IDEAYA Biosciences, Inc. engages in the research and development of oncology-focused precision medicine. The firm focuses on the targeted therapeutics for patients selected using molecular diagnostics. Its product candidate, IDE196, is a protein kinase C inhibitor for genetically defined cancers having GNAQ or GNA11 gene mutations. The company was founded by Yujiro S. Hata and Jeffrey Hager in June 2015 and is headquartered in South San Francisco, CA.
相关临床试验
22
6 进行中
药物批准
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监管机构
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成立时间
2015
进行中（未招募）
6
27.3%
招募中
15
68.2%
撤回
1
4.5%
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- IDEAYA Biosciences and Servier have dosed the first patient in OptimUM-11, a global Phase III registrational trial of darovasertib plus crizotinib as adjuvant therapy in primary uveal melanoma. - The trial will enroll approximately 450 patients at elevated risk of metastatic recurrence after local therapy, randomizing them 1:1 to 12 months of the combination or observation. - Relapse-free survival is the primary endpoint in a setting where no adjuvant treatment is currently approved, despite up to 50% of patients developing metastatic disease. - The companies are simultaneously running three randomized Phase III registrational trials of darovasertib across metastatic, neoadjuvant and adjuvant uveal melanoma.
- IDEAYA Biosciences completed a successful FDA Type C meeting to finalize the Phase 3 registrational trial design for IDE849, a DLL3-targeting Topo-I-payload ADC, in extensive-stage small cell lung cancer (ES-SCLC). - The company targets initiating a randomized Phase 3 study by year-end 2026, using ORR by blinded independent central review for potential accelerated approval and median overall survival for potential full approval. - The global Phase 3 trial plans to enroll approximately 400 ES-SCLC patients with prior tarlatamab treatment, randomized 1:1 against an investigator's choice control arm including topotecan and ambrucin. - IDE849 is also being evaluated in combination with AstraZeneca's PDL1 inhibitor Imfinzi and IDEAYA's PARG inhibitor IDE161 to inform a potential first-line SCLC registrational trial design.
- IDEAYA Biosciences has elected President and CEO Yujiro S. Hata as Chairman of its Board of Directors, consolidating leadership as the company prepares for commercial launches. - Terry Rosen, Ph.D., a founding figure alongside Hata, transitions to Lead Independent Director, ensuring continued board oversight and governance balance. - The leadership change reflects IDEAYA's evolution from a science-driven startup to a precision medicine oncology company with an extensive clinical pipeline and active commercial launch preparations underway. - IDEAYA's pipeline focuses on synthetic lethality and antibody-drug conjugates (ADCs) for molecularly defined solid tumors, targeting high unmet medical needs in cancer.
- IDEAYA Biosciences has completed enrollment of 435 patients in its Phase 2/3 OptimUM-02 trial evaluating darovasertib plus crizotinib for first-line treatment of HLA*A2-negative metastatic uveal melanoma. - The company expects to report median progression-free survival data in Q1 2026 to support a potential accelerated approval filing in the United States. - Previous Phase 1/2 trial data demonstrated a 21.1-month median overall survival and 7.0-month median progression-free survival with the combination therapy. - Darovasertib has received FDA Breakthrough Therapy and Fast Track designations, addressing a rare cancer with limited treatment options and poor survival outcomes.
- IDEAYA Biosciences has submitted an IND application to the FDA for IDE574, a potential first-in-class KAT6/7 dual inhibitor with high selectivity over related KAT5/8 enzymes. - The company plans to initiate a Phase 1 dose escalation trial of monotherapy IDE574 in the first quarter of 2026 for patients with hormone receptor-positive breast cancer and lung adenocarcinoma. - Preclinical studies demonstrate that IDE574 disrupts tumor lineage identity and delivers robust anti-tumor activity in patient-derived lung and breast cancer xenograft models. - IDEAYA targets to present preclinical data detailing the pharmacologic profile and evidence of anti-tumor activity at a medical conference in the first half of 2026.
- GSK has quietly terminated its synthetic lethality collaboration with Ideaya Biosciences, returning the last two assets IDE275 and IDE705 according to an SEC filing. - The termination follows GSK's earlier return of the MAT2A inhibitor IDE397 in August 2022, marking the end of a partnership that began in June 2020 with $100 million upfront. - Ideaya will assess strategic options for the returned Werner helicase inhibitor IDE275 and DNA Pol theta inhibitor IDE705 in 2026, while maintaining its cash runway into 2030. - The company's lead value driver remains darovasertib for uveal melanoma, with Phase II/III data expected by year-end or early next year.
- IDEAYA Biosciences has completed full enrollment of 435 patients in its registration-enabling Phase 2/3 OptimUM-02 trial testing darovasertib plus crizotinib for first-line HLA*A2-negative metastatic uveal melanoma. - The FDA has cleared the company's IND application for IDE034, a first-in-class bispecific antibody-drug conjugate targeting B7H3 and PTK7 in solid tumors. - The Q1 2026 progression-free survival readout from the OptimUM-02 trial represents a critical catalyst for potential accelerated approval of darovasertib. - IDEAYA's stock has gained approximately 53% over three months, though the company trades at a premium 14.6x price-to-sales multiple amid high growth expectations.
- IDEAYA Biosciences received FDA IND clearance for IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate targeting multiple solid tumors. - The Phase 1 trial will begin enrolling patients in Q1 2026, initially evaluating those with lung, colorectal, head and neck, and ovarian cancers expressing both targets. - Preclinical studies demonstrated that IDE034 monotherapy induced deep and durable tumor regressions in multiple B7H3/PTK7-positive tumor models. - B7H3 and PTK7 are co-expressed in approximately 30% of lung cancers, 46% of colorectal cancers, and 27% of head and neck cancers.
- IDEAYA Biosciences received FDA IND clearance for IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 antibody-drug conjugate targeting multiple solid tumor types. - The therapy targets B7H3/PTK7 co-expression found in approximately 30% of lung cancers, 46% of colorectal cancers, and 27% of head and neck cancers. - Preclinical studies demonstrated deep and durable tumor regressions with IDE034 monotherapy and enhanced durability when combined with PARG inhibitor IDE161. - Phase 1 clinical trial enrollment is expected to begin in Q1 2026, initially evaluating patients with lung, colorectal, head and neck, and ovarian/gynecological cancers.
- WRN inhibitors represent a fast-emerging precision oncology segment targeting DNA repair vulnerabilities in microsatellite instability-high (MSI-H) tumors through synthetic lethality mechanisms. - Multiple promising candidates including NDI-219216, GSK4418959, HRO761, and RO7589831 are advancing through early-stage clinical trials, demonstrating potent anti-tumor activity and strong selectivity for MSI tumors. - The market is expected to surge significantly by 2040, driven by advances in biomarker-driven patient stratification and compelling preclinical data showing tumor regression in patient-derived xenograft models. - Leading pharmaceutical companies including Nimbus Therapeutics, GlaxoSmithKline, Ideaya Biosciences, and Novartis are developing these novel therapies for colorectal, endometrial, and other solid tumors.
