Orgenesis announces results for study of CD19 CAR-T therapy

Orgenesis announced positive clinical trial results for a real-world study of CD19 CAR-T therapy, ORG-101, in patients with CD19+ Acute Lymphoblastic Leukemia. Harley Street Healthcare Group intends to set up a Global Cancer Initiative through its joint venture with Orgenesis, with a focus to democratize Advance Therapies and support further clinical development. The top-line efficacy and safety data from the study had a complete response of 82% in adult patients and 93% in pediatric patients. Moreover, the incidence of severe Cytokine Release Syndrome, a common safety concern associated with CAR-T therapies, was found to be low, 2% in adult patients and 6% in pediatric patients, compared to currently approved treatments. This suggests a favorable safety profile for ORG-101. CRS is a systemic reaction caused by an exaggerated immune response to immunotherapy, which is a significant safety issue in conventional CAR-T treatments.