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China's NMPA Clears Oricell Therapeutics to Start Studying CAR T-Cell Therapy in Multiple Myeloma

NEW YORK – Oricell Therapeutics said on Thursday that China's National Medical Products Administration (NMPA) has cleared an investigational new drug (IND) application for OriCAR-017, allowing it to begin studying the autologous CAR T-cell therapy in advanced multiple myeloma patients.

OriCAR-017 targets GPRC5D, a protein receptor expressed on multiple myeloma cells but not in normal tissues. Oricell intends to study the treatment in late-line relapsed or refractory multiple myeloma patients who have failed or responded poorly to BCMA-targeted therapies.

Oricell CEO Helen Yang said in a statement that the company has a global development plan for OriCAR-017 and is working through registration and technology transfer processes to bring the agent into clinical trials in the US, as well.

Last year, researchers presented results from a small study of OriCAR-017 in multiple myeloma, in which all 10 patients responded to the treatment and eight of 10 had a complete response. In October, OriCAR-017 received orphan drug designation from the US Food and Drug Administration for the treatment of relapsed or refractory multiple myeloma.

Earlier this year, Shanghai-based Oricell raised $45 million in a Series B1 funding round, which the company said it would put toward developing its products, including OriCAR-017, in the US.