Gamida Cell Announces Data to Be Presented at 63rd ASH Annual Meeting
New data on omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant, will be presented during an oral presentation showing that hematopoietic stem cell transplantation with omidubicel is associated with robust immune constitution and lower rates of severe infection compared to standard umbilical cord blood transplantation. Additionally, there will be three poster presentations and one e-publication highlighting additional clinical data from omidubicel and GDA-201, the company’s natural killer (NK) cell immunotherapy in development for the treatment of hematologic and solid tumors with standard of care antibody therapies. Together the data that will be presented at ASH reflect the progress across Gamida Cell’s NAM-enabled pipeline of cell therapies being developed as potentially curative approaches for cancer patients in need of new and better therapeutic options.
Details about the ASH presentations are as follows:
Title: Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel Is Associated with Robust Immune Reconstitution and
Abstract Number: 333
Title: Allogeneic Stem Cell Transplantation with Omidubicel: Long-Term Follow-up from a Single Center (Poster)
Abstract Number: 1827
Title: GDA-201, a Novel Metabolically Enhanced Allogeneic Natural Killer (NK) Cell Product Yields High Remission Rates in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): 2-Year Survival and Correlation with Cytokine IL7 (Poster)
Abstract Number: 3854
Lead Author: Veronika Bachanova, M.D., Ph.D.,
Title: Hospitalization and Healthcare Resource Use of Omidubicel Vs Cord Blood Transplantation for Hematological Malignancies in a Global Randomized Phase III Clinical Trial (Poster)
Abstract Number: 4036
Title: Transcriptional and Metabolic Profiling of Nicotinamide-Enhanced Natural Killer (NAM-NK) Cells (GDA-201) (e-Publication)
Abstract Number: 4791
Lead Author: Dima Yackoubov,
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status by the FDA. 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 www.clinicaltrials.gov.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
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 Cell’s product candidates (including GDA-201), anticipated regulatory filings and the potentially life-saving or curative therapeutic and commercial potential of omidubicel. Any statement describing Gamida Cell’s 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 Cell’s 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 Cell’s Annual Report on Form 20-F, filed with the
1 Bachanova, et al. ASH 2020. Abstract #63.
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