On July 27, 2022 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported it has entered into a clinical trial collaboration and supply agreement with Amgen Inc. to evaluate the efficacy and safety of IDE397, its investigational, potential best-in-class, small molecule MAT2A inhibitor, with Amgen’s AMG 193, an investigational small molecule MTA-cooperative inhibitor of PRMT5, in a Phase 1 clinical trial (Press release, Ideaya Biosciences, JUL 27, 2022, View Source [SID1234616986]).
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"This clinical collaboration with Amgen builds on IDEAYA’s ongoing clinical evaluation of IDE397 as monotherapy and in selected combinations in our Phase 1/2 clinical trial, including with taxanes and pemetrexed. We are pleased to collaborate with Amgen to also evaluate the MAT2A-PRMT5 synthetic lethality combination in the clinic," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.
"Mechanistically, each of MAT2A and PRMT5 are synthetic lethal with MTAP gene deletion in tumors. The synthetic lethality of each of these targets provides a complementary approach for targeting MTAP-null tumors," said Dr. Michael White, Ph.D., Senior Vice President and Chief Scientific Officer, IDEAYA Biosciences.
IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. The MTAP deletion patient population is estimated to represent approximately 15% of solid tumors, including approximately 15% of NSCLC, 28% of esophageal, 26% of bladder, and 10% of esophagogastric cancers.
IDEAYA is evaluating IDE397 in an ongoing Phase 1/2 clinical trial. The company has initiated and is actively enrolling patients into monotherapy expansion and combination cohorts of the IDE397 Phase 1 clinical trial, including in combination with docetaxel in NSCLC, paclitaxel in esophagogastric cancer and pemetrexed in NSCLC. IDEAYA is leading early clinical development of IDE397 in collaboration with GSK. Subject to exercise of its option, GSK will lead later-stage clinical development of IDE397.
Amgen is developing AMG 193, an investigational small molecule methylthioadenosine (MTA) cooperative inhibitor targeting protein arginine methyltransferase 5 (PRMT5), as monotherapy and in combination with docetaxel in MTAP null solid tumors, in an ongoing Phase 1 clinical trial.
Under the mutually non-exclusive clinical trial collaboration and supply agreement, IDEAYA will provide IDE397 drug supply to Amgen, who will be the sponsor of the Phase 1 clinical combination trial. IDEAYA and Amgen will jointly share external costs of the clinical trial and will jointly oversee clinical development of the combination therapy. IDEAYA and Amgen each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.