IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a company focused on synthetic lethality and precision medicine in oncology, announced updates on its corporate status and portfolio during the J.P. Morgan 40th Annual Healthcare Conference. Yujiro Hata, President and CEO, presented these updates, which included a strong balance sheet with approximately $386 million in cash, cash equivalents, and marketable securities as of September 30, 2021, expected to fund operations into 2025.
Key highlights from the presentation include the completion of enrollment into dose escalation Cohort 5 of the Phase 1 clinical trial for IDE397, a MAT2A inhibitor targeting MTAP-deletion tumors. The company plans to submit a protocol amendment to the FDA in Q1 2022 for IDE397 to enable monotherapy cohort expansions and combination initiation in the first half of 2022. Additionally, IDEAYA aims to deliver a GSK option data package for IDE397 in the first half of 2022, which could trigger a $50 million opt-in decision.
IDEAYA also discussed preclinical in vivo efficacy of IDE397 combined with standard-of-care agents, targeting IND submission for a PARG inhibitor in Q4 2022, and initiating IND-enabling studies for the Pol Theta Helicase program in the first half of 2022. The company observed significant tumor growth inhibition with its Werner Helicase inhibitor and plans to nominate a development candidate in 2023.
Furthermore, IDEAYA is enrolling patients in a Phase 2 clinical trial evaluating the combination of darovasertib and crizotinib in Metastatic Uveal Melanoma, with an update on clinical data and regulatory guidance expected in the first half of 2022. The company is also exploring the expansion of darovasertib's indications into additional MET-driven tumors, such as hepatocellular carcinoma and non-small cell lung cancer.
A live audio webcast of the presentation was made available on IDEAYA's website, with a replay accessible for 30 days post-event. The company's updated corporate presentation can be found on its Investor Relations page.
