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Ideaya Biosciences, Gilead Sciences to Study IDE397-Trodelvy Combo in MTAP-Null Bladder Cancer

NEW YORK – Ideaya Biosciences said on Monday that it has partnered with Gilead Sciences to study its investigational MAT2A inhibitor IDE397 plus Gilead's antibody-drug conjugate Trodelvy (sacituzumab govitecan) in bladder cancer patients harboring MTAP deletions.

Under this collaboration, Gilead will supply Trodelvy for the Phase I clinical trial, which Ideaya will sponsor. The drugmakers will retain the commercial rights to their own agents when given as monotherapies and in combination with other drugs.

In the Phase I trial, Ideaya and Gilead will enroll bladder cancer patients with MTAP deletions, which show up in just more than a quarter of patients with this type of tumor, according to Ideaya. Across all solid tumor indications, roughly 15 percent of patients have this biomarker.

"We believe the strong mechanistic rationale of this combination, and the monotherapy efficacy observed by both agents in MTAP-deletion bladder cancer, may enable this combination to be differentiated and studied in an earlier-line clinical setting," Ideaya CEO and President Yujiro Hata said in a statement.

Ideaya is also evaluating IDE397 as a single agent for MTAP-null solid tumors in an ongoing basket study, and in combination with Amgen's PRMT5 inhibitor AMG193 in MTAP-null solid cancers in another Phase I/II trial.