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

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...

Sierra Space, UC San Diego Partner to Develop the First Stem Cell Research Institute in Space – Business Wire

LOUISVILLE, Colo.--(BUSINESS WIRE)--Sierra Space, a leading commercial space company at the forefront of building the future of space transportation and infrastructure for low-Earth orbit (LEO) commercialization, and University of California San Diego, one of the worlds top 15 research universities and a leader in microgravity research, have formed a new agreement with the goal of defining the future of human health care research in space.

In a new Memorandum of Understanding (MOU) between the two organizations, Sierra Space and UC San Diego agreed to collaborate on Orbital Reef, the first commercial space station in LEO, to expand the universitys Integrated Space Stem Cell Orbital Research (ISSCOR) program, which is currently operational on the International Space Station (ISS). Together they will help define and shape the future of biotech and biopharma research and development in microgravity.

This agreement with UC San Diego is a major breakthrough in human health care research conducted in space and signals the beginning of a new era of discovery, said Tom Vice, Sierra Space CEO. Through our collaboration, the highly impactful work that researchers are already doing on the International Space Station today can expand and deliver even greater impact for humanity. As the ISS completes its time in service, UC San Diego will now have a place to grow and expand its vital research in biotech and biopharma with full, on-orbit biomanufacturing and biofabrication centers to foster breakthrough advancements and products in medical science that will benefit all life on Earth.

Microgravity and radiation exposure in low-Earth orbit offers a unique opportunity to study stem cell aging and pre-cancer development in a compressed time frame in a manner that is unavailable on Earth, said Catriona Jamieson, MD, PhD, a stem cell biologist, hematologist and director of the new UC San Diego Sanford Stem Cell Institute, funded with a $150 million gift from philanthropist T. Denny Sanford.

In collaboration with NASA, our Integrated Space Stem Cell Orbital Research team has launched six missions carrying stem cells and stem cell-derived organoids into LEO. We are learning things that we never could under normal gravity; knowledge that can elevate the search for new pre-cancer diagnostics and therapeutics that eradicate cancer at its earliest stages into addition to a broad array of degenerative diseases that arise as a result of stem cell dysfunction.

UC San Diego will provide input to Sierra Space on the design and concept of operations for providing new, state-of-the-art biomanufacturing, biofabrication and related in-space laboratory capabilities and services to industry, academia and government researchers. The university will also participate in a Sierra Space-led in-space biomanufacturing research consortium of industry, academia, philanthropic and government researchers that will focus on R&D objectives, priorities and technical requirements.

Sierra Space will lead the development, launch and deployment of space habitats to establish the necessary infrastructure for UC San Diego and other partners to conduct microgravity research and in-space manufacturing. The companys Dream Chaser spacecraft, the worlds only winged commercial spaceplane, will provide transportation to LEO, while its Large Integrated Flexible Environment (LIFE) modules will offer ample habitable spaces in which to live and work on orbit.

Sierra Space recently made two key appointments to lead development of research capabilities for future LEO commercialization. Dr. Jonathan Volk, Senior Manager of In-Space Manufacturing and Advanced Materials joined the company from Space Commerce Matters where he was the Director of Commercialization Strategies. Prior to this role, Volk was the Commercial Innovation Manager for Physical and Materials Science at the Center for the Advancement of Science in Space (CASIS), which managed the U.S. National Laboratory on the ISS. Dr. Marc Giulianotti takes on the role of Senior Manager, In-Space Biomanufacturing, joining Sierra Space from his role as Director of Science and Technology with the ISS U.S. National Laboratory. Dr. Giulianotti also has more than 20 years working in early drug discovery efforts at the Torrey Pines Institute for Molecular Studies. Both Volk and Giulianotti will focus on advancing the transformative research and technologies in the commercial space destinations of the future.

About Sierra Space

Sierra Space (www.sierraspace.com) is a leading commercial space company at the forefront of innovation and the commercialization of space. Sierra Space is building platforms in space to benefit life on Earth. The company is in the latter stages of doubling its headcount, with large presences in Colorado, Florida and Wisconsin. Significant investors in Sierra Space include General Atlantic, Coatue, and Moore Strategic Ventures.

With more than 30 years and 500 missions of space flight heritage, Sierra Space is enabling the future of space transportation with Dream Chaser, the worlds only winged commercial spaceplane. Under construction at its Colorado headquarters and expected to launch in 2023 on the first of a series of NASA missions to the International Space Station, Dream Chaser can safely carry cargo - and eventually crew - to on-orbit destinations, returning to land on compatible commercial airport runways worldwide. Sierra Space is also building an array of in-space destinations for low-Earth orbit (LEO) commercialization including the LIFE (Large Integrated Flexible Environment) habitat at the Kennedy Space Center in Florida, a three-story commercial habitation and science platform designed for LEO. Both Dream Chaser and LIFE are central components to Orbital Reef, a mixed-use business park in LEO being developed by principal partners Sierra Space and Blue Origin, which is expected to be operational by 2027.

About UC San Diegos Sanford Stem Cell Clinical Center

Sanford Stem Cell Clinical Center (Sanford Center) is among the Universitys most highly visible and top priority interdisciplinary and multi-institutional programs. Sanford Center provides essential physical and human resources needed to leverage stem cell research currently being conducted at UC San Diego. Due to the complexity of regenerative medicine projects and substantial institutional investment, on a daily basis Sanford Center personnel works with a large variety of departments in Health Sciences, Health System, and the school of engineering.

As part of UC San Diego Health, Sanford Center motivates University-wide change and sustainability, focusing on creating the structure under which various innovative regenerative medicine units and initiatives are developed. Sanford Center has led several successful and highly visible interdisciplinary faculty recruitments, committing to over $48M towards faculty start-up, retention, and research funds for over 25 faculty members. Sanford Center also played a pivotal role in securing over $77M of grants from California Institute of Regenerative Medicine (CIRM), awarded respectively to dept. of Bioengineering, Pediatrics, Cellular & Molecular Medicine, Medicine, Neurosciences, and Sanford Center.

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Therapeutic Solutions International Identifies CD103 Expressing Dendritic Cells and Exosomes Thereof as Novel Mechanism for JadiCell Mesenchymal Stem…

Clinical Stage Stem Cell Company Leverages Knowledge Gained from Cancer Dendritic Cell Therapy StemVacs to Open New Door for COPD and ARDS Research

ELK CITY, Idaho, October 03, 2022--(BUSINESS WIRE)--Therapeutic Solutions International (TSOI) announced today new data suggesting that therapeutic effects of its universal donor stem cell product are mediated in part through CD103 expressing dendritic cells.

In a series of experiments, it was found that protection against both Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Distress Syndrome (ARDS) could be transferred to nave mice by dendritic cells expressing the molecule CD103. Furthermore, exosomes, which are nanoparticles produced by cells, were capable of transferring protection to nave mice.

"I am pleased to have worked with a team of opinion leaders that are at the cutting edge to have discovered this quite unexpected finding," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "While the field of exosome therapeutics is growing exponentially, the use of dendritic cell exosomes for respiratory conditions is completely unheard of."

Therapeutic Solutions International is currently running a Phase III clinical trial using JadiCells in the treatment of COVID-19 associated ARDS. Additionally, the Company has an Investigational New Drug Application IND# 28508 for treatment of COPD, for which the Company is still in discussions with the FDA.

"Dr. Veltmeyer has performed unparalleled work in advancing both clinical translation of the JadiCell, as well as leveraging scientific lessons learned from our cancer program to identify a new mechanism by which our cells exert this previously unknown therapeutic efficacy," said Timothy Dixon, President, and CEO of the Company. "Having filed our patent today on this new finding, we anticipate potential development of adjuvant products around dendritic cell generated exosomes."

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About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is http://www.therapeuticsolutionsint.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221003005541/en/

Contacts

Timothy G. Dixon ir@tsoimail.com

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Growth in Cell and Gene Therapy Market – Pharmaceutical Technology Magazine

Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.

Cell and gene therapies (CGTs) offer significant advances in patient care by helping to treat or potentially cure a range of conditions that have been untouched by small molecule and biologic agents. Over the past two decades, more than 20 CGTs have been approved by FDA in the United States and many of these one-time treatments cost between US$375,00 and US$2 million a shot (1). Given the high financial outlay and patient expectations of these life-saving therapies, it is essential that manufacturers provide integrated services across the whole of the supply chain to ensure efficient biomanufacturing processes and seamless logistics to reduce barriers to uptake.

The following looks at the who, what, when, and why of biomanufacturing and logistics in CGTs in the bio/pharmaceutical industry in more detail.

According to market research, the global gene therapy market will reach US$9.0 billion by 2027 due to favorable reimbursement policies and guidelines, product approvals and fast-track designations, growing demand for chimeric antigen receptor (CAR) T cell-based gene therapies, and improvements in RNA, DNA, and oncolytic viral vectors (1).

In 2020, CGT manufacturers attracted approximately US$2.3 billion in investment funding (1). Key players in the CGT market include Amgen, Bristol-Myers Squibb Company, Dendreon, Gilead Sciences, Novartis, Organogenesis, Roche (Spark Therapeutics), Smith Nephew, and Vericel. In recent years, growth in the CGT market has fueled some high-profile mergers and acquisitions including bluebird bio/BioMarin, Celgene/Juno Therapeutics, Gilead Sciences/Kite, Novartis/AveXis and the CDMO CELLforCURE, Roche/Spark Therapeutics, and Smith & Nephew/Osiris Therapeutics.

Many bio/pharma companies are re-considering their commercialization strategies and have re-invested in R&D to standardize vector productions and purification, implement forward engineering techniques in cell therapies, and improve cryopreservation of cellular samples as well as exploring the development of off-the-shelf allogeneic cell solutions (2).

The successful development of CGTs has highlighted major bottlenecks in the manufacturing facilities, and at times, a shortage of raw materials (3). Pharma companies are now taking a close look at their internal capabilities and either investing in their own manufacturing facilities or outsourcing to contract development and manufacturing organizations (CDMOs) or contract manufacturing organizations (CMOs) to expand their manufacturing abilities (4). Recently, several CDMOsSamsung Biologics, Fujifilm Diosynth, Boehringer Ingelheim, and Lonzahave all expanded their biomanufacturing facilities to meet demand (5).

A major challenge for CGT manufacturers is the seamless delivery of advanced therapies. There is no room for error. If manufacturers cannot deliver the CGT therapy to the patient with ease, the efficacy of the product becomes obsolete. Many of these therapies are not off-the-shelf solutions and therefore require timely delivery and must be maintained at precise temperatures to remain viable. Thus, manufacturers must not only conform to regulations, but they must also put in place logistical processes and contingency plans to optimize tracking, packaging, cold storage, and transportation through the products journey. Time is of the essence, and several manufacturers have failed to meet patient demands, which have significant impacts on the applicability of these agents.

Several CAR T-cell therapies have now been approved; however, research indicates that a fifth of cancer patients who are eligible for CAR-T therapies pass away while waiting for a manufacturing slot (6). Initially, the manufacture of many of these autologous products took around a month, but certain agents can now be produced in fewer than two weeks (7). Companies are exploring new ways to reduce vein-to-vein time (collection and reinfusion) through the development of more advanced gene-transfer tools with CARs (such as transposon, CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) among others, and the use of centralized organization with standardized apheresis centers (5). Others are exploring the use of the of allogeneic stem cells including Regen Biopharma, Escape Therapeutics, Lonza, Pluristem Therapeutics, and ViaCord (7).

Several gene therapies have also been approved, mainly in the treatment of rare disease (8). Many companies are evaluating novel gene therapy vectors to increase levels of gene expression/protein productions, reduce immunogenicity and improve durability including Astellas Gene Therapies, Bayer, ArrowHead Pharmaceuticals, Bayer, Bluebird Bio, Intellia Therapeutics, Kystal Biotech, MeiraGTx, Regenxbio, Roche, Rocket Pharmaceuticals, Sangamo Therapeutics, Vertex Pharmaceuticals, Verve Therapeutics, and Voyager Therapeutics (8).

While many biopharma companies have established their own in-house CGT good manufacturing practice (GMP) operation capabilities, others are looking to decentralize manufacturing and improve distribution by relying on external contracts with CDMOs and CMOs such as CELLforCURE, CCRM, Cell Therapies Pty Ltd (CTPL), Cellular Therapeutics Ltd (CTL), Eufets GmbH, Gravitas Biomanufacturing, Hitachi Chemical Advances Therapeutic Solutions, Lonza, MasTHerCell, MEDINET Co., Takara Bio, and XuXi PharmaTech (6, 9, 10).

The top 50 gene therapy start-up companies have attracted more than $11.6 billion in funds in recent years, with the top 10 companies generating US$5.3 billion in series A to D funding rounds (10). US-based Sana Biotechnology leads the field garnering US$700 million to develop scalable manufacturing for genetically engineered cells and its pipeline program, which include CAR-T cell-based therapies in oncology and CNS (Central Nervous System) disorders (11). In second place, Editas Medicine attracted $656.6 million to develop CRISPR nuclease gene editing technologies to develop gene therapies for rare disorders (12).

Overall, CGTs have attracted the pharma industrys attention as they provide an alternative route to target diseases that are poorly served by pharmaceutical and/or medical interventions, such as rare and orphan diseases. Private investors continue to pour money into this sector because a single shot has the potential to bring long-lasting clinical benefits to patients (13). In addition, regulators have approved several products and put in place fast track designation to speed up patient access to these life-saving medicines. Furthermore, healthcare providers have established reimbursement policies and manufacturers have negotiated value- and outcome-based contracts to reduce barriers to access to these premium priced products

On the downside, the manufacture of CGTs is labor intensive and expensive with manufacturing accounting for approximately 25% of operating expenses, plus there is still significant variation in the amount of product produced. On the medical side, many patients may not be suitable candidates for CGTs or not produce durable response due to pre-exposure to the viral vector, poor gene expression, and/or the development of immunogenicity due to pre-exposure to viral vectors. Those that can receive these therapies may suffer infusion site reactions, and unique adverse events such as cytokine release syndrome and neurological problems both of which can be fatal if not treated promptly (14).

Despite the considerable advances that have been made in the CGT field to date, there is still much work needed to enhance the durability of responses, increase biomanufacturing efficiencies and consistency and to implement a seamless supply chain that can ensure these agents are accessible, cost-effective, and a sustainable option to those in need.

Cleo Bern Hartley is a pharma consultant, former pharma analyst, and research scientist.

Pharmaceutical Technology Volume 46, Number 10 October 2022 Pages: 54-55

When referring to this article, please cite it as C.B. Hartley, "Growth in Cell and Gene Therapy Market," Pharmaceutical Technology 46 (10) 5455 (2022).

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ANDREWS MEDICINE AND CELLTEX THERAPEUTICS CORPORATION JOIN FORCES TO BRING CUTTING EDGE TECHNOLOGIES TO ATHLETIC INJURIES – Yahoo Finance

HOUSTON, Oct. 4, 2022 /PRNewswire/ -- James R. "Jim" Andrews, MD, Chairman and CEO of Andrews Medicine of Pensacola, Florida, and David G. Eller, Chairman and CEO of Celltex Therapeutics Corporation of Houston, Texas, announced today that together they will form a new biotechnology company to bridge the divide between stem cell research and the current treatment of athletic injuries. The jointly owned company will operate under the name of "Andrews Celltex Biologics".

Celltex

The new company will undertake the operation of a Sports Injury Program that includes the Celltex-sponsored FDA developmental study associated with its Investigational New Drug (IND) for the use of Celltex-produced autologous Mesenchymal Stem Cells (MSCs) in the treatment of orthopedic indications. Andrews Medicine will participate in this FDA observed IND research study and will be responsible for selection of participants and administration for this new study. The new venture promises to bring the best medical orthopedic practices of Andrews Medicine for treatment of sports injuries with best practices of Celltex for production of therapeutic quality autologous MSCsas a regenerative component of the treatment. Andrews Celltex Biologics will break new ground with this combined effort. The goal is an FDA approved Biologic License for this Celltex product.

Dr. Andrews said: "I have always known that stem cells, when properly handled, can add value to already effective treatments of inflammatory conditions caused by injury or disease. I am delighted that the FDA has been working with Celltex for studying the safety and efficacy of this combination of Celltex-produced MSCs with traditional medical treatment of multiple sports injury indications. Our know-how and network of sports teams and physicians will add immediate value to our new joint company. I am convinced that Andrews Celltex Biologics will be a leader in this huge growth sector of health care coupled with regenerative medicine."

"Celltex is excited about the opportunity to join forces with one of the best orthopedic and sports medicine companies in the country," said David G. Eller, Chairman and CEO of Celltex. "It is a perfect match. Surgical treatments coupled with Celltex-produced regenerative MSCs will improve recovery time and remediation. This joint effort of the two leading companies in their field will bring cutting edge regenerative health care for sports injuries and beyond."

David Eller continued, "Over the past 11 years, Celltex has developed unique know-how and proprietary technology to produce, in its specially designed cGMP lab, millions of MSCs from a small extraction of a person's adipose tissue. The integrity and vibrancy of the MSCs are of therapeutic quality. Over one trillion MSCs have been produced by Celltex, in its cGMP lab, from individuals wanting their own stem cells reintroduced into their bodies by medical doctors to fight a variety of diseases, especially those caused by inflammatory conditions. Given the autologous nature of Celltex-produced stem cells, there have been no severe adverse events when these stem cells have been reintroduced into the individuals from whom the small, one-time adipose tissue sample had been extracted."

ABOUT ANDREWS MEDICINE OF PENSACOLA, FLORIDA

Andrews Medicine is an integrated healthcare platform built on five decades of research, innovation, and clinical expertise led by internationally recognized orthopaedic surgeon, Dr. James "Jim" Andrews. Widely known as the surgeon for elite athletes from around the world, Dr. Andrews is also a pioneering thought leader in the field of research, injury prevention, new surgical techniques, and practice management. Andrews Medicine brings this experience and expertise to healthcare systems, medical providers, sports organizations, and the communities they serve, ensuring that every patient has access to exceptional clinical care. Read more at: http://www.andrewsmedicine.com

ABOUT CELLTEX THERAPEUTICS CORPORATION

Founded in 2011, Celltex Therapeutics Corporation is a Houston, Texas-based biotechnology company that specializes in the manufacturing and cryopreservation of Mesenchymal Stem Cells (MSCs).Celltex is a leading commercial provider of autologous MSCs for therapeutic use. The Company uses its proprietary technology to isolate, cryopreserve and culture billions of undifferentiated and genetically stable MSCs in its state-of-the-art current Good Manufacturing Practices (cGMP)-compliant laboratory.The Company is dedicated to pioneering technological breakthroughs in regenerative medicine. For more information see: http://www.celltexbank.com

Andrews Medicine

Cision

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Kadimastem Receives Approval of Patent Registration for Its Cell Selection and Enrichment Technology Used to Develop Its IsletRx Treatment for…

This approval of registration in Israel, strengthens the company's demonstrated global leadership including the recent signing of an evaluation agreement with US-based company Implant Therapeutics, Inc.

NESS ZIONA, Israel, Sept. 28, 2022 /PRNewswire/ -- Kadimastem Ltd.(TASE: KDST), a clinical stage cell therapy company developing treatments for ALS and diabetes, has been granted its third patent approval for the company's innovative cell selection and enrichment technology and its use in the production of IsletRx, the company's treatment and potential cure for diabetes. The third patent was awarded by the Israel Patent Office. The patent for the Company's technology was also recently approved and successfully registered in Japan and Australia. This trend is likely to inspire other patent approvals in other important territories such as in the US.

The ability to select and enrich only the highest functioning and purest islet cells from the expanded and differentiated population of pluripotent stem cells enables the maximum therapeutic effect.

The Israel patent is particularly important as it reconfirms the company's production is high quality and more advanced than others. As a result, Kadimastem now has a competitive advantage with regard to future unique collaborations with international companies like Implant Therapeutics, Inc.

On June 8, 2022, Kadimastem announced that it signed an agreement with Implant Therapeutics, Inc. for use of "Immune Evasive Cell" iACT cells, which are implant cells that the immune system does not recognize as foreign to the body and as such can prevent transplant rejection. A joint feasibility study is underway. If successful, the iACTTM cells could be a good cell source for Kadimastem to create its glucose sensing, insulin producing pancreatic cells, the basis for IsletRx, without the need of immune protection or immunosuppression.

In May 2021, the selection technology covered by this patent was described in a peer-reviewed journal articlein Frontiers in Endocrinology.

"Receiving the patent in Israel further strengthens our intellectual property. This patent follows our very recent receipt of a US patent for our ALS technology. Likewise, our diabetes and ALS programs are working at full speed," said Kadimastem CEO Asaf Shiloni. "In the coming year we intend to significantly increase the company's cell production capacity in order to support further pre-clinical trials of IsletRx, continue to examine the efficacy and safety of this product, and enable partnerships to examine encapsulation solutions. The company's management has a vast number of relationships with the companies active in the field, and we anticipate engaging in several cooperations that will significantly advance our diabetes program."

Kadimastem Chief Scientific Officer Professor Michel Revel said, "The technology that this patent protects is an important and unique part of ensuring the quality of the cells for the treatment of diabetes that the company produces from stem cells and gives an advantage to the company's product."

It is estimated that there are more than 550 thousand people living with diabetes in Israel1 with a current local Israel market size estimated at around NIS 3.5 billion2.

About IsletRx The IsletRx product is a clinical-grade collection of pancreatic islet cells. Preclinical studies have shown that the cells are able to detect the sugar levels in the body and to produce, and secrete, on demand, the required amounts of insulin and glucagon, just like a healthy pancreas and enables the insulin dependent patient to avoid an abnormal drop in sugar level (hypoglycemia). In addition, the method of production and selection of the cells enables their implantation in various types of smaller size devices, suitable for maximum comfort for people living with diabetes.

About Kadimastem

Kadimastemis a clinical stage cell therapy company, developing and manufacturing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx, the company's lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications.

IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional, insulin and glucagon producing and releasing pancreatic islet cells, intended to treat and potentially cure patients with insulin-dependent diabetes.

Kadimastem was founded by Professor Michel Revel, CSO of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).

Forward Looking Statement This document may include forward-looking information as defined in the Securities Law, 5728 1968. Forward-looking information is uncertain and mostly is not under the Company's control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company's activity, as well as developments in the general environment and external factors affecting the Company's activity. The Company's results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company's securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future.

Social Media: LinkedIn, Twitter, Facebook

Company Contacts: Asaf Shiloni CEO

s.bazak@kadimastem.com

Press Contact: Marjie Hadad General Manager Must Have Communications 917-790-1178 marjie@mhc-pr.com

[1] https://www.gov.il/he/departments/news/14112021-01

[2] https://www.btl.gov.il/Mediniyut/BakashatNetunim/dohot/Documents/Cost_of_Diabetes.pdf

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Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to the Remestemcel-L BLA for SR-aGVHD – GlobeNewswire

NEW YORK, Oct. 02, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) substantial new information on clinical and potency assay items identified in the Complete Response Letter (CRL) received from FDA in September 2020 to the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Mesoblast has maintained an active dialog with the FDA since receiving the CRL, and the substantial new information submitted to the Investigational New Drug (IND) file for remestemcel-L in the treatment of children with SR-aGVHD, as guided by FDA, represents a major milestone in the Companys complete response to the FDA. Remestemcel-L has been granted Fast Track Designation and BLA Priority Review from the FDA.

Survival outcomes have not improved over the past two decades for children or adults with the most severe forms of SR-aGVHD.1-3 The lack of any approved treatments for children under 12 means that there is an urgent need for a therapy that improves the dismal survival outcomes in children.

The submission summarizes controlled data providing further evidence of remestemcel-Ls ability to save lives, said Dr. Silviu Itescu, Chief Executive of Mesoblast. Additionally, the improved process controls we have put in place to assure robust and consistent commercial product, together with a potency assay that predicts consistent survival outcomes, makes remestemcel-L a compelling treatment for these children.

About Steroid-refractory Acute Graft Versus Host Disease Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, including about 20% in pediatric patients.4,5 SR-aGVHD is associated with mortality as high as 90% and significant extended hospital stay costs.6,7 There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD.

About Mesoblast Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast is developing product candidates for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease, biologic-resistant inflammatory bowel disease, and acute respiratory distress syndrome. Rexlemestrocel-L is in development for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

References / Footnotes

Forward-Looking Statements This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including BLA resubmission), manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblasts expenses, future revenues, capital requirements and its needs for additional financing; Mesoblasts financial performance; developments relating to Mesoblasts competitors and industry; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

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Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to the Remestemcel-L BLA for SR-aGVHD - GlobeNewswire

QC Kinetix (The Heights) Helping Patients Heal Better from Joint Pain Through Houston Heights Sports Medicine – Yahoo Finance

Houston, TX - (NewMediaWire) - October 03, 2022 - Joint pain is one of the leading causes of discomfort among the American populace. It is estimated that more than 65 million American adults suffer from low back pain, while over 16 million deal with acute or chronic joint pain due to arthritis. The number seems to be growing at an alarming rate annually, with the problem spreading to more young adults due to their lifestyle choices, occupation, accidents, and other reasons. QC Kinetix (The Heights) estimates that a whopping number of Americans will be battling chronic joint pain in years to come if no real step is taken.

As a pain control clinic focusing on health and wellness, QC Kinetix (The Heights) understands the health problems associated with heavy medication use to combat joint pain. The lead treatment provider at the clinic noted that more people who depend on medication for pain relief are growing tired and abandoning it because of its negative side effects on their bodies and organs. Others are too scared to consider surgical interventions which offer no real promises of long-term health benefits.

In the face of these health challenges, QC Kinetix (The Heights) is offering a better solution with better healing potential to patients suffering from joint pain and related problems. Speaking on their natural treatment therapies, the clinic's spokesperson maintained that they offer a minimally invasive and natural treatment solution that helps patients avoid the costs, risks, and complications associated with surgeries. He added that their treatment plan is also devoid of medication use, which means patients can significantly dump the unhealthy habit of medication consumption while improving their health and wellness through other natural means.

The clinic's spokesperson noted that their sports and regenerative medicine treatment focuses on each patient's challenges and finds a way to improve their body's natural healing abilities. Speaking on the treatment modality's effectiveness for Houston Heights back pain treatment, Scott Hoots said: "In our QC Kinetix The Heights regenerative medicine clinics, we serve our patients by providing leading regenerative therapies that reduce joint pain associated with direct trauma, a sports-related injury, or a degenerative medical condition. These techniques target the impacted area to reduce inflammation and repair damaged tissue. Our team of medical professionals receives the highest quality training and research to provide our clients with the latest therapies to alleviate their ailments. In addition, we pride ourselves on providing the highest level of respect and care for our clients, as returning their ability to live with pain relief is our primary goal."

Each patient coming into the clinic will have access to a personalized health and wellness service centered around their needs. The treatment providers offer an initial consultation service where they get to learn more about the patient's health, symptoms, past treatments, allergies, and other information. Patients will also have access to a comprehensive examination and physical assessment for diagnostic purposes. Once diagnosed, the team will determine the patient's suitability for the treatment and develop a personalized treatment plan to alleviate their pain and discomfort while equipping the body with the needed building blocks for long-term health and wellness.

Welcoming Houston residents to schedule an appointment, the lead treatment provider at the clinic noted that regenerative medicine offers a wide range of benefits to patients. He maintained that several of their patients have been able to save money and avoid the complications of surgical intervention through their natural treatment plans. He further noted that their minimally invasive treatments are low risks and require a shorter recovery time compared to surgeries. Using stem cell therapy, platelet-rich plasma therapy, Class IV laser therapy, and others, patients will also enjoy positive health benefits like reduced inflammation, pain relief, improved healing, and a better range of motion from the affected joints.

QC Kinetix (The Heights) is currently taking new patients as its appointment slots are filling up fast. The pain control clinic can be reached via phone at (713) 913-5285 or via its website. The clinic is located at 1900 North Loop West, Suite 300, Houston, TX, 77018, US.

Media Contact:

Company Name: QC Kinetix (The Heights)

Contact Person: Scott Hoots

Phone: (713) 913-5285

Address: 1900 North Loop West, Suite 300

City: Houston

State: TX

Postal Code: 77018

Country: USA

Website: https://qckinetix.com/houston/the-heights/

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QC Kinetix (The Heights) Helping Patients Heal Better from Joint Pain Through Houston Heights Sports Medicine - Yahoo Finance

Magrolimab Development Continues for the Treatment of AML and MDS – Targeted Oncology

There are 4 types of CD47 antibodies currently available in the clinic for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). According to Naval G. Daver, MD, a novel option magrolimab, could be the fifth CD47 antibody once data supporting the drug mature.

[Magrolimab] is a CD47 monoclonal antibody that has been combined with azacitidine [Vidaza] in the frontline setting and in a now completed a phase 1b study, which had 2 parts. One was for high-risk MDS patients.The other part was for TP53-mutated frontline AML, stated Daver, an associate professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, in an interview with Targeted OncologyTM.

Daver explained how first, a prospective, phase 1 trial (NCT03248479) evaluated single-agent magrolimab in patients with relapsed/refractory AML. Due to the overall positive findings from this trial, a new phase 3 ENHANCE trial (NCT04313881) has begun enrolling patients.

In the ENHANCE trial, the combination of magrolimab plus azacitidine will be examined vs azacitidine plus placebo in treatment-nave patients with higher-risk MDS. Investigators aim to evaluate the efficacy of magrolimab in combination with azacitidine in this patient population as measured by complete remission and overall survival.

During a panel at the 10th Annual Society of Hematologic Malignancies (SOHO), experts, including Daver, discussed on how to optimize frontline hypomethylating agent (HMA) and venetoclax (Venclexta).

Further, though the combination has only been approved for 4 years, research aims to examine the different ways to move beyond this treatment approach for this patient population as more work is always needed to improve better outcomes for patients.

In the interview, Daver discussed the approved and investigation CD47 monoclonal antibodies for patients with AML and MDS. He also provided a prediction on where research for AML and MDS is headed.

Targeted Oncology: Based on data from preclinical and clinical studies, which in type CD47 agents have shown promise as targeted therapies?

There are 4 different CD47 antibodies in clinic for AML and MDS. The one that has the most advanced clinical data, most mature so far, is a drug called magrolimab. This is a CD47 monoclonal antibody that has been combined with azacitidine in the frontline setting and in a now completed a phase 1b study, which had 2 parts. One was for high-risk MDS patients, including intermediate, high, or very high IPSS patients. The other part was for TP53-mutated frontline AML.

Overall, the data for the MDS patients was that we had 95 patients with this higher risk MDS, and the response rate is encouraging, 75% with a true CR rate of about 33% or 34%. What's interesting is in the subsets that included TP53 mutated, which made up about 25 of those 95 patients, the median survival is quite promising at greater than 16 months. Historically, pretty much in any other study that we have seen in MDS TP53, the survival has been between 9 and 12 months.

This is single arm, but this data looks quite promising. In the non-TP53 subgroup, the median survival has not been reached, with a median follow-up of about 18 months. Overall, it's a single-arm study, so it's hard to know for sure, but this data does look encouraging. This has led to a randomized phase 3 study now ongoing, called the ENHANCE study, which in fact just completed accrual a couple of weeks ago. We're hoping to start seeing some of the primary end point data early next year.

Then the AML study was looking at the most difficult population of AML called TP53-mutated AML patients. In these patients, historically, the response rate is about 30%-40%, with survival about 6-8 months. This is with azacitidine alone, azacitidine/ venetoclax, intensive chemotherapy, low dose cytarabine. With the azacitidine and magrolimab doublet, we're seeing a response rate of close to about 49% or 50% and a true complete response [CR] rate of 34%, which are better than what we have seen in the past with other therapies. Not hugely higher, but they looked to be slightly better response rates.

More importantly, the median survival was around 11 months. Even though that's not very high on its own, it's better than what we have ever seen with TP53. This has also led to a randomized study of azacitidine and magrolimab vs investigator choice, either intensive chemotherapy or azacitidine and venetoclax, and that study is ongoing.

What other CD47 inhibitors are available in this space?

There are other CD47s which are very early and ALX148 [evorpacept] is one of them. One of the potential benefits of evorpacept is it may cause less anemia. There was very early clinical data presented of about 12 patients. Some responses we're seeing, and it is very hard to know at this time if this is going to be in the same efficacy range as with the azacitidine and magrolimab, or different, and we hope for updates.

Then there are others that we don't have much clinical data yet they're ongoing in phase 1 studies such as lemzoparlimab [also known as TJ011133 or TJC4], TTI622, but hopefully, either by the end of this year or early next year, we will see more information from those. It's a very active field and a major target and pathway for clinical development in acute myeloid leukemia and MDS.

What were the key takeaways from your presentation given this year at 10th Annual Meeting of the Society of Hematologic Oncology?

There was a lot of discussion and focus on how to optimize frontline hypomethylating agent and venetoclax and moving beyond HMA and venetoclax. HMA and venetoclax has not been approved that long, it's only been around 4 years. But at MD Anderson Cancer Center, we were involved in and enrolled a large number of patients and led the studies. We realize that even though it's a good breakthrough, at the end of the day, the 3-year survival is about 35%. That is better than 10%, which it was before that for older unfit patients. But still a lot of work has to be done.

What has research focused on over the past few years?

Our effort over the last 2 or 3 years has been to identify molecular biomarkers of resistance. We have found that certain molecular groups like FLT3, TP53, RAS, KIT mutation, don't seem to have the same durability and survival with HMA and venetoclax as other molecular groups like NPM1, IDH1, IDH2, which do well.

Now, we've been trying to design ways to add targeted therapies in patients who don't have as good outcomes but have a particular targetable mutation. Sort of a rationalized personalized improvement of the HMA event. This is where several combos of HMA/venetoclax with second generation FLT3 inhibitor or HMA/venetoclax with an IDH inhibitor, HMA/venetoclax with CD47 for TP53, and coming soon, HMA/venetoclax with menin inhibitors.

Of course, the inherent issue with combining drugs is you have to be aware of and adjust for myelosuppression toxicities. With a lot of these combinations, the response rates are high with HMA and FLT3 and IDH, but we do see that there's an additional myelosuppression. Now we're cutting down the duration of them. FLT3, because of their response being so high, the synergy is good, and you may not need full doses of them. Now we're getting to a point where we are seeing synergy with less myelosuppression. But again, this has to be more mature before it can be adopted widely, but there was a lot of discussion about how we can optimize these doublets and triplets, and what is the benefit of using them upfront in combination vs sequencing. They were all great questions for clinical trials that are starting and will be coming.

What other panels stood out to you at SOHO 2022?

There was a very nice debate on MRD. The question was, is MRD the most critical marker for selecting subsequent therapy or prognosis? Is it the baseline molecular cytogenetic profile of the patient and is that information actually sufficient? Once you have that, do you benefit more from MRD data or not? It's quite a provocative question.

Going into the debate, I think a lot of us would say that MRD is the king and trumps all but both presenters gave very astute and useful arguments from both sides. What is true is that although MRD negativity is a good factor and is usually just associated with sensitivity or not resistance to chemotherapy, it is not really the eventual decision maker for most patients. Case in point, if you have a TP53-mutated AML, and even if they achieve MRD negativity, we would still consider a patient high-risk and go to transplant because we know that the TP53 biology is present in the leukemia stem cells and may be present at a very low level below the detection threshold. We don't feel comfortable that MRD eradication is sufficient to avoid it.

I think the point is that MRD may be useful in certain situations, NPM1, maybe FLT3 where we have effective therapies and presence of MRD. Despite that, effective therapy is poor. Maybe you need to do a transplant earlier. I escalate therapy. But for a large majority, the baseline molecular cytogenetic features, if you can really do them in a comprehensive fashion, will give you the similar predictive value as you would have gotten from MRD. And the advantages, you could get that upfront in the beginning. I think it really speaks to the need to enhance our comprehensive genomic cytogenetic potentially the near future RNA expression data. And hopefully then we can really segregate and triage the appropriate prognostic and therapeutic selection for AML.

What unmet needs still exist in this space?

The whole space is an unmet need because in general for AML, the frontline survival is about 35%-40% if you take all patients. It's a little better in the younger patients, those who are below 65, but the 5-year survival is closer to about 60%-65%. For those who are above 65, it's poor at about 20%-25%. In general, we are looking for new strategies for all of them. The most difficult group is probably in AML is TP53. With these, the median survival is 6-8 months across pretty much every therapy we have tried in the last decade, and the 5-year survival is less than 10%. There's usually a small subset of patients who if they can make a stem cell transplant with some degree of Disease Control, we could hope for 30%-35% long term survival.

Our goal is to get these people quickly to transplant if we can. The other big unmet need, both from a diagnostic perspective and therapeutic perspective is MRD [minimal residual disease]. We are getting better at identifying MRD with more sensitive techniques, especially molecular techniques including In single cell sequencing, potential duplex sequencing, and we're now able to probably get down to 10 raise to minus five or so routinely with some of these technologies. These have not yet been validated in prospective trials, hopefully they will be and then could be used prospectively potentially as Registration Status strategies.

The other big problem is we don't have great MRD eradicating strategies yet in the acute myeloid leukemia like we have in acute myeloid leukemia, lymphoma, and others. There has not yet been a chimeric antigen receptor T or bispecific that has shown that degree of activity, but there are many of these now in early stage or going into clinic. Hopefully, we will have some MRD based therapies. These are probably the 2 biggest areas of unmet need.

Then of course, in any relapse disease, the outcome is still poor. We look for targetable mutations, FLT3 IDH1, IDH2, MLL rearrangement, and for this, we do have targeted therapies with FLT3 inhibitors, IDH inhibitors, Menin inhibitors, but for the others, we still are looking at clinical trial options and nothing has really made a breakthrough yet.

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Magrolimab Development Continues for the Treatment of AML and MDS - Targeted Oncology

Carbon Dioxide Incubators Market to Reach US$ 483.5 Million by 2027 as Application in In Vitro Fertilization Rises – Yahoo Finance

NEW YORK, Oct. 4, 2022 /PRNewswire/ --

Growing Use of IVF and Stem Cell Therapies to Create US$ 323 Million Market Opportunity for Carbon Dioxide Incubator Manufacturers

The carbon dioxide incubators market is well covered by Fact.MR for the upcoming decade. The study looks closely at key growth factors such trends, future projections, and business strategies. The research also provides a thorough analysis of the top segments including product, application, capacity, and region, in order to provide well-rounded perspective.

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Fact.MR A Market Research and Competitive Intelligence Provider: The global carbon dioxide incubators market is likely to reach US$ 483.5 Million by 2027, growing at 8.4% CAGR between 2022 and 2027. Growing investment in research and clinical trial activities is likely to fuel the sales of carbon dioxide incubators during the assessment period. Further, use of carbon dioxide incubators in IVF and stem cell treatments is also likely to drive growth.

The popularity and acceptance of in-vitro fertilizations has grown significantly. According toNational Library of Medicine, around 10% to 15% couples in the U.S. have trouble in having a baby. These challenges have been well-addressed by in vitro fertilization (IVF), owing to which it has become a popular healthcare solution.

Use of in-vitro fertilization (IVF) to help couples in becoming parents is likely to grow in the future, which is likely to drive demand for accessories and equipment used in this process. Owing to this, demand for carbon dioxide incubators is likely to witness an upward trend over the upcoming decade.

Further, sales of carbon dioxide incubators are also likely to increase on account of growth in overall stem cell procedures. For instance, as perHealth Resources and Services Administration, 4,864 unrelated and 4,160 related bone marrow and cold transplants were conducted in the U.S. in 2020. Growing use of stem cell treatment is likely to be a key factor driving the sales of carbon dioxide incubators during the assessment period.

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Globally, North America and Europe are likely to remain at the pinnacle of growth in the carbon dioxide incubators market. The U.S., U.K., France, and Germany are at the forefront of new innovation in R&D, and sales of medical accessories and equipment will also remain high, as per Fact.MR. Owing to these factors, carbon dioxide incubator manufacturers are likely to witness incremental growth opportunities across these regions.

Key Takeaways:

By product, water-jacketed carbon dioxide incubators are likely to reman preferred among end-users.

By capacity, below 100-liter carbon dioxide incubators are expected to witness high demand during the assessment period.

By application, use of carbon dioxide incubators in laboratory research and clinical applications is likely to remain high during the assessment period.

By region, North America and Europe are likely to hold sway over the forecast period, with the U.S. and the U.K. leading the growth.

China and India are expected to create sizeable opportunities for market players on the back of improved healthcare infrastructure.

Growth Drivers:

Increasing applications of carbon dioxide incubators in in-vitro fertilization (IVF) and stem cell treatment is likely to drive the market.

Use of carbon dioxide incubators in cell culture development and tissue engineering is expected to create growth avenues for market players.

Efficiency of incubators in maintaining consistent temperature during genetically modified organism (GMO) cultivation is expected to drive growth.

Advancement in carbon dioxide incubator technology is likely to create new growth avenues for market players.

Restraints:

Carbon dioxide incubators are highly prone to errors due to which they require highly experienced technicians. Due to skill shortage, sales of these incubators can be limited.

Lack of standardization is a longstanding challenge and failure to address this issue might hamper growth.

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Competitive Landscape:

Carbon dioxide incubator manufacturers are focusing on launching innovative technologies to consolidate their position in the market. Further, leading players are concentrating on providing training and guidelines to end-users so their products can be used without any issue.

For instance,

In May 2021, Esco introduced an innovative incubator featuring High Heat Sterilization that is highly effective in eliminating bacteria and vegetative cells.

In January 2020, CO2Meter Inc., launched incubators that regulate and monitor bacterial development patterns.

Key Companies Profiled by Fact.MR

More Valuable Insights on Carbon Dioxide Incubators Market

In its latest study, Fact.MR offers a detailed analysis of the global carbon dioxide incubators market for the forecast period of 2022 to 2027. This study also divulges key drivers and trends promoting the sales of carbon dioxide incubators through detailed segmentation as follows:

By Product:

Water Jacketed

Air Jacketed

Direct Heat

By Capacity:

Below 100 Litres

100-200 Litres

Above 200 Litres

By Application:

By Region:

North America

Latin America

Europe

East Asia

South Asia & Oceania

MEA

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Key Questions Covered in the Carbon Dioxide Incubators Market Report

What is the estimated market size of carbon dioxide incubators in 2022?

At what pace will worldwide carbon dioxide incubators sales increase till 2027?

What factors are driving demand in the carbon dioxide incubators market?

Which region is predicted to lead the worldwide carbon dioxide incubators market between 2022 and 2027?

What are the elements driving carbon dioxide incubators market sales during the forecast period?

What is the expected market estimation of the carbon dioxide incubators market during the forecast period?

Explore Fact.MR's Coverage on the Healthcare Domain

Biological Indicator Incubator Market:The biological indicator incubators market is projected to benefit from rising biopharmaceutical production. The market for biological indicator incubators may continue to increase quickly as a result of the manufacturing of biopharmaceuticals that are grown via cell culture.

Tissue Culture Incubator Market:The introduction of CO2 incubators with infrared radiation control systems and other technological advancements in tissue culture incubators, along with increased funding for tissue-based research, are anticipated to be major factors driving the growth of the tissue culture incubator market over the forecast period.

Pneumatic Nebulizers Market:Pneumatic nebulizer sales are anticipated to grow steadily at a CAGR of 4% and reach a market value of US$ 850.4 million by 2027 from US$ 699 million in 2022. An increase in local healthcare spending and patient awareness has spurred the need for pneumatic nebulizers.

Implantable Medical Devices Market: The global implantable medical devices market is predicted to reach US$ 155 billion by 2027. Key factors driving market growth include rising geriatric population & burden of chronic diseases and increasing demand for cosmetic dentistry.

Disinfection Caps Market: Key factors driving market growth include stringent regulations for safe injection practices and rising prevalence of hospital-acquired infections across the world. The global disinfection caps market is estimated to reach US$ 420 million by 2027.

Check it Out More Reports by Fact.MR on Healthcare Domain

https://www.factmr.com/industry/healthcare

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Fact.MR is a market research and consulting agency with deep expertise in emerging market intelligence. Spanning a wide range from automotive & industry 4.0 to healthcare, technology, chemical and materials, to even the most niche categories. We are committed to deliver insights that help businesses gain deeper understanding of their target markets. We understand that making sense of the vast labyrinth of data can be overwhelming for businesses. That's why focus on offering insights that can actually make a difference to bottom-lines.

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Carbon Dioxide Incubators Market to Reach US$ 483.5 Million by 2027 as Application in In Vitro Fertilization Rises - Yahoo Finance