Gamida wins FDA approval for off-the-shelf cell therapy

The US FDA has approved Gamida Cell’s Omisirge (omidubicel), an allogeneic cell therapy for patients with blood cancers who are set to undergo stem cell transplantation.

Omisirge is a modified allogeneic cord blood-based cell therapy to quicken the recovery of neutrophils and reduce the risk of infection. It is intended for use in patients with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen, such as radiation or chemotherapy.

The product, a single intravenous dose composed of human allogeneic stem cells from umbilical cord blood, becomes the first US Food and Drug Administration (FDA) approved off-the-shelf cell therapy based on a global, randomized Phase III study. Atara Biotherapeutics made history in December last year, winning approval for the first allogeneic T-cell product, Ebvallo (tabelecleucel), from European regulators.

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The approval was welcomed as “an important advance in cell therapy treatment in patients with blood cancers” by Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). “Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation.”

Omisirge was developed by Israeli biotech Gamida Cell. The firm worked with contract development and manufacturing organization (CDMO) Lonza for clinical supply from its site in Geleen, The Netherlands. However, a $60 million fundraiser in 2020 saw Gamida invest in its own manufacturing capabilities in Kiryat Gat, Israel, named on the BLA Approval letter as an approved commercial production site. According to Gamida, Omisirge is expected to be delivered to transplant centers within 30 days after the start of manufacturing.

The road to approval has been relatively rocky for Gamida. The FDA asked for more information regarding the manufacturing process and facility used to make omidubicel in November 2021, and – last year – delayed the approval process by a further three months. Meanwhile, Gamida has twice undergone cost-cutting measures, cutting 10% of its workforce in January 2022 and 17% of its staff just three weeks ago.

The firm’s CEO Abbey Jenkins described yesterday’s approval as “a major advancement in the treatment of patients with hematologic malignancies that we believe may increase access to stem cell transplant and help improve patient outcomes.”