NEW YORK – Ideaya Biosciences on Thursday said it dosed the first cancer patient with its MAT2A inhibitor, IDE397, in a Phase I study.
The trial will enroll up to 40 participants with advanced or metastatic solid tumors with MTAP deletions who are unresponsive to standard-of-care therapy or out of treatment options. Patients will be selected for the trial using commercial next-generation sequencing tests and an immunohistochemistry assay to confirm MTAP protein levels that Ideaya developed with Roche subsidiary Ventana.
MTAP gene deletions occur in about 15 percent of all solid tumors. In data presented at the American Association for Cancer Research's virtual annual meeting this week, IDE397 showed significant single-agent anti-tumor activity in several major cancer types including non-small cell lung cancer, gastric, esophageal, and bladder cancer, the company said.
In this Phase I trial, researchers will study IDE397 as a monotherapy, but Ideaya is also exploring the drug's preclinical activity in combination with other drugs including in a study pairing its drug with GlaxoSmithKline's PRMT inhibitor GSK3368715.
"Dosing our first patient for IDE397 in our Phase I MTAP-deletion solid tumor trial is a substantial company milestone," Ideaya CEO Yujiro Hata said in a statement, adding that the company is also making progress on the development of its two synthetic lethality programs in PARG and Pol Theta, and advancing its pipeline in the MTAP-deletion synthetic lethality space to complement the Phase I IDE397 program.
This year, Ideaya also began a Phase I study of its PKC inhibitor IDE196 with Pfizer's cMET inhibitor crizotinib (Xalkori) in patients with uveal melanoma. Last year, the South San Francisco-based firm also partnered with Pfizer to study drug combinations to treat GNAQ or GNA11 hotspot-mutated solid tumors and partnered with the Broad Institute of MIT and Harvard to identify synthetic lethality drug targets for ovarian and breast cancer.