IDEAYA Biosciences receives FDA clearance for IDE034, a first-in-class dual-target cancer therapy aimed at lung, colorectal, and head and neck tumors.

IDE034 is a B7H3/PTK7 bispecific TOP1 ADC designed to target tumor cells expressing both B7H3 and PTK7 preferentially, and is being evaluated as monotherapy and in …

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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. This article was generated with the support of AI and reviewed by an editor. For more information see our T&C. The fastest way to find out is with our Fair Value calculator. We use a mix of 17 proven industry valuation models for maximum accuracy. Get the bottom line for IDYA plus thousands of other stocks and find your next hidden gem with massive upside.

IDEAYA Biosciences has announced the enrollment of its first patient in the Phase 1 trial of IDE034, targeting specific types of cancers with promising results.

IDEAYA Biosciences announces FDA clearance for IDE034, a potential first-in-class bispecific ADC targeting solid tumors. This groundbreaking therapy aims to enhance cancer treatment efficacy significantly.

Biocytogen announced that partner IDEAYA (Nasdaq: IDYA) dosed the first patient in the Phase 1 trial of IDE034, a first-in-class B7H3/PTK7 bispecific TOP1 ADC.First dosing triggers a $5 million milestone payment to Biocytogen under the companies' July 2024 license agreement. The Phase 1 study will evaluate safety, tolerability, and PK, with planned combination testing including IDEAYA's oral PARG inhibitor IDE161.

Biocytogen Pharmaceuticals Co., Ltd., announced that its partner IDEAYA Biosciences, Inc., a precision oncology company, has received the clearance of an investigational new drug application with the U.S. Food and Drug Administration for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug...

Phase 1 dose escalation trial to determine safety, tolerability and PK of IDE034 Potential as a monotherapy and in combination with proprietary PARG inhibitor, IDE161 B7H3/PTK7 co-expressed in 30-40% of multiple solid tumor types, including lung, breast, ovarian and colorectal cancers...

B7H3 and PTK7 is co-expressed in multiple solid tumor types, including lung, colorectal, and head and neck cancers, at approximately 30%, 46%, and 27%, respectively Deep and durable regressions observed with IDE034 monotherapy in multiple preclinical in-vivo models with B7H3 and PTK7...