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BOSTON – (BUSINESS WIRE) –
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to the treatment of cancer and other serious diseases, today announced four presentations at the 63rd Annual Meeting of the American Society of Hematology (ASH), which will be held in Atlanta, Georgia or virtually from December 11-14, 2021.
New data on omidubicel, a potentially life-saving treatment for patients with blood cancers requiring stem cell transplantation, will be presented in an oral presentation showing that hematopoietic stem cell transplantation with omidubicel is associated with strong immune constitution and lower rates of severe infection. compared to standard umbilical cord blood transplantation. Additionally, there will be three poster presentations and an ezine highlighting additional clinical data from omidubicel and GDA-201, the company’s natural killer cell (NK) immunotherapy in development for the treatment of hematologic and solid tumors with standard antibody therapies. Taken together, the data that will be presented to ASH reflects the progress made in Gamida Cell’s pipeline of NAM-compatible cell therapies being developed as potentially curative approaches for cancer patients in need of new and better treatment options.
Details on ASH presentations are as follows:
Title: Hematopoietic Stem Cell Transplant (HSCT) with Omidubicel is associated with robust immune reconstitution and lower rates of serious infections compared to standard umbilical cord blood transplant (oral)
Abstract number: 333
Main author: Paul Szabolcs, MD, Division of Blood and Marrow Transplantation and Cell Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA
Time: Saturday, December 11, 2021, 4 p.m. – 5:30 p.m. EST (session time) and 4:30 p.m. EST (presentation)
Title: Allogeneic stem cell transplant with Omidubicel: long-term follow-up from a single center (poster)
Abstract number: 1827
Main author: Chenyu Lin, MD, Department of Medicine, Division of Blood Malignancies and Cell Therapy, Duke University Medical Center, Durham, NC
Time: Saturday, December 11, 2021 from 5:30 p.m. to 7:30 p.m. EST
Title: GDA-201, a new product of metabolically enhanced allogeneic natural killer (NK) cells gives high remission rates in patients with relapsed / refractory non-Hodgkin lymphoma (NHL): 2 year survival and correlation with cytokine IL7 ( attach)
Abstract number: 3854
Main author: Veronika Bachanova, MD, Ph.D., Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN
Time: Monday, December 13, 2021, 6:00 p.m. – 8:00 p.m. EST
Title: Hospitalization and Health Care Resource Utilization of Omidubicel Against Cord Blood Transplantation for Hematologic Malignancies in a Global Randomized Phase III Clinical Trial (Poster)
Abstract number: 4036
Main author: Navneet Majhail, MD, Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, OH
Time: Monday, December 13, 2021, 6:00 p.m. – 8:00 p.m. EST
Title: Nicotinamide Enhanced Natural Killer Cell Transcription and Metabolic Profiling (NAM-NK) (GDA-201) (Electronic Publication)
Abstract number: 4791
Main author: Dima Yakoubov, M.Sc., Cell Gamida, Jerusalem, Israel
Omidubicel is an advanced cell therapy in development as a potentially vital allogeneic hematopoietic stem cell (bone marrow) transplant for patients with hematologic malignancies (blood cancers), for which it has achieved breakthrough status from the FDA . Omidubicel is also being evaluated in a phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The investigational new drug application for aplastic anemia is currently filed with the FDA under the brand name CordIn®, which is the same investigational development candidate as omidubicel. For more information on omidubicel clinical trials, please visit www.clinicaltrials.gov.
Omidubicel is an investigational treatment, and its safety and effectiveness have not been established by the FDA or any other health authority.
Gamida Cell applied the capabilities of its Nicotinamide Activated Cell Expansion (NAM) technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard antibody therapies. GDA-201, the lead candidate of the NAM-activated NK cell pipeline, demonstrated promising initial clinical trial results, as reported at the American Society of Hematology (ASH) Annual Meeting and Exhibition in 20201. GDA-201 addresses the main limitations of NK cells by increasing cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Additionally, GDA-201 enhances antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information on GDA-201, please visit https://www.gamida-cell.com.
GDA-201 is an investigational therapy, and its safety and effectiveness have not been established by the FDA or any other health authority.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapies for patients with solid tumors and blood cancers and other serious blood diseases. We are applying a proprietary expansion platform leveraging the properties of NAM to allogeneic cellular sources, including umbilical cord blood-derived cells and NK cells, to create therapies with the potential to redefine the standards of care. These include omidubicel, an investigational product that may be a vital alternative for patients in need of bone marrow transplantation, and a modified and unmodified NK cell line activated by NAM targeting solid tumors. and malignant hemopathies. For more information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.
Caution 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 timing of the initiation and progress of clinical trials of Gamida Cell’s product candidates (including GDA – 201), the expected regulatory filings and the potentially life-saving or curative therapeutic and commercial potential of omidubicel. Any statement that describes Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered a risky statement. These statements are subject to a number of risks, uncertainties, and assumptions, including those related to the impact the COVID-19 pandemic could have on our business, and including the scope, progress and l expansion of clinical trials of Gamida Cell and the ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; and those inherent in the process of developing and marketing product candidates that are safe and effective for use as human therapeutics, and in the effort to build a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties described in the Risk Factors section and other sections of Gamida Cell’s annual report on Form 20-F, filed with the Securities and Exchange Commission (SEC ) March 9, 2021, as amended, and other documents filed by Gamida Cell with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances referred to in these forward-looking statements may not occur, and the actual results of Gamida Cell could differ materially and adversely from those anticipated or implied. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, such statements are based only on facts and factors currently known to Gamida Cell. Therefore, you are cautioned not to rely on these forward-looking statements.
1 Bachanova, et al. ASH 2020. Abstract # 63.
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Source: Gamida Cell Ltd.