Noticias y eventos de IDEAYA Biosciences Inc (IDYA)IDYAIDEAYA Biosciences Inc

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.

Ideaya Enters Clinical Collaboration with Genentech

Ideaya Biosciences (IDYA) announced it has entered into a clinical collaboration with Genentech, a member of Roche (RHHBY), to evaluate the efficacy and safety of IDE892, its investigational MTA-cooperative PRMT5 inhibitor, in combination with GDC-7035, Genentech's KRAS G12D inhibitor, in patients with pancreatic ductal adenocarcinoma harboring both an MTAP-deletion and a KRAS G12D mutation. Genentech will sponsor the clinical combination study, and Ideaya will supply IDE892. Under the clinical collaboration, Ideaya and Genentech each retain all commercial rights to their respective compounds, including as monotherapy and as combination therapies. There will be joint governance to oversee the clinical supply collaboration.

Ideaya Biosciences Q2 Revenue $8.86M Beats Expectations

Reports Q2 revenue $8.86M, consensus $7.45M. "This quarter marked another successful step forward in our mission to deliver new, potentially best-in-class precision therapies for people with cancer. We presented the positive topline results at ASCO from our registrational Phase 2/3 OptimUM-02 trial in HLA*A2:01-negative metastatic uveal melanoma while continuing to advance our NDA submission and pre-commercial activities to support a possible commercial launch. Additionally, our clinical pipeline is poised to deliver several key updates throughout the remainder of 2026, including updated data from IDE849, our DLL3 TOP1 ADC, in SCLC and NEC and clinical progress in MTAP-deleted cancers with IDE892, our PRMT5 inhibitor, as both a monotherapy and in combination with IDE397, our proprietary MAT2A inhibitor, and RG6505, Roche's Phase 1 pan-RAS inhibitor in NSCLC and PDAC, respectively. With over $1.2 billion in cash following our successful financing in June, IDEAYA is well-positioned to continue advancing our precision medicine pipeline through multiple key data updates," said Yujiro S. Hata, President and Chief Executive Officer of Ideaya Biosciences.