Business
IDEAYA Announces IDE397 Phase 1 Clinical Pharmacodynamic Data and Phase 2 Initiation of Darovasertib and Crizotinib Combination
‒ Observed plasma SAM reduction in each of the first two dose escalation cohorts of the IDE397 Phase 1 clinical trial, satisfying the clinical protocol
About this update from Ideaya Biosciences, Inc.
[{"type":"text","content":"‒ Observed plasma SAM reduction in each of the first two dose escalation cohorts of the IDE397 Phase 1 clinical trial, satisfying the clinical protocol threshold of approximately 60% or greater plasma S-adenosyl methionine (SAM) pharmacodynamic (PD) reduction to initiate IDE397 tumor biopsy cohort for evaluation of tumor PD markers\n ‒ The GSK MAT2A option is exercisable with a $50M option exercise fee within a review period after IDEAYA's delivery of preclinical and clinical data from the Phase 1 dose escalation, including tumor PD data to be obtained from the tumor biopsy cohort\n ‒ IDE397 has initiated the third cohort of the dose escalation portion of the Phase 1 clinical trial, and has enrolled multiple solid tumor types with MTAP-deletion, including NSCLC, pancreatic cancer and thymic cancer, with no drug-related serious adverse events reported\n ‒ Earlier reported unconfirmed partial responses (PR) have been confirmed in a patient in each of the darovasertib / crizotinib combination and the darovasertib / binimetinib combination arms, with a 56.5% and 51.7% tumor reduction, respectively\n\n\nSOUTH SAN FRANCISCO, Calif., June 28, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced updates for its Phase 1 clinical trial evaluating IDE397 in patients having solid tumors with MTAP deletion and Phase 1/2 clinical trial evaluating darovasertib combination therapies in metastatic uveal melanoma (MUM). \n\n \n \n \n \n \n \n\n \n\"The observation of a clinical pharmacodynamic signal in the initial cohorts of the IDE397 dose escalation study is significant. Modulation of plasma SAM is evidence of target engagement and supports our preclinical observations that IDE397 is a highly potent and active MAT2A inhibitor,\" said Mark Lackner, Ph.D., Senior Vice President, Head of Biology and Translational Sciences of IDEAYA Biosciences. \n\"We continue to be encouraged by the early clinical responses observed in the daraovasertib combination treatments in heavily pretreated patients and are excited to initiate our Phase 2 clinical trial to further evaluate the darovasertib and crizotinib combination in MUM patients,\" said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology an...