IDEAYA Biosciences Inc (IDYA) News & EventsIDYAIDEAYA Biosciences Inc

IDEAYA Biosciences Promotes Michael White to President, Research and Development

IDEAYA Biosciences announced the promotion of Dr. Michael White, from Chief Scientific Officer to President, Research and Development. White has served as CSO since 2021.

Ideaya Biosciences Doses First Patient in OptimUM-11 Trial

Ideaya Biosciences announced that the first patient has been dosed in OptimUM-11, a global Phase 3 registrational trial evaluating darovasertib, an oral protein kinase C inhibitor, in combination with crizotinib, an oral cMET inhibitor, as adjuvant therapy for patients with primary uveal melanoma who have completed local therapy and have an increased risk of developing metastatic disease. Currently, there are no approved adjuvant treatment options for patients with primary uveal melanoma.

Ideaya Biosciences Successfully Holds FDA Meeting, Plans Phase 3 Trial by End of 2026

Ideaya Biosciences (IDYA) announced a successful FDA Type C meeting to determine the Phase 3 registrational trial design for IDE849, a potential delta-like ligand 3, or DLL3-targeting Topo-I-payload antibody drug conjugate, in extensive stage small cell lung cancer. Ideaya is targeting to initiate the Phase 3 registrational study in ES-SCLC by year-end 2026. The anticipated enrollment target for the Ideaya-sponsored global Phase 3 registrational study is approximately 400 ES-SCLC patients with prior tarlatamab treatment. The study will be randomized 1:1 between the treatment and an investigator's choice control arm that will include topotecan and ambrucin. The primary endpoint for accelerated approval will be overall response rate by blinded independent central review and the primary endpoint for full approval will be median overall survival. The secondary endpoints will include median duration of response by BICR, progression free survival, safety, among others. Ideaya has an ongoing multi-site global Phase 1 clinical trial for IDE849 in DLL3 upregulated solid tumor indications, including SCLC, and neuroendocrine carcinomas. The study is enrolling patients globally, including in North America, Europe, Australia, South America, and Asia. In this ongoing Phase 1 dose escalation study, IDE849 is currently evaluating the expansion doses of 2.4 mg/kg and 3.5 mg/kg IV once every 3-weeks to determine the recommended Phase 3 dose. In addition, IDE849 is being evaluated in clinical combination study with AstraZeneca's (AZN) PDL1 inhibitor Imfinzi, and IDEAYA's potential first-in-class Phase 1 PARG inhibitor, IDE161, to determine a potential first-line SCLC Phase 3 registrational trial design. IDE161 prevents the removal of poly chains generated by PARP during the DNA damage response, leading to persistent PARylation and impaired resolution of DNA repair complexes. Together with TOP1-payload ADCs, this unique mechanism-of-action results in sustained TOP1 cleavage complexes and the accumulation of DNA damage that delivers enhanced anti-tumor activity. DLL3 has been reported to be upregulated in multiple solid tumor types, including in SCLC, NEC and melanoma, among others. Ideaya estimates the annual incidence of SCLC and NEC in the United States is approximately 34,000 and 19,000 patients, respectively. DLL3 has limited extracellular expression in normal tissues, making it a promising potential therapeutic target in these solid tumors, for which there remains significant unmet medical need.