NEW YORK – Orgenesis on Thursday said it will begin a Phase I/II trial of ORG-101 at the General University Hospital of Patras in Greece after the investigational CD19-directed CAR T-cell therapy showed promising activity in a real-world study involving patients with acute lymphoblastic leukemia.
The real-world study, conducted in China, included 233 patients and showed an 82 percent complete response rate among adults and a 93 percent complete response rate among children. The rate of cytokine release syndrome was 2 percent and 6 percent in adults and children, respectively.
Based on this data, the company said it will initially launch the multicenter Phase I/II trial at the General University Hospital of Patras and then expand it to other sites at partner hospitals in its network. Orgenesis said it has already held meetings with the US Food and Drug Administration, the Israeli Ministry of Health, and the Paul-Ehrlich-Institute in Germany about ORG-101's development.
Orgenesis manufactures ORG-101 using a proprietary CAR construct and a third-generation lentiviral vector. It processes cell and gene therapies near local hospitals and treatment facilities via its Mobile Processing Units and Labs. In May, the firm signed an agreement with the contract development and manufacturing organization SCTbio to facilitate point-of-care development of cell and gene therapies and to enable production of lentiviral vectors for CAR T-cell and gene therapies.
Germantown, Maryland-based Orgenesis also said it will set up a global cancer initiative through a joint venture with Harley Street Healthcare Group (HSHG), aiming to support clinical development of advanced therapies and improve patients' access. Orgenesis and HSHG announced the formation of the JV earlier this month, with Orgenesis owning 49 percent and London-headquartered HSHG owning 51 percent.
Through the JV, Orgenesis and HSHG expect to launch a suite of wellness and longevity products by the end of 2024, including immune cell banking, aging and longevity therapies, preventive illness screening, and stem cell therapies in the UK, United Arab Emirates, Canada, Africa, the Indian subcontinent, and other regions. HSHG will also invest up to $10 million over three years in Orgenesis and the JV.
The overarching aim within the global cancer initiative is to make advanced cancer therapies more affordable and lower the cost of cell therapy development using Orgenesis' decentralized manufacturing solutions, according to Sanjeev Kumar, HSHG chief visionary officer, and Orgenesis and HSHG will work with other organizations to achieve these goals.