IDEAYA Biosciences

IDEAYA Biosciences announced the IDMC's recommendation of a move-forward dose for their potential registration-enabling phase 2/3 trial evaluating darovasertib and crizotinib in first-line HLA-A2(-) metastatic uveal melanoma patients, aligning with FDA's Project Optimus guidelines. The combination has shown compelling preliminary clinical results and has FDA Fast Track designation.

IDMC recommends move-forward dose for darovasertib and crizotinib combination in 1L HLA-A2(-) MUM trial, with over 185 patients enrolled. The combination has FDA Fast Track designation and shows promising clinical efficacy and safety.

IDEAYA Biosciences announced IDMC recommended a move-forward dose for Part 2a of their trial evaluating darovasertib and crizotinib in first-line HLA-A2-negative metastatic uveal melanoma, with over 185 patients enrolled and FDA Fast Track designation.

IDEAYA Biosciences announced the nomination of its new development candidate, IDE251, a potential first-in-class dual inhibitor targeting KAT6 and KAT7 implicated in certain cancers. The company plans to submit an Investigational New Drug application to the FDA in 2025, contingent on successful preclinical and IND-enabling studies. IDE251 has shown robust anti-tumor activity in preclinical studies, particularly in tumor models with 8p11 amplifications. IDEAYA Biosciences focuses on targeted therapeutics for cancer, emphasizing molecular diagnostics and synthetic lethality.

IDEAYA Biosciences nominates IDE251, a potential first-in-class KAT6/7 inhibitor, for breast and NSCLC with 8p11 amplification (~15% in breast cancer, ~17.5% in squamous NSCLC). IDE251 demonstrates robust anti-tumor activity in preclinical models and targets IND submission in 2025.

IDEAYA Biosciences dosed the first patient with IDE161, a potential first-in-class PARG inhibitor, in combination with Merck's KEYTRUDA in a Phase 1 trial for MSI-high and MSS endometrial cancer. The trial aims to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy.

IDEAYA Biosciences dosed the first patient with IDE161, a potential first-in-class PARG inhibitor, combined with Merck’s KEYTRUDA in a Phase 1 trial for MSI-high and MSS endometrial cancer. The trial aims to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy.

IDEAYA Biosciences nominated IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, as its 7th development candidate. IDE892 aims to enhance efficacy in MTAP-deletion solid tumors through a PRMT5 and MAT2A combination. IND-enabling studies are ongoing for a mid-2025 FDA filing.