Gamida Cell Presents Data Demonstrating the Impact of Transplantation with Omidubicel for Patients with Hematologic Malignancies at 2022 Cord Blood Connect Meeting
- Patients treated with omidubicel reported higher health-related quality of life scores during first-year post-transplant as compared to transplantation with umbilical cord blood (UCB)
- If approved, Omidubicel is projected to have meaningful improvement in patient outcomes among racial and ethnic minorities by potentially extending access to allogeneic hematopoietic cell transplant (allo-HCT) and reducing time to transplant
- Data highlights robust and diverse T cell reconstitution, with significantly higher recent thymic emigrant (RTE) T cells at 1 year, no loss of TCR repertoire diversity, providing mechanistic rationale for lower viral and overall infection rates observed in patients transplanted with omidubicel
In a poster titled “Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel Leads to Robust Recovery and Diversity of T cells” patients treated with omidubicel were found to have robust and diverse T cell constitution. In an analysis of the T-cell development of 37 patients, patients transplanted with omidubicel demonstrated higher numbers of Recent Thymic Emigrants (RTEs) in peripheral blood at one year post transplant compared to transplantation with UCB, which suggest faster thymopoiesis and provide mechanistic rational for the lower infection rates and improved outcomes in these patients. Learn more
All three posters were made available beginning
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 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.
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 omidubicel), regulatory filings submitted to the FDA (including the potential timing of the FDA’s review of the BLA for omidubicel), commercialization planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including omidubicel), and Gamida Cell’s expectations for the expected clinical development milestones set forth herein. 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 Quarterly Report on Form 10-Q, filed with the
1CIBMTR 2019 – allogeneic transplants in patients 12+ years with hematological malignancies.
Stern Investor Relations, Inc.
Director, Investor Relations and Corporate Communications