Orgenesis (NASDAQ: ORGS) announced positive results from a real-world study of its CD19 CAR-T therapy, ORG-101, in patients with CD19+ Acute Lymphoblastic Leukemia. The study showed complete response rates of 82% in adults and 93% in pediatric patients, with low incidence of severe Cytokine Release Syndrome (2% in adults, 6% in pediatrics).
ORG-101 utilizes a third-generation lentiviral vector with a proprietary CAR construct and decentralized onsite production, offering a potentially more affordable solution compared to traditional CAR-T therapies. Orgenesis is preparing to initiate a Phase 1/2 clinical multicenter study, starting in Greece.
Harley Street Healthcare Group plans to set up a Global Cancer Initiative through its joint venture with Orgenesis, aiming to democratize Advanced Therapies and support further clinical development.