After going all-in on blood cancer therapy, Gamida Cell scores big win at FDA

Just three weeks after reducing its staff by 17% and shelving three pipeline candidates, cash-strapped Gamida Cell has received its long-awaited lifeline.

Monday, the company scored FDA approval for Omisirge (omidubicel-onlv), an allogenic cell therapy to reduce the risk of infection in blood cancer patients.

Omisirge works by speeding the recovery of neutrophils—a type of white blood cells—which combat infection. Specifically, the drug is approved for patients 12 and older who are undergoing umbilical cord blood transplantation following radiation or chemotherapy.

“Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation,” Peter Marks, M.D., Ph.D., the director of the FDA’s Center for Biologics Evaluation and Research, said in a release.

Gamida is a 25-year-old Israel-based biotech. The company has struggled to get Omisirge across the finish line and has seen its funding dry up, forcing its recent cost-cutting measures.

One delay came in 2021 when the FDA requested more information on Gamida’s manufacturing facility for the treatment after its successful phase 3 trial used drug supplies made from three different sites.

Another delay came late last year when the FDA said it needed an additional three months to decide on Gamida’s application after the company submitted additional data the regulator considered “a major amendment” to the submission.

With the setbacks, Gamida made two waves of layoffs. Then, last month, it also halted preclinical work on natural killer cell therapies GDA-301, GDA-501 and GDA-601.

Upon Monday’s approval, however, Gamida regained some of its flagging support as its shares jumped 39%.

Omisirge is a single-dose therapy administered intravenously. It is made up of donor stem cells from umbilical cord blood that are processed with nicotinamide, which is a form of vitamin B3.

The approval was approved based on a study of 125 blood cancer patients comparing transplantation of Omisirge to transplantation of umbilical cord blood. The efficacy of Omisirge was assessed based on the amount of time needed for recovery of the subject’s neutrophils and the incidence of infections following transplantation.