IDEAYA Advances Phase 2 Dosing for IDE397 in MTAP-Deleted Squamous NSCLC

IDEAYA Biosciences, a company dedicated to precision oncology, has announced the advancement of its drug candidate IDE397 into a Phase 2 expansion study for patients with squamous non-small cell lung cancer (NSCLC) that have a specific genetic alteration, known as MTAP deletion. The decision to proceed was informed by the drug's adverse event profile and early signs of clinical effectiveness, which included several partial tumor responses as measured by RECIST 1.1 criteria.
The company's research involved assessing more than 40 preclinical models with MTAP deletion, identifying squamous NSCLC as the most responsive to IDE397 monotherapy. Approximately half of these models showed tumor regression at a dosage of 30mg/kg daily. It is estimated that there are over 100,000 new cases of MTAP-deleted squamous NSCLC globally each year.
IDEAYA's Chief Medical Officer, Darrin Beaupre, expressed enthusiasm for the potential of IDE397 as a novel MAT2A inhibitor, noting the high unmet need in this area of cancer treatment. The company is also exploring various combination therapies with pharmaceutical partners and its own pipeline of drugs.
Michael White, the Chief Scientific Officer at IDEAYA, highlighted the promising early clinical results and the company's anticipation of validating additional preclinical findings throughout the year. IDE397 is designed to inhibit MAT2A, a protein that is overactive in tumors with MTAP deletion, and is currently being evaluated in two clinical trials: a Phase 2 study of IDE397 as a solo treatment for MTAP-deleted solid tumors (NCT04794699), and a Phase 1/2 study combining IDE397 with AMG 193 for MTAP-deleted NSCLC (NCT05975073), sponsored by Amgen. Additionally, there is a Phase 1 trial combining IDE397 with Trodelvy for MTAP-deleted bladder cancer (NCT04794699), sponsored by IDEAYA.
IDEAYA Biosciences focuses on identifying and developing targeted cancer therapies using molecular diagnostics to select patients who are most likely to benefit. The company's strategy includes the identification of biomarkers and the development of drugs aimed at synthetic lethality, an emerging class of precision medicine targets.