iTolerance, Inc. Awarded Industry Discovery and Development Partnership with JDRF for Advanced Pre-Clinical Development of iTOL-100 and iTOL-101 for…

Company advancing development of lead program, iTOL-101, as a potential breakthrough in curing Type 1 Diabetes with the potential to eliminate the need for chronic life-long immunosuppression

The up to $850,000 award issued to iTolerance was given in furtherance of JDRF's charitable mission to cure and mitigate the effects of Type 1 Diabetes

MIAMI, FL / ACCESSWIRE / June 28, 2022 / iTolerance, Inc. ("iTolerance" or the "Company"), an early-stage regenerative medicine company developing technology to enable tissue, organoid or cell therapy without the need for life-long immunosuppression, today announced it has been awarded an Industry Discovery and Development Partnership ("IDDP") of up to $850,000 from JDRF, a nonprofit organization that funds Type 1 Diabetes (T1D) research, provides a broad array of community and activist services to the T1D population and actively advocates for regulation favorable to medical research and approval of new and improved treatment modalities.

iTolerance, Inc., Tuesday, June 28, 2022, Press release picture

Anthony Japour, MD, Chief Executive Officer of iTolerance, commented, "We are incredibly pleased to expand and deepen our partnership with the JDRF. We are grateful for their continued support and dedication to the Type 1 Diabetes community. This funding provides us with the additional capital to support the translation of iTOL-100 production, iTolerance's proprietary biotechnology-derived fusion protein immunomodulator platform, from the academic research laboratories to commercial manufacturing. In addition, the partnership will support Good Laboratory Practice efficacy, safety, toxicology, and pharmacokinetic studies. This will put us a step closer toward a first in human Phase 1/2a clinical trial."

Dr. Japour continued, "The support that the JDRF has provided to our team thus far has been significantly valuable in enabling us to complete our pre-clinical non-human primate study which demonstrated long-term success of allogeneic islet implantation without chronic immunosuppression for the treatment of diabetes. The results from that landmark study were recently published[1] in the peer-reviewed journal, Science Advances. We believe the extension of their support with this IDDP is truly a natural next step as we collectively advance towards a potential breakthrough cure for T1D without the need for chronic immunosuppression."

Story continues

The JDRF award to iTolerance is in support of advancing the Company's platform technology, iTOL-100, which leverages the naturally occurring protein, Fas Ligand (FasL) which is present in all mammals and functions as a natural way for the body to establish local immune tolerance. In pre-clinical studies conducted to date, iTOL-100 has been shown to establish durable, localized immune tolerance, allowing the implanted tissue, organoid or cell therapy to function as a replacement for damaged native cells. Additionally, the award supports the advancement of pre-clinical studies evaluating iTolerance's lead program, iTOL-101, to support a first-in-human clinical study in Type 1 Diabetes.

"We enthusiastically support the iTolerance team's effort toward translating to the clinic the work of our JDRF-funded researchers. The recently published study demonstrates long-term glycemic control in a non-human primate model of diabetes by combining allogenic islets with the SA-FasL microgel. This work has the promise to provide a cell replacement therapy that cures T1D without the need for chronic immunosuppression. The advancement of pre-clinical development builds on the ongoing support from JDRF and we look forward to this next stage of development," added Esther Latres, Ph.D., JDRF Vice President of Research.

About JDRF

JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter (@JDRF), Facebook (@myjdrf), and Instagram (@jdrfhq).

About iTOL-100

The Company's iTOL-100 platform technology is a biotechnology-derived Strepavidin-FasL fusion protein, a synthetic form of the naturally occurring protein FasL, mixed with a biotin-PEG microgel (SA-FasL microgel) that potentially allows convenient and effective co-administration with implanted cells or organoids to induce local immune tolerance without the need for life-long immunosuppression. In pre-clinical studies, iTOL-100 has been shown to establish durable, localized immune tolerance, allowing the implanted tissue, organoid or cell therapy to function as a replacement for damaged native cells. iTOL-100 has broad applicability and can be applied to both allogenic and stem cell-derived organoids across a number of diseases.

About iTolerance, Inc.

iTolerance is an early-stage privately held regenerative medicine company developing technology to enable tissue, organoid or cell therapy without the need for life-long immunosuppression. Leveraging its proprietary biotechnology-derived Strepavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic pancreatic islets and stem cells that have the potential to cure diseases. The Company's lead program, iTOL-101 is being developed for Type 1 Diabetes and in a pre-clinical non-human primate study, pancreatic islet cells co-implanted with iTOL-101 exhibited long-term function with control of blood glucose levels and restoration of insulin secretion without the use of chronic immune suppression. The Company's second lead candidate, iTOL-102, is leveraging significant advancements in stem cells to derive pancreatic islets which allows an inexhaustible supply of insulin-producing cells. Utilizing iTOL-100 to induce local immune tolerance, iTOL-102 has the potential to be a cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for liver failure and iTOL-301 as a potential regenerative protein and cell therapy that leverages stem cell sources to produce proteins or hormones in the body in conditions of high unmet need without the need for life-long immunosuppression. For more information, please visit itolerance.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the "safe-harbor" provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as "anticipate", "being", "will", "plan", "may", "continue", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

All forward-looking statements are based upon the Company's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company's platform technology. Consequently, forward-looking statements should be regarded solely as the Company's current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

[1] https://www.science.org/doi/abs/10.1126/sciadv.abm9881

Investor Contact:

Jenene Thomas Chief Executive Officer JTC Team, LLC T: 833.475.8247 iTolerance@jtcir.com

SOURCE: iTolerance, Inc.

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iTolerance, Inc. Awarded Industry Discovery and Development Partnership with JDRF for Advanced Pre-Clinical Development of iTOL-100 and iTOL-101 for...

BMS cancer drug’s expanded approval gives it an edge over a Gilead cell therapy – MedCity News

A Bristol Myers Squib cancer drug made by engineering a patients own immune cells is now approved to treat patients in earlier stages of their disease, a regulatory decision that expands the number of patients that can be reached with this type of personalized cell therapy. The decision could also give BMS an edge over a rival cell therapy marketed by Gilead Sciences.

The CAR T-therapy from BMS, named Breyanzi, was initially approved last year as a treatment for diffuse large B-cell lymphoma, (DLBCL) a type of non-Hodgkin lymphoma in which the body produces abnormal B lymphocytes. Standard treatment is chemotherapy plus the antibody drug Rituximab. When that treatment doesnt work or the cancer relapses, the next treatment option is an autologous stem cell transplant.

Breyanzis initial approval made it a third-line treatment for DLBCL patients whose cancer relapsed or has not responded to two earlier therapies. The expanded approval of the drug, announced late Friday, moves the drug up in the treatment hierarchy and makes it a second-line therapy for patients whose disease has relapsed within 12 months of the initial chemotherapy regimen. That matches the expanded approval earlier this year of Gilead Sciences cell therapy, Yescarta. Furthermore, Breyanzis additional approval also covers those who are not eligible for a stem cell transplant.

Leo Gordon, an investigator in Breyanzis PILOT study and a professor of medicine at Northwestern University, said factors that may make patients bad candidates for a stem cell transplant include age, poor kidney or heart function, or low scores according to an assessment of frailty. Usually, such patients would receive palliative care to ease the cancers symptoms.

We thought there was a possible place for CAR T-therapy, Gordon said during an interview earlier this month at the annual meeting of the American Society of Clinical Oncology. The purpose of this is to get another option for patients for what is considered to be the standard [of care treatment]. Thats why this is an important group to look at.

CAR T-therapy is a personalized treatment made by harvesting a patients T cells and engineering them to target a protein on the surface of cancer cells. Those immune cells are multiplied in a lab and then infused back into the patient. Expanded approval of Breyanzi was based on the results of two studies evaluating the drug as a second-line therapy.

The TRANSFORM study evaluated Breyanzi in 184 patients still eligible for a stem cell transplant. The main goal was to measure how long a patient remains free of certain cancer complications. At one year, 45% of patients treated with Breyanzi achieved this mark compared with 24% of those who received standard therapy. Event-free survival in the treatment group was an estimated 10.1 months compared with 2.3 months in the control arm. Of those patients who received standard treatment, nearly half went on to receive an autologous stem cell transplant.

Measuring complete response and overall response were the main goals of PILOT, an open-label study that enrolled patients with a median age of 73. Gordon said that efficacy in PILOT was similar to what was observed in healthier and younger patients who were evaluated in tests of the drug as a third-line therapy. The median duration of response has not yet been reached, but in the 61 patients, 54% achieved a complete response. That is actually better than what we would expect for a transplant, Gordon said.

The major safety risks of CAR T-therapies as a class include an immune response called cytokine release syndrome and toxic effects in the brain. Gordon said the cytokine release syndrome cases observed in the latest Breyanzi study were mild to moderate. While some patients had severe neurotoxicity, Gordon said no one had to go to the intensive care unit and everyone recovered. About 20% of patients were treated on an outpatient basis.

In a research note sent to investors on Monday, William Blair analyst Matt Phipps noted that compared to Yescarta, Breyanzis broader label as a second-line treatment gives it access to a bigger pool of patients that Gileads drug is not approved to treat.

We assume around 40% of patients are refractory or will relapse at some point following first-line therapy, and with 50% of these patients being transplant ineligible, around 6,000 patients per year could be eligible for Breyanzi based on PILOT, Phipps wrote. Thus, this approval clearly provides Bristol Myers with a bigger opportunity with less CAR T-competition.

Breyanzi accounted for $87 million in total revenue in 2021, according to BMSs financial reports. For the first quarter of this year, the drug tallied $44 million in sales. Phipps said that Breyanzis new approval and broad label are positive signs for BMS as the company looks to other drugs that can offset patent expirations facing key products in coming years. He added that BMS projects Breyanzi could top $3 billion in annual sales by the end of the decade.

Photo by Bristol Myers Squibb

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Cell Separation Technology Market Size, Scope and Forecast | Beckman Coulter, Becton, Dickinson and Company, GE Healthcare, Merck KGaA, Miltenyi…

New Jersey, United States This Cell Separation Technology Market research examines the state and future prospects of the Cell Separation Technology market from the perspectives of competitors, regions, products, and end Applications/industries. The Worldwide Cell Separation Technology market is segmented by product and Application/end industries in this analysis, which also analyses the different players in the global and key regions.

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Cell Separation TechnologyMarket Segmentation:

Cell Separation Technology Market, By Type

Density Gradient Centrifugation Immunodensity Cell Separation Microfluidic Cell Separation Immunomagnetic Cell Separation Fluorescence-activated Cell Sorting (FACS) Others

Cell Separation Technology Market, By Application

Stem Cell Research Immunology Neuroscience Cancer Research Others

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North Island College alum on cutting edge of bio-medical research – Comox Valley Record

NIC alumna Milena Restan bioprints on a BioX printer at the Willerth Laboratory in Victoria. photo supplied

North Island College alum Milena Restan is combining her love of medicine and engineering in ground-breaking stem cell and tissue engineering research to help patients.

Restan has completed a biomedical engineering degree at the University of Victoria and was recently the lead author of a research paper on 3D bioprinting stem cell-derived neural tissue.

It was very special to be a lead author as an undergrad student, said Restan.

Originally from the Comox Valley, Restan began her engineering journey at NIC but was always torn between medicine and engineering.

I always wanted to be a doctor, but after taking a calculus course I was really torn between pursuing my love of mathematics and medicine, she said. When I learned about NICs engineering transfer with UVic, and about the option of biomedical engineering, I realized I didnt have to choose it was the perfect combination.

Biomedical engineering focuses on mechanical and electrical engineering, combined with anatomy, physiology and biochemistry.

Engineering is learning about why things work the way they do, and then using that knowledge to solve all kinds of real-world problems, said Dennis Lightfoot, NIC engineering instructor. Todays engineering students are going to be preparing to solve the problems of the present and the future including mitigating climate change, designing for sustainability, and developing new renewable energy sources for the future. Biomedical research and development like Milena is working on will also be a growth area for our future engineers.

NIC students can seamlessly transfer directly to UVic thanks to a partnership agreement between the two institutions one of many partnership and transfer agreements NIC has with institutions across B.C., Canada and internationally.

Our goal is to make it as easy as possible for students to complete their first year at NIC and then move on to the institution of their choice to continue their studies, said Neil Cruickshank, dean of arts, science, technology, business and applied studies.

It was after her transfer to UVic that Restans career path turned again. Her original focus was on medical device design and prosthetics when she was introduced to 3D tissue printing. She then got a job working with Willerth Lab, run by Dr. Stephanie Willerth at the University of Victoria, which specialized in tissue engineering and regenerative medicine.

You can take a mature cell, reprogram it back to a pluripotent stem cell and 3D bioprint it along with various biomaterials, she explained. This allows us to engineer personalized tissue models which can be used to study disease progression. Right now, were focusing on neural tissues, but were hoping to expand to cardiac tissues. Theres a lot of potential with this approach.

Restan is wrapping up her final year at UVic and looking forward to graduation in June. For now, Restan is looking forward to furthering her research work and is also considering pursuing her MD/PhD, which combines clinical medical training with research.

What Ive learned through all this is that you never know what opportunities may present themselves. My advice to students would be to take electives youre interested in and to look for opportunities to volunteer outside the classroom. You never know what pathways will open up for you.

CourtenayNorth Island College

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North Island College alum on cutting edge of bio-medical research - Comox Valley Record

What was the value of the Canine Stem Cell Therapy market in Europe in 2022? Indian Defence News – Indian Defence News

Canine Stem Cell Therapy Market Report Coverage: Key Growth Factors & Challenges, Segmentation & Regional Outlook, Top Industry Trends & Opportunities, Competition Analysis, COVID-19 Impact Analysis & Projected Recovery, and Market Sizing & Forecast.

Latest launched research on Global Canine Stem Cell Therapy Market, it provides detailed analysis with presentable graphs, charts and tables. This report covers an in depth study of the Canine Stem Cell Therapy Market size, growth, and share, trends, consumption, segments, application and Forecast 2030. With qualitative and quantitative analysis, we help you with thorough and comprehensive research on the global Canine Stem Cell Therapy Market. This report has been prepared by experienced and knowledgeable market analysts and researchers. Each section of the research study is specially prepared to explore key aspects of the global Canine Stem Cell Therapy Market. Buyers of the report will have access to accurate PESTLE, SWOT and other types of analysis on the global Canine Stem Cell Therapy market. Moreover, it offers highly accurate estimations on the CAGR, market share, and market size of key regions and countries.

Major Key players profiled in the report include: Aratana Therapeutics, Okyanos, Magellan Stem Cells, Stem Cell Vet, VetStem Biopharma, Medrego, Regeneus Ltd, MediVet Biologic, Cell Therapy Sciences

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Segmental Analysis: The report has classified the global Canine Stem Cell Therapy market into segments including product type and application. Every segment is evaluated based on share and growth rate. Besides, the analysts have studied the potential regions that may prove rewarding for the Canine Stem Cell Therapy manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, there by helping market players to gain deep insights into the overall Canine Stem Cell Therapy industry.

Market split by Type, can be divided into: Allogeneic Stem Cells, Autologous Stem Cells

Market split by Application, can be divided into: Veterinary Hospitals, Veterinary Clinics, Veterinary Research Institutes

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The authors of the report have analyzed both developing and developed regions considered for the research and analysis of the global Canine Stem Cell Therapy market. The regional analysis section of the report provides an extensive research study on different regional and country-wise Canine Stem Cell Therapy industry to help players plan effective expansion strategies.

Regions Covered in the Global Canine Stem Cell Therapy Market: North America (U.S., Canada) Europe (U.K., Germany, France, Italy) Asia Pacific (China, India, Japan, Singapore, Malaysia) Latin America (Brazil, Mexico) Middle East & Africa (Kuwait, Saudi Arabia Egypt)

Years Considered to Estimate the Market Size: History Year: 2019-2020 Base Year: 2021 Estimated Year: 2022 Forecast Year: 2022-2030

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What was the value of the Canine Stem Cell Therapy market in Europe in 2022? Indian Defence News - Indian Defence News

Circulating Tumor Cells (CTC) Liquid Biopsy Market Provides in-depth analysis of the Industry, with Current Trends and Future forecast 2022-2029 …

Circulating Tumor Cells (CTC) Liquid Biopsy Market report is a comprehensive background analysis of the industry, which includes an assessment of the parental market. With the global market data provided in the reliable marketing report, it has become easy to gain global perspective for the international business. The market report also contains the drivers and restraints for the market that are derived from SWOT analysis, and also shows what all the recent developments, product launches, joint ventures, mergers and acquisitions by the several key players and brands that are driving the market are by systemic company profiles.

In the persuasive market report, the complete and crystal clear outline of the market is penned down which is useful for many businesses. With this business report not only an unskilled individual but also a professional can easily extrapolate the entire market within a few seconds. This business report is prepared using data sourced from in-house databases, secondary and primary research performed by a team of industry experts. An influential market research report can be explored in terms of breakdown of data by manufacturers, region, type and application, market status, market share, growth rate, future trends, market drivers, opportunities and challenges, emerging trends, risks and entry barriers, sales channels, and distributors.

Global circulating tumor cells (CTC) liquid biopsy market is expected to gain market growth in the forecast period of 2022 to 2029. Data Bridge Market Research analyses that the market is growing with a CAGR of 25.3% in the forecast period of 2022 to 2029 and is expected to reach USD 5,756.44 million by 2029 from USD 1,001.83 million in 2021. The high prevalence of chronic diseases and increasing R&D activities for its effective application is likely to be the major drivers which propel the demand of the market in the forecast period.

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The major companies which are dealing in the global circulating tumor cells (CTC) liquid biopsy market are Eurofins Genomics ( a subsidiary of Eurofins Scientific), MDx Health, Guardant Health, IMMUCOR, Thermo Fisher Scientific, Inc., Menarini Silicon Biosystems, QIAGEN, Exact Sciences Corporation, Myriad Genetics, Inc., LungLife AI, Inc., Bio-Rad Laboratories, Inc., Illumina, Inc. , Natera Inc., ExoDx ( a subsidiary of Bio-Techne Corporation), Biocept, Inc., F. Hoffman-La Roche Ltd. ,FOUNDATION MEDICINE, INC., Lucence Health, Inc., Inivata Ltd, Biolidics Limited, Vortex Biosciences among others.

Competitive Landscape and GlobalCirculating Tumor Cells (CTC) Liquid Biopsy Share Analysis

The circulating tumor cells (CTC) liquid biopsy market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, product approvals, patents, product width, and breath, application dominance, technology lifeline curve. The above data points provided are only related to the companys focus related to the circulating tumor cells (CTC) liquid biopsy market.

For instance,

Collaboration, joint ventures, and other strategies by the market player is enhancing the company market in the circulating tumor cells (CTC) liquid biopsy market, which also provides the benefit for the organization to improve their offering for circulating tumor cells (CTC) liquid biopsy market.

The liquid biopsy is a non-invasive blood test which detects circulating tumor cells and tumor DNA fragments which are released into the blood from primary tumors and metastatic sites.It is a simple and precise alternative to surgical biopsy procedure, which allows surgeon to detect cancer at a very early stage.

The circulating tumor cells are a rare sub-set of cells which function as a seed of metastases. It is found in blood of patients who have developed solid tumors. The testing of circulating tumor cells allows the detection and quantification of tumor cells in the blood of cancer patients. The various types of biological phenotypes of circulating tumor cells (CTCs) exits includes stem cell-like or mixed, mesenchymal or epithelial. These phenotypes are present in blood in a very small quantity. Due to which, their detection needs a phase of isolation-enrichment. After that, a second phase of detection.

The growing demand of circulating tumor cells (CTC) liquid biopsy because of their efficacy, high prevalence of cancer are the major drivers propelling the demand for circulating tumor cells (CTC) liquid biopsy market in the forecast period. However, the unclear regulatory and reimbursement scenario, shortage of skilled personnel is restraining the circulating tumor cells (CTC) liquid biopsy market growth in the forecast period.

The global circulating tumor cells (CTC) liquid biopsy market report provides details of market share, new developments, and impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions and technological innovations in the market. To understand the analysis and the market scenario, contact us for an Analyst Brief. Our team will help you create a revenue impact solution to achieve your desired goal.

Global Circulating Tumor Cells (CTC) Liquid Biopsy Market Scope and Market Size

Global circulating tumor cells (CTC) liquid biopsy market is categorized into three notable segments which are based on technology, application and end user. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Table of Contents:

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Global Circulating Tumor Cells (CTC) Liquid Biopsy Market Country Level Analysis

The global circulating tumor cells (CTC) liquid biopsy market is analysed and market size information is provided by country, technology, application and end user.

The countries covered in the global circulating tumor cells (CTC) liquid biopsy market report are U.S., Canada, Mexico, Germany, France, U.K., Italy, Spain, Russia, Poland, Turkey, Switzerland, Netherlands, Hungary, Austria, Norway, Ireland, Lithuania, rest of Europe in Europe, China, Japan, India, Australia, South Korea, Singapore, Thailand, Malaysia, Indonesia, Philippines, Vietnam, rest of Asia-Pacific (APAC) in Asia-Pacific(APAC) Brazil, Argentina, Peru, rest of South America in South America, South Africa, Saudi Arabia, UAE, Israel, Egypt, Kuwait and rest of Middle East and Africa in Middle East and Africa (MEA).

The U.S. is dominating the global circulating tumor cells (CTC) liquid biopsy in the North American region due to rise in number of cancer patients and presence of major players in the market. Whereas, Germany is dominating the circulating tumor cells (CTC) liquid biopsy market in the European region due to presence of untapped opportunities in Germany and growing geriatric population in Germany. Additionally, China is dominating the circulating tumor cells (CTC) liquid biopsy maket in the Asia Pacific region due to increased awareness regarding the early diagnosis and treatment of diseases such as cancer and increasing healthcare expenditure which leads to improvement in diagnostic rate.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

The Technological Development along with Public-Private Funding are Creating Opportunities in the GlobalCirculating Tumor Cells (CTC) Liquid Biopsy Market

Global circulating tumor cells (CTC) liquid biopsy market also provides you with detailed market analysis for every country growth in particular industry with wound debridement device sales, impact of advancement in the market, changes in regulatory scenarios with their support for the circulating tumor cells (CTC) liquid biopsy market. The data is available for historic period 2011 to 2019.

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Sana Biotechnology Presents Data at ISSCR 2022 Annual Meeting Showing Survival of Transplanted Hypoimmune iPSC-Derived Differentiated Cell Types…

Sana Biotechnology, Inc

First demonstration of the survival of allogeneic islet cells, cardiomyocytes, and retinal pigment epithelium cells transplanted into an immunocompetent non-human primate model without any immune suppression

The islet autoimmune data suggest that cells with hypoimmune (HIP) edits evade allogeneic immune response and autoimmune response in a type 1 diabetes mouse model

Transplanting allogeneic cells into a non-human primate without immune suppression represents a key step toward development of engineered cells for the treatment of disease

SEATTLE, June 17, 2022 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, presented data showing survival of transplanted allogeneic, hypoimmune cells of several different types in a variety of locations in non-human primates (NHPs). The transplanted cells were induced pluripotent stem cell (iPSC)-derived cardiomyocytes, retinal pigment epithelium (RPE) cells, and islet cells, which were engineered to include Sanas hypoimmune gene modifications that enable immune evasion. Data were presented by Sonja Schrepfer, M.D., Ph.D., Head of Hypoimmune Platform at Sana, during sessions at the International Society for Stem Cell Research (ISSCR) 2022 Annual Meeting taking place from Wednesday, June 15 through Sunday, June 19 in San Francisco.

These data, demonstrating that three types of transplanted cells are able to survive and function in NHPs without immunosuppression, highlight the transformative potential of Sanas hypoimmune platform across a number of different cell types that can address a variety of diseases, said Steve Harr, Sanas President and Chief Executive Officer. As an example, the use of allogeneic islet transplant has had limited success in treating type 1 diabetes due to morbidities from the necessary immunosuppression. In contrast, our data indicate that we successfully engineered HIP human pancreatic islet cells to evade immune recognition, and these cells persisted and normalized glucose levels in in vivo models. We are applying the hypoimmune platform to a number of programs in our pipeline, including SC291, our CD19 targeted allogeneic CAR T therapy for blood cancers, with a goal of an IND this year, and SC451, our islet cell program with a goal of an IND for the treatment of type 1 diabetes in 2023.

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Transplanting cells or tissues from a donor to a different recipient currently requires intense immunosuppression to prevent rejection of the transplant. Sanas HIP platform goal is to eliminate the need for immunosuppression by cloaking cells from immune recognition. The platform includes disruption of the major histocompatibility (MHC) class I and MHC class II expression to hide cells from the adaptive immune system, which includes antibody and T cell responses. These changes alone make cells susceptible to innate immune cell killing, in particular by natural killer (NK) cells. However, Sanas HIP platform additionally provides for evasion from innate cell killing, including via the overexpression of CD47, a molecule that protects HIP-modified cells from innate cell killing involving either NK cells or macrophages. HIP-modified pluripotent stem cells can serve as the starting material for the differentiation of specialized cell types to serve as cell-based therapeutics. Sanas goal is to use these HIP-modified cells to replace damaged or missing cells in the body in a number of different diseases, including, among others, cancer, type 1 diabetes, and cardiac disease.

Survival of HIP-modified islet cells for type 1 diabetes

Primary NHP pancreatic islet cells In this study, allogeneic primary pancreatic islet cells were HIP edited and transplanted intramuscularly into a healthy NHP without immunosuppression (n=1) as proof-of-concept. Islet cell survival was followed by in vivo bioluminescence imaging. The imaging showed that transplanted cells survived for the duration of the study (three months at data lock) with no evidence of a systemic immune response, including no T cell activation, antibody production, or NK cell activity as seen previously with other HIP edited cell types in NHPs (iPSC, cardiomyocytes, and RPE). Allogeneic unmodified primary pancreatic islet cells disappeared rapidly within 2 weeks.

Autoimmune mice Type 1 diabetes is a disease in which the patients immune system attacks and kills their pancreatic beta cells. Therefore, allogeneic transplanted cells in type 1 diabetes need to overcome both allogeneic and autoimmune rejection. Autoimmune diabetes arises spontaneously in non-obese diabetic (NOD) mice, and the pathophysiology of this disease shares many similarities with human type 1 diabetes. Since its development in 1980, this model has represented the gold standard of spontaneous disease models, allowing for investigation of autoimmune diabetes disease progression and susceptibility traits, as well as to test a wide array of potential treatments and therapies.

In this study, syngeneic or allogeneic mouse islet cells were transplanted intramuscularly without immunosuppression into diabetic autoimmune mice (n=15), split into three cohorts. The first cohort received unmodified syngeneic islet cells, the second cohort received unmodified allogeneic islet cells, and the third cohort received allogeneic HIP islet cells. The unmodified cells disappeared rapidly in the allogeneic setting (within 10 days) as well as in the syngeneic setting (within two weeks) due to autoimmune recognition. Neither cohort had a decrease in glucose levels. The HIP islet cells survived in all five diabetic mice for the duration of the study (one month at data lock), and glucose levels dropped, demonstrating therapeutic function of the HIP islet cells.

Survival of HIP-modified cardiomyocytes (iPSC-derived) In this study, allogeneic iPSC-derived cardiomyocytes were transplanted without immunosuppression into the hearts of healthy NHPs split into two cohorts. The first cohort received unmodified allogeneic iPSC-derived cardiomyocytes (WT; n=2), while the second cohort received allogeneic HIP iPSC-derived cardiomyocytes (HIP; n=4). The unmodified cells were almost eliminated in all NHPs, with significant T cell activation in addition to antibody production and binding. The HIP cardiomyocytes survived in all four monkeys for the duration of the study (up to two months at data lock), and there was no evidence of a systemic immune response, including no T cell activation, antibody production, or NK cell activity. After two months, injection sites were recovered, and local immune cells were analyzed for their donor-specific cell recognition and killing. While local immune cells kill unmodified cardiomyocytes, HIP cardiomyocytes were not recognized by these immune cells.

Survival of HIP-modified retinal pigmental epithelial (RPE) cells (iPSC-derived) In this study, allogeneic iPSC-derived RPEs were transplanted into the eye of healthy NHPs without immunosuppression split into two cohorts. The first cohort received unmodified allogeneic iPSC-derived RPE (WT; n=3), while the second cohort received allogeneic HIP iPSC-derived RPE (HIP; n=3). The unmodified cells were almost completely eliminated in all NHPs within three weeks, with significant T cell activation, antibody production and local microglial activation, demonstrating in this context that the eye is not an immunoprivileged site.

The HIP RPE survived in all three monkeys for the duration of the study (three weeks at data lock), and there was no evidence of a systemic immune response, including no T cell activation, antibody production, microglial or NK cell activity. Two weeks after the initial dose, the NHPs were re-injected with the same cell type into the second eye, so that the NHPs received a total of two doses. Unmodified WT RPEs again evoked a rapid systemic immune response in all NHPs, with activation of T cells and antibody production, and cells almost completely eliminate within one week. HIP RPE cells continued to survive even after re-injection without stimulation of adaptive or innate immune responses. These data suggest the potential to re-administer HIP RPE cells.

Sana intends to submit the data behind its presentations for publication in a peer-reviewed journal.

About Hypoimmune Platform Sanas hypoimmune platform is designed to create cells ex vivo that can hide from the patients immune system to enable the transplant of allogeneic cells without the need for immunosuppression. We are applying the hypoimmune technology to both pluripotent stem cells, which can then be differentiated into multiple cell types, and to donor-derived allogeneic T cells, with the goal of making potent and persistent CAR T cells at scale. Preclinical data demonstrates across a variety of cell types that these transplanted allogeneic cells are able to evade both the innate and adaptive arms of the immune system while retaining their activity. Our most advanced programs utilizing this platform include an allogeneic CAR T program targeting CD19+ cancers and stem-cell derived beta islet cells for patients with type 1 diabetes.

About Sana Biotechnology Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, South San Francisco, and Rochester. For more information about Sana Biotechnology, please visit https://sana.com/.

Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements about Sana Biotechnology, Inc. (the Company, we, us, or our) within the meaning of the federal securities laws, including those related to the companys vision, progress, and business plans; expectations for its development programs, product candidates and technology platforms, including its pre-clinical, clinical and regulatory development plans and timing expectations; the potential ability to make allogeneic, hypoimmune cells, including iPSC-derived cardiomyocytes, RPE cells, and islet cells, that survive and evade the immune system without immunosuppression and the potential persistence and efficacy of such hypoimmune cells; and the Companys expectations with respect to the submission and publication of data. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Companys strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as aim, anticipate, assume, believe, contemplate, continue, could, design, due, estimate, expect, goal, intend, may, objective, plan, positioned, potential, predict, seek, should, target, will, would and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Companys current and future research and development programs, preclinical and clinical trials, as well as the economic, market and social disruptions due to the ongoing COVID-19 public health crisis. For a detailed discussion of the risk factors that could affect the Companys actual results, please refer to the risk factors identified in the Companys SEC reports, including but not limited to its Quarterly Report on Form 10-Q dated May 10, 2022. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Investor Relations & Media: Nicole Keith Investor.relations@sana.com media@sana.com

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Sana Biotechnology Presents Data at ISSCR 2022 Annual Meeting Showing Survival of Transplanted Hypoimmune iPSC-Derived Differentiated Cell Types...

Growing scope of Genetic Medicine and Stem Cell Research – The Hindu

Various career paths are available in the field of Genetic Medicine and Stem Cell Research Various career paths are available in the field of Genetic Medicine and Stem Cell Research

Among the various streams of science and medicine that have evolved with time, stem cell research and genetic medicine have risen as top contenders for various path-breaking discoveries. The treatment of more than 1,800 known monogenic hereditary disorders today, depends on the development of genetic medicines coupled with advanced stem cell research.

The field of genetic medicine comprises many areas, including the clinical practice of physicians, genetic counsellors and nutritionists, clinical diagnostic laboratory activities, and research into the causes and inheritance of genetic disorders. Simply put, it incorporates areas such as gene therapy, personalised medicine, and the rapidly emerging new medical speciality, including predictive medicine.

Stem cells are basically adaptable and versatile cells in ones body that are capable of complex actions, unlike conventional medication. These cells exist both in embryos and adult cells and can differentiate into any cell of an organism with the ability of self-renewal. Stem cell therapy uses these cells to treat or prevent a disease or condition. Also known as regenerative medicine, it promotes the repair response of diseased, dysfunctional or injured tissue using stem cells or their derivatives.

Amid a prevailing global healthcare crisis, stem cell research and genetic medicine have given us hope. The former was and continues to be an integral part of research conducted to treat COVID-19 symptoms, and genome sequencing has been extensively employed globally to analyse mutations and variations of the virus. In the coming years, the industry is only expected to grow.

Also, there is a general misconception that only people with medical education can take up jobs in these fields. This is not completely true because students who have studied Biology, B.Sc. graduates with at least one subject of the Biological Sciences, MBBS, B.Pharma, B.D.S., B.V.Sc. or B.E. Biotechnology students are eligible too.

Possible career options include Clinical geneticist, Genetic Counsellor, Clinical Researcher, Research Scientist, Biochemical Diagnostics Professional, Biomedical Research Assistant, Biomedical Technician, Cancer Research Scientist, Biomedical Engineer, Molecular Genetics Professional, Laboratory Technician, and Laboratory Director.

The writer is Senior Medical Director - LifeCell.

Excerpt from:
Growing scope of Genetic Medicine and Stem Cell Research - The Hindu

Cell Culture Market 2022 By Emerging Trends, Industry Share, Regional Overview and SWOT Analysis till 2030 – Digital Journal

Cell Culture Market: Introduction

According to the report, the globalcell culture marketwas valued at US$10.5Bn in 2020 and is projected to expand at a CAGR of9%from 2021 to 2031. The global cell culture market is driven by development of new products, technological advancements, and increase in use of single-use bioprocessing systems during the forecast period. The cell culture market in Asia Pacific is anticipated to expand at the fastest CAGR during the forecast period due to high unmet clinical needs, improvements in the healthcare infrastructure, and increase in focus on research & development activities.

Rise in Demand and Approvals for Biosimilar Products & Other Biologic Therapeutics to Drive Market

Cell culture is one of the most important steps for the production of biosimilar antibodies, as cell culture helps increase efficiency & productivity and reduce the cost of manufacture. The increase in demand & approvals for biosimilars products and other biologic therapeutics for the treatment of chronic diseases in developed as well as developing countries has led to the demand for efficient and cost-effective products. This is expected to drive the global cell culture market during the forecast period.

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Moreover, rise in demand for cost-effective and highly efficient cell culture products such as bioreactors, media, reagents, and sera for the production of high-yield cell lines has led to a surge in the number of new product launches. This is likely to provide lucrative opportunities in the global cell culture market during the forecast period. Major manufactures strive to expand their product portfolio by launching new and advanced systems for large-scale production, which is cost-effective and has low risk of contamination.

For instance, in 2018, Merck launched capsule filters that are designed to decrease the risk of contamination in a bioreactor. These filters are used for the separation of mycoplasma and bacteria from cell culture media. However, ethical issues associated with the use of fetal bovine serum, stringent regulations, and high cost of infrastructure for cell culture are projected to hamper the growth of global cell culture market during the forecast period.

Technological Advancements in Cell Culture Production Media & Instruments to Drive Demand for Protein-based Therapeutics

In terms of product, the global cell culture market has been classified into instruments, media, sera, and reagents. The instruments segment has been categorized into cell culture vessels (bioreactors), carbon dioxide incubators, biosafety cabinets, cryogenic tanks, and others. Technological advancements for improving the efficiency and reducing the risk of cross contamination are anticipated to propel the instruments segment during the forecast period.

The media segment has been split into chemically defined, classical media, protein free media, Lysogeny media, serum free media, and specialty media. The efficiency of different media used for cell culture production is expected to drive the media segment over the next few years.

The sera segment has been bifurcated into fetal bovine serum and others. Sera are used as cell culture supplements consisting of growth factors, nutrients, and other important trace elements. The reagents segment has been segregated into albumin, amino acid, attachment factors, growth factors & cytokines, protease inhibitor, thrombin, and others. Applications such as stem cell research have vast potential in future. Stem cell culture assists in standardization of drug production and enables production of a number of cell lines & related products.

Traditional pharmaceutical therapeutics help in treating only disease symptoms, whereas stem cell therapies assist in treating the cause of the disease. Hence, further research in the field of stem cell culture for development of drugs presents significant opportunities in the market in the near future.

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Increase in Usage of Cell Culture Products in Drug Development & Manufacturing to Propel Pharmaceutical Companies Segment

Based on end-user, the global cell culture market has been divided into biotechnology companies, pharmaceutical companies, academic institutes, and research institutes. The pharmaceutical companies segment dominated the global market in 2020, and the trend is anticipated to continue during the forecast period due to increase in usage of cell culture products in drug development and manufacturing. The biotechnology companies segment is expected to account for a significant market share by 2031. The growth of the segment can be attributed to increase in the number of biotechnology companies and rise in strategic collaborations among market players to expand global presence.

Asia Pacific to Dominate Global Market

In terms of region, the global cell culture market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America is anticipated to account for a major share of the global market during the forecast period, owing to the presence of key players, increase in research & development activities, and new drug approvals.

Shift in trend toward continuous processing is expected to drive the cell culture market in North America. The cell culture market in Asia Pacific is at a pivotal point. Increase in focus of key players on expansion in the region, large untapped population, and rise in awareness about healthcare augment the cell culture market in Asia Pacific. For instance, Thermo Fisher expanded its Fisher BioServices and cryogenic service capabilities in Japan.

Thermo Fisher Scientific and Merck KGaA to Lead Global Market

Key players covered in this report are Sartorius AG, Thermo Fisher Scientific, Inc., Eppendorf AG, GE Healthcare, Corning Incorporated, Becton, Dickinson and Company, Merck KGaA, Lonza, VWR International, LLC, and PromoCell GmbH. Companies operating in the global cell culture market focus on strategic collaborations for developing new products in the emerging markets such as Asia Pacific and Latin America.

For instance, in May 2017, Merck announced the launch of EX-CELL Advanced HD perfusion medium, which helps increase the production yield and streamline the regulatory compliances.

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Global Cell Culture Market: Segmentation

Cell Culture Market, by Product

Cell Culture Market, by End-user

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Cell Culture Market 2022 By Emerging Trends, Industry Share, Regional Overview and SWOT Analysis till 2030 - Digital Journal

4 million awarded to University of Sheffield to turn bright ideas into global opportunities – University of Sheffield News

The University of Sheffield has been awarded 4.29 million in funding from UK Research and Innovation (UKRI), to jumpstart the early-stage translation of research that can create real impact for people across the UK.

The University of Sheffield has been awarded 4.29 million in funding from UK Research and Innovation (UKRI), to jumpstart the early-stage translation of research that can create real impact for people across the UK.

The University is one of 64 UK universities and research organisations to be awarded IAA funding and in the top 10 in terms of the highest amounts of funding from UKRIs 118 million pot of IAA funding. The funding will support critical early-stage translation of UK research, knowledge exchange, translation and commercialisation.

IAA funding drives economic growth and attracts private investment, allowing research to be turned into reality through the development of new technologies. It also supports evidence-based policymaking to transform public services, create new jobs, and forge new partnerships with business and charities.

The programme empowers organisations to respond to emerging global opportunities and has provided early-stage support to projects that are now established global businesses.

IAA funding has supported successful knowledge exchange projects at the University of Sheffield for more than 10 years, including:

Vice-President for Innovation at the University of Sheffield, Professor Dave Petley, said: For the University, our innovation and knowledge exchange activities are vital to meeting the challenges society faces, whether this is generating economic prosperity through spin-outs and new ventures, establishing collaborations with our regional partners to improve health and patient care or delivering projects to tackle societal and sustainability challenges.

The University has a strong ambition to drive innovation through knowledge exchange with our partners. Just one example is the development of innovative start-ups and spin-outs through Northern Gritstone, a company created jointly with the Universities of Manchester and Leeds to invest in our spin-out companies.

Last month, Northern Gritstone announced a first close of 215 million, which will lead to investments across emerging sectors such as advanced materials, health technology, cognitive computation and AI in northern England.

UKRI Director of Commercialisation Tony Soteriou, said: The UK is home to some of the brightest, most innovative and creative research teams in the world. They have the ideas and they have the entrepreneurial energy to create businesses and services that could turn sectors on their head.

What they need, what every great commercial idea needs, is support in the critical early stages. The Impact Acceleration Account is the catalyst that allows projects to grow to the next level, attracting investment, forging partnerships and creating jobs.

The breadth of UKRI allows us to work right across the UKs world-class research and innovation system to ensure it builds a green future, secures better health, ageing and wellbeing, tackles infections, and builds a secure and resilient world."

UKRI Chief Executive Professor Dame Ottoline Leyser, said: "Research and innovation has the potential to improve peoples lives and livelihoods, rejuvenating communities across the UK and tackling global challenges. It is imperative that we harness that potential.

The path between discovery and impact is not simple and so it is vital that we provide flexible support that allows talented people and teams, and world-class institutions to connect discovery to prosperity and public good.

Our impact acceleration funding has a fantastic track-record in providing support that helps brilliant ideas become realities that make a real difference.

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4 million awarded to University of Sheffield to turn bright ideas into global opportunities - University of Sheffield News