Gamida Cell Announces Results from Phase 3 Study of Omidubicel to be Presented at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT)
Gamida Cell Ltd. (Nasdaq: GMDA) announced the presentation of results from its Phase 3 clinical trial of omidubicel at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2021). The presentation is scheduled for March 15, 2021, at 3:24 p.m. CET. Omidubicel, an advanced cell therapy for blood cancers, has shown significant results in prior studies and plans to submit a Biologics License Application (BLA) to the FDA in H2 2021. The company aims to redefine standards of care in hematologic malignancies.
- Omidubicel achieved statistically significant results in Phase 3 trial.
- Plans to submit Biologics License Application (BLA) to the FDA in H2 2021.
- Omidubicel is well tolerated, showing rapid engraftment.
- Regulatory hurdles may affect BLA submission timeline.
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that results from the Phase 3 clinical trial of omidubicel will be presented in an oral session at the Presidential Symposium of the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2021), which is being held virtually March 14–17, 2021.
Details about the presentation are as follows:
Time: Monday, March 15, 2021, at 3:24 p.m. CET (10:24 a.m. EST)
Abstract Number: GS2-7
Title: Results of a Phase III Randomized, Multicenter Study Comparing Omidubicel with Standard Umbilical Cord Blood Transplantation (UCBT) in Patients with High-Risk Hematologic Malignancies Following Myeloablation
Lead Author: Professor Guillermo F. Sanz, M.D., Ph.D.
The abstract will also be featured in a live panel discussion, “EBMT Talks: Live with Best Abstracts,” on March 15 at 6:10 p.m. CET (1:10 p.m. EST).
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), for which it has been granted Breakthrough Status by the US Food and Drug Administration. 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.1,2 Based on the recently reported Phase 3 clinical study, in which omidubicel achieved statistically significant and clinical meaningful results in the prespecified primary and secondary endpoints, Gamida Cell plans to submit the full Biologics License Application (BLA) to the FDA in the second half of 2021. 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 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 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 anticipated submission of a BLA for omidubicel, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to Gamida Cell’s ability to prepare regulatory filings and the review process therefor; complications in Gamida Cell’s plans to manufacture its products for commercial distribution; and 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 and other sections of Gamida Cell’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on February 26, 2020 and its Report on Form 6-K furnished to the SEC on August 12, 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 Cell’s 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.
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1 Gamida Cell press release, “Gamida Cell Announces Positive Topline Data from Phase 3 Clinical Study of Omidubicel in Patients with High-Risk Hematologic Malignancies,” issued May 12, 2020. Last accessed August 31, 2020.
2 Horwitz M.E., Wease S., Blackwell B., Valcarcel D. et al. Phase I/II study of stem-cell transplantation using a single cord blood unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019 Feb 10;37(5):367-374.
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