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Gamida Cell’s Bone Marrow Transplant Alternative Succeeds In Phase III

 
• By Mandy Jackson

The Novartis-backed company will begin a rolling submission to the US FDA for its cord blood-derived cell therapy omidubicel in Q4 based on improved engraftment versus standard cord blood. 

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Gamida Cell's omidubicel is on the path to US FDA submission • Source: Shutterstock

Gamida Cell Ltd. plans to initiate a rolling biologic license application (BLA) submission to the US Food and Drug Administration in the fourth quarter of 2020 for omidubicel to treat patients eligible for bone marrow transplants. The company reported on 12 May that its umbilical cord blood-derived cell therapy reduced the time to neutrophil engraftment and increased engraftment rates compared with standard umbilical cord blood transplant in a Phase III clinical trial.

Needham analyst Chad Messer said in a same-day note that the Phase III trial met its primary endpoint with “remarkable consistency” relative to Gamida Cell’s Phase I/II results

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