Gamida’s Allogeneic Cell Therapy Snags FDA Approval for Blood Cancers

As cell therapy technology advances rapidly, Israeli biotech Gamida Cell is the most recent company to rope in coveted FDA approval with its cell therapy, Omisirge (omidubicel-onlv), an allogeneic cell therapy designed to help treat blood cancers. The U.S. FDA approved the therapy based on the results from a Phase 3 trial which demonstrated that Omisrige could help replenish white blood cells while reducing the risk of infection. 

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Reducing Infection Rates in Stem Cell Transplants

Making up about 10% of all cancer cases in the U.S. each year, blood cancers take a massive toll on society, and researchers are always searching for better solutions to treat the diverse subgroup of cancer. With blood cancer, abnormal cell growth often starts in the bone marrow, requiring myeloablative conditioning like chemotherapy and radiation therapy before considering a stem cell transplant. 

The FDA approved Gamida’s Omisirge for patients 12 and older with blood cancers planned for umbilical cord blood transplantation after myeloablative conditioning. Omisirge is a cord-based allogeneic therapy, meaning the stem cells come from a donor rather than the patient.

Because stem cell transplantations often require patients to undergo chemotherapy or radiation therapy before a transplant, an individual’s immune system is usually weakened, increasing the risk of infection after a transplant. Reducing the risk of infection is where Omisirge shines due to its ability to replenish white blood cells.

In a Phase 3 trial consisting of 125 participants, 39% of patients who received Omisirge developed bacterial or fungal infections in the 100 days following transfusion compared to 60% in the control arm. The infection rates might still seem alarmingly high, but Omisirge received Priority Review, Breakthrough Designation, and Orphan Drug Designation from the FDA, highlighting the intense unmet need for more adequate cell therapies for blood cancer. 

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said, “Today’s approval is an important advance in cell therapy treatment in patients with blood cancers. Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation.”

Providing Access to Cell Therapy for Broader Populations

One of Gamida’s main selling points throughout Omisirge’s development is its potential to treat more diverse groups. According to the company, more than 40% of patients in the Phase 3 study were racially and ethnically diverse. 

Chief Medical Officer at the National Marrow Donor Program said, “Patients who are Black or African American have just a 29% chance of finding a match via the donor registry vs. a 79% chance for patients who are White. Adding Omisirge as a new donor source may help increase access to stem cell transplant for patients from racially or ethnically diverse backgrounds who struggle to find a fully matched donor in the registry.”

With the FDA’s approval, Gamida, which manufactures Omisirge out of Israel, is looking to get the ball rolling and get Omisirge to blood cancer patients in need. The company said transplant centers across the U.S. can begin ordering Omisirge and that it plans to start delivering the cell therapy to transplant centers within 30 after the start of manufacturing. Gamida says it is still pursuing strategic partnerships to support Omisirge’s launch and commercialization.

With its first product approved and ready to hit the market, Gamida’s stock is on the rise, marking a momentous occasion for the company. With one other therapy in the works designed to treat non-Hodgkin lymphoma, Gamida will still be hard at work in the coming months and years. For now, though, the company can take some pride in Omisirge’s accomplishments as a new stem cell therapy to help treat blood cancers. 

Author

Reed Slater