Gamida Cell Announces Data to Be Presented at 62nd ASH Annual Virtual Meeting – Business Wire

BOSTON--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, today announced that updated data from the ongoing Phase 1 clinical study of GDA-201, an investigational, natural killer (NK) cell-based cancer immunotherapy for the treatment of patients with non-Hodgkin lymphoma, will be presented in an oral presentation at the American Society of Hematology (ASH) 62nd Annual Meeting, which is being held virtually from December 5-8, 2020. NK cell immunotherapies are thought to offer tremendous potential for transforming the care of hematologic malignancies. Gamida Cell is pioneering a novel approach that harnesses the power of its cell expansion technology, which uniquely improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells.

Additionally, new data from the ongoing Phase 1/2 study of omidubicel in patients with severe aplastic anemia will be shared in a poster presentation during the meeting. Omidubicel is an investigational advanced cell therapy in development as a potential life-saving treatment option for patients in need of a bone marrow transplant.

Omidubicel is also being evaluated in a Phase 3 study in patients with hematologic malignancies. Earlier this year, Gamida Cell reported that its Phase 3 study of omidubicel met its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in recovery from a stem cell transplant. Last month, Gamida Cell also reported that all three secondary endpoints for the study demonstrated statistical significance. The secondary endpoints in the study include outcomes for: platelet engraftment, infections and hospitalizations.

Details about the ASH presentations are as follows:

Title: Results of a Phase 1 Trial of GDA-201, Nicotinamide-Expanded Allogeneic Natural Killer (NK) Cells in Patients with Refractory Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma Abstract Number: 63 Lead Author: Veronika Bachanova, M.D., Ph.D., Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN Time: Saturday, December 5, 2020, 7:30 a.m. 9:00 a.m. PT (session time) and 7:30 a.m. PT (presentation)

Title: Rapid Engraftment, Immune Recovery, and Resolution of Transfusion Dependence in Treatment-Refractory Severe Aplastic Anemia Following Transplantation with Ex Vivo Expanded Umbilical Cord Blood (Omidubicel) Abstract Number: 1531 Lead Author: Mohamed Samour, M.D., Hematology Branch, National Heart, Lung, and Blood Institute, Bethesda, MD Time: Saturday, December 5, 2020, 7:00 a.m. 3:30 p.m. PT

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit http://www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.1

GDA-201 is an investigational therapy, and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

About Gamida Cell

Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter 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 the potential of NK cell immunotherapies and the continuation of Gamida Cells clinical programs, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope and progress of Gamida Cells clinical trials and other clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of Gamida Cells public filing on Form 20-F, filed with the SEC on February 26, 2020, 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. Any forward-looking statements speak only as of the date of this press release and are based on information available to Gamida Cell as of the date of this release.

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Gamida Cell Announces Data to Be Presented at 62nd ASH Annual Virtual Meeting - Business Wire

XNK Therapeutics receives US orphan drug status for NK cell-based immunotherapy in multiple myeloma – BioSpace

STOCKHOLM, Nov. 4, 2020 /PRNewswire/ --XNK Therapeutics AB ("XNK") today announced it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its leading investigational drug candidate in the treatment of multiple myeloma (MM).

Receiving ODD status from the FDA for the treatment of multiple myeloma is a critical next step for the development of XNK's leading investigational drug candidate. XNK has already received ODD status in the EU.

"Obtaining an ODD by the FDA is a significant milestone for XNK and our goal of taking the present drug candidate to the next level," said Johan Liwing, CEO of XNK Therapeutics. "This is the starting point for us to expand clinical development into the most important market globally for cancer treatment."

XNK has already completed its first-in-human Phase I/II clinical trial (ACP-001) in multiple myeloma at the Karolinska University Hospital in Stockholm, Sweden, showing a very good safety profile, and promising efficacy data. The company is continuing the clinical development in multiple myeloma in Europe and plans to initiate a Phase II clinical trial in the near future.

For more information, please contact:

Johan Liwing, CEO, XNK Therapeutics Tel: +46706 70 36 75 E-mail: johan.liwing@xnktherapeutics.com

About XNK Therapeutics AB

XNK Therapeutics is a clinical stage, immunotherapy company focusing its efforts on preventing and treating cancer by developing novel NK cell-based therapies. The company has established a leadership position in the clinical development and manufacture of autologousNK cell-based products using its proprietary technology platform. The company's platform technology and leading investigational drug candidate have ideal properties for targeting cancers, including settings where allogeneic cell products are not readily applicable. It is foreseen that the product will bring a critical component to tomorrow's cancer treatment strategies. XNK Therapeutics is headquartered in Stockholm, Sweden. For more info, please visit http://www.xnktherapeutics.com.

About XNK Therapeutics's technology platform

The platform has ideal properties to produce autologous NK cell-based drug candidates for targeting malignant diseases across a wide range of indications in mono- and combination therapy. It encompasses a unique closed manufacturing system for development of the NK cell-based products. The process includes a selective expansion and activation of NK cells from peripheral blood of patients with cancer. The product is produced in less than three weeks. It is delivered to the clinic upon need, where the product is thawed and infused into the patient without any further processing. The product has demonstrated an up to 10-year stability in liquid nitrogen. The assets of XNK Therapeutics are protected by patents in the US, Europe and certain other jurisdictions. Additional patent applications have been filed.

About Our Therapy

The leading drug candidate from XNK Therapeutics' technology platform was previously clinically tested in a first-in-human Phase I/II clinical trial (ACP-001). The study was performed at the Karolinska University Hospital, Stockholm, Sweden in a setting of consolidation treatment following high dose stem cell transplantation in patients newly diagnosed with multiple myeloma. The study was an open, single-arm, triple escalating dose/patient clinical trial with the primary objective of studying the product's safety and tolerability. In the study, the therapy showed a very good safety profile, and promising efficacy data. XNK Therapeutics is continuing its clinical development in multiple myeloma and plans to initiate a Phase II clinical trial in the near future.

About multiple myeloma

Multiple myeloma, the company's first target, is the third most frequent hematological malignancy worldwide. Multiple myeloma treatment has improved over the last two decades with the development and introduction of new agents leading to more effective treatments. Still, it remains a fatal disease in the majority of cases.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/xnk-therapeutics-ab/r/xnk-therapeutics-receives-us-orphan-drug-status-for-nk-cell-based-immunotherapy-in-multiple-myeloma,c3231231

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Global Autologous Cell Therapy Market will Showcase Neutral Impact During 2020-2024 | Use of Biomass as a Fuel in Boiler to Boost Market Growth |…

LONDON--(BUSINESS WIRE)--Technavio has been monitoring the global autologous cell therapy market and it is poised to grow by USD 1.97 billion during 2020-2024, progressing at a CAGR of almost 22% during the forecast period. The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment.

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The market is fragmented, and the degree of fragmentation will accelerate during the forecast period. Bayer AG, Brainstorm Cell Therapeutics Inc., Daiichi Sankyo Co. Ltd., FUJIFILM Holdings Corp., Holostem Terapie Avanzate Srl, Osiris Therapeutics Inc., Takeda Pharmaceutical Co. Ltd., Teva Pharmaceutical Industries Ltd., Sumitomo Chemical Co. Ltd., and Vericel Corp. are some of the major market participants. To make the most of the opportunities, market vendors should focus more on the growth prospects in the fast-growing segments, while maintaining their positions in the slow-growing segments.

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The use of biomass as a fuel in boilers has been instrumental in driving the growth of the market.

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Autologous Cell Therapy Market 2020-2024: Segmentation

Autologous Cell Therapy Market is segmented as below:

Autologous Cell Therapy Market 2020-2024: Scope

Technavio presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources. The autologous cell therapy market report covers the following areas:

This study identifies the increasing demand for effective drugs for cardiac and degenerative disorders as one of the prime reasons driving the Autologous Cell Therapy Market growth during the next few years.

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Autologous Cell Therapy Market 2020-2024: Key Highlights

Table of Contents:

Executive Summary

Market Landscape

Market Sizing

Five Forces Analysis

Market Segmentation by Therapy

Customer landscape

Geographic Landscape

Drivers, Challenges, and Trends

Vendor Landscape

Vendors covered

Appendix

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Global Autologous Cell Therapy Market will Showcase Neutral Impact During 2020-2024 | Use of Biomass as a Fuel in Boiler to Boost Market Growth |...

Covid-19 Impact On Animal Stem Cell Therapy Market Analysis, Trends, Share, Size, Consumption 2020 2026 | MediVet Biologic, VETSTEM BIOPHARMA, J-ARM,…

Chicago, United States: Global Animal Stem Cell Therapy Market Report 2020, Forecast to 2026, The report focuses on encompassing several factors such as global distribution, manufacturers, and various regions. The report has summed up industry analysis size, share, application, and statistics associated with the global Peptide Synthesis market. The report delivers an in-depth competitive landscape, Growth opportunities, market share coupled with product type and applications. The report also estimates comprehensive market revenue along with Growth patterns, and the overall volume of the market.

Crucial information and forecast statistics covered in the Animal Stem Cell Therapy Market report will arm both existing and emerging market players with necessary insights to craft long-term strategies as well as maintain business continuity during a crisis such as the ongoing COVID-19 pandemic.

Key players covered in the report include: MediVet Biologic, VETSTEM BIOPHARMA, J-ARM, Celavet, Magellan Stem Cells, U.S. Stem Cell, Cells Power Japan, ANIMAL CELL THERAPIES, Animal Care Stem, Cell Therapy Sciences, VetCell Therapeutics, Animacel, Aratana Therapeutics

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NOTE: Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Animal Stem Cell Therapy Market which would mention How the Covid-19 is affecting the Animal Stem Cell Therapy Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for Animal Stem Cell Therapy Players to Combat Covid-19 Impact. Valuable information covered in the Animal Stem Cell Therapy Market report has been segregated into key segments and sub-segments.

By Service type Dogs Horses Others

By End use Veterinary Hospitals Research Organizations

This report can be dispatched within 24-48 Hours.

Animal Stem Cell Therapy Market: Competition Analysis

The Report Hive Research study presents a comprehensive analysis of global, regional, and country-level players active in the Animal Stem Cell Therapy Market. Competitive information detailed in the Animal Stem Cell Therapy Market report has been based on innovative product launches, distribution channels, local networks, industrial penetration, production methods, and revenue generation of each market player.

Important Questions Answered in the Animal Stem Cell Therapy Market Report

Key Offerings of the Report

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Animal stem cell therapy is a usage of animals stem cell to treat a disease or disorder. The ability of stem cell is to divide and differentiate into a cell with specialized function useful for repairing body tissues damaged by injury or disease. The animal stem cell therapy process involves three steps which include collection of stem cell sample from animals and preparing the sample to concentrate the stem cells. Finally, the therapy includes transferring the stem cells into the injured site for treatment. Animal stem cell therapy increases the expectancy of life in animals with no side effects. It is available for the treatment of arthritis, degenerative joint disorders, tendon, and ligaments injuries in animals. Stem cell therapy is most often used to treat dogs, cats, and horses. But recent developments made it possible to use animal stem cell therapy in tiger, pig, etc. Present animal stem cell therapy is studied in treatments of the inflammatory bowel, kidney, liver, heart and immune-mediated diseases respectively. The global Animal Stem Cell Therapy market is expected to reach xxx Million USD by 2025, with a CAGR of xx% from 2020 to 2025.

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Covid-19 Impact On Animal Stem Cell Therapy Market Analysis, Trends, Share, Size, Consumption 2020 2026 | MediVet Biologic, VETSTEM BIOPHARMA, J-ARM,...

Animal Stem Cell Therapy Market Size 2020-2026 Review, Key Findings, Growth Strategy, Developing Technologies, Trends And Global Forecast By Regions -…

The Animal Stem Cell Therapy market report provides a detailed analysis of the emerging trends, opportunities, and as well as the challenges in the market. This extensive report sheds light on the latest developments, market drivers, and competitive analysis to help the new entrants and emerging players to make crucial decisions.

Besides this, the market research report presents insights on consumer behavior, regulatory policies, and supply & demand scenario to provide a holistic view of the market. The primitive aim of the report is to represent the critical data and figures of the market concisely and layout top winning strategies to aid industry players to leverage their market position.

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The dedicated research team has included Porters Five Point Force analysis to tailor the Global Animal Stem Cell Therapy Market. They have conducted interviews with industry experts to provide accurate predictions and better insights in a detailed manner. The research report covers the latest advancements that have overhauled the market dynamics while examined the threats which has impacted the overall market.

Key Answers Captured in the Study are

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Important Features that are under offering & key highlights of the report:

Detailed overview of Animal Stem Cell Therapy

Changing market dynamics of the industry

In-depth market segmentation by Type, Application, etc.

Historical, current, and projected market size in terms of volume and value

Recent industry trends and developments

Competitive landscape of Animal Stem Cell Therapy

Strategies of key players and product offerings

Potential and niche segments/regions exhibiting promising growth

A neutral perspective towards Animal Stem Cell Therapy performance

Market players information to sustain and enhance their footprint

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Research Objectives

To analyze and forecast the Worldwide Animal Stem Cell Therapy, in terms of value and volume.

Which segment has the potential to gain the highest market share?

To help decision-makers from a new offer perspective and benchmark existing marketing strategy.

Correlate cost structure historical data with key business segments.

Analyze marketing contribution and customer acquisition by up-selling and cross-selling.

Identifying Influencing factors keeping Worldwide Animal Stem Cell Therapy Intense, factored with periodic analysis of CR4 & CR8 concentration ratio & HHI Index.

Important Features that are under offering & key highlights of the report:

1) Does the study cover COVID-19 Impact Analysis and its effect on Growth %?

Yes, the overall industry has seen quite a big impact due to slowdown and shutdown in the production line & supply chain. The study covers a separate qualitative chapter on COVID-19 Impact analysis. Additionally, it also provides before and after the scenario of COVID-19 on sales growth & market size estimation to better analyze the exact scenario of the industry.

2) How companies are selected or profiled in the report?

List of some players that are profiled in the report include:

Medivet Biologics LLC VETSTEM BIOPHARMA J-ARM U.S. Stem Cell, Inc VetCell Therapeutics Celavet Inc. Magellan Stem Cells Kintaro Cells Power Animal Stem Care Animal Cell Therapies Cell Therapy Sciences Animacel

Usually, we follow NAICS Industry standards and validate company profile with product mapping to filter relevant Industry players, furthermore the list is sorted to come up with a sample size of at least 50 to 100 companies having greater topline value to get their segment revenue for market estimation.

** List of companies mentioned may vary in the final report subject to Name Change / Merger etc.

3) Can we add or profiled a new company as per our needs?

Yes, we can add or profile a new company as per client need in the report, provided it is available in our coverage list as mentioned in answer to Question 1 and after feasibility run, final confirmation will be provided by the research team checking the constraints related to the difficulty of survey.

4) Can we narrow the available business segments?

Yes, depending upon the data availability and feasibility check by our Research Analyst, a further breakdown in business segments by end-use application or product type can be provided (If applicable) by Revenue Size or Volume*.

Animal Stem Cell Therapy market segmentation

The Study is segmented by following Product Type:

Dogs Horses Others

Major applications/end-users industry are as follows:

Veterinary Hospitals Research Organizations

5) Can a specific country of interest be added? What all regional segmentation covered?

Yes, Country-level splits can be modified in the study as per objectives. Currently, the research report gives special attention and focus on the following regions:

North America [United States, Canada, Mexico], Asia-Pacific [China, India, Japan, South Korea, Australia, Indonesia, Malaysia, Philippines, Thailand, Vietnam], Europe [Germany, France, UK, Italy, Russia, Rest of Europe], South America [Brazil, Argentina, Rest of South America], Middle East & Africa [GCC Countries, Turkey, Egypt, South Africa, Rest of the Middle East & Africa]

** One country of specific interest can be included at no added cost. For inclusion of more regional segment quotes will vary.

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Animal Stem Cell Therapy Market Size 2020-2026 Review, Key Findings, Growth Strategy, Developing Technologies, Trends And Global Forecast By Regions -...