IDEAYA Biosciences Inc. (NASDAQ:IDYA) advanced 5.1% in premarket trading on Monday after revealing that the FDA has cleared its investigational new drug (IND) application for IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 antibody-drug conjugate.
The oncology-focused precision medicine company expects to launch a Phase 1 clinical trial in the first quarter of 2026. The initial study cohort will include patients with solid tumors that express B7H3 and PTK7, such as lung, colorectal, head and neck, and ovarian or gynecological cancers.
Data from the Human Protein Atlas indicate that B7H3/PTK7 co-expression appears in roughly 30% of lung cancers, 46% of colorectal cancers, and 27% of head and neck cancers—supporting the drug’s potential for broad monotherapy impact.
“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 work demonstrated strong anti-tumor responses in B7H3/PTK7-positive models, with IDE034 monotherapy producing deep and durable tumor regressions. IDEAYA also reported improved durability when IDE034 was combined with IDE161, its PARG inhibitor, in preclinical in vivo studies.
The company plans to present additional preclinical findings supporting the combination’s mechanistic rationale at a medical conference in the first half of 2026.