Gamida Cell Announces Data to be Presented at 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings
New data and analyses on omidubicel will be presented including an oral presentation by Dr.
Details about the TCT presentations are as follows:
Title: Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplant with Omidubicel Demonstrates Sustained Clinical Improvement Versus Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT): Final Results of a Phase III Randomized, Multicenter Study (oral presentation)
Abstract Number: 86
- Abstract highlights: One-year post-transplant follow up from the omidubicel Phase 3 trial showed that the advantages of early engraftment and lower infections with omidubicel translated into long term benefits in the first year post-transplant, as demonstrated by reduction in non-relapse mortality and no increase in relapse rates compared to UCBT. There was a continued trend toward improved OS in favor of the omidubicel arm over time (73% vs 60%). The overall and sustained clinical benefit of omidubicel makes it an important addition to the options for allogeneic HSCT.
Title: Health-Related Quality of Life (HRQL) Following Transplantation with Omidubicel Versus UCB In Patients with Hematologic Malignancies: Results from a Phase III Randomized, Multicenter Study (poster)
Abstract Number: 509
- Abstract highlights: This study compared changes in HRQL measures (FACT-G and EQ-5D) that were assessed in the Phase III study of omidubicel. Along with statistically significantly faster time to engraftment, shorter hospitalizations and lower infection risk, omidubicel was associated with meaningfully greater preservation or improvement of important HRQL domains compared to UCB.
Title: Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant (allo-HCT) Access and Outcomes for Patients with Hematologic Malignancies in the US (poster)
Abstract Number: 325
- Abstract highlights: The under-representation of racial and ethnic minorities in donor registries is well-established and a source of inequity in access to care. Over 40% of patients enrolled in the omidubicel Phase III study were racial and ethnic minorities. The study assessed the projected impact of omidubicel access on racial and ethnic health disparities in a projection model. Broad access to omidubicel was projected to decrease time to allo-HCT and improve allo-HCT outcomes overall, with the greatest improvements among racial and ethnic groups least served by current graft sources, thus helping to reduce racial disparities and improving health equity in allo-HCT care.
Title: Total Costs of Care and Complication Rates Among Patients with Hematologic Malignancies Who Receive Allogeneic Hematopoietic Cell Transplants (allo-HCT) in the US (poster)
Abstract Number: 334
- Abstract highlights: A commercial claims and encounters database was utilized to quantify the total cost of care associated with allo-HCT and real-world complication rates after allo-HCT among US commercially insured patients. The study concluded that patients with hematologic malignancies undergoing allo-HCT experienced significant health resource use and costs post-HCT. Hospitalizations accounted for 80% of the total costs. Complications, especially acute GVHD and infections, were commonly observed in post-transplant medical billings, which may still underestimate the full clinical incidence. Reducing need for in-patient care can significantly reduce total cost of care in this population.
Title: Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Enhanced Circulatory Plasmacytoid Dendritic Cells (pDC), NK Cells and CD4+ T Cells with
Abstract Number: 5
Title: Transcriptional and Metabolic Profiling of Nicotinamide-Enhanced Natural Killer (NAM-NK) Cells (GDA-201) (poster; initial data presented at
Abstract Number: 266
Lead Author: Dima Yackoubov, Scientist,
Title: Hospitalization and Healthcare Resource Use of Omidubicel vs Umbilical
Abstract Number: 419
Title: Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) with Omidubicel: Long-Term Follow-Up from a Single Center (poster; encore presentation from
Abstract Number: 322
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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