Gamida Cell Presents Two-Year Survival Data for GDA-201 and Resource Utilization Analysis for Omidubicel at 63rd ASH Annual Meeting

Rhea-AI Summary

Gamida Cell Ltd. (NASDAQ: GMDA) announced promising two-year follow-up data for GDA-201, a cell therapy for relapsed or refractory non-Hodgkin lymphoma (NHL), showing a median duration of response of 16 months and a two-year overall survival rate of 78%. Additionally, the company revealed that omidubicel treatment significantly reduces hospitalization and healthcare resource utilization compared to standard cord blood transplants. These findings will be presented at the 63rd American Society of Hematology Annual Meeting in Atlanta on December 13, 2021.

Positive

• Median duration of response for GDA-201 is 16 months.
• Overall survival rate at two years is 78%.
• Omidubicel shows significant reductions in hospitalization and healthcare resource use.

Negative

• None.

• Data from patients with NHL treated in Phase 1 investigator-led study of GDA-201 demonstrates median duration of response of 16 months; safety outcomes consistent after two years
• Poster presentation highlights reductions in hospitalization and healthcare resource utilization for omidubicel

BOSTON--(BUSINESS WIRE)-- Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced that two-year follow-up data for GDA-201, the company’s lead candidate in its NAM-enabled NK cell therapy pipeline, will be presented at the 63^rd American Society of Hematology (ASH) Annual Meeting, being held in Atlanta, Georgia. Additionally, for patients who participated in the phase 3 trial of omidubicel, the company will be presenting a poster of an analysis of resource utilization data from the first 100 days after bone marrow transplant.

The poster titled “GDA-201, A Novel Metabolically Enhanced Allogeneic Natural Killer (NK) Cell Product Yields High Remission Rates in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): 2-year survival and correlation with cytokine IL7” includes longer term follow-up from the phase 1, investigator-led study of GDA-201 in combination with rituximab (NCT03019666) in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) and reports on 2-year outcomes and cytokine biomarkers associated with survival. The data demonstrated a median duration of response of 16 months (range 5- 36 months), an overall survival at 2 years of 78% (95% CI, 51%–91%) and a safety profile similar to that reported previously.

“We are excited to share this compelling two-year data from our investigator-led study of GDA-201 which demonstrate an extended duration of response in patients with NHL,” said Julian Adams, Ph.D., Chief Executive Officer, of Gamida Cell. “The durable response in this patient group provides strong support as we work to progress GDA-201 through the development process for patients in need.”

Gamida Cell will also present a poster related to its omidubicel program titled “Hospitalization and Healthcare Resource Use of Omidubicel Vs Cord Blood Transplantation for Hematological Malignancies in a Global Randomized Phase III Clinical Trial,” which includes an analysis of resource utilization data from the first 100 days after transplant for 108 patients in the phase 3 trial showing that the omidubicel-treated patients had significantly shorter durations of hospitalization, intensive care unit stays, consultant visits, procedures, and transfusions than the control arm. These data provide further evidence of the clinical benefit associated with the more rapid hematopoietic recovery in patients treated with omidubicel and the corresponding reduction in healthcare resource utilization.

“This analysis clearly demonstrates the potential of omidubicel to significantly shorten a patient’s hospital length of stay, reduce time in ICU settings and decrease usage of healthcare resources, likely resulting in lower overall costs to the healthcare system,” said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. “These findings are particularly important as they demonstrate the impact of omidubicel on the experience for patients during the critical post-transplant period.”

Both posters will be available today, Monday, December 13, 2021, 6:00-8:00 p.m. ET, during the ASH Annual Meeting and Exposition.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information about GDA-201, please visit https://www.gamida-cell.com.

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

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 blood cancers. Omidubicel is the first bone marrow transplant graft to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. For more information about omidubicel, please visit https://www.gamida-cell.com.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About Gamida Cell

Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapies for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapies with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram 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 (including GDA-201), anticipated regulatory filings (including the timing of submission of the BLA for omidubicel to the FDA), commercialization planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of 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 Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on March 9, 2021, as amended, 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. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.

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For investors:

Courtney Turiano

Stern Investor Relations, Inc.

courtney.turiano@sternir.com

1-212-362-1200

For media:

Rhiannon Jeselonis

Ten Bridge Communications

rhiannon@tenbridgecommunications.com

1-978-417-1946

Source: Gamida Cell Ltd.

FAQ

What are the results of the GDA-201 study by Gamida Cell?

The GDA-201 study showed a median duration of response of 16 months and a two-year overall survival rate of 78%.

What is the significance of the omidubicel findings?

Omidubicel significantly reduces hospitalization and healthcare resource utilization compared to cord blood transplants.

When will Gamida Cell present its data?

Gamida Cell will present its data at the 63rd American Society of Hematology Annual Meeting in Atlanta on December 13, 2021.

What is the stock symbol for Gamida Cell?

The stock symbol for Gamida Cell is GMDA.