ORGCAR19 / Orgenesis - LARVOL DELTA

Orgenesis touts early clinical promise of CAR-T therapy with decentralized production in mind (BioPharma-Reporter) - "Orgenesis expects to publish more details of the ORG-101 clinical trial in the near future and plans to launch a phase 1/2 trial of the CAR-T therapy candidate. With the help of Good Manufacturing Practice (GMP)-validated platforms that Orgenesis recently acquired, the company has also generated production data suggesting that it can make ORG-101 cheaply in a decentralized manner...On the back of Orgenesisʼ latest data, the UK-based Harley Street Healthcare Group (HSHG) plans to support the development of the candidate by setting up a Global Cancer Initiative. The initiative has the mission to democratize advanced therapies by sharing the costs and risks of drug development between its partners and lowering the cost for patients."

Clinical data • Commercial • New P1/2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Orgenesis Announces Positive Results From a Real-World Study of ORG-101 CAR-T Therapy in Patients with CD19+ Acute Lymphoblastic Leukemia (GlobeNewswire) - "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 (B-cell ALL). 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 (CR) of 82% in adult patients and 93% in pediatric patients. Moreover, the incidence of severe Cytokine Release Syndrome (CRS), a common safety concern associated with CAR-T therapies, was found to be low, 2% in adult patients and 6% in pediatric patients....The Company is now preparing to initiate its own Phase 1/2 clinical multicenter study with an initial clinical site at the General University Hospital of Patras in Greece, supported by its Enterprise Greece Grant..."

New P1/2 trial • Real-world • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology