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Ideaya Biosciences announces FDA clearance of IDE034 IND application

Ideaya Biosciences (IDYA) announced the clearance of an investigational new drug application with the FDA for the initiation of a Phase 1 clinical trial to evaluate IDE034, a bispecific B7H3/PTK7 TOP1 antibody-drug conjugate. Ideaya expects to begin enrolling the study in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck and ovarian/gynecological cancers. Based on the Human Protein Atlas database, B7H3/PTK7 has been reported to be co-expressed in lung, colorectal, and head and neck cancers at approximately 30%, 46% and 27%, respectively.

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