Gamida Cell to Present Full Data from Phase 3 Study of Omidubicel at TCT, the Combined Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR

Rhea-AI Summary

Gamida Cell Ltd. (Nasdaq: GMDA) announced the presentation of full Phase 3 trial results for omidubicel at the upcoming TCT Meetings, scheduled from February 8–12, 2021. This randomized, international study assessed omidubicel's efficacy and safety compared to standard umbilical cord blood transplants in patients with blood cancers undergoing transplant. Previous data indicated successful primary and secondary endpoints, notably improved engraftment timelines. The presentation is led by Dr. Mitchell E. Horwitz on February 9, 2021, and the company plans to file a biologics license application with the FDA later in 2021.

Positive

• First presentation of full Phase 3 trial results for omidubicel.
• Achieved primary endpoint with a statistically significant reduction in neutrophil engraftment time.
• Successfully met secondary endpoints regarding platelet engraftment and reduced hospitalizations.

Negative

• None.

Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the full results of the Phase 3 clinical trial of omidubicel will be presented for the first time at the TCT Meetings, the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR), which is being held virtually from February 8–12, 2021.

The international, multi-center, randomized Phase 3 study for omidubicel evaluated the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.

This will be the first presentation of the full efficacy and safety results of this study. Gamida Cell previously reported in 2020 top-line data for omidubicel, an advanced cell therapy under development as a potentially life-saving allogeneic hematopoietic stem cell transplant solution for patients with hematologic malignancies. Last May, Gamida Cell reported that the study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient’s recovery from a bone marrow transplant. Last October, the company reported that the omidubicel phase 3 study achieved its secondary endpoints of platelet engraftment, infections, and hospitalizations.

Details about the presentation are as follows:
Title: Improved Clinical Outcomes with Omidubicel Versus Standard Myeloablative Umbilical Cord Blood Transplantation: Results of a Phase III Randomized, Multicenter Study
Lead Author: Mitchell E. Horwitz, M.D.
Time: Tuesday, February 9, 2021, 4:45-5:00 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). 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. The company expects to submit a full biologics licensing application to the U.S. 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 timing of initiation and progress of and data reported from the clinical trials of Gamida Cell’s product candidates, anticipated regulatory filings, launch readiness and FDA approval, commercialization efforts and Gamida Cell’s expectations regarding its projected ongoing operating activities, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Gamida Cell’s clinical trials and ramifications for the cost thereof; 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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FAQ

What are the main findings from the Phase 3 trial of omidubicel by Gamida Cell?

The Phase 3 trial showed a significant reduction in time to neutrophil engraftment and successfully met both primary and secondary efficacy endpoints.

When will the full results of the omidubicel trial be presented?

The full results will be presented on February 9, 2021, at the TCT Meetings.

What is the significance of the omidubicel trial results for GMDA?

The results could enhance GMDA's market position by supporting future FDA approval and potential commercialization of omidubicel for blood cancer treatments.

What regulatory steps is Gamida Cell planning after the omidubicel trial?

Gamida Cell intends to submit a biologics licensing application to the FDA in the second half of 2021.