NEW YORK – Ideaya Biosciences on Monday said that it has submitted an investigational new drug application with the US Food and Drug Administration for its MAT2A inhibitor IDE397, an agent that the firm is developing to treat solid tumors with MTAP gene deletions.
If the FDA accepts the IND, Ideaya will begin evaluating IDE397 in a Phase I basket trial involving patients with a variety of solid tumors with MTAP deletions, which occur in roughly 15 percent of cancers. In the study, patients will have their tumors molecularly tested using next-generation sequencing panels and their MTAP protein levels will be confirmed via an immunohistochemistry assay developed in collaboration with Roche subsidiary Ventana. The company plans to evaluate the agent as a monotherapy to begin with and then with GlaxoSmithKline's PRMT inhibitor GSK3368715 among other clinical combinations.
"The IDE397 IND submission is an important milestone for Ideaya as we advance our broader synthetic lethality pipeline of potential first-in-class therapies," Ideaya's CSO Michael Dillon said in a statement. "IDE397 was discovered through our efforts to develop a potential best-in-class MAT2A inhibitor, and we have achieved our target product profile."
In addition to the MAT2A inhibitor, Ideaya announced last week that it has begun evaluating a PKC inhibitor IDE196 with Pfizer's cMET inhibitor crizotinib (Xalkori) in a clinical trial of patients with uveal melanoma.