
IDEAYA Biosciences initiates Phase 1/2 monotherapy expansion for IDE892 in solid tumors
- IDEAYA Biosciences (NASDAQ:IDYA) reported the initiation of the Part 2 monotherapy expansion in its Phase 1/2 trial of IDE892, an MTA-cooperative PRMT5 inhibitor.
- The expansion begins at projected efficacious human exposures achieving 24-hour EC90 target coverage, while researchers continue dose escalation.
- The company is concurrently advancing IDE892 combination studies alongside IDE397 and Roche's pan-RAS inhibitor RG6505.
IDEAYA Biosciences (NASDAQ:IDYA) announced the initiation of the Part 2 monotherapy expansion for its Phase 1/2 clinical trial evaluating IDE892.
The investigational drug, an MTA-cooperative PRMT5 inhibitor, is being assessed for the treatment of MTAP-deleted solid tumors, with a primary clinical focus on non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC).
The monotherapy expansion phase is commencing at projected efficacious human exposures designed to achieve 24-hour EC90 target coverage.
Management noted that the dose escalation portion of the study remains ongoing, as a maximum tolerated dose (MTD) has not yet been reached.
Following these clinical pipeline updates, IDEAYA Biosciences' share price traded near $35.40.
The company highlighted several specific pharmacological characteristics of IDE892 supporting its clinical profile.
The inhibitor demonstrates an approximately 1,400-fold selective MTA-PRMT5 binding compared to SAM-PRMT5. Additionally, the drug features a lack of brain penetration and a favorable cytochrome P450 (CYP) profile.
Looking beyond the current monotherapy evaluation, IDEAYA is advancing combination therapies for the asset.
The clinical pipeline includes pairing IDE892 with the company's own MAT2A inhibitor, IDE397, as well as with Roche's pan-RAS inhibitor, RG6505.
Furthermore, the company provided a brief update on its broader oncology pipeline, noting that its distinct CDKN2A program is currently targeting an Investigational New Drug (IND) submission in the first half of 2027.