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IDEAYA Announces IDE397 Clinical Program Update and ctDNA Molecular Responses Demonstrating Tumor Pharmacodynamic Modulation

  • Initiated monotherapy expansion cohorts with enrollment open for NSCLC and esophagogastric tumors with MTAP deletion
  • Initiated combination dose escalation cohorts with enrollment open for combinations with taxanes and separately, with potential first-in-class combinations, including pemetrexed
  • Entered into Clinical Trial Collaboration and Supply Agreement with Amgen to clinically evaluate IDE397 in combination with AMG 193, Amgen’s investigational MTA-Cooperative PRMT5 inhibitor
  • ctDNA Molecular Responses observed in 3 of 4 (75%) patients in Cohorts 5 and 6, demonstrating target engagement and tumor pharmacodynamic modulation
  • Delivered Option Data Package to GSK, including preclinical data and clinical data from the IDE397 monotherapy dose escalation study of the Phase 1 clinical trial

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., July 27, 2022 /PRNewswire/ — IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced clinical program updates for IDE397, an investigational, potential best-in-class, small molecule MAT2A inhibitor being evaluated in an ongoing Phase 1/2 clinical trial (NCT04794699).  

“We are excited to advance our clinical development of IDE397 and to progress our strategic collaborations with GSK and Amgen on this program.  Delivery of the IDE397 Option Data Package to GSK represents an important milestone in our collaboration with GSK.  The clinical collaboration with Amgen enables clinical evaluation of a potential first-in-class combination to inhibit two synthetic lethal nodes within the MTAP pathway – MAT2A and PRMT5, providing a complementary approach for targeting MTAP-null tumors,” said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. 

“The ctDNA molecular response clinical pharmacodynamic data reflects evidence of dose-dependent tumor pharmacodynamic modulation and target engagement at clinically achievable doses in patients having MTAP-deleted tumors,” said Dr. Michael White, Senior Vice President and Chief Scientific Officer, IDEAYA Biosciences.

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