DKosig Ideaya Biosciences ( NASDAQ: IDYA ) shares jumped as much as 23% premarket on Monday after the oncology company reported positive interim data from an expansion dose cohort of a mid-stage trial of IDE397. IDE397 is a potential first-in-class MAT2A (methionine adenosyltransferase 2 alpha) inhibitor, that is being advanced as a monotherapy agent in priority MTAP-deletion solid tumor types and in high conviction rational combinations, including with Amgen's ( AMGN ) investigational MTA-cooperative protein arginine methytranferase 5 inhibitor, AMG 193, in non-small cell lung cancer (NSCLC) and with Gilead's ( GILD ) Trop-2 directed anti-body conjugate Trodelvy in urothelial cancer. There are currently no FDA-approved therapies for patients with MTAP-deletion solid tumor.
In a Phase 2 clinical trial, IDE397 expansion dose of 30mg once-a-day showed ~39% overall response rate and 94% disease control rate in the 18 evaluable MTAP-deletion urothelial cancer and NSCLC patients. In addition, 14 patients observed tumor shrinkage. The expansion cohort also demonstrated a favorable safety profile, with no drug-related serious adverse events (SAEs) observed.
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