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.
More:
Gamida Cell Announces Data to Be Presented at 62nd ASH Annual Virtual Meeting - Business Wire
- Co-founder Thomas Smeenk on the benefits of Hemostemix autologous stem cell therapy - InvestorIntel - January 12th, 2021
- Covid-19 Impact On Stem Cell Therapy Market 2020 Huge Potential in Future Growth by 2027 | Magellan, Medipost Co., Ltd, Osiris Therapeutics, Inc.,... - January 12th, 2021
- Adipose Derived Stem Cell Therapy Market Analysis and Forecast, 2020-2026 Coherent Market Insights | BioRestorative Therapies, Inc., Celltex... - January 12th, 2021
- New COVID-19 Treatment Uses Stem Cells - Freethink - January 12th, 2021
- Creative Medical Technology Holdings Files Investigational New Drug Application (IND) with FDA for Treatment of Stroke using ImmCelz Regenerative... - January 12th, 2021
- Global Cell Freezing Media for Cell Therapy Market 2020 Dynamics Analysis, Size Witness Growth Acceleration During 2025 - KSU | The Sentinel Newspaper - January 12th, 2021
- Gamida Cell to Present Full Data from Phase 3 Study of Omidubicel at TCT, the Combined Transplantation and Cellular Therapy Meetings of ASTCT and... - January 12th, 2021
- Cate Dyer of StemExpress is Named Businesswoman of the Year! - PRNewswire - January 12th, 2021
- Adocia Files Patent on a Hydrogel Scaffold for Cell Therapy in the Treatment of Type 1 Diabetes - Business Wire - January 12th, 2021
- Gene Therapy Market Estimated to Record Highest CAGR by 2024 - KSU | The Sentinel Newspaper - January 12th, 2021
- Stem cell treatment corrects skull shape and restores brain function in mouse model of childhood disorder - National Institutes of Health - January 9th, 2021
- Doctors Make Medical Breakthrough In Treating Severe Cases Of COVID - CBS New York - January 9th, 2021
- Global Stem Cell Therapy Market Report 2020: Market to Recover and Reach $14.76 Billion in 2023 at a CAGR of 19.62% - Forecast to 2030 - Yahoo Finance - January 9th, 2021
- Engineered stem cells that evade immune detection could boost cell therapy and I-O - FierceBiotech - January 9th, 2021
- BENEV Announces Investigative Report on Combination Treatment with Human Adipose Tissue Stem Cell- derived Exosomes and Fractional CO2 Laser for Acne... - January 9th, 2021
- Four promising COVID-19 therapies being tested at nearby UVA - Rappahannock News - January 9th, 2021
- MCL Landscape Adapts to Changes After CAR T-Cell Therapy Approval - OncLive - January 9th, 2021
- Regenerative Medicine Market to Reach Valuation US$ 23.7 Bn by 2027 - GlobeNewswire - January 9th, 2021
- Unlocking The Unlimited Potential Of Stem Cells - CodeBlue - January 9th, 2021
- Stem Cell Treatment Proving Highly Successful In Treating Most Severe Cases Of COVID - Yahoo News - January 9th, 2021
- Factor Bioscience spins out a new cell therapy player with eyes on the clinic within 2 years - Endpoints News - January 9th, 2021
- Comparison of the efficiency, safety, and survival outcomes in two stem cell mobilization regimens with cyclophosphamide plus G-CSF or G-CSF alone in... - January 9th, 2021
- Top 10 ALS Stories of 2020 - ALS News Today - January 9th, 2021
- Celularity and GX Acquisition Corp. Announce Merger Agreement to Create a Publicly Listed Leader in Allogeneic Cellular Therapy - BioSpace - January 9th, 2021
- Results Show Promising Efficacy in MCL With Next-Generation BTK Inhibitor LOXO-305 - Cancer Network - January 9th, 2021
- BlueRock Therapeutics in Collaboration with Memorial Sloan Kettering Cancer Center Receives IND Clearance for DA01 in Parkinson's Disease - BioSpace - January 9th, 2021
- Stem Cell Therapy Market Size, Share & Trends Analysis Report By Product Types, And Applications Forecast To 2026 - Farming Sector - January 5th, 2021
- Stem Cell Therapy Market by Treatment,Application,End Users and Geography Forecast To 2027 - LionLowdown - January 5th, 2021
- Stem Cell Therapy Market Analysis, COVID-19 Impact,Outlook, Opportunities, Size, Share Forecast and Supply Demand 2021-2025 - Farming Sector - January 5th, 2021
- AGC Biologics Confirms Cell and Gene Therapy Commercial Expertise as Manufacturer of Orchard Therapeutics' Newly Approved Libmeldy - PRNewswire - January 5th, 2021
- Forge Biologics Announces FDA Clearance of Investigational New Drug Application for Phase 1/2 Clinical Trial (RESKUE) of FBX-101 Gene Therapy for... - January 5th, 2021
- MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application f - PharmiWeb.com - January 5th, 2021
- Healthcare resource utilization and costs among patients with relapsed and/or refractory multiple myeloma treated with proteasome inhibitors in... - January 5th, 2021
- Global Circulating Tumor Cells and Cancer Stem Cells Market To Reach A New Threshold of Growth By 2026 - The Courier - January 5th, 2021
- Catheters Market: Europe and North America Emerge as Leading Regional Market with Well-established Healthcare Infrastructure - BioSpace - January 5th, 2021
- The Worldwide Cell Isolation/Cell Separation Industry is Expected to Grow at a CAGR of 16.8% Between 2020 to 2025 - PRNewswire - January 5th, 2021
- Near-infrared oxidative phosphorylation inhibitor integrates acute myeloid leukemiatargeted imaging and therapy - Science Advances - January 5th, 2021
- Global Cell Therapy Market Report 2020: Market to Recover in 2023 - PRNewswire - January 3rd, 2021
- Lonza's Cocoon will soon make dozens of stem cell therapies all at once - Innovation Origins - January 3rd, 2021
- Induced Pluripotent Stem Cell Derived Human Lung Organoids to Map and Treat the SARS-CoV2 Infections In Vitro - DocWire News - January 3rd, 2021
- Creative Medical Technology Holdings Announces Patent filing based on Preclinical Data in Model of Heart Attack using ImmCelz Regenerative... - January 3rd, 2021
- Haywards Heath carer trying to raise funds for MS treatment - The Argus - January 3rd, 2021
- Chronic graft-versus-host disease in children and adolescents with thalassemia after hematopoietic stem cell transplantation - DocWire News - January 3rd, 2021
- COVID-19-positive cancer patients undergoing active anticancer treatment: An analysis of clinical features and outcomes - DocWire News - January 3rd, 2021
- Cell Therapy Market 2020-2026 by Growth, Demand and Upcoming Business Opportunities - Farming Sector - January 3rd, 2021
- Rheumatoid Arthritis Stem Cell Therapy Market Latest Trends and Future Growth Study by 2029 - Farming Sector - December 31st, 2020
- Creative Medical Technology Holdings Announces Reversion of Liver Failure Using ImmCelz Personalized Cellular Immunotherapy in Preclinical Model -... - December 31st, 2020
- Impacts of COVID 19 on Stem Cell Therapy Market 2020 Size, Demand, Opportunities & Forecast To 2026 - Factory Gate - December 31st, 2020
- Efficacy and safety of mesenchymal stem cells for the treatment of patients infected with COVID-19: a systematic review and meta-analysis protocol -... - December 31st, 2020
- Global Stem Cell Therapy Market Industry 2021 In-depth Market Analysis and Recent Developments, Share, Revenue and Forecast 2025 | Anterogen Co. Inc.... - December 31st, 2020
- Nociceptive neurons shown to boost hematopoiesis | 2020-12-28 - BioWorld Online - December 28th, 2020
- Stem Cell Therapy Market 2020: Demand Analysis, Key Players, Trends, Sales, Supply, Deployment Model, Segments, Organization Size, Production, Revenue... - December 28th, 2020
- Stem Cell Therapy Market (COVID-19 Analysis) 2020-2025 Is Booming Worldwide with Comprehensive Study Explores Huge Revenue Scope in Future - Farming... - December 28th, 2020
- Humanigen Secures US Patent for Lenzilumab in Preventing Cytokine Storm and Neurotoxicity Related to CAR-T Cell Therapy - BioSpace - December 28th, 2020
- Immunotherapy Continues on Positive Trajectory in Lymphoid Malignancies - OncLive - December 28th, 2020
- Stem Cell Therapy Market Size 2020 | Opportunities, Regional Overview, Top Leaders, Revenue and Forecast to 2025 - LionLowdown - December 28th, 2020
- Adipose Derived Stem Cell Therapy Market 2020 Analysis, Growth, Size, Shares, Drivers, Advancements, Challenges, Sophisticated Demand & Key... - December 28th, 2020
- Stem cells from cord blood can now be used across many conditions: Mayur Abhaya, MD & CEO, LifeCell Internat.. - ETHealthworld.com - December 28th, 2020
- Comprehensive Report on NK Cell Therapy and Stem Cell Therapy Market 2021 | Size, Growth, Demand, Opportunities & Forecast To 2027 | Chipscreen... - December 28th, 2020
- The Top 5 Most-Read Oncology Stories of 2020 - AJMC.com Managed Markets Network - December 28th, 2020
- Adipose Tissue-derived Stem Cell Therapy Market Share Analysis, Application, Strategies of Key Players & Forecast to 2025 - Factory Gate - December 28th, 2020
- Study clarifies the impact of getting old on hematopoietic stem cells - Microbioz India - December 28th, 2020
- Report On Canine Stem Cell Therapy Market to 2026: (Industry Insights, Company Overview and Investment Analysis) - Farming Sector - December 24th, 2020
- Six Benefits of All-on-4 Implants Compared to Regular Dentures - Magazine of Santa Clarita - December 24th, 2020
- Allogeneic SCT Benefits Children and Adolescents With Relapsed Anaplastic Large Cell Lymphoma - OncLive - December 24th, 2020
- Stem cells in the brain remain active and divide over months - News Landed - December 24th, 2020
- Canine Stem Cell Therapy Market 2026 by Product Type, Applications, Manufacturers, Revenue, Price, Share and Growth Rate & Forecast -... - December 24th, 2020
- Exclusive Research on Stem Cell Therapy Products Market 2020 Segments, Regions, Strategy Analysis: Mesoblast, TiGenix, Osiris - LionLowdown - December 24th, 2020
- Heterogenous Nature of MDS Warrants Further Research, Review Finds - AJMC.com Managed Markets Network - December 24th, 2020
- Stem Cell Therapy Shows 2-year Benefit for Progressive MS Patients in Phase 1 Trial - Multiple Sclerosis News Today - December 19th, 2020
- Dr Clarence Moore Discusses the Importance of Stem Cell Therapy, Heart Health in Beta Thalassemia - AJMC.com Managed Markets Network - December 19th, 2020
- For Patients With HMA-Resistant MDS, What Are Their Options? - AJMC.com Managed Markets Network - December 19th, 2020
- The Adrenomyeloneuropathy Treatment Market to grow on an emphatic note from 2019 to 2029 - PharmiWeb.com - December 19th, 2020
- Are Hiccups a Sign of the New Coronavirus? - Healthline - December 19th, 2020
- Every Patient Treated With CRISPR Gene Therapy for Blood Diseases Continues to Thrive, More Than a Year On - Good News Network - December 19th, 2020
- Therapeutic Solutions International Files Investigational New Drug Application (IND) with FDA for Treatment of Chronic Traumatic Encephalopathy Using... - December 18th, 2020
- Physio Logic Brings Cutting-edge Regenerative Treatments for Sport Injuries and Arthritis to New York City - PRNewswire - December 18th, 2020
- AlloVir Announces FDA Clearance of Investigational New Drug Application for ALVR106, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T Cell Therapy... - December 18th, 2020
- ONK Therapeutics Announces Three Exclusive Option License Agreements, Which Extend and Strengthen its Dual-Targeted NK Cell Therapy Pipeline -... - December 18th, 2020
- Mesoblast shares fall on trials mixed results with heart injection treatment - Stockhead - December 18th, 2020