On March 7, 2024 BridGene Biosciences, Inc., a pioneer in the development of covalent small molecule drugs for traditional "hard-to-drug" targets, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for the clinical study of its TEAD inhibitor BGC515 for the treatment of cancers harboring genetic mutations in the hippo signaling pathway (Press release, Bridgene Biosciences, MAR 7, 2024, View Source [SID1234644278]).

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"We are pleased to announce the FDA acceptance of our IND application for BGC515 and look forward to initiating this Phase I clinical study to evaluate the safety and efficacy profile of BGC515 in patients with advanced solid tumors," stated Ping Cao, Ph.D., Co-Founder and CEO of BridGene Biosciences. "Discovered through our unique chemoproteomic platform, IMTAC, the TEAD inhibitor BGC515 represents a significant breakthrough. The FDA’s endorsement of this IND not only validates our innovative platform but also highlights a critical step forward in our mission to develop pioneering treatments for cancer patients."