IDEAYA Biosciences announced that the U.S. Food and Drug Administration has granted clearance for an investigational new drug (IND) application for IDE034, a bispecific antibody‑drug conjugate that targets the tumor antigens B7H3 and PTK7. The clearance allows the company to begin a Phase 1 trial that will enroll patients with lung, colorectal, head‑and‑neck, and ovarian/gynecological cancers expressing both antigens.
IDE034 is a top‑oisomerase 1 (TOP1) payload‑conjugated bispecific ADC that has shown deep and durable tumor regressions in pre‑clinical models. In vitro and in vivo studies demonstrated that the drug’s dual‑targeting strategy improves tumor selectivity and reduces off‑target toxicity, while combination with the PARG inhibitor IDE161 further enhances antitumor activity and durability. The pre‑clinical data support the hypothesis that synthetic lethality between TOP1 inhibition and DNA damage response blockade can translate into clinical benefit.
The company plans to initiate enrollment in the first quarter of 2026, with the trial designed to evaluate safety, tolerability, and preliminary efficacy of the TOP1 payload. Eligible patients will be screened for B7H3 and PTK7 co‑expression, which occurs in approximately 30% of lung cancers, 46% of colorectal cancers, and 27% of head‑and‑neck cancers, according to the Human Protein Atlas. The trial will provide the first human data on a bispecific ADC that leverages a dual‑antigen approach in solid tumors.
IDEAYA’s strategy to develop first‑in‑class TOP1 ADCs in combination with PARG inhibitors positions the company to address a sizable addressable market. The FDA clearance moves the program from pre‑clinical to clinical, validating the company’s synthetic‑lethality platform and reinforcing its differentiated pipeline. Management highlighted that the IND approval is a key milestone that supports the company’s broader goal of expanding its precision‑medicine portfolio and generating new revenue streams from a potentially first‑in‑class therapeutic.
Dr. Darrin M. Beaupre, Chief Medical Officer, said the IND clearance “is an important step in expanding our potential first‑in‑class TOP1 ADC clinical pipeline into bispecific, precision‑guided approaches.” CEO Yujiro S. Hata added that the approval “strengthens our differentiated clinical strategy, which now includes three potentially first‑in‑class programs focused on enhancing TOP1 ADC efficacy through PARG DDR combinations.” Investors reacted positively, with IDEAYA’s shares rising in pre‑market trading, reflecting confidence in the company’s scientific progress and pipeline expansion.
The company will present additional preclinical data on the IDE034/IDE161 combination at a major medical conference in the first half of 2026. IDEAYA’s strong cash position and disciplined capital allocation give it the runway to fund the upcoming clinical program while continuing to invest in other pipeline candidates. The IND clearance is expected to accelerate the company’s path to regulatory approval and commercial launch, potentially unlocking new revenue opportunities in the solid‑tumor oncology market.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.