Gracell Biotechnologies: FDA Clears IND Application Of GC012F

(RTTNews) - Gracell Biotechnologies Inc. (GRCL) announced the FDA has cleared the company's Investigational New Drug application and the company can proceed to initiate a Phase 1b/2 clinical trial in the U.S. of GC012F for the treatment of relapsed/refractory multiple myeloma. The company plans to initiate a Phase 1b/2 clinical trial in the second quarter of 2023 in the U.S. to further evaluate GC012F in RRMM patients.

"Advancing our lead therapeutic candidate into a U.S. clinical trial is major milestone for Gracell, and further validates our GC012F program, proprietary FasTCAR next-day manufacturing platform and novel dual-targeting approach," said William Cao, CEO of Gracell.

Shares of Gracell Biotechnologies are up 31% in pre-market trade on Friday.

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