NEW YORK – Shenzhen Pregene Biopharma on Wednesday announced it has licensed its anti-BCMA CAR T-cell therapy PRG-1801 to CellPoint for development and commercialization in Europe and the US as a point-of-care treatment.
Under the license agreement, CellPoint will pay Pregene more than €20 million ($21.8 million) upfront. Pregene, which will provide translational and lentivirus manufacturing services to CellPoint, is also eligible to receive additional development, commercial milestone, and royalty payments in the deal.
Shenzhen, China-based Pregene is studying the autologous PRG-1801 in two multiple myeloma trials. A Phase I/II trial is evaluating the drug in relapsed or refractory multiple myeloma patients after anti-BCMA CAR-T infusion. Early clinical data from that trial showed a 100 percent response rate, according to the company.
A second, Phase I investigator-initiated study in China is also exploring the drug in relapsed or refractory multiple myeloma. Initial results from 34 patients treated in that trial showed that 30 patients, or 88 percent, achieved an objective response and 19 patients, or 56 percent, achieved a complete response.
CellPoint, based in the Netherlands, will develop PRG-1801 to work with its online xCellit platform for workflow management and a decentralized, point-of-care cell therapy manufacturing device from Lonza, CellPoint CEO Tol Trimborn said in a statement. The company's goal is to develop therapies that can be manufactured on-site using Lonza's Cocoon platform and a kit comprising CAR-T reagents. With this platform, CellPoint aims to reduce the time to treatment for CAR-T cell therapies by manufacturing the therapies within one week.
"This is our second clinical stage program, and we have demonstrated we can provide cell therapy to cancer patients in only six days vein-to-vein, from apheresis to infusion," Trimborn said.