Gamida Cell Ltd (GMDAQ)

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Gamida Cell Announces Two-Part Virtual Miniseries Focused on Omidubicel to Take Place in September

BOSTON--(BUSINESS WIRE)--Sep. 3, 2020-- Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that it will host a two-part virtual miniseries in September focused on key topics related to omidubicel, an advanced cell therapy in Phase 3 clinical development as a potentially life-saving treatment option for patients in need of a bone marrow transplant. The webcasts will take place on Friday, September 11, 2020, and Wednesday, September 23, 2020, both at 1:00 p.m. ET.

The miniseries topics are as follows:

September 11: A discussion of the patient journey and treatment paradigm in allogeneic bone marrow transplant featuring Steven Devine, M.D., Chief Medical Officer, Be The Match BioTherapies, National Marrow Donor Program®/Be The Match®, and Associate Scientific Director, the CIBMTR® (Center for International Blood and Marrow Transplant Research®)

September 23: A discussion of the healthcare economics of bone marrow transplant featuring Krishna Komanduri, M.D., Kalish Family Chair in Stem Cell Transplantation and Chief, Division of Transplantation and Cellular Therapy at the Sylvester Comprehensive Cancer Center, University of Miami

In May, Gamida Cell reported that its Phase 3 study of omidubicel met its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in recovery from a bone marrow transplant. Gamida Cell expects to present the full data set, including secondary endpoint data, at a medical meeting in the fourth quarter of 2020. The company also expects to begin submitting the biologics license application for omidubicel to the U.S. Food and Drug Administration (FDA) on a rolling basis in the fourth quarter of 2020. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the U.S. and EU.

Each webcast will be available on the “Investors & Media” section of the Gamida Cell website at www.gamida-cell.com. A replay of the webcast will be available about two hours after the event, for approximately 90 days.

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). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230 and NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.1,2 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 has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

https://finance.yahoo.com/news/gamida-cell-announces-two-part-120100479.html