Gracell stock surges ~30% on FDA nod to start trial of blood cancer drug

Feb. 03, 2023 8:24 AM ETGracell Biotechnologies Inc. (GRCL)By: Ravikash, SA News Editor

Gracell Biotechnologies (NASDAQ:GRCL) said that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application to start a trial of blood cancer drug GC012F.
The Chinese company plans to begin a phase 1b/2 trial in the U.S. in Q2 of GC012F, an autologous CAR-T therapy, to treat relapsed/refractory multiple myeloma (RRMM).
GC012F is currently being studied in multiple investigator-initiated trials (IIT) in RRMM, newly-diagnosed multiple myeloma, and B-cell non-Hodgkin's lymphoma, according to Gracell.
The company noted that the drug has shown deep responses and favorable safety profile in proof of concept clinical studies.
"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 Gracell's Founder, Chairman and CEO William (Wei) Cao.
In November 2021, the FDA had granted GC012F orphan drug designation to treat multiple myeloma.
GRCL +29.11% to $2.75 premarket Feb. 3