Gracell Biotechnologies Inc. (GRCL) has announced that the FDA (Food and Drug Administration) has approved their Investigational New Drug (IND) application. This will allow the company to start a Phase 1 clinical trial in the United States for GC012F. This early-line treatment is aimed at patients suffering from multiple myeloma. It's worth noting, this is the third time that the U.S. has given IND clearance for GC012F.
The CEO of Gracell, William Cao, expressed his excitement about this development stating, "This IND is a significant milestone as we expand our efforts to meet significant unmet needs earlier in the treatment of multiple myeloma. Through GC012F's unique dual-targeting approach and FasTCAR manufacturing, we have already seen immense promise for deeper, durable responses."
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