Gamida Cell Cuts Workforce, Discontinues Programs as it Awaits Potential FDA Approval

Rare Daily Staff

Gamida Cell revealed a strategic restructuring to prioritize the potential approval and launch of its lead rare cancer cell therapy candidate and extend its cash runway.

Shares of Gamida Cell fell 30 percent on the news.

The details were outlined in its full year 2022 financial report, in which the company highlighted positive data, productive regulatory interactions and progress on commercial readiness activities supporting its lead product candidate, omidubicel, an advanced cell therapy candidate for allogeneic stem cell transplant, as it advances toward its May 1, 2023, target Prescription Drug User Fee Act action date. The company also announced a strategic restructuring of its operations to prioritize launch of omidubicel to ensure that, if approved, patients who may potentially benefit will have access to therapy. To reduce expenses, the company will discontinue development of its preclinical NK cell therapy candidates while continuing to enroll patients in the GDA-201 phase 1 clinical trial.

“We believe we have a clear path to approval and are preparing for the commercial launch of omidubicel, if approved,” said Abbey Jenkins, president and CEO of Gamida Cell. “Given the challenging economic environment, to date, we have not been able to raise adequate funding to support our full pipeline and enable a more robust launch of omidubicel, if approved.”

The restructuring includes prioritize resources toward the launch, reduce expenses across the board, and seeking potential commercial or strategic partnerships to maximize patient access to omidubicel, a potentially life-saving therapy.

“Today’s actions are difficult,” said Jenkins. “Especially since our engineered NK cell therapy candidates, which are derived from healthy donors, have demonstrated encouraging pre-clinical data that differentiate them from other NK cell therapy approaches. The science is promising, but these changes are economically necessary to ensure omidubicel reaches as many patients as possible.”

Recently presented data continue to support the clinical benefits and safety of omidubicel, which, if approved, may be a valuable new donor source for patients in need of allogeneic stem cell transplant. Commercial readiness activities have made progress as the company prepares to onboard approximately 10-15 of the top 70 transplant centers in the United States in 2023. Omidubicel has received positive feedback from leading transplant centers, including ones that did not participate in the company’s clinical trials. The company has met with U.S. payers, including payers that cover more than 90 percent of commercially covered lives, and reported that payers indicate they anticipate covering a one-time therapy with curative intent.

Gamida Cell will discontinue the development of its engineered NK cell therapy preclinical pipeline, including GDA-301, GDA-501 and GDA-601, while maintaining the IP to these candidates, and reduce headcount by 17 percent, with the majority of impacted headcount tied to the discontinuation of the pre-clinical NK cell therapy candidates. The company will also close its operations in Jerusalem and consolidate Israel operations at its state-of-the-art manufacturing facility in Kiryat Gat. These changes are expected to extend the company’s cash runway through the third quarter of 2023.

Photo: Abbey Jenkins, president and CEO of Gamida Cell