy, thanks to which the patient, suffering from inflammatory diseases of the digestive tract for years, rejuvenated and regained the ability to function normally in society. In a matter of months, she got rid of years of severe disorders caused by malabsorption, SIBO, chronic inflammation of the small intestine and colon, and anemia. Thanks to the therapy, the patients life was completely transformed - she began to enjoy it again.

Polish specialists set world standards in anti-aging medicine and chronic disease treatment

The inclusion of these therapies among the finalists of the competition, selected from over 1 000 submissions from around the world, is a tremendous honor. The therapy, submitted in the Best Non-Surgical Body Contouring category, has been recognized as one of the top three nominees for the main award. It has been recognized for its comprehensive, non-invasive, effective and completely safe approach.

Participation in such a prestigious congress and recognition in the competition is an extremely important achievement for Trawinska, and the functional medicine clinic from Poland. This young, extremely talented specialist, a pioneer in personalized treatment and clinical nutrition, contributes to promoting the achievements of Polish lifestyle medicine worldwide.

VIMED

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Young scientist, longevity expert from Poland, at the AMWC 2023 ... - The First News

Desert Hot Springs man comes forward as fifth person in remission … – Desert Sun

'I still have to remind myself that it's real'

Video: Paul Edmonds is fifth person in HIV remission

Paul Edmonds, a current Desert Hot Springs resident, is the fifth person living with HIV worldwide to go into full remission following a stem cell transplant.

Taya Gray, Palm Springs Desert Sun

For the past two years, Paul Edmonds has been part of an extremely exclusive club with a membership that has reached five people.

After navigating HIV for more than 30 years, along with a leukemia diagnosis that came in 2018, a life-saving stem cell transplant became available thanks to a donor who had a rare genetic mutation that makes the body resistant to most strains of HIV. In 2021, Edmonds stopped taking his HIV medication, what he was dependent on for almost half his life. Today the 67-year-old who lives in Desert Hot Springs is the fifth person in the world in remission of HIV.

Edmonds joins four others who have received similar news, including the late Palm Springs residentTimothy Ray Brown (who was known as the "Berlin Patient"), the first person cured of the virus, who died from a reoccurrence of cancerin 2020. Others who are in remission of HIV are "London Patient" Adam Castillejo, "Dsseldorf Patient" Marc Franke and the "New York Patient," the first woman to be considered cured who has not come forth publicly. Edmonds is the eldest among the group and had HIV the longest.

"I can remember the day and hearing about Timothy Ray Brown, that was huge," Edmonds told The Desert Sun in a recent interview. "That was the first time that I ever thought there could be a cure."

After two years of being anonymously known as the "City of Hope Patient," he decided to publicly come forward with his story. By sharing his journey, he wants to advocate for and offer hope to those living and aging with HIV that a cure could be possible one day.

Related: 'People with HIV are my family': London patient revealed as cured joins Palm Springs man, who was the first

Related: 'London Patient' Adam Castillejo, second person cured of HIV

Edmonds grew up in a small town in Georgia about 100 miles northeast of Atlanta. During his high school years, he struggled with his sexual identity and didn't have a support system because he kept it all to himself. His "lifesaver" at the time was his involvement in his school's band, which consisted of a close-knit group of people, some of whom he's still in contact with today.

By the end of his senior year, Edmonds felt he couldn't handle the pressure anymore. He decided to live with his cousins in Pensacola, Florida, where he would finish high school and begin college, until he moved back to Atlanta. He received therapy, found support and was able to "accept who I was and come out" as a gay man.

With a different outlook on life, Edmonds, 21 at the time, made the decision to move to San Francisco in 1976.

"Gay men were kind of flocking there from all over at that time," he said of the California city. "It was just an unbelievable experience. I'd never seen anything like it, and I no longer felt alone. It was just exciting and thrilling."

Everything was "just great" until the 1980s rolled around, and many of his peers started getting sick. "No one knew what was going on," Edmonds said about that time, although many would refer to it as a "gay cancer."

Human immunodeficiency virus, more commonly referred to as HIV, is a virus that attacks cells that help the body fight infections. If left untreated, it can lead to AIDS, or acquired immunodeficiency syndrome. On June 5, 1981, the Centers for Disease Control and Prevention reported on the first five cases of what would be known as AIDS.

Rare lung infections and anaggressive cancer calledKaposis sarcoma first began to show among men who have sex with men (MSM) in 1981, and by the end of the year, there were 270 reportedcases of severe immune deficiencyamong MSM. The following year,more cases appeared among MSM in Southern California, which suggested the illness wassexual,leading to the name "gay-related immune deficiency." Cases also surfaced among those who inject drugs, hemophiliacs and Haitians.

Today, it is widely understood that the virus can be spread to all people, though some are still at higher risk of infection. Approximately84.2 million people around the world have been infected by HIV since the start of the epidemicand40.1 million people have died from AIDS-related illnesses.

Related: For decades, queer men have had trouble donating blood. Change could be on the horizon

Related: Reflections on 40 years of HIV/AIDS: Community members compare epidemic to COVID-19 pandemic

By the mid-1980s, the first HIV blood test was developed, but Edmonds was not ready to get results himself.

"Anyone who I knew who was testing positive was dead within two years," he said. "I just wasn't ready to go there."

He moved to Los Angeles for a few years to change his environment, but moved back to San Francisco in 1988. That same year, his father died, which served as the catalyst for Edmonds getting tested. The result came back positive, and because his helper T cell count was below 200 then, he was diagnosed with AIDS. He was 33.

"It just felt like my heart sank," Edmonds recalled, though he noted he did not feel sick. "The intern who was my doctor in this clinic, I can see her emotions. I think it was a hard thing for her to do."

He began using AZT, the first drug to gain approval from the U.S. Food and Drug Administration for treating AIDS. The drug helped decrease deaths and infections among those who were diagnosed with the virus, although it had serious side effects, such as intestinal problems, nausea, vomiting and headaches. Around the time Edmonds began taking the drug, doctors decided to cut the dosage in half, which lessened those effects. As new drugs became available, he would switch to them, and he "pretty much felt sick all the time."

"But I did what I had to do," he added. "I am not a person who just easily gives up. I don't look to the worst-case scenario, I don't allow myself to."

Though things looked dark in the HIV/AIDS fight back then, Edmonds focused on living in the moment and taking his diagnosis one step at a time. As medical advancement came, like protease inhibitors, medications that help slow the progression of HIV, he would allow himself to think about the future and felt hopeful that things would be brighter.

Sure enough, the birthdays kept coming. He always dreamed of having a big party for his 50th birthday, and he got to enjoy that moment surrounded by 100 guests in a lodge on the Russian River.

Edmonds also said he had an "incredible" support system in his life. The LGBTQ community "stepped forward" and helped when no one else would. Then in February 1992, during happy hour at the San Francisco bar Midnight Sun, he met Arnie House, who had served in the Air Force.

"It really was kind of like love at first sight. I don't know that we knew that right then, but that's what it was," Edmonds said of his husband. "Once we met, we've had very few days apart."

Edmonds encouraged House to get tested for HIV, who also received a positive diagnosis. But that didn't change anything between them, as they've "always been there for each other," Edmonds said.

In August 2018, Edmonds was diagnosed with myelodysplastic syndrome, which eventually developed into acute myeloid leukemia, a cancerthat starts in the bone marrow but often moves into the blood. Those living and aging with HIV are at higher risk of developing leukemia and other blood cancers due to suppressed immune systems.

It was recommended that Edmonds start chemotherapy as soon as possible, and later undergo a stem cell transplant. At the same time, Edmonds and House were planning on moving to the Palm Springs area, and he was referred to seek treatment at City of Hope in Duarte, one of the highest-volume transplant centers in the nation.

Not only would doctors look for a donor to address his leukemia, but also one who carried a rare mutation, homozygous CCR5 delta 32 mutation, which makes people resistant to most strains of HIV infection. Only roughly 1% of people carry this mutation. The four other people who have been declared in remission of HIV have received transplants that have targeted their HIV and a type of cancer.

It took almost a month before a donor was found via the Be The Match donor registry. Before he could undergo the transplant, his acute myeloid leukemia had to go into remission. He went through three rounds of chemotherapy, and he developed a fungal infection in his lungs during one. He also had to change the antiretroviral drugs he was taking in order to minimize drug interactions with the chemotherapy.

Finally in mid-January 2019, his leukemia went into full remission thanks to a reduced intensity chemotherapy that was developed for older patients. Afterward, he received a week of chemotherapy to wipe out his immune system and prepare his body to receive his donor's healthy stem cells, which he said was the "hardest of all of them."

But despite all the pain and side effects, "I didn't have to think at all whether I wanted to move forward to get a bone marrow transplant," Edmonds said. "I didn't even see it as an option ... it was that or death."

On Feb. 6, 2019, the transplant lasted about 30 to 40 minutes via an IV transfusion. Edmonds said he didn't have any side effects and almost immediately "felt great." Nurses even gave him a medal and started singing "Happy Birthday" to celebrate the moment.

"New life came into me," he said, noting that his blood type changed to his donor's, which is common in transplants. Some recipients might also notice other changes regarding allergies or their hair texture. "I was kind of hoping I would start getting some new hair, but that didn't happen. That's OK," he joked. Among lingering side effects that Edmonds deals with are dry eyes and mouth sores.

Edmonds had to stay close to the hospital after his treatment, and many friends from across the country stayed with him and made sure he was never alone. "I just had the best time," he recalled of all the trips they took, like playing tourist in his once-home of Los Angeles.

Doctors carefully monitored Edmonds following his transplant for both his cancer and HIV status.

Dr. Jana Dickter, associate clinical professor with City of Hopes Division of Infectious Diseases, did a number of tests to see if there was any evidence of HIV found in his body. When she and her colleagues could not find any, she opened up a "second trial" and asked Edmonds to stop taking his HIV medications.

"I monitored him for any occurrence of HIV virus and this entailed getting blood tests on him every week initially and then converted to every two weeks just because we wanted to catch if there was any recurrence in the system and start him back on his medications," Dickter said. "The longer the time went, there was no evidence of circulating HIV."

Additional testing was done in labs, such as challenging his cells with HIV, but they could not be infected with the virus, and there was no evidence of an HIV reservoir found in his body.

Edmonds officially stopped taking his HIV medication in March 2021.

"I still have to remind myself that it's real," he said of his in-remission HIV status. "But I'm feeling it."

There's still a little bit of worry in the back of his mind about whether his cancer or HIV will return, but he said he's gotten to the point where "it's OK for me to let myself believe it, and I absolutely believe it." He also said the people he's told locally have been "just thrilled for me and very, very supportive."

For Dickter, witnessing the journey firsthand has been "incredibly exciting." When she entered medical school in the 1990s, she got to see the excitement when antiretroviral therapy became available and it provided patients who were so close to death with a "second life." Fast forward to today, she was one of those in the room to tell a patient they were in remission of HIV.

"I've always wanted to be able to tell a patient that there was no evidence of remaining virus in their system, and at City of Hope we were able to do just this," Dickter said. "The experiences that he encountered, especially early on and the stigma and the fear, he's a true survivor of the epidemic, and it's so wonderful to see this happy ending for him and his family."

The success of Edmonds' treatment and his unique circumstances also give Dickter hope that it could be reciprocated in others. He was unique in the sense that, compared to the four other people who underwent transplants, he was the oldest patient, had been living with HIV the longest and had received reduced intensity chemotherapy. "This case gives me hope that there might be other opportunities in the future for older people who have HIV and blood cancers that we may be able to put them in remission for both," she said.

There's also plenty of research taking place at City of Hope in hopes of potentially finding a cure for HIV. Not only are there discussions about providing transplants for other patients with HIV and blood malignancies, but Dickter said there's an upcoming clinical trial that will look at chimeric antigen receptor T cells to treat HIV. She explained there has been preclinical research that has shown these "T cells can target and kill HIV-infected cells and potentially control HIV, and this has the potential to provide HIV patients with lifelong viral suppression without antiretroviral therapy."

Edmonds also hopes to be an advocate for HIV cure research and provide support wherever he can. He currently sits on the Community Advisory Board for RID-HIV (Reversing Immune Dysfunction for HIV-1 Eradication) Collaboratory, one of 10 Martin Delaney Collaboratories for HIV Cure Research funded by the National Institutes of Health, which he is "very honored" to be a part of. He is also in contact with his peers Castillejo, who has spoken at a number of conferences, and Franke, just beginning his public journey, and hopes to do work with them.

For now, Edmonds gets to live his life on his own terms, although he still visits City of Hope for routine care and tests. He and House are avid painters and have their art showcased throughout their home Edmonds paints more abstract pieces while House does more figurative work. Edmonds wants to create collages that tell his story in some way, but they also have a bit of work to do around their Desert Hot Springs home, where they've lived for almost two years. As they emerge out of mostly sheltering-in-place during the height of the COVID-19 pandemic, there are also plans to visit San Francisco this summer.

Aside from encouraging the HIV-positive community, there's also a part of Edmonds that hopes the intern who informed him of his AIDS diagnosis in 1988 stumbles upon his story and sees where life has taken him. Where he stands today is a moment so many have hoped for, and one that seemed unthinkable decades ago.

"It truly is a miraculous story," he said with a smile.

Ema Sasic covers entertainment and health in the Coachella Valley. Reach her at ema.sasic@desertsun.com or on Twitter @ema_sasic.

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Desert Hot Springs man comes forward as fifth person in remission ... - Desert Sun

Effectiveness of Monovalent mRNA COVID-19 Vaccination in … – CDC

Jennifer DeCuir, MD, PhD1,*; Diya Surie, MD1,*; Yuwei Zhu, MD2; Manjusha Gaglani, MBBS3,4,5; Adit A. Ginde, MD6; David J. Douin, MD6; H. Keipp Talbot, MD2; Jonathan D. Casey, MD2; Nicholas M. Mohr, MD7; Tresa McNeal, MD3,4; Shekhar Ghamande, MD3,4; Kevin W. Gibbs, MD8; D. Clark Files, MD8; David N. Hager, MD, PhD9; Minh Phan, MS9; Matthew E. Prekker, MD10; Michelle N. Gong, MD11; Amira Mohamed, MD11; Nicholas J. Johnson, MD12; Jay S. Steingrub, MD13; Ithan D. Peltan, MD14; Samuel M. Brown, MD14; Emily T. Martin, PhD15; Arnold S. Monto, MD15; Akram Khan, MD16; William S. Bender, MD17; Abhijit Duggal, MD18; Jennifer G. Wilson, MD19; Nida Qadir, MD20; Steven Y. Chang, MD, PhD20; Christopher Mallow, MD21; Jennie H. Kwon, DO22; Matthew C. Exline, MD23; Adam S. Lauring, MD, PhD24; Nathan I. Shapiro, MD25; Cristie Columbus, MD4,5; Robert Gottlieb, MD, PhD4,5; Ivana A. Vaughn, PhD26; Mayur Ramesh, MD26; Lois E. Lamerato, MD26; Basmah Safdar, MD27; Natasha Halasa, MD2; James D. Chappell, MD, PhD2; Carlos G. Grijalva, MD2; Adrienne Baughman2; Kelsey N. Womack, PhD2; Jillian P. Rhoads, PhD2; Kimberly W. Hart, MA2; Sydney A. Swan, MPH2; Nathaniel Lewis, PhD1; Meredith L. McMorrow, MD1,; Wesley H. Self, MD2,; IVY Network (View author affiliations)

What is already known about this topic?

Waning of monovalent mRNA COVID-19 vaccine effectiveness against COVID-19associated hospitalization among adults is recognized; however, little is known about the durability of protection provided by these vaccines against COVID-19associated invasive mechanical ventilation (IMV) and in-hospital death during the Omicron variant period.

What is added by this report?

Monovalent mRNA vaccination was 76% effective in preventing COVID-19associated IMV and death <6 months after the last dose and remained 56% effective at 12 years.

What are the implications for public health practice?

Monovalent mRNA COVID-19 vaccines provided substantial, durable protection against COVID-19associated IMV and death. All adults should remain up to date with recommended COVID-19 vaccination to prevent critical outcomes of COVID-19.

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As of April 2023, the COVID-19 pandemic has resulted in 1.1 million deaths in the United States, with approximately 75% of deaths occurring among adults aged 65 years (1). Data on the durability of protection provided by monovalent mRNA COVID-19 vaccination against critical outcomes of COVID-19 are limited beyond the Omicron BA.1 lineage period (December 26, 2021March 26, 2022). In this case-control analysis, the effectiveness of 24 monovalent mRNA COVID-19 vaccine doses was evaluated against COVID-19associated invasive mechanical ventilation (IMV) and in-hospital death among immunocompetent adults aged 18 years during February 1, 2022January 31, 2023. Vaccine effectiveness (VE) against IMV and in-hospital death was 62% among adults aged 18 years and 69% among those aged 65 years. When stratified by time since last dose, VE was 76% at 7179 days, 54% at 180364 days, and 56% at 365 days. Monovalent mRNA COVID-19 vaccination provided substantial, durable protection against IMV and in-hospital death among adults during the Omicron variant period. All adults should remain up to date with recommended COVID-19 vaccination to prevent critical COVID-19associated outcomes.

Monovalent mRNA COVID-19 vaccination has been shown to prevent hospitalization and critical outcomes, including IMV and death, during SARS-CoV-2 Alpha, Delta, and early Omicron variant periods (2,3). However, rapid waning of COVID-19 VE against infection, outpatient illness, and hospitalization has been observed during Omicron variant predominance (4). Understanding the durability of protection provided by monovalent mRNA vaccination against critical outcomes is vital. Although a bivalent mRNA dose was recommended on September 1, 2022, for all persons who had completed a primary COVID-19 vaccination series, bivalent vaccination coverage among adults aged 18 years is 20%, and most adults have only received monovalent mRNA vaccines (1,5). In addition, COVID-19 VE against hospitalization might be artificially reduced by routine testing for SARS-CoV-2 at admission, which can detect SARS-CoV-2 infection in patients admitted for reasons other than COVID-19 (4,6,7). VE against critical outcomes might be less susceptible to this bias and is therefore needed to help guide COVID-19 vaccination policy regarding revaccination intervals.

Data from the Investigating Respiratory Viruses in the Acutely Ill (IVY) Network were used to conduct a case-control analysis measuring the effectiveness of monovalent mRNA COVID-19 vaccination against COVID-19associated IMV and in-hospital death. During February 1, 2022January 31, 2023, adults aged 18 years admitted to 24 hospitals in 19 U.S. states who met a COVID-19like illness case definition and received SARS-CoV-2 testing were enrolled. IVY Network methods have been described previously (2,3). Briefly, case-patients were defined as those who received a positive SARS-CoV-2 reverse transcriptionpolymerase chain reaction (RT-PCR) or antigen test result within 10 days of illness onset and within 3 days of hospital admission, and either received IMV or died in the hospital within 28 days of admission. Control patients were defined as those who received negative SARS-CoV-2 and influenza test results by RT-PCR within 10 days of illness onset and within 3 days of hospital admission. Patients who received positive influenza test results were excluded from the analysis because of potential correlation between COVID-19 and influenza vaccination behaviors (8).

Demographic and clinical data, including receipt of IMV and in-hospital death within 28 days of admission, were collected through electronic medical record (EMR) review and patient or proxy interview. COVID-19 vaccination history was ascertained from state or jurisdictional registries, EMRs, vaccination cards, and self-report. Patients were included in the analysis if they 1) received zero COVID-19 vaccines doses (unvaccinated) or 2) received 2, 3, or 4 monovalent mRNA COVID-19 vaccine doses (monovalent-vaccinated), with the last dose received 14 days before illness onset for a primary series dose or 7 days before illness onset for a booster dose. Patients were excluded from the analysis if they were immunocompromised,** received a non-mRNA COVID-19 vaccine dose, received only 1 monovalent mRNA COVID-19 vaccine dose, received a bivalent mRNA COVID-19 vaccine dose, or for other reasons that made the patient ineligible.

VE against IMV and in-hospital death was calculated using logistic regression, in which the odds of monovalent mRNA vaccination (versus being unvaccinated) were compared between COVID-19 case-patients and control patients. Logistic regression models were adjusted for U.S. Department of Health and Human Services region, calendar time in biweekly intervals, age, sex, and self-reported race and Hispanic ethnicity. VE was calculated as (1 adjusted odds ratio) x 100%. Results were stratified by age group, time since receipt of last monovalent mRNA vaccine dose, and number of monovalent mRNA vaccine doses received. Differences between VE point estimates with nonoverlapping 95% CIs were considered statistically significant. Analyses were conducted using SAS (version 9.4; SAS Institute). This activity was determined to be public health surveillance by each participating site and CDC and was conducted in a manner consistent with all applicable federal laws and CDC policy.

During February 1, 2022January 31, 2023, a total of 6,354 immunocompetent control patients and COVID-19 case-patients with IMV or in-hospital death were enrolled in the IVY Network. After exclusion of 1,933 patients,*** 4,421 (70%) were included in the analysis (362 case-patients and 4,059 control patients). Patients were most commonly excluded because of receipt of a bivalent mRNA COVID-19 vaccine dose (446 [23% of excluded patients]), receipt of a non-mRNA COVID-19 vaccine (392 [20%]), or receipt of only 1 monovalent mRNA COVID-19 vaccine dose (260 [13%]). Among included patients, the median age was 64 years (IQR=5375 years) (Table 1). Ninety-one percent of patients had one or more chronic condition, and 20% had a previous self-reported or documented SARS-CoV-2 infection. Among 362 case-patients with IMV or in-hospital death, 146 (40%) were unvaccinated, 216 (60%) were monovalent-vaccinated, 293 (81%) received IMV, and 156 (43%) died in the hospital within 28 days of admission. Among 4,059 control patients, 979 (24%) were unvaccinated, and 3,080 (76%) were monovalent-vaccinated.

Among monovalent-vaccinated patients, the median interval from receipt of last dose to illness onset was 248 days (IQR=138378 days) (Table 2). When compared with unvaccinated patients, the VE of 24 monovalent mRNA vaccine doses against IMV and in-hospital death was 62%. VE was 57% among patients aged 1864 years and 69% among patients aged 65 years. When stratified by interval since receipt of last monovalent dose, VE against IMV and in-hospital death was 76% at 7179 days, 54% at 180364 days, and 56% at 365 days. Within each interval since receipt of last monovalent dose, VE estimates did not differ significantly by number of doses received. VE point estimates were higher 7179 days since last dose compared with 180 days since last dose, although 95% CIs overlapped.

Among immunocompetent adults aged 18 years admitted to 24 hospitals in the IVY Network in 19 U.S. states, receipt of 24 monovalent mRNA COVID-19 vaccine doses provided substantial protection against COVID-19associated IMV and in-hospital death during the Omicron variant period. Protection was highest during the first 6 months after the last monovalent dose, with persistent residual protection remaining after 6 months and sustained at 12 years. Monovalent mRNA vaccination also provided substantial protection against COVID-19associated IMV and death among adults aged 65 years, the age group that remains at highest risk of severe COVID-19 (1). These findings underscore the importance of staying up to date with COVID-19 vaccination to prevent critical outcomes of COVID-19, including optional, additional bivalent mRNA booster doses for persons at highest risk of severe disease.

A previous analysis from the IVY Network showed high effectiveness of monovalent mRNA COVID-19 vaccination against COVID-19associated IMV and death during the Delta and early Omicron variant periods (2). The current analysis expands on these findings by reporting monovalent mRNA COVID-19 VE against IMV and in-hospital death for a full year during the Omicron variant period. These results suggest some waning of protection against IMV and death after 6 months from receipt of the last dose but demonstrate clinically meaningful levels of protection for 1 year (median=455 days). In stratified analyses, VE appeared to correlate more closely with time since last dose than with total number of doses received. These findings are consistent with evidence from the United Kingdom showing that among adults aged 65 years, VE of monovalent COVID-19 vaccination against COVID-19associated mortality during the Omicron variant period was 49.7% for 2 doses and 56.9% for 3 doses after 40 weeks (280 days) from vaccination (9). Together, these results suggest maximal benefit of COVID-19 vaccination during the first 6 months after receipt, which should be considered along with trends in COVID-19 incidence and risk factors for severe disease when planning COVID-19 revaccination schedules.

The findings in this report are subject to at least four limitations. First, the sample size was insufficient to generate VE estimates for each Omicron lineage period separately or to calculate some VE estimates stratified by both time since last monovalent mRNA dose and number of doses received. Second, although case-patients had evidence of acute respiratory illness and received a positive SARS-CoV-2 test result, inclusion of case-patients who died or required IMV for reasons other than COVID-19 could have reduced VE because of misclassification. Third, previous SARS-CoV-2 infection was infrequently reported or documented among patients in this analysis, which prevented evaluation of the impact of previous infection on VE against critical outcomes. Finally, although VE estimates were adjusted for patient-level demographic characteristics, calendar time, and geographic region, residual confounding, including from COVID-19 antiviral treatment, cannot be excluded.

Since the start of the COVID-19 pandemic, approximately 1.1 million COVID-19associated deaths have occurred in the United States, with the majority occurring among patients aged 65 years. Monovalent mRNA COVID-19 vaccination provided substantial, durable protection against COVID-19associated IMV and death during the Omicron variant period, including among older adults. Protection against these critical outcomes appeared to correlate more closely with time since last dose than with total number of doses received. On April 18, 2023, bivalent mRNA vaccines became the only mRNA COVID-19 vaccines authorized for use in the United States. Only 42% of adults aged 65 years have received a bivalent mRNA COVID-19 vaccine dose and are up to date with COVID-19 vaccination (1). CDC recommends that all adults remain up to date with COVID-19 vaccination, including the updated bivalent vaccine, to prevent critical outcomes of COVID-19.

1National Center for Immunization and Respiratory Diseases, CDC; 2Vanderbilt University Medical Center, Nashville, Tennessee; 3Baylor Scott & White Health, Temple, Texas; 4Texas A&M University College of Medicine, Temple, Texas; 5Baylor Scott & White Health, Dallas, Texas; 6University of Colorado School of Medicine, Aurora, Colorado; 7University of Iowa, Iowa City, Iowa; 8Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina; 9Johns Hopkins Hospital, Baltimore, Maryland; 10Hennepin County Medical Center, Minneapolis, Minnesota; 11Montefiore Healthcare Center, Albert Einstein College of Medicine, New York, New York; 12University of Washington School of Medicine, Seattle, Washington; 13Baystate Medical Center, Springfield, Massachusetts; 14Intermountain Medical Center and University of Utah, Salt Lake City, Utah; 15University of Michigan School of Public Health, Ann Arbor, Michigan; 16Oregon Health & Science University Hospital, Portland, Oregon; 17Emory University School of Medicine, Atlanta, Georgia; 18Cleveland Clinic, Cleveland, Ohio; 19Stanford University School of Medicine, Stanford, California; 20Ronald Reagan UCLA Medical Center, Los Angeles, California; 21University of Miami, Miami, Florida; 22Washington University, St. Louis, Missouri; 23The Ohio State University Wexner Medical Center, Columbus, Ohio; 24University of Michigan School of Medicine, Ann Arbor, Michigan; 25Beth Israel Deaconess Medical Center, Boston, Massachusetts; 26Henry Ford Health, Detroit, Michigan; 27Yale University School of Medicine, New Haven, Connecticut.

Abbreviations: HHS=U.S. Department of Health and Human Services; IMV=invasive mechanical ventilation.* Hospitals by HHS region included Region 1: Baystate Medical Center (Springfield, Massachusetts), Beth Israel Deaconess Medical Center (Boston, Massachusetts), and Yale University (New Haven, Connecticut); Region 2: Montefiore Medical Center (New York, New York); Region 3: Johns Hopkins Hospital (Baltimore, Maryland); Region 4: Emory University Medical Center (Atlanta, Georgia), University of Miami Medical Center (Miami, Florida), Vanderbilt University Medical Center (Nashville, Tennessee), and Wake Forest University Baptist Medical Center (Winston-Salem, North Carolina); Region 5: Cleveland Clinic (Cleveland, Ohio), Hennepin County Medical Center (Minneapolis, Minnesota), Henry Ford Health (Detroit, Michigan), The Ohio State University Wexner Medical Center (Columbus, Ohio), and University of Michigan Hospital (Ann Arbor, Michigan); Region 6: Baylor Scott & White Medical Center (Temple, Texas) and Baylor University Medical Center (Dallas, Texas); Region 7: Barnes-Jewish Hospital (St. Louis, Missouri) and University of Iowa Hospitals (Iowa City, Iowa); Region 8: Intermountain Medical Center (Murray, Utah) and UCHealth University of Colorado Hospital (Aurora, Colorado); Region 9: Stanford University Medical Center (Stanford, California) and Ronald Reagan UCLA Medical Center (Los Angeles, California); and Region 10: Oregon Health & Science University Hospital (Portland, Oregon) and University of Washington (Seattle, Washington). Other race, non-Hispanic includes American Indian or Alaska Native, Asian, and Native Hawaiian or other Pacific Islander categories, which were combined because of small counts. Other includes patients who self-reported their race and ethnicity as Other and those for whom race and ethnicity were unknown. Chronic medical condition categories include autoimmune, cardiovascular, endocrine, gastrointestinal, hematologic, neurologic, pulmonary, and renal diseases.** Previous SARS-CoV-2 infection was defined as any self-reported or documented previous SARS-CoV-2 infection. Previous Omicron infection was defined as any self-reported or documented previous SARS-CoV-2 infection that occurred during December 26, 2021January 31, 2023.

Abbreviations: IMV=invasive mechanical ventilation; VE=vaccine effectiveness.* https://www.cdc.gov/flu/vaccines-work/ivy.htm Monovalent-vaccinated patients received 24 monovalent mRNA COVID-19 vaccine doses and zero bivalent mRNA COVID-19 vaccine doses. VE was estimated by comparing the odds of monovalent mRNA vaccination among case-patients and control patients, calculated as VE=100 (1 odds ratio). Logistic regression models were adjusted for date of hospital admission (biweekly intervals), U.S. Department of Health and Human Services region (10 regions), categorical age (1849, 5064, and 65 years), sex, and race and ethnicity (Black or African American, non-Hispanic; White, non-Hispanic; Hispanic or Latino, any race; Other race, non-Hispanic; and Other, unknown) unless otherwise noted. Logistic regression models for age groupspecific VE estimates were adjusted for continuous age. Logistic regression models for VE of 4 monovalent doses were restricted to patients aged 50 years admitted during April 5, 2022January 31, 2023, and were adjusted for continuous age.** VE estimate was not reported because of insufficient sample size.

Suggested citation for this article: DeCuir J, Surie D, Zhu Y, et al. Effectiveness of Monovalent mRNA COVID-19 Vaccination in Preventing COVID-19Associated Invasive Mechanical Ventilation and Death Among Immunocompetent Adults During the Omicron Variant Period IVY Network, 19 U.S. States, February 1, 2022January 31, 2023. MMWR Morb Mortal Wkly Rep 2023;72:463468. DOI: http://dx.doi.org/10.15585/mmwr.mm7217a3.

MMWR and Morbidity and Mortality Weekly Report are service marks of the U.S. Department of Health and Human Services.Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services. References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of pages found at these sites. URL addresses listed in MMWR were current as of the date of publication.

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Effectiveness of Monovalent mRNA COVID-19 Vaccination in ... - CDC

Stem cell research can help people with hard-to-heal wounds – EurekAlert

Advances in burns treatment open up new possibilities for healing other complicated wounds. For the first time, stem cells produced in compliance with the regulations governing the manufacture of medicinal products, are now being tested as a treatment for hard-to-heal leg ulcers in Linkping, Sweden.

Using stem cells in the treatment of hard-to-heal wounds and burns is a new method under development. Its success depends on close collaboration between researchers and health care staff. The objective is clear: meeting health care needs.

I recall a man in his 40s, this was a couple of months after I came to Linkping Universityas a researcher, who was fighting for his life. Im sad to say he died. If wed had the technologies we have now, we might have been able to help him. I still think about him, says Ahmed Elserafy, who was recruited to Linkping University (LiU) as a researcher to find the right type of cells to treat wounds.

One of Swedens two national Burn Centres is located at Linkping University Hospital. Here, near-clinical and internationally recognised research is carried out next to advanced burns care. One important task is developing the burn care of the future.

Burn treatment has been the same for a very long time and is based on taking skin grafts from the patient for transplant to the wound area. Our research focuses on finding other ways to cover open wounds, says Folke Sjberg, professor at LiU and consultant at the Linkping national Burn Centre (Brnnskadecentrum).

But not only burns cause serious open wounds. A very large group of wounds identified as hard-to-heal wounds, cause extensive suffering and present a difficult health care challenge.

There are significant differences between burns and hard-to-heal wounds. Burns occur suddenly. Burn patients do not normally have underlying diseases adversely affecting the healing of wounds. A hard-to-heal wound, however, is caused by underlying conditions that impair healing, such as diabetes, or multimorbidity in the case of elderly people.

The prognosis is grim for the around 100,000 people in Sweden with hard-to heal wounds. In more than half of the cases, such wounds lead to amputation of the limb affected. Hard-to-heal wounds are most often treated with dressings and wound care products. It is also possible to transplant the patients own skin to the wound.

The team of researchers and care staff have developed a model for growing new skin cells from a tissue sample from the patient. The cells are administered to the wound area in the form of a solution. The team has shown that the wound heals from the edges to the centre, just like it would naturally. Most wounds have shrunk to only half the size after 15 days.

This model forms the basis for the researchers next step, where they investigate the viability of using cells from another person instead of the patients own.

Cells from elderly patients are not optimal for transplantation. What were doing now is that we use cells from younger individuals with much better healing potential, says Folke Sjberg.

Specialist nurse Matilda Karlsson and consultant Moustafa Elmasry are working on a clinical study at the Burn Centres wound clinic. It is the first study in the world where stem cells, produced in compliance with the regulations governing the manufacture of medicinal products, are tested on patients with hard-to-heal leg ulcers.

Its a revolutionising, active treatment compared with traditional treatment using dressings or transplantation of the patients own skin, which is a very invasive procedure, says Moustafa Elmasry.

The cells used are derived from fat harvested from plastic surgery patients. The researchers collaborate with the company Xintela in Lund, which purifies a well-defined group of stem cells. What is unique about stem cells is that they can be developed into any type of cell in the body. Studies have shown that even if the cells come from another person, the bodys immune defence system does not react to them.

The study, which will comprise eight patients, is in its start-up phase. As with all clinical studies, the first step is to find out whether the treatment is safe. The researchers hope that the stem cells will also have a positive effect on wound healing. Should this turn out to be the case, it will be interesting to develop the process to ensure a sufficiently large amount of cells at a reasonable cost, to enable broad application in health care. The larger the wound, the more cells are required.

If the treatment proves successful, the researchers hope that, in the long term, it can also be used to cover extensive burns. Matilda Karlsson does not hesitate for a second when asked what they hope their research will eventually lead to:

A product that can heal all types of hard-to-heal wounds, with no need for skin grafts from the patient. This could hopefully save people from amputation of the limbs affected and, in the case of severe burns, save lives.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Girl in the fight of her life looks for stem cell donor – BlackburnNews.com

By Paul Pedro April 12, 2023 11:28am

A little girl who desperately needs a Stem Cell Transplant to survive is asking area residents for help.

Zoe Dudzianiec, 7, of Tecumseh has a rare disease called Diamond-Blackfan Anemia, which is a very rare bone marrow disorder with no cure.

She has been getting treatment since birth and must receive 10 hours of medical treatment every day. Zoe also gets blood transfusions every 10 days at Sick Kids Hospital in Toronto because the blood she requires isnot available to her in Windsor anymore.

Her best treatment option is a stem cell transplant. She needs to rely on the generosity of a stranger to save her life by registering as a potential donor, said officials with The Katelyn Bedard Bone Marrow Association.

They are hosting a swab clinic at St. Clair College in Chatham next week to find a potential donor for Zoe. The clinic will be held at the Chatham Campus of St. Clair College on Monday, April 17, 2023 from 10 a.m. to 2 p.m. The swabbing event will be held in the lobby of the main building at 1001 Grand Avenue West.

Zoe needs someone who shares her Middle Eastern/European ethnic background to donate stem cells to save her life.

Sign up here to become a stem cell donor if you cant make it to the clinic in Chatham. Your stem cells could give her the carefree childhood she deserves. Those wishing to register must be between the ages of 17 and 35. Potential donors of all ethnic backgrounds are welcome, according to organizers.

Diversification of the Canadian Registry is vital, organizers said.

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Girl in the fight of her life looks for stem cell donor - BlackburnNews.com