Cancer Research Institute Awards $30.2 Million in Grants and Fellowships to Support Basic and Clinical Research in Immunology and Cancer Immunotherapy…

Newswise NEW YORK, August 5, 2020The Cancer Research Institute (CRI), a U.S. nonprofit organization dedicated to the discovery and development of powerful immunotherapies for all cancers, awarded more than $30.2 million in research grants and fellowships in the 2020 fiscal year ending June 30, 2020. In total, CRI gave 94 awards that will advance cancer immunology research at 56 institutions in 8 countries. This also includes an unprecedented six-month extension of funding support for 23 postdoctoral fellows in response to the global COVID-19 pandemic.

While the novel coronavirus has upended all aspects of life across the globe, CRI and our scientists remain committed to fulfilling the promise of cancer immunotherapy, said Jill ODonnell-Tormey, Ph.D., CEO and director of scientific affairs at the Cancer Research Institute. Were proud to support these brilliant scientists and clinicians, especially our young researchers and future leaders, at a critical time in order to bring the benefits of immunotherapy to more cancer patients.

The awards, which are funded entirely by individual, foundation, and corporate donors, include:

The 2020 Cancer Research Institute Lloyd J. Old STARs, or Scientists Taking Risks include:

To help advance immunotherapy for two types of ultra-rare cancer, chordoma and fibrolamellar cancer, which affect the bones of the spine and the liver, respectively, the Cancer Research Institute has partnered with two nonprofits focused on these diseases to fund promising research aimed at improving outcomes for patients with these cancers. These include:

Among this years Technology Impact Award recipients is Neville Sanjana, Ph.D., of the New York Genome Center, who is using massively-parallel genome engineering to comprehensively map all genes that can boost immune responses against pancreatic cancer, which will hopefully enable the development of next-generation T cell therapies for difficult-to-treat cancers.

Finally, included in the Impact Grants is funding for a glioma study carried out by Robert Michael Angelo, M.D., Ph.D., and Sean Bendall, Ph.D., of Stanford University in collaboration with investigators at City of Hope, Stanford, the University of California, Los Angeles, and the University of California, San Francisco, who will use Multiplexed Ion Beam Imaging (MIBI) to image intact, well-annotated glial tumor tissue from pediatric and adult patients in response to vaccine, checkpoint inhibitor, and cellular therapies. This dataset will inform therapeutic strategies based on the presence of tumor targets, expression of immune inhibitory proteins, and the types and functional statuses of T cells and myeloid cells within the context of an intact tumor microenvironment.

To view our full roster of 2020 grant and fellowship award recipients, visit cancerresearch.org/funding. More information about CRIs grants, fellowships, and other programs is available at cancerresearch.org/grants.

About the Cancer Research InstituteThe Cancer Research Institute (CRI), established in 1953, is a highly-rated U.S. nonprofit organization dedicated exclusively to saving more lives by fueling the discovery and development of powerful immunotherapies for all cancers. Guided by a world-renowned Scientific Advisory Council that includes four Nobel laureates and 26 members of the National Academy of Sciences, CRI has invested $445 million in support of research conducted by immunologists and tumor immunologists at the worlds leading medical centers and universities, and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to cancerresearch.org.

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Cancer Research Institute Awards $30.2 Million in Grants and Fellowships to Support Basic and Clinical Research in Immunology and Cancer Immunotherapy...

Croydon mum’s urgent appeal for stem cell donors who could save her two-year-old daughter – My London

People who meet two-year-old Shahera Khan adore her.

The young girl is described as wonderful, funny and calm.

Sadly, however, her life is not that of a normal girl her age. Shahera, who lives in Croydon with her mum, dad and five-year-old brother, suffers with a very rare immunodeficiency disease.

Its a fault in her immune system and means Shahera is unable to produce enough white blood cells, making her susceptible to infections. A worst case scenario would be she sustains a serious bacterial infection which could prove fatal.

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"Shahera is currently taking medication to protect her against serious bacterial infections and she has immunoglobulin transfusions every week," said her mum, Amina.

"At the moment she is doing okay but shes getting side effects from the medication."

Shaheras family have been told a stem cell transplant is her best chance of leading a normal life. Doctors will give her new, healthy stem cells via the bloodstream, where they begin to grow and create healthy red blood cells, white blood cells and platelets.

But Shahera needs a stem cell donor. Nobody in her family is a genetic match, so the family is working with blood cancer charity Anthony Nolan to raise awareness of the stem cell donor register.

The search is made more difficult due to her Bangladeshi heritage. Data shows patients like Shahera, from a black, Asian and minority ethnic background, have a 20 per cent chance of finding the best possible stem cell donor match, compared to 69 per cent for people with white, European heritage.

Amina said: "We need to find Shahera a donor as soon as possible.

"We want to raise awareness in the Asian, and particularly Bangladeshi community so people come forward - not only to help Shahera but for anyone who needs a donor.

"Its shocking that there is no match for Shahera and other people from Asian communities.

"With Shaheras condition the doctors would like to do the transplant as soon as possible. Theyve given us a couple of months to find a donor and suggested spring or summer next year for the transplant."

Shahera has regular appointments at Great Ormond Street Hospital and waiting for a stem cell donor is a "nerve wracking" process, Amina admitted.

"Shahera is wonderful. She touches everybody she meets; from family and friends to the people she meets in the hospital," Amina said.

"Shes very calm and everyone just loves her, shes funny too. To look at her, you wouldnt believe she was ill but what is going on inside is a totally different story.

"We dont want her to miss out on anything. She should be starting nursery this September, but we dont know what will happen because of her treatment.

"Were a happy family unit. My husband and I both work and we slot Shaheras appointments in around family life.

"Its nerve wrecking and upsetting, waiting to find a donor. It feels like a long process. Its not easy, we have our bad days as well as good days, but all we can do is look forward, and do everything we can to find Shahera a donor."

So far no match has been found but the family are hoping blood cancer charity Anthony Nolan can help raise awareness of the stem cell donor register.

Sarah Rogers, register development manager at Anthony Nolan, said: "Little Shahera wants to go to nursery, learn and make more friends just like other toddlers across the UK. For this to happen she needs a stranger to donate their stem cells.

"If youre aged 16-30 you can join the register online and well send you a cheek swab in the post.

"If youre found to be a match for a patient, you could donate your stem cells and give hope to families like Shaheras. Your support could help us give a patient, their family and their friends a second chance of life."

People aged 16-30 who are in good general health can find out more, and join the Anthony Nolan register at http://www.anthonynolan.org/saveourshahera.

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Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19 – Yahoo…

- University of California Irvine is the first California site participating in Celularity's CYNK-001-COVID-19 clinical trial NCT04365101 using Celularity's investigational immunotherapy to treat adults who tested COVID-19 positive in underserved and disproportionately affected populations.

- CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells.

FLORHAM PARK, N.J., Aug. 5, 2020 /PRNewswire/ --Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) cells (CYNK-001) for the treatment of adults with COVID-19.The University of California Irvine is the first CA site to open for patient enrollment.

(PRNewsfoto/Celularity, Inc.)

CIRM's COVID-19 Project supports promising discovery, preclinical and clinical trial stage projects that could quickly advance treatments or vaccines that utilize stem and/or progenitor cells. Celularity will use the CIRM grant to support the evaluation of the anti-viral activities of its cryopreserved investigational product, CYNK-001, in underserved and disproportionately affected populations with COVID-19, an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Celularity received clearance from the United States Food and Drug Administration to proceed with a Phase I/II study to evaluate the safety, tolerability, and efficacy of CYNK-001 in patients with COVID-19.

"Our investigational product CYNK-001 showed great promise in preclinical studies, and we are optimistic that it will prove effective against corona virus diseases, including COVID-19. As part of our rapidly-scalable placental-derived cellular medicine platform, CYNK-001 could play an important role in the public health response to outbreaks of COVID-19 or other coronaviruses," said Robert J. Hariri, MD, PhD, Founder, Chairman and CEO of Celularity. "We are very grateful to CIRM for supporting our effort to make novel cellular medicines available to medically underserved and disproportionately affected persons in California."

Xiaokui Zhang, PhD, Chief Scientific Officer and Principal Investigator under the CIRM grant says "CYNK-001 has a range of biological activities that not only recognize and destroy virus-infected cells, but also coordinate a robust immune response that may lead to an effective and durable defense against the viral infection."

The trial will evaluate the safety and the clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects as measured by clearance of the SARS-CoV-2 and improvement in clinical symptoms or improvement in radiological evaluation of disease related chest x-ray. The primary objective of the Phase I portion of the study is to evaluate the safety, tolerability, and efficacy of multiple CYNK-001 intravenous (IV) infusions in COVID-19 patients and will be administered to up to 14 patients in three doses over the course of seven days.

The Phase II portion of the study is a randomized, open-label, multi-site study measuring multiple doses of CYNK-001 against a control group experiencing a similar degree of infection with best supportive care, with two co-primary endpoints. The first co-primary endpoint is to determine the virologic efficacy of CYNK-001 in facilitating the clearance of SARS-CoV-2 from mucosal specimens and/or peripheral blood. The second co-primary endpoint is to assess the impact of treatment with CYNK-001 on clinical symptoms among patients with COVID-19 related lower respiratory tract infection.

Story continues

Celularity has treated patients with severe COVID-19 and on ventilator support under compassionate use programs in U.S. CYNK-001 was well tolerated and may be associated with clinical benefit in selected cases.

About NK CellsNK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.

About CYNK-001CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM). On 1 April, the U.S. Food and Drug Administration cleared the Company's Investigational New Drug (IND) application for the use of CYNK-001 in adults with COVID-19.

About COVID-19The virus causing COVID-19 is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is a novel coronavirus that has not been previously identified. COVID-19 has become a global pandemic, with over 4.2 million confirmed cases in the USA and over 650,000 deaths reported to date worldwide.

About Celularity Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by delivering off-the-shelf allogeneic cellular therapies, at unparalleled scale, quality, and economics. Celularity's innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post partum placenta. Through nature's immunotherapy engine the placenta Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com

Media Contact:

Name:Dani Frank

Email:celularity@factorypr.com

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Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19 - Yahoo...

Stem Cell Therapy Market Report Aims To Outline and Forecast , Organization Sizes, Top Vendors, Industry Research and End User Analysis By 2026 -…

Detailed Analysis & SWOT analysis, Stem Cell Therapy Market Trends 2020, Stem Cell Therapy Market Growth 2020, Stem Cell Therapy Industry Share 2020, Stem Cell Therapy Industry Size, Stem Cell Therapy Market Research, Stem Cell Therapy Market Analysis, Stem Cell Therapy market Report speaks about the manufacturing process. The process is analyzed thoroughly with respect three points, viz. raw material and equipment suppliers, various manufacturing associated costs (material cost, labor cost, etc.) and the actual process of whole Enterprise Stem Cell Therapy Market.

Stem Cell Therapy market 2020 is a professional and in-intensity look at on the modern state of the key-word industry. The document provides a simple review of the key-word marketplace together with definitions, classifications, programs and chain shape. The key-word enterprise evaluation is supplied for the worldwide marketplace which include improvement records, competitive landscape evaluation, and principal local development popularity.

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The Stem Cell Therapy marketplace file elaborates Stem Cell Therapy industry evaluation with various definitions and category, Product kinds & its packages and chain shape. Stem Cell Therapy market document presentations the manufacturing, sales, charge, and market proportion and boom rate of every type as following.

2020 Short Detail of this Stem Cell Therapy market report:

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. Bone marrow transplant is the most widely used stem-cell therapy, but some therapies derived from umbilical cord blood are also in use.

In the last several years, global stem cell therapy market developed fast at a average growth rate of 46.81%.

Market Analysis and Insights: Global Stem Cell Therapy Market

In 2019, the global Stem Cell Therapy market size was USD 403.6 million and it is expected to reach USD 1439.9 million by the end of 2026, with a CAGR of 19.7% during 2021-2026.

Global Stem Cell Therapy Scope and Market Size

Stem Cell Therapy market is segmented by Type, and by Application. Players, stakeholders, and other participants in the global Stem Cell Therapy market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by Type and by Application in terms of revenue and forecast for the period 2015-2026.

Segment by Type, the Stem Cell Therapy market is segmented into Autologous, Allogeneic, etc.

Segment by Application, the Stem Cell Therapy market is segmented into Musculoskeletal Disorder, Wounds & Injuries, Cornea, Cardiovascular Diseases, Others, etc.

Regional and Country-level Analysis

The Stem Cell Therapy market is analysed and market size information is provided by regions (countries).

The key regions covered in the Stem Cell Therapy market report are North America, Europe, China, Japan, Southeast Asia, India and Central & South America, etc.

The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of revenue for the period 2015-2026.

Competitive Landscape and Stem Cell Therapy Market Share Analysis

Stem Cell Therapy market competitive landscape provides details and data information by vendors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on revenue (global and regional level) by player for the period 2015-2020. Details included are company description, major business, company total revenue and the revenue generated in Stem Cell Therapy business, the date to enter into the Stem Cell Therapy market, Stem Cell Therapy product introduction, recent developments, etc.

The major vendors include Osiris Therapeutics, NuVasive, Chiesi Pharmaceuticals, JCR Pharmaceutical, Pharmicell, Medi-post, Anterogen, Molmed, Takeda (TiGenix), etc.

This report focuses on the global Stem Cell Therapy status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Stem Cell Therapy development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.

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Stem Cell Therapy Market by Product Type:

Stem Cell Therapy Market by Applications:

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Next part of the Stem Cell Therapy Market analysis report speaks about the manufacturing process. The process is analysed thoroughly with respect three points, viz. raw material and equipment suppliers, various manufacturing associated costs (material cost, labour cost, etc.) and the actual process. Stem Cell Therapy market competition by top manufacturers, with production, price, and revenue (value) and market share for each manufacturer as per following;

Top Manufacturer Included in Stem Cell Therapy Market:

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Stem Cell Therapy Market Report by Key Region:

The global Stem Cell Therapy market is anticipated to rise at a considerable rate during the forecast period, between 2020 and 2026. In 2020, the market was growing at a mild rate and with the rising adoption of strategies by key players, the market is predicted to rise over the projected horizon. The report also tracks the most recent market dynamics, like driving factors, restraining factors, and industry news like mergers, acquisitions, and investments.

The report can help to know the market and strategize for business expansion accordingly. Within the strategy analysis, it gives insights from market positioning and marketing channel to potential growth strategies, providing in-depth analysis for brand fresh entrants or exists competitors within the Stem Cell Therapy industry. Global Stem Cell Therapy Market Report 2020 provides exclusive statistics, data, information, trends and competitive landscape details during this niche sector.

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Further in the report, Stem Cell Therapy Market is examined for price, cost and gross revenue. These three points are analysed for types, companies and regions. In prolongation with this data sale price for various types, applications and region is also included. The Stem Cell Therapy Industry consumption for major regions is given. Additionally, type wise and application wise consumption figures are also given.

To provide information on competitive landscape, this report includes detailed profiles of Stem Cell Therapy Market key players. For each player, product details, capacity, price, cost, gross and revenue numbers are given. Their contact information is provided for better understanding.

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Stem Cell Therapy Market Report Aims To Outline and Forecast , Organization Sizes, Top Vendors, Industry Research and End User Analysis By 2026 -...

Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Awa – PharmiWeb.com

FLORHAM PARK, N.J., Aug. 5, 2020 /PRNewswire/ --Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) cells (CYNK-001) for the treatment of adults with COVID-19.The University of California Irvine is the first CA site to open for patient enrollment.

CIRM's COVID-19 Project supports promising discovery, preclinical and clinical trial stage projects that could quickly advance treatments or vaccines that utilize stem and/or progenitor cells. Celularity will use the CIRM grant to support the evaluation of the anti-viral activities of its cryopreserved investigational product, CYNK-001, in underserved and disproportionately affected populations with COVID-19, an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Celularity received clearance from the United States Food and Drug Administration to proceed with a Phase I/II study to evaluate the safety, tolerability, and efficacy of CYNK-001 in patients with COVID-19.

"Our investigational product CYNK-001 showed great promise in preclinical studies, and we are optimistic that it will prove effective against corona virus diseases, including COVID-19. As part of our rapidly-scalable placental-derived cellular medicine platform, CYNK-001 could play an important role in the public health response to outbreaks of COVID-19 or other coronaviruses," said Robert J. Hariri, MD, PhD, Founder, Chairman and CEO of Celularity. "We are very grateful to CIRM for supporting our effort to make novel cellular medicines available to medically underserved and disproportionately affected persons in California."

Xiaokui Zhang, PhD, Chief Scientific Officer and Principal Investigator under the CIRM grant says "CYNK-001 has a range of biological activities that not only recognize and destroy virus-infected cells, but also coordinate a robust immune response that may lead to an effective and durable defense against the viral infection."

The trial will evaluate the safety and the clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects as measured by clearance of the SARS-CoV-2 and improvement in clinical symptoms or improvement in radiological evaluation of disease related chest x-ray. The primary objective of the Phase I portion of the study is to evaluate the safety, tolerability, and efficacy of multiple CYNK-001 intravenous (IV) infusions in COVID-19 patients and will be administered to up to 14 patients in three doses over the course of seven days.

The Phase II portion of the study is a randomized, open-label, multi-site study measuring multiple doses of CYNK-001 against a control group experiencing a similar degree of infection with best supportive care, with two co-primary endpoints. The first co-primary endpoint is to determine the virologic efficacy of CYNK-001 in facilitating the clearance of SARS-CoV-2 from mucosal specimens and/or peripheral blood. The second co-primary endpoint is to assess the impact of treatment with CYNK-001 on clinical symptoms among patients with COVID-19 related lower respiratory tract infection.

Celularity has treated patients with severe COVID-19 and on ventilator support under compassionate use programs in U.S. CYNK-001 was well tolerated and may be associated with clinical benefit in selected cases.

About NK CellsNK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.

About CYNK-001CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM). On 1 April, the U.S. Food and Drug Administration cleared the Company's Investigational New Drug (IND) application for the use of CYNK-001 in adults with COVID-19.

About COVID-19The virus causing COVID-19 is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is a novel coronavirus that has not been previously identified. COVID-19 has become a global pandemic, with over 4.2 million confirmed cases in the USA and over 650,000 deaths reported to date worldwide.

About Celularity Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by delivering off-the-shelf allogeneic cellular therapies, at unparalleled scale, quality, and economics. Celularity's innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post partum placenta. Through nature's immunotherapy engine the placenta Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com

Media Contact:

Name:Dani Frank

Email:celularity@factorypr.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/celularity-announces-the-activation-of-first-california-clinical-trial-site-following-cirm-grant-award-to-advance-treatments-for-covid-19-301106515.html

SOURCE Celularity

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Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Awa - PharmiWeb.com

Another Nice Thing We Can’t Have in 2020: Shohei Ohtani’s Pitching – FanGraphs

The list of things that havent gone according to plan in 2020 is long enough to reach to the moon and back, and to that, we can add the return of Shohei Ohtani to competitive pitching. After more than a year spent recovering from Tommy John surgery, the 26-year-old wonders reacquaintance with the mound was hotly anticipated, but after two brief and miserable outings, hes injured, and Angels manager Joe Maddon said on Tuesday that he doesnt expect to see Ohtani pitch again this year.

On Sunday, Ohtani made his second start of the season, and it began with promise, as he retired the top of the Astros lineup George Springer, Jose Altuve, and Alex Bregman in order on a total of eight pitches. He topped 95 mph a few times with his four-seamer, struck out Springer swinging at a splitter, and induced Altuve to pop up a bunt foul. Heres the Springer strikeout:

Things were looking up, particularly given that in his July 26 start against the As, Ohtani failed to retire any of the six hitters he faced, yielding three hits, three walks, and five runs. Though he dialed his fastball as high as 97.1 mph in the second inning on Sunday, he labored and grew visibly frustrated while walking the bases loaded on 26 pitches. He went to two strikes on six consecutive hitters, squandering 0-2 counts twice before striking out Kyle Tucker and Jack Mayfield. By the time he walked both Dustin Garneau and Springer, he had thrown 42 pitches in the inning a ridiculously high number in any context, let alone one for a pitcher in his second start back from surgery. His three fastballs to Springer in the second inning failed to break 90 mph; belatedly, Maddon gave him the hook, bringing in Jose Rodriguez, who retired Altuve via a groundout.

I thought it was fatigue, from where I was standing, said Maddon of Ohtanis rough second inning. We were trying to get him out there as quickly as we could at that point. There was also the chance that he could get through it, and then I wasnt certain if hed be able to continue or not. It was one of those cusp situations. I thought he was just out of his delivery at that point.

Once removed, however, Ohtani complained of discomfort in his forearm, prompting an MRI exam. He was diagnosed with a Grade 1-2 strain of his flexor pronator mass, which helps in part to explain why his average fastball velocity has been so far removed from 2018 (93.8 mph vs. 97.4, via Pitch Info). Hell be shut down from throwing for four to six weeks, which likely would not leave him enough time to build up to game activity on the mound. He will remain available to serve as a designated hitter, though for the moment hes considered day-to-day, like the rest of us.

Im not anticipating him pitching at all this year, Maddon told reporters on Tuesday. In whatever kind of throwing program, itll be very conservative. I dont have any projection on that other than hes not going to pitch this year.

This is a heartbreaker. Ohtani dazzled the baseball world with a nine-start run in early 2018, before a blister and then elbow soreness sidelined him in early June. Diagnosed with a Grade 2 sprain of his ulnar collateral ligament, he underwent both both platelet-rich plasma and stem-cell injections, but lasted just 2.1 innings in his return to the mound on September 2. Soon after that, doctors recommended that he undergo Tommy John surgery, which he did in October 2018. He returned to the majors on May 7 of last season, and spent the remainder of the year splitting his time between rehabbing his throwing arm and serving as a DH, but in September it was discovered that he needed surgery on his left knee to repair a bipartite patella, a congenital issue that had been aggravating him throughout the season. In his injury-bookended campaign, Ohtani hit .286/.343/.505 with 18 homers and 12 steals in 425 PA before being shut down, a very good performance but a step down from his .285/.361/.564 (151 wRC+) as a rookie.

The knee surgery delayed Ohtanis post-Tommy John rehab program, but he finally completed it in December, after which he was shut down until spring training. The plan as of February was that he would return to the mound in mid-May, pitching once a week, and that he would have an innings limit. The coronavirus pandemic delayed those plans but he started the Angels third game of the season, and there was plenty of optimism that he could help the teams quest to reach the postseason for the first time since 2014.

Now, if hes going to do it, hell have to do so as the primary DH. So far, things havent gone that well for Ohtani on that side of the ball, either; hes hitting .148/.179/.407 with two homers, one walk, and nine strikeouts in 28 PA. Despite those ugly numbers, hes actually making good contact, with an average exit velocity of 91.7 mph, an xwOBA of .382, and an xSLG of .642.

The Angels rotation will be the poorer without Ohtani, though the other five pitchers who have started (Dylan Bundy, Andrew Heaney, Griffin Canning, Matt Andriese, and Patrick Sandoval, the last two of whom have taken just one start apiece) have combined for a 3.45 ERA and 3.00 FIP thus far. The return of Julio Teheran, who arrived in camp late after testing positive for COVID-19, will help compensate for Ohtanis loss; hell make his Angels debut on Wednesday, starting against the Mariners, but even so, the rotation ranks just 19th in the majors in our projection-driven Depth Charts, suggesting that the units current overperformance which has still only led to a 4-7 record thus far may be fleeting.

The Angels still view Ohtani as a legitimate two-way player, but should they? His total body of work on major league mounds now amounts to 12 outings spread over three seasons, with three appearances totaling four innings since June 6, 2018. Recall that he also made just five starts for the Nippon Ham Fighters in 2017, his final year in NPB, due to a right ankle injury that required surgery. In other words, hes thrown just 78.2 competitive innings over four seasons, with the previous three ending with an injury that required surgery, and hell head into another offseason with health questions. Thats a lot of work and a lot of rehab with only a minimal payoff, and it has come with roster issues that the Angels have had to work around days off before and after his starts, and extra rest between starts, necessitating some rotation juggling. With a healthy Ohtani playing every day in an outfield alongside Mike Trout and Jo Adell (who made his major league debut on Tuesday night, going 1-for-4 with an infield single that showed off his elite speed), that unit might be the best in baseball and the cornerstone of a contender.

On the other hand, Ohtani has shown that he has high-quality stuff on the mound, this years struggles notwithstanding. He pitched to a 3.31 ERA and 3.57 FIP with a 29.1% strikeout rate in 2018, and Sundays first inning suggested that he can still get good hitters out even if hes not dialing it up to 100 mph. A player who can put up All-Star caliber rate stats as both a pitcher and a hitter is a once-in-a-century talent; Ohtanis high-level performance as both a pitcher and hitter has only early Babe Ruths 1918 and 19 seasons as a precedent. To give up on that simply so that Maddon has an everyday DH or outfielder to write into the lineup feels like using a Van Gogh painting as a TV tray.

Maddon told reporters he still believes Ohtani can be a two-way player. We just got to get past the arm maladies and figure that out, he said. Hes such a high-end arm and, of course, what he can do in the batters box. It might get to the point where he may choose to want to do one thing over the other and just express that to us.

So far as anybody knows, thats not the case yet, and in a normal six-month season, Ohtanis forearm strain would be viewed as a setback, not a crossroads. He wont be able to help the Angels as a pitcher during this brief, weird season, but thats not enough of a reason to surrender the possibility that he could return to dazzling the baseball world with his unique combination of talents.

We hoped you liked reading Another Nice Thing We Cant Have in 2020: Shohei Ohtanis Pitching by Jay Jaffe!

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Another Nice Thing We Can't Have in 2020: Shohei Ohtani's Pitching - FanGraphs

IMAC Holdings Receives FDA Authorization to Initiate Clinical Study of Its Umbilical Cord-Derived Allogenic Mesenchymal Stem Cells for the Treatment…

August 05, 2020 11:58 ET | Source: IMAC Holdings, Inc.

BRENTWOOD, Tenn., Aug. 05, 2020 (GLOBE NEWSWIRE) -- IMAC Holdings, Inc. (Nasdaq: IMAC) (the Company or IMAC), a provider of innovative medical advancements and care specializing in regenerative rehabilitation orthopedic treatments without the use of surgery or opioids, today announced the United States Food and Drug Administration (the FDA) approved its investigational new drug application, which IMAC submitted in May 2020, for the use of umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia, or the gradual loss and slowing down of spontaneous body movement, due to Parkinsons disease.

The Company will now initiate enrollment of 15 patients for its Phase 1 trial to evaluate the safety and tolerability of the stem cell product acquired from technology developed by a major research university to treat patients with Bradykinesia due to Parkinsons utilizing intravenous administration of Whartons jelly-derived mesenchymal stem cells. The Company believes that the causes of bradykinesia may be related to an inflammatory response in the body. The Companys new study is designed to confirm this belief and support the Companys long-term strategy for the use of regenerative medicine in combination with physical rehabilitation to reduce the effect of movement-restricting diseases.

Our regenerative rehabilitation centers have long focused on the importance of finding and applying non-opioid, non-surgical solutions to physical ailments in orthopedics. In 2017, our neurosurgeon researched opportunities to apply stem cells to treating Parkinsons, and we put a team together to design a treatment for our neurological patients that simply could not achieve maximum benefit from physical therapy alone, commented Jeffrey Ervin, IMACs Chief Executive Officer. Having received approval to proceed with our study, IMAC is extremely optimistic regarding the potential of this stem cell technology. This has the potential to not only expand proprietary service options for neurological patients, but also advance the way physically debilitating inflammatory conditions are managed as a whole. We would like to thank the FDA for the collaborative process and the partners who helped us achieve this milestone, including patient advocate, Doug Oliver and his team at Regenerative Outcomes.

The Phase 1 trial will consist of three treatment protocols: five patients with bradykinesia due to Parkinsons will receive a low dose intravenous infusion of stem cells, five patients will receive a medium dose intravenous infusion of stem cells and five patients will receive a high dose intravenous infusion of stem cells. The Phase 1 trial will be conducted over 12 months to determine the incidence and extent of adverse events, although the Company will also investigate the efficacy of its stem cell treatment. More information on the clinical trial, including patient criteria, can be found on clinicaltrials.gov.

IMAC will enroll participants from its existing clinics in Illinois, Tennessee, Kentucky and Missouri in its Phase 1 trial. Prospective enrollees may email fdatrial@imacregeneration.com to be considered for the trial. IMACs medical doctors and physical therapists have been trained to administer the treatment and manage the therapy for the clinical trial, which is anticipated to begin in 30 days.

About IMAC Holdings, Inc.

IMAC Holdings was created in March 2015 to expand on the footprint of the original IMAC Regeneration Center, which opened in Kentucky in August 2000. IMAC Regeneration Centers combine life science advancements with traditional medical care for movement restricting diseases and conditions. IMAC owns or manages 16 outpatient clinics that provide regenerative, orthopedic and minimally invasive procedures and therapies. It has partnered with several active and former professional athletes, opening six Ozzie Smith IMAC Regeneration Centers, two David Price IMAC Regeneration Centers, as well as Mike Ditka IMAC Regeneration Centers and a Tony Delk IMAC Regeneration Center. IMACs outpatient medical clinics emphasize its focus around treating sports and orthopedic injuries and movement-restricting diseases without surgery or opioids. More information about IMAC Holdings, Inc. is available at http://www.imacregeneration.com.

# # #

Safe Harbor Statement

This press release contains forward-looking statements. These forward-looking statements, and terms such as anticipate, expect, believe, may, will, should or other comparable terms, are based largely on IMAC's expectations and are subject to a number of risks and uncertainties, certain of which are beyond IMAC's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, risks and uncertainties associated with its ability to raise additional funding, its ability to maintain and grow its business, variability of operating results, its ability to maintain and enhance its brand, its development and introduction of new products and services, the successful integration of acquired companies, technologies and assets, marketing and other business development initiatives, competition in the industry, general government regulation, economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the skills and experience necessary to meet customers requirements, and its ability to protect its intellectual property. IMAC encourages you to review other factors that may affect its future results in its registration statement and in its other filings with the Securities and Exchange Commission. In light of these risks and uncertainties, there can be no assurance that the forward-looking information contained in this press release will in fact occur.

IMAC Press Contact: Laura Fristoe lfristoe@imacrc.com

IMAC Investor Contact: Bret Shapiro (516) 222-2560 brets@coreir.com

Source: IMAC Holdings, Inc.

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Hematopoietic Stem Cell Transplantation (HSCT) Market 2020: Regen Biopharma Inc, China Cord Blood Corp, CBR Systems Inc, Escape Therapeutics Inc,…

The latest report published by Regal Intelligence on Hematopoietic Stem Cell Transplantation (HSCT) market provides crucial market insights along with detailed segmentation analysis. The report examines key driving factors that are expected to drive the growth of the market.

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Leading players of Hematopoietic Stem Cell Transplantation (HSCT) including: Regen Biopharma Inc, China Cord Blood Corp, CBR Systems Inc, Escape Therapeutics Inc, Cryo-Save AG, Lonza Group Ltd, Pluristem Therapeutics Inc, ViaCord Inc

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Hematopoietic Stem Cell Transplantation (HSCT) Market 2020: Regen Biopharma Inc, China Cord Blood Corp, CBR Systems Inc, Escape Therapeutics Inc,...

In Depth Analysis and Survey of COVID-19 Pandemic Impact on Global Precision Cancer Therapies Market Report 2020 Key Players Abbott Laboratories,…

Report is a detailed study of the Precision Cancer Therapies market, which covers all the essential information required by a new market entrant as well as the existing players to gain a deeper understanding of the market.The primary objective of this research report named Precision Cancer Therapies market is to help making reliable strategic decisions regarding the opportunities in Precision Cancer Therapies market. It offers business accounts, industry investors, and industry segments with consequential insights enhancing decision making ability.nicolas.shaw@cognitivemarketresearch.com or call us on +1-312-376-8303.

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Global and Regional Precision Cancer Therapies Market Segmentation by Type: Hormone Therapy, Immunotherapies, Targeted Therapy, Monoclonal Antibody Therapy, Gene Therapy

Global Precision Cancer Therapies Market Segmentation by Applications: Hospitals, Diagnostic Centers, Oncology Clinics, Research Institutes

Major Market Players with an in-depth analysis: Abbott Laboratories, Bayer HealthCare, GlaxoSmithKline, OncoGenex Pharmaceuticals, Hospira, Boehringer Ingelheim, AstraZeneca, Aveo Pharmaceuticals

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In Depth Analysis and Survey of COVID-19 Pandemic Impact on Global Precision Cancer Therapies Market Report 2020 Key Players Abbott Laboratories,...

Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19 – PRNewswire

FLORHAM PARK, N.J., Aug. 5, 2020 /PRNewswire/ --Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) cells (CYNK-001) for the treatment of adults with COVID-19.The University of California Irvine is the first CA site to open for patient enrollment.

CIRM's COVID-19 Project supports promising discovery, preclinical and clinical trial stage projects that could quickly advance treatments or vaccines that utilize stem and/or progenitor cells. Celularity will use the CIRM grant to support the evaluation of the anti-viral activities of its cryopreserved investigational product, CYNK-001, in underserved and disproportionately affected populations with COVID-19, an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Celularity received clearance from the United States Food and Drug Administration to proceed with a Phase I/II study to evaluate the safety, tolerability, and efficacy of CYNK-001 in patients with COVID-19.

"Our investigational product CYNK-001 showed great promise in preclinical studies, and we are optimistic that it will prove effective against corona virus diseases, including COVID-19. As part of our rapidly-scalable placental-derived cellular medicine platform, CYNK-001 could play an important role in the public health response to outbreaks of COVID-19 or other coronaviruses," said Robert J. Hariri, MD, PhD, Founder, Chairman and CEO of Celularity. "We are very grateful to CIRM for supporting our effort to make novel cellular medicines available to medically underserved and disproportionately affected persons in California."

Xiaokui Zhang, PhD, Chief Scientific Officer and Principal Investigator under the CIRM grant says "CYNK-001 has a range of biological activities that not only recognize and destroy virus-infected cells, but also coordinate a robust immune response that may lead to an effective and durable defense against the viral infection."

The trial will evaluate the safety and the clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects as measured by clearance of the SARS-CoV-2 and improvement in clinical symptoms or improvement in radiological evaluation of disease related chest x-ray. The primary objective of the Phase I portion of the study is to evaluate the safety, tolerability, and efficacy of multiple CYNK-001 intravenous (IV) infusions in COVID-19 patients and will be administered to up to 14 patients in three doses over the course of seven days.

The Phase II portion of the study is a randomized, open-label, multi-site study measuring multiple doses of CYNK-001 against a control group experiencing a similar degree of infection with best supportive care, with two co-primary endpoints. The first co-primary endpoint is to determine the virologic efficacy of CYNK-001 in facilitating the clearance of SARS-CoV-2 from mucosal specimens and/or peripheral blood. The second co-primary endpoint is to assess the impact of treatment with CYNK-001 on clinical symptoms among patients with COVID-19 related lower respiratory tract infection.

Celularity has treated patients with severe COVID-19 and on ventilator support under compassionate use programs in U.S. CYNK-001 was well tolerated and may be associated with clinical benefit in selected cases.

About NK CellsNK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.

About CYNK-001CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM). On 1 April, the U.S. Food and Drug Administration cleared the Company's Investigational New Drug (IND) application for the use of CYNK-001 in adults with COVID-19.

About COVID-19The virus causing COVID-19 is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is a novel coronavirus that has not been previously identified. COVID-19 has become a global pandemic, with over 4.2 million confirmed cases in the USA and over 650,000 deaths reported to date worldwide.

About Celularity Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by delivering off-the-shelf allogeneic cellular therapies, at unparalleled scale, quality, and economics. Celularity's innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post partum placenta. Through nature's immunotherapy engine the placenta Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com

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Name:Dani Frank

Email:[emailprotected]

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Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19 - PRNewswire