Orgenesis Announces Positive Results From a Real-World Study of ORG-101 CAR-T Therapy in Patients with CD19+ Acute Lymphoblastic Leukemia

Core Insights - Orgenesis' CD19 CAR-T therapy, ORG-101, demonstrated a complete response (CR) of 82% in adults and 93% in pediatric patients, with low incidence rates of severe Cytokine Release Syndrome (CRS) at 2% and 6% respectively [1][2] - Harley Street Healthcare Group plans to establish a Global Cancer Initiative to democratize advanced therapies and support further clinical development in collaboration with Orgenesis [1][6] Efficacy and Safety Data - The study revealed a complete response (CR) of 82% in adult patients and 93% in pediatric patients, with severe CRS incidence at 2% for adults and 6% for pediatric patients, indicating a favorable safety profile for ORG-101 compared to existing treatments [2] - CRS is a significant safety concern in conventional CAR-T therapies, and the low incidence in this study suggests a potential advantage for ORG-101 [2] Production and Cost Efficiency - Orgenesis is utilizing a GMP-Validated Platform for CAR-T therapy, which is adapted to a decentralized production model aimed at expediting capacity setup, enhancing production efficiency, and reducing treatment costs [3] - The decentralized approach is positioned as a cost-effective alternative to traditional CAR-T therapies produced in centralized facilities [4] Clinical Development Plans - The company is preparing to initiate a Phase 1/2 clinical multicenter study for ORG-101, starting at the General University Hospital of Patras in Greece, supported by an Enterprise Greece Grant [5] - Meetings have been held with regulatory bodies including the FDA, Israeli MOH, and the Paul-Ehrlich-Institute in Germany regarding ORG-101 [5] Strategic Vision - The CEO of Orgenesis emphasized the importance of combining positive clinical results with a decentralized production strategy to improve access and reduce costs for patients [6] - The Chief Visionary Officer of Harley Street Healthcare Group highlighted the initiative's goal to make cancer therapies more affordable and accessible globally, focusing on partnerships and biobanking [6]