(RTTNews) - IDEAYA Biosciences, Inc. (IDYA), announced that the U.S. FDA has cleared its IND application for IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 antibody-drug conjugate (ADC) for the treatment of multiple solid tumors, including lung, colorectal, head and neck, and ovarian/ gynecological cancers.
IDE034 is designed to target tumors that co-express B7H3 and PTK7, proteins reported to be present in multiple solid tumor types. According to the Human Protein Atlas database, B7H3/PTK7 co-expression occurs in approximately 30% of lung cancers, 46% of colorectal cancers, and 27% of head and neck cancers.
IDEAYA plans to initiate a Phase 1 clinical trial in Q1 2026, enrolling patients with lung, colorectal, head and neck, and ovarian/ gynecological cancers.
Preclinical in vivo studies demonstrated deep and durable tumor regressions with IDE034 monotherapy in models with B7H3/PTK7 co-expression. Enhanced durability was observed when IDE034 was combined with IDE161, a poly (ADP-ribose) glycohydrolase (PARG) inhibitor, supporting a mechanistic rationale for combination therapy.
IDEAYA explained that TOP1 inhibition induces replication stress and DNA damage, increasing reliance on the PARG pathway. Combining IDE034 with IDE161 may therefore enhance anti-tumor activity in patients with B7H3/PTK7 co-expression, consistent with preclinical findings.
Chief Medical Officer Dr. Darrin M. Beaupre commented that IDE034 has demonstrated robust antitumor activity and selective targeting of B7H3- and PTK7-expressing solid tumor models. The high prevalence of B7H3/PTK7 co-expression in solid tumors such as lung, colorectal, and head and neck cancers underscores its broad indication potential.
President and CEO Yujiro S. Hata added that IDEAYA's differentiated clinical strategy now includes three potentially first-in-class clinical-stage programs focused on enhancing the efficacy of TOP1 ADCs through PARG DDR combinations.
IDEAYA intends to share additional preclinical data at a medical conference in the first half of 2026.
The IND clearance marks a significant milestone for IDEAYA as it expands its pipeline of targeted oncology therapeutics.
IDEAYA is currently trading in the pre-market at $37.45, up 5.14%. Trading volume came in at roughly 494k shares versus an average volume of over 1.23million shares. Over the past 12 months the stock has traded between $13.45 to $36.55.
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