IDEAYA Biosciences Updates Clinical Program for Phase 2 MAT2A Inhibitor IDE397

IDEAYA Biosciences, Inc., a precision medicine oncology company, has announced significant updates in its clinical program for IDE397, a promising Phase 2 MAT2A inhibitor targeting MTAP-deletion solid tumors. This announcement highlights the progress in the IDE397 Phase 2 clinical program, which includes its monotherapy expansion in specific cancer types and the activation of multiple clinical trial sites globally.

IDEAYA is now focusing on updating the clinical data for the IDE397 Phase 2 monotherapy expansion dose in lung and bladder cancer patients with MTAP deletions. The update is expected to occur in the second half of 2024 and will involve approximately 15 evaluable patients. This upcoming data release will provide a clinical efficacy summary, including a RECIST 1.1 clinical efficacy waterfall, a swim-lane plot, and a ctDNA molecular response analysis. Additionally, the update will cover adverse events, pharmacokinetics, and pharmacodynamics associated with the IDE397 Phase 2 monotherapy expansion dose.

Further advancing its clinical program, IDEAYA has initiated the IDE397 Phase 2 monotherapy expansion in MTAP-deletion bladder cancer. This is in addition to the already progressing Phase 2 expansion in MTAP-deletion squamous lung cancer. To facilitate rapid patient enrollment for these trials, the company has activated over 35 clinical trial sites across the U.S., Canada, Europe, and Asia Pacific. This extensive network aims to expedite the enrollment process and gather comprehensive clinical data efficiently.

IDE397 is designed as a highly potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2 alpha (MAT2A) in patients with solid tumors that exhibit methylthioadenosine phosphorylase (MTAP) deletion. This targeted approach aims to provide a new therapeutic option for patients with these specific genetic alterations, potentially offering enhanced efficacy and safety compared to broader-spectrum treatments.

The ongoing Phase 2 expansion of IDE397 monotherapy in MTAP-deletion solid tumors is registered under the clinical trial identifier NCT04794699. Additionally, there is a collaborative effort with Amgen in a Phase 1/2 trial investigating the combination of IDE397 and AMG 193 in MTAP-deletion non-small cell lung cancer (NSCLC), under the clinical trial identifier NCT05975073. IDEAYA and Amgen plan to develop a joint publication strategy for this combination treatment in 2024.

Another Phase 1 clinical trial is set to assess the combination of IDE397 with Trodelvy, focusing on its safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy. This trial is also registered under the clinical trial identifier NCT04794699. Alongside these clinical trials, IDEAYA is advancing several preclinical programs targeting MTAP deletions to enable proprietary combinations with IDE397. One of these programs is expected to nominate a Development Candidate in the second half of 2024.

IDEAYA Biosciences is dedicated to the discovery and development of targeted therapeutics for cancer patients identified through molecular diagnostics. Their approach combines the identification and validation of translational biomarkers with drug discovery efforts to select patient populations most likely to benefit from their therapies. The company is particularly focused on the emerging field of synthetic lethality, aiming to target specific genetic vulnerabilities in cancer cells.

These updates on IDE397 represent IDEAYA's commitment to advancing precision medicine and providing new therapeutic options for patients with MTAP-deletion cancers. The company's extensive efforts in clinical trials and global site activation underscore its strategic approach to accelerating the development and potential approval of IDE397.