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Investing.com -- IDEAYA Biosciences Inc (NASDAQ:IDYA) stock rose 5.1% in Monday’s premarket trading after the company announced FDA clearance for its investigational new drug application for IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 antibody-drug conjugate.
The precision medicine oncology company plans to begin enrolling patients in a Phase 1 clinical trial in the first quarter of 2026. The study will initially evaluate patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck, and ovarian/gynecological cancers.
According to the Human Protein Atlas database, B7H3/PTK7 is co-expressed in lung, colorectal, and head and neck cancers at approximately 30%, 46%, and 27%, respectively. This co-expression pattern supports the potential for broad monotherapy activity.
"IND clearance for IDE034 is an important step in expanding our potential first-in-class TOP1 ADC clinical pipeline into bispecific, precision-guided approaches," said Darrin M. Beaupre, Chief Medical Officer of IDEAYA Biosciences.
Preclinical studies have shown strong anti-tumor activity in B7H3/PTK7-positive tumor models, including deep and durable tumor regressions with IDE034 monotherapy. The company also reported enhanced durability with IDE034 when combined with IDE161, IDEAYA’s PARG inhibitor, in preclinical in vivo models.
The company plans to share additional preclinical data supporting the mechanistic rationale for this combination at a medical conference in the first half of 2026.
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