Gamida Cell Ltd. announced that the first patient has received a stem cell transplant with Omisirge (omidubicel-onlv). Omisirge was approved by the U.S. FDA in April 2023 for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Gamida Cell has already exceeded its 2023 launch goals, with 15 transplant centers onboarded across the United States and confirmed coverage with payers that cover 90% of commercial lives.

Gamida Cell is actively engaged with more than 90% of the top 70 transplant centers, which conduct approximately 80% of transplants. An increasing number of patients are being enrolled in Gamida Cell Assist®, which signals a transplanter?s intent to use Omisirge as the donor source. Approximately 8,000 stem cell transplants are performed in the U.S. each year in patients with hematologic malignancies and another 1,700 patients are estimated to be eligible for transplant but unable to find a donor.

The ability to find a donor is historically more challenging for racially and ethnically diverse populations than for patients who are white. Gamida Cell market analyses indicate that Omisirge has the ability to capture approximately 20% of allogeneic stem cell transplant market share by ~2028. Omisirge Indication: Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

Important Safety Information for Omisirge. Boxed Warning: Infusion Reactions, Graft Versus Host Disease, Engraftment Syndrome, And Graft Failure: Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions.

Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material. Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.

Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids. Graft failure may be fatal.

Monitor patients for laboratory evidence of hematopoietic recovery. Contraindications: OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products. Warnings and Precautions: Hypersensitivity Reactions: Allergic reactions may occur with the infusion of OMISIRGE.

Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero.

Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration.