Category Archives: Stem Cell Therapy

A large number of clinical trials have shown stem cell therapy to be a promising therapeutic approach for the treatment of cardiovascular diseases. Since the first transplantation into human patients, several stem cell types have been applied in this field, including bone marrow derived stem cells, cardiac progenitors as well as embryonic stem cells and their derivatives. However, results obtained from clinical studies are inconsistent and stem cell-based improvement of heart performance and cardiac remodeling was found to be quite limited. In order to optimize stem cell efficiency, it is crucial to elucidate the underlying mechanisms mediating the beneficial effects of stem cell transplantation. Based on these mechanisms, researchers have developed different improvement strategies to boost the potency of stem cell repair and to generate the "next generation" of stem cell therapeutics. Moreover, since cardiovascular diseases are complex disorders including several disease patterns and pathologic mechanisms it may be difficult to provide a uniform therapeutic intervention for all subgroups of patients. Therefore, future strategies should aim at more personalized SC therapies in which individual disease parameters influence the selection of optimal cell type, dosage and delivery approach.

Keywords: Cardiac regeneration; Cardiovascular diseases; Cell replacement; Mesenchymal stem cells; Stem cell modification.

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Stem Cell Therapy in Heart Diseases - Cell Types, Mechanisms and ...

BOSTON--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced the presentation of new long term follow-up data and health-related quality of life scores of patients treated with omidubicel at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO), being held in Houston, Texas.

These data reinforce our commitment to advance transformational cell therapy research and underscore the potential of our NAM technology platform. Our lead stem cell therapy candidate, omidubicel, addresses the unmet need for patients with hematologic malignancies, demonstrated by the robust and growing body of encouraging clinical evidence, including the long-term follow up data and quality of life improvement, said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. As we approach the PDUFA date of January 30, 2023, and upon potential FDA approval, we are prepared to execute our plan that ensures access to those patients who can benefit from omidubicel as quickly as possible.

The long-term, durable clinical benefit of omidubicel was observed at three years across a patient population that typically has a poor prognosis. A study titled, Multicenter Long-Term Follow Up of Allogeneic Hematopoietic Stem Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials, highlighted long-term follow-up of 105 patients transplanted with omidubicel between 2006-2020 (median follow-up of 22 months). The data demonstrated an overall survival and disease-free survival of 63% (95% CI, 53%-73%) and 56% (95% CI, 47%-67%) at three years, respectively, as well as durable long-term hematopoiesis and immune competence. Learn More

Overall well-being health-related quality of life scores for patients treated with omidubicel demonstrated clinical benefit compared to standard of care. A study titled, Health-Related Quality of Life Following Allogeneic Hematopoietic Stem Cell Transplantation with Omidubicel Versus Standard Umbilical Cord Blood featured an analysis of 108 patients that completed validated health-related quality of life (HRQL) surveys on screening and days 42, 100, 180, and 365 post-transplant. Measures of physical and functional well-being and other HRQL scores were more favorable with omidubicel. These data suggest clinically meaningful and sustained improvements in physical, functional, and overall well-being compared to umbilical cord blood transplantation. Learn More

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types including stem cells and natural killer cells with appropriate growth factors to maintain the cells active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

About Omidubicel

Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.

Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.

About Gamida Cell

Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapy candidates with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of initiation and progress of, and data reported from, the clinical trials of Gamida Cells product candidates (including omidubicel), regulatory filings submitted to the FDA (including the potential timing of the FDAs review of the BLA for omidubicel), commercialization planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cells product candidates (including omidubicel), and Gamida Cells expectations for the expected clinical development milestones set forth herein. Any statement describing Gamida Cells goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to the impact that the COVID-19 pandemic could have on our business, and including the scope, progress and expansion of Gamida Cells clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (SEC) on May 12, 2022, as amended, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cells forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.

1CIBMTR 2019 allogeneic transplants in patients 12+ years with hematological malignancies.2Gamida Cell market research

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Long-Term Data from Omidubicel Phase 3 Trial Demonstrates Overall Survival and Sustainable Durable Outcomes for Patients with Blood Cancers at the...

To employ this technology for patient imaging and to aid in interpreting outcomes from stem cell therapy and gene therapy trials for inherited retinal illnesses.

FREMONT, CA: Optoretinography is an imaging technique that examines light-induced functional activity in the retina, the network of neurons at the back of the eye responsible for detecting light and initiating vision. Researchers have devised a simple and rapid method for doing optoretinography. Retinal illnesses, such as macular degeneration and diabetic retinopathy, afflict over half of the U.S. population over 60. Researchers have previously utilized adaptive optics and optical coherence tomography (OCT) to view and track these neurons in the living, moving eye and then employed motion correction techniques to stabilize the images and extract the functional response. These illnesses impair the retina's function in ways that can lead to blindness if left untreated. The new strategy could expedite the discovery of novel eye disease medicines.

Monitoring form change: Optoretinography identifies minute alterations in the structure of neurons that create or transmit retinal signals. This expensive and time-consuming procedure includes resolving and recording the position of individual cellular characteristics and using those positions to assess if the cell's shape has altered. The requirement is to determine and monitor individual neurons by measuring the velocity, or speed, at which retinal neurons move relative to one another. While utilizing adaptive optics systems to do optoretinography measurements, the experiment can easily take a half-day and generate a terabyte of data that must analyze. Processing the data to obtain a functional signal requires a minimum of two additional days.

Measuring neuronal activity

For velocity-based optoretinography, the researchers created a new OCT camera that enables a single operator to collect retinal images from more sites than is possible with previous optoretinography methods. The innovative procedure is by collecting measurements from three participants in good health. In under ten minutes, they could collect data from each patient, a process that data, and make the results public. They demonstrated that the functional optoretinographic responses obtained with the simple method were proportional to the light stimulus dose and that the dose-stimulus response was reproducible across subjects. The researchers would like to adapt the new optoretinography technique to animal models of retinal illness.

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Innovative Imaging Techniques to Accelerate the Discovery of New... - Healthcare Tech Outlook

THE family of a Scots dad who was left fighting for his life following a horror attack are fundraising for stem cell therapy treatment.

Kevin Hammond, from Castlemilk, sustained a brain injury after a brutal attack outside The Braes pub in Rutherglen on December 8, 2019.

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The 54-year-old was put in an induced coma and spent weeks in intensive care before being transferred to a high-dependency unit at the Queen Elizabeth University Hospital.

He had part of his skull removed to relieve the pressure on his brain.

Ryan Wilson, from Cambuslang, was previously jailed for four-and-a-half years after he admitted assaulting Kevin to his severe injury, permanent impairment, and to the danger of his life.

Three years on, Celtic-daft dad Kevin is still struggling with his devastating injury and is still unable to talk.

His family are now fundraising for a stem cell therapy treatment in Switzerland in the hope of improving his quality of life.

His daughter Ashley, 29, told the Daily Record: Were just trying to get his life as back to normal as possible. Its three years down the line and hes stuck in the house. He still cant talk so he needs 24/7 care and we communicate through his phone. Before all this, his family, his friends and his work were his life.

He enjoyed coming home on a Friday night after finishing his shift before heading away out for a pint with his pals. His life has just completely turned upside down now. He was left fighting for his life in a coma and we didnt know if he would ever wake up.

He had to get part of his skull removed because he was getting continuous blood clots and swelling of the brain. They put the skull into his stomach so his body wouldnt reject it when they put it back. They then had to bring that surgery forward because he wasnt coping. He went all off balance.

Most read in The Scottish Sun

He still to this day has problems with that, like his hand and general weakness down one side of his body. This is his way of life now.

Donations can be made via Kevin's GoFundMe page.

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Celtic-mad dad left unable to talk after horror attack as family fundraise for stem cell therapy... - The Scottish Sun

Chicago, Sept. 14, 2022 (GLOBE NEWSWIRE) -- Stem Cell Therapy Marketis projected to reach USD 558 million by 2027 from USD 257 million in 2022, at a CAGR of 16.8% during the forecast period, according to a new report by MarketsandMarkets. Key drivers of the stem cell therapy market include increase in stem cell research funding, expanding number of clinical trials related to stem cell therapies, and growing number of GMP-certified cell therapy production facilities. However, high costs associated with the development of stem cell therapy along with the ethical concerns related to embryonic stem cells are likely to hamper the market growth to a certain extent.

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Browse in-depth TOC on "Stem Cell Therapy Market"155 Tables 43 Figures 166 Pages

The adipose tissue-derived MSCs segment dominates the cell source market in the stem cell therapy through 2020-2027.

The global stem cell therapy market is segmented into adipose tissue-derived MSCs (mesenchymal stem cells), bone marrow-derived MSCs, placenta/umbilical cord-derived MSCs, and other cell sources. Adipose-derived stem cell tissues can be obtained easily and also possess a variety of the regenerative properties similar to other mesenchymal stem cells/tissues. These cells are multipotent and are easy to isolate & harvest; these qualities have collectively rendered the adipose tissue-derived MSCs segment highest revenue in 2021.

In 2021, the musculoskeletal disorders ranked first in terms of revenue in the stem cell therapy market.

Based on therapeutic application, the global stem cell therapy market is segmented into musculoskeletal disorders, wounds & injuries, cardiovascular diseases, surgeries, inflammatory & autoimmune diseases, neurological disorders, and other therapeutic applications. In 2021, the musculoskeletal disorders application segment accounted for the largest share of the stem cell therapy market. Increasing market availability of stem cell-based therapeutic products across major markets and the growing patient preference for effective & early treatment strategies are driving the growth of this segment.

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The Asia Pacific region is the fastest-growing region of the stem cell therapy market in 2021.

The Asia Pacific region is estimated to grow at the highest CAGR in the stem cell therapy market during the forecast period. Japan and South Korea are the key revenue contributors of the Asia Pacific stem cell therapy market. Favorable government support for product approvals and the presence of major players in these countries are anticipated to drive the regional market growth.

The stem cell therapy market is consolidated in nature with prominent players in the stem cell therapy market include Smith+Nephew (UK), MEDIPOST Co., Ltd. (South Korea), Anterogen Co., Ltd. (South Korea), CORESTEM (South Korea), Pharmicell Co., Ltd. (South Korea), NuVasive, Inc. (US), RTI Surgical (US), AlloSource (US), JCR Pharmaceuticals Co., Ltd. (Japan), Takeda Pharmaceutical Company Limited (Japan), Holostem Terapie Avanzate Srl (Italy), Orthofix (US), Regrow Biosciences Pvt Ltd. (India), and STEMPEUTICS RESEARCH PVT LTD. (India).

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Stem Cell Manufacturing Market by Product (Consumables, Instrument, HSCs, MSCs, iPSCs, ESCs), Application (Research, Clinical (Autologous, Allogenic), Cell & Tissue Banking), End User (Pharma & Biotech, Hospitals, Tissue Bank) - Global Forecast to 2026

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Stem Cell Therapy Market worth $558 million by 2027 Exclusive Report by MarketsandMarkets - Benzinga

Five people with the autoimmune condition lupus are now in remission after receiving a version of CAR-T therapy, which was originally developed for cancer

By Clare Wilson

Illustration of a CAR-T cell

CHRISTOPH BURGSTEDT/SCIENCE PHOTO LIBRARY

A high-tech cell therapy used to treat cancer has been repurposed as a treatment for lupus, an autoimmune condition that can cause joint, kidney and heart damage.

CAR T-cell therapy has put all five people with lupus treated so far into remission. The participants have been followed up for an average of 8 months, with the first person treated 17 months ago. Thats kind of unheard of, says Chris Wincup at Kings College London, who wasnt involved in the study. This is incredibly exciting.

But it is too soon to know how long the remissions will last, says Georg Schett at the University of Erlangen-Nuremberg in Germany, who was part of the study team.

CAR T-cells were developed to treat blood cancers that arise when B cells, a type of immune cell that normally makes antibodies, start multiplying out of control.

The approach requires taking a sample of immune cells from a persons blood, genetically altering them in the lab so they attack B cells and then infusing them back into the individuals blood. It seems to put 4 out of 10 people with these kinds of cancers into remission.

Lupus, also called systemic lupus erythematosus, is caused by the immune system mistakenly reacting against peoples own DNA. This is driven by B cells making antibodies against DNA released from dying cells.

It is currently treated with medicines that suppress the immune system or, in more severe cases, with drugs that kill B cells. But the treatments cant kill all the B cells, and if the disease flares up badly, some people develop kidney failure and inflammation of their heart and brain.

Schett and his team wondered whether using CAR T-cells to hunt down all the B cells would be more effective. Within three months of receiving the treatment, all five participants were in remission, without needing to take any other medicines to control their symptoms.

The CAR T-cells were barely detectable after one month, and after three and a half months, the volunteers B cells started to return, having been produced by stem cells in bone marrow. These new B cells didnt react against the DNA.

We dont know what normally causes B cells to start reacting against DNA in people with lupus, so it is possible that some kind of trigger may start the process happening again, says Wincup.

The achievement means CAR T-cells may also be useful against other autoimmune diseases that are driven by antibodies, such as multiple sclerosis (MS), in which the immune system attacks nerves, says Schett.

Another radical treatment for MS involves rebooting the immune system by destroying it with chemotherapy. By comparison, CAR T-cells would be less invasive and more tolerable, he says.

But it is too soon to know how effective CAR T-cells will be for autoimmune conditions, says Wincup. This is a small number of patients, so we dont know if this is going to be the result for everyone.

When used in cancer, CAR T-cells are expensive to create for each person, so they may only be used for autoimmune conditions in people with severe disease when no other treatments are available, he says.

Journal reference: Nature Medicine , DOI: 10.1038/s41591-022-02017-5

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Radical lupus treatment uses CAR T-cell therapy developed for cancer - New Scientist

Chicago, Sept. 14, 2022 (GLOBE NEWSWIRE) -- Stem Cell Therapy Marketis projected to reach USD 558 million by 2027 from USD 257 million in 2022, at a CAGR of 16.8% during the forecast period, according to a new report by MarketsandMarkets. Key drivers of the stem cell therapy market include increase in stem cell research funding, expanding number of clinical trials related to stem cell therapies, and growing number of GMP-certified cell therapy production facilities. However, high costs associated with the development of stem cell therapy along with the ethical concerns related to embryonic stem cells are likely to hamper the market growth to a certain extent.

Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=48

Browse in-depth TOC on "Stem Cell Therapy Market155 Tables 43 Figures 166 Pages

The adipose tissue-derived MSCs segment dominates the cell source market in the stem cell therapy through 2020-2027.

The global stem cell therapy market is segmented into adipose tissue-derived MSCs (mesenchymal stem cells), bone marrow-derived MSCs, placenta/umbilical cord-derived MSCs, and other cell sources. Adipose-derived stem cell tissues can be obtained easily and also possess a variety of the regenerative properties similar to other mesenchymal stem cells/tissues. These cells are multipotent and are easy to isolate & harvest; these qualities have collectively rendered the adipose tissue-derived MSCs segment highest revenue in 2021.

In 2021, the musculoskeletal disorders ranked first in terms of revenue in the stem cell therapy market.

Based on therapeutic application, the global stem cell therapy market is segmented into musculoskeletal disorders, wounds & injuries, cardiovascular diseases, surgeries, inflammatory & autoimmune diseases, neurological disorders, and other therapeutic applications. In 2021, the musculoskeletal disorders application segment accounted for the largest share of the stem cell therapy market. Increasing market availability of stem cell-based therapeutic products across major markets and the growing patient preference for effective & early treatment strategies are driving the growth of this segment.

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The Asia Pacific region is the fastest-growing region of the stem cell therapy market in 2021.

The Asia Pacific region is estimated to grow at the highest CAGR in the stem cell therapy market during the forecast period. Japan and South Korea are the key revenue contributors of the Asia Pacific stem cell therapy market. Favorable government support for product approvals and the presence of major players in these countries are anticipated to drive the regional market growth.

The stem cell therapy market is consolidated in nature with prominent players in the stem cell therapy market include Smith+Nephew (UK), MEDIPOST Co., Ltd. (South Korea), Anterogen Co., Ltd. (South Korea), CORESTEM (South Korea), Pharmicell Co., Ltd. (South Korea), NuVasive, Inc. (US), RTI Surgical (US), AlloSource (US), JCR Pharmaceuticals Co., Ltd. (Japan), Takeda Pharmaceutical Company Limited (Japan), Holostem Terapie Avanzate Srl (Italy), Orthofix (US), Regrow Biosciences Pvt Ltd. (India), and STEMPEUTICS RESEARCH PVT LTD. (India).

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Related Reports:

Stem Cell Manufacturing Market by Product (Consumables, Instrument, HSCs, MSCs, iPSCs, ESCs), Application (Research, Clinical (Autologous, Allogenic), Cell & Tissue Banking), End User (Pharma & Biotech, Hospitals, Tissue Bank) - Global Forecast to 2026

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Stem Cell Therapy Market worth $558 million by 2027 Exclusive Report by MarketsandMarkets - GlobeNewswire

Jasper Therapeutics

JSP191 is currently being evaluated in four ongoing clinical studies in allogeneic hematopoietic stem cell transplant in patients with Acute Myeloid Leukemia (AML) / Myelodysplastic Syndromes (MDS), SCID, Fanconi anemia and Sickle Cell Disease

On track to initiate a new study of JSP191 as a therapeutic in second-line therapy for patients with lower-risk MDS later this year

REDWOOD CITY, Calif., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR), a biotechnology company focused on developing multiple new therapies for the field of stem and cellular medicine, today announced that JSP191, an anti-CD117 monoclonal antibody, has received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with severe combined immunodeficiency (SCID) undergoing allogeneic hematopoietic stem cell transplant. To date, JSP191 has been studied in 14 SCID patients in an ongoing multicenter clinical trial with clinical outcome data presented at academic medical conferences.

Patients born with SCID have a severely compromised immune system and need to rely on an allogeneic hematopoietic stem cell transplant to create the immune cells needed to fight infection, said Ronald Martell, President and Chief Executive Officer of Jasper Therapeutics. Unfortunately many patients are too fragile to tolerate the toxic chemotherapy doses typically used in transplant, and may suffer severe side effects or fail transplant. Along with the FDAs previous designations of Orphan and Rare Pediatric Disease for JSP191, this new Fast Track designation recognizes the potential role of JSP191 in improving clinical outcomes for these patients and will allow us to more closely work with the FDA in the upcoming months to determine a path toward a Biologics License Application (BLA) submission.

The FDAs Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill unmet medical needs. The purpose is to accelerate the development of important new drugs for patients. Drugs granted Fast Track designation are eligible for more frequent meetings with the FDA to discuss the drugs development plan and ensure the collection of appropriate data needed to support approval, as well as eligibility for Accelerated Approval, Priority Review and Rolling Review if relevant criteria are met.

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About JSP191

JSP191 is a humanized monoclonal antibody that blocks stem cell factor receptor signaling leading to the clearance of hematopoietic stem and progenitor cells from the bone marrow. JSP191 is in clinical development as a stem cell transplant conditioning agent where it helps create an empty space for donor or gene-corrected transplanted stem cells to engraft. While hematopoietic cell transplantation can be curative for patients, its use is limited because standard high-dose myeloablative conditioning is associated with severe toxicities and standard low-dose conditioning has limited efficacy. To date, JSP191 has been evaluated in more than 110 healthy volunteers and patients. Four clinical trials for myelodysplastic syndromes (MDS)/ acute myeloid leukemia (AML), severe combined immunodeficiency (SCID), Fanconi anemia (FA) and Sickle Cell Disease undergoing allogeneic transplant are currently ongoing. JSP191 is also planned to enter clinical development as a second-line therapeutic in transfusion-dependent, lower-risk MDS patients to preferentially drive recovery of healthy hematopoietic stem cells in order to help restore normal hematopoiesis.

About Jasper Therapeutics

Jasper Therapeutics is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, an anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow in patients undergoing hematopoietic cell transplantation. It is designed to enable safer and more effective curative allogeneic hematopoietic cell transplants and gene therapies. Clinical study of JSP191 as a novel, disease-modifying, therapeutic for patients with lower risk MDS is also planned to begin in 2022. In parallel, Jasper Therapeutics is advancing its preclinical mRNA hematopoietic stem cell grafts platform, which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases and autoimmune diseases than is possible today. For more information, please visit us at jaspertherapeutics.com.

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as believe, may, will, estimate, continue, anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future, outlook and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding any potential benefits of the Fast Track Designation for JSP191, the potential for JSP191 to significantly improve clinical outcomes, the potential for JSP191 to address the limitations of transplant conditioning, the potential plans to initiate clinical development of JSP191 and any potential Biologics License Application for JSP191 and the expected timing for initiating clinical studies and trials. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper Therapeutics and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Jasper Therapeutics. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper Therapeutics develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Jasper Therapeutics product candidates; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper Therapeutics will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that final study data may not be consistent with preliminary study data; the risk that Jasper Therapeutics product candidates may not be beneficial to patients or successfully commercialized; the risk that Jasper Therapeutics has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper Therapeutics business; the risk that third parties on which Jasper Therapeutics depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper Therapeutics business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic; the risk that Jasper Therapeutics will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others and other risks and uncertainties indicated from time to time in Jasper Therapeutics public filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper Therapeutics assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Jasper Therapeutics does not presently know, or that Jasper Therapeutics currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. While Jasper Therapeutics may elect to update these forward-looking statements at some point in the future, Jasper Therapeutics specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper Therapeutics assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts:

John Mullaly (investors)LifeSci Advisors617-429-3548jmullaly@lifesciadvisors.com

Jeet Mahal (investors)Jasper Therapeutics650-549-1403jmahal@jaspertherapeutics.com

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Jasper Therapeutics Announces FDA Fast Track Designation for JSP191, a novel monoclonal antibody targeting CD117, in the treatment of patients with...

In a retrospective analysis of 115 patients with relapsed/refractory multiple myeloma who progressed after therapy on a bispecific antibody, researchers found that the myeloma patients can be salvaged with sequential T-cell redirection therapy.

While the depth and duration of response to bispecific antibodies do not predict how patients with multiple myeloma will respond to CAR T-cell therapy as a second-line treatment, the T-cell therapy is effective for this patient population, according to data published in Blood Advances.1

In a retrospective analysis of 115 patients with relapsed/refractory multiple myeloma (RRMM) who progressed after therapy on a bispecific antibody, phase 1 dose escalation or phase 2 clinical trial researchers found that the myeloma patients can be salvaged with sequential T-cell redirection therapy.

This T-cell therapy led to an 84% (95% CI, 60%-97%) overall response rate (ORR), but median overall survival (OS) was not reached at a 30.5-month follow-up. Moreover, the clinical benefit rate favored patients on T-cell therapy at 84% (95% CI, 60%-97%) compared with 54% (95% CI, 37%-70%) in the non-T-cell redirection arm.

Eight patients given T-cell redirection as first salvage therapy (FST) had a complete response (CR), 4 had a stringent CR (sCR), 4 had a partial response, 1 patient had stable disease, and 2 patients had partial disease. In the non-T-cell redirection arm (n = 39), there were no sCRs, 1 CR, 4 very good partial responses, 14 partial responses, 2 had minimal responses (MR), 8 had stable disease, and 10 patients had partial disease.

Of the 115 patients that failed bispecific antibody treatment, 58 patients went on to receive their FST with either T-cell redirection or a non-T- cell redirection therapy, such as chemotherapy. Nineteen patients were given T-cell redirection as their FST with 32% of these patients needing to receive a second salvage therapy (SST) due to a relapse of non-response to therapy. In comparison, 79% of patients given a non-T-cell redirected therapy needed a SST with some of these patients moving on to T-cell redirected therapy for a total of 28 patient that ultimately received T-cell redirected therapy.

Our data suggests that after treatment with a bispecific antibody, this high-risk patient population can still exhibit favorable outcomes when exposed again to T-cell redirection therapeutics such as other bispecific antibodies and CAR T-cell therapy, the researchers wrote in their published results. While conventional salvage therapy had a relatively good ORR of around 50%, it did not lead to durable responses, which translated to significantly lower [progression-free survival (PFS)] and OS.

While the researchers noted the survival results were not durable, nor significant, they did favor the initial 19 patients given T-cell redirection therapy as FST. The median PFS1 of these patients was 28.9 months (95% CI, 18.7-NE), compared to 2.6 months (95% CI, 1.9-4.1) in the non-redirection arm. Within the 19 patients, those who received a bispecific antibody as FST had a median PFS of 18.7 months (95% CI, 2.3-18.7) vs the 9 patients who got CAR-T cell therapy who did not reach their median PFS1 (95% CI, 28.9-NE), however, this finding was not statistically significant.

PSF2 was also evaluated due to the additional patients that moved to T-cell redirection therapy with the researchers observing a median PFS2 of 30.9 months (95% CI, 21.3%-37.3%) in the 28 patients given T-cell redirection as either FST or SST, compared with 5.7 months (95% CI, 3.7-7.7) for the 30 patients the didnt receive T-cell redirection therapy as either FST or SST.

OS was not reached among patients with T-cell redirection as FST nor patients on CAR T-cell therapy, but comparisons to patients in the other arm were not statistically significant. Sixty-two percent (95% CI, 44%-88%) of patients given T-cell redirection therapy had an OS at 2 years compared with to 24% (95% CI, 11%-49%) at 2 years for the remaining 30 patients.

As the clinical use and advancement of T-cell redirection therapies continue to grow, effective strategies are needed to manage outcomes for patients who relapse or are unresponsive to this initial treatment, said senior author of the study Samir Parekh, MD, director of Translational Research in Myeloma, co-leader of the Cancer Clinical Investigation program at The Tisch Cancer Institute, and a member of the Icahn Genomics Institute at the Icahn School of Medicine at Mount Sinai.2 This study shows patients relapsing after initial bispecific antibodies therapy can benefit from a second bispecific antibody or CAR T-cell therapy.

Patients in the analysis were treated on phase 1/2 trials and were a median of 60 years old at diagnosis and 67 years old at the time of their FST. Most patients in the analysis had IgG multiple myeloma with that subtype making up 50% of the T-cell redirection group. Moreover, 78% of patients overall were considered high-risk with 88% being triple-refractory and 84% progressed after being on pomalidomide (Pomalyst). Fifty-nine percent of patients had 1 prior autologous stem cell transplant.

All patients observed in the analysis were on bispecific antibody studies conducted at the Tisch Cancer Center at Mount Sinai hospital.

Future clinical trials incorporating sequential combinations of T-cell redirection therapy will build upon these findings to further develop treatment guidelines and improve long-term outcomes for multiple myeloma patients, Parekh said.

The rest is here:
T-Cell Redirection Therapy Shows Promise As Salvage Therapy in R/R Multiple Myeloma - Targeted Oncology

This facility will support the late-stage clinical development and commercialization of Orca Bios precision cell therapies, including Orca-T, which is currently being evaluated in a Phase 3 registrational trial.

The new facility is located in Sacramento's newly developed Metro Air Park next to the Sacramento International Airport, enabling direct shipping access to transplant centers across the US. It is also in close proximity to Orca Bio's existing clinical manufacturing building.

The facility is uniquely tailored to manufacture precision cell therapies designed to replace cancerous blood and immune systems with healthy ones. It will include modular production suites, which are adjustable for future growth, quality control laboratories, warehouse space and offices.

The site will have the capacity to manufacture around 3,000 cell therapy products a year: thus allowing the company to scale to meet future demand and providing the critical infrastructure to enable Orca Bio to expand its pipeline.

Construction has already begun and is scheduled to be completed later this year, with the facility set to be fully validated and operational in the first half of 2023.

Orca Bio uses precision cell selection technology to identify the less than 1% of the 100 billion donor cells that potentially contain therapeutic benefits for patients. These cells are then manufactured into potentially curative cell therapies designed to maximize efficacy of treatment and significantly limit treatment-related risks.

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

At the head of its pipeline is Orca-T: which recently entered a Phase 3 study for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndromes (MDS).

Throughout the clinical development of our products, we have demonstrated the ability to reliably manufacture and deliver high-precision cell therapies with rapid turnaround times, regardless of donor and patient location, said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio.

This new facility will further enhance our capabilities to deliver our therapies urgently and seamlessly to patients at scale, while meeting the highest quality and regulatory standards.

Link:
Orca Bio expands manufacturing capabilities to take cell therapies through to commercialization - BioPharma-Reporter.com