Precision medicine oncology company IDEAYA Biosciences Inc (NASDAQ: IDYA) disclosed on Monday that it has enrolled the first patient in a Phase 1 clinical trial evaluating IDE892, an investigational PRMT5 inhibitor being developed for MTAP-deleted solid tumours, including non-small cell lung cancer and pancreatic ductal adenocarcinoma.
The study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IDE892 as a monotherapy treatment. The company also plans to evaluate the drug in combination with IDE397, its MAT2A inhibitor, with a combination first-patient-in targeted for mid-2026. Preclinical studies have shown durable tumour regressions in MTAP-deleted models using the dual inhibition approach.
IDE892 has been designed as a potential best-in-class PRMT5 inhibitor, demonstrating around 1,400-fold selective binding to MTA-PRMT5 complexes and single-digit nanomolar potency in MTAP-deleted cell lines. The drug has also shown tumour regressions in preclinical models as a monotherapy and durable complete responses when combined with IDE397.
Separately, IDEAYA Biosciences said it is advancing its CDKN2A-deficiency programme, with plans to nominate a development candidate in the second half of 2026 and submit an investigational new drug application in the first half of 2027. CDKN2A deficiency occurs in a significant proportion of cancers, including more than 80% of pancreatic cancer cases.
As part of a strategic focus on its proprietary MTAP-deleted and CDKN2A pipeline, the company will deprioritise combination activities with Trodelvy and conclude enrolment in ongoing Phase 1/2 trials conducted with Gilead Sciences Inc.
MTAP deletion is estimated to occur in 15–20% of non-small cell lung cancer cases, up to 40% of pancreatic cancer and around 15% of all solid tumours, with no approved targeted therapies currently available for these patients.
Merck reports positive Phase 3 data for Enflonsia in high-risk children across two RSV seasons
Beyfortus study shows sustained reduction in infant RSV hospitalisations across two seasons
AstraZeneca reports positive Phase III results for BREZTRI in uncontrolled asthma
Akeso's AK139 Phase II clinical trials approved in China
Median Technologies secures FDA clearance for AI lung cancer screening software
Insilico Medicine names new vice president, Clinical Development – Oncology
Cizzle Biotechnology secures Canadian patent for lung cancer biomarker test
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
United Therapeutics reports positive phase 1 data for bioengineered liver in acute liver failure