IDEAYA Biosciences
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2015-01-01
- Employees
- 124
- Market Cap
- $3.3B
- Website
- http://www.ideayabio.com
- Introduction
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.
FDA Clears IND for IDEAYA's Novel DLL3-Targeting Antibody Drug Conjugate IDE849 for Solid Tumors
• IDEAYA Biosciences has received FDA clearance for a Phase 1 clinical trial of IDE849, a potential first-in-class DLL3-targeting Topo-I-payload antibody drug conjugate for solid tumors including small cell lung cancer and neuroendocrine tumors.
• The ongoing Phase 1 study by partner Hengrui Pharmaceuticals has already demonstrated multiple partial responses at therapeutic dose levels with predominantly Grade 1-2 adverse events and no drug-related discontinuations reported.
• IDEAYA plans to evaluate IDE849 both as monotherapy and in combination with their PARG inhibitor IDE161, with clinical data from over 40 SCLC patients expected to be presented at a medical conference in Q3 2025.
Trodelvy-Keytruda Combination Shows Promising Results in First-Line Treatment for Triple-Negative Breast Cancer
• Gilead Sciences and Merck's phase 3 ASCENT-04/KEYNOTE-D19 trial demonstrated statistically significant improvement in progression-free survival with Trodelvy plus Keytruda compared to Keytruda with chemotherapy in metastatic TNBC patients.
• The novel combination of antibody-drug conjugate (Trodelvy) with immunotherapy (Keytruda) represents a potential paradigm shift in treatment approach for aggressive triple-negative breast cancer, potentially displacing conventional chemotherapy.
• Early data shows a positive trend toward improved overall survival, with detailed results to be presented at upcoming medical meetings and discussed with regulatory authorities.
FDA Grants Breakthrough Therapy Designation to IDEAYA's Darovasertib for Neoadjuvant Uveal Melanoma
• The FDA has granted Breakthrough Therapy designation to darovasertib, a first-in-class protein kinase C inhibitor, for neoadjuvant treatment of primary uveal melanoma patients facing eye removal.
• Interim Phase 2 data showed promising results with 82% ocular tumor shrinkage rate and 61% eye preservation rate in uveal melanoma patients, addressing a significant unmet need with no FDA-approved systemic therapies.
• IDEAYA Biosciences plans to initiate a Phase 3 randomized registrational trial in neoadjuvant uveal melanoma in the first half of 2025, targeting approximately 12,000 patients annually across North America, Europe, and Australia.
IDEAYA's WRN Inhibitor IDE275 Shows Promise for MSI-H Cancers, Featured in AACR 2025 Oral Presentation
• IDEAYA Biosciences and GSK will present promising data on IDE275 (GSK959), a potential best-in-class Werner Helicase inhibitor for MSI-H solid tumors, at AACR 2025's New Drugs on the Horizon series.
• The novel WRN inhibitor has demonstrated selective preclinical efficacy in MSI-H tumors with a unique binding mechanism, targeting cancers with high prevalence rates including endometrial (31%), colorectal (20%), and gastric (19%) cancers.
• Under their collaboration agreement, IDEAYA could receive up to $950 million in milestone payments plus 50% of U.S. profits and tiered royalties on global sales, with Phase 1 dose escalation trials currently underway.
IDEAYA and ATTMOS Partner to Pioneer AI-Driven Drug Discovery for Undruggable Cancer Targets
• IDEAYA Biosciences has formed a strategic collaboration with ATTMOS to develop a physics-based computational platform for discovering small molecule drugs targeting previously undruggable oncology targets.
• The partnership will focus on implementing high-throughput absolute binding free energy perturbation predictions (ABFEP) to enable more accurate and efficient virtual screening of drug candidates.
• The collaboration leverages IDEAYA's expertise in structural biology and drug discovery combined with ATTMOS's computational chemistry capabilities to overcome current limitations in AI/ML approaches for novel drug targets.
Verastem Oncology to Present New LGSOC Treatment Data at SGO 2025 Annual Meeting
• Verastem Oncology will present additional analyses from the Phase 2 RAMP 201 trial evaluating avutometinib plus defactinib in recurrent low-grade serous ovarian cancer at SGO 2025, building on their FDA Priority Review submission.
• The presentations include new subgroup analyses by KRAS mutational status, supporting the company's ongoing efforts to advance treatment options for RAS/MAPK pathway-driven cancers.
• The company's NDA for the avutometinib-defactinib combination therapy has received Priority Review from the FDA with a PDUFA date of June 30, 2025, for KRAS mutant LGSOC patients.
IDEAYA Biosciences Reports Strong Pipeline Progress and $1.1B Cash Position for 2024
• IDEAYA Biosciences advances multiple oncology programs, with over 230 patients enrolled in potential registration-enabling trial for darovasertib in metastatic uveal melanoma, targeting key readouts by end of 2025.
• Company strengthens its position with approximately $1.1 billion cash reserve as of December 2024, expected to fund operations into at least 2028.
• Pipeline expansion includes progress on DLL3 TOP1i ADC IDE849 showing 73% response rate in early SCLC data, and advancement of three new candidates targeting solid tumors.
IDEAYA and Amgen Discontinue IDE397/AMG 193 Combination Study Despite Promising Preclinical Data
• IDEAYA Biosciences and Amgen have mutually agreed to terminate their clinical combination study of IDE397 and AMG 193, leading Oppenheimer to reduce IDEAYA's price target to $40 from $53.
• Despite the setback, IDEAYA remains committed to the therapeutic pathway and is strengthening its partnership with Gilead for Trodelvy while advancing their proprietary PRMT5 candidate.
• Oppenheimer maintains an Outperform rating on IDEAYA shares, noting that the 2023 preclinical data was among the most impressive they had observed.
IDEAYA Biosciences Announces Strategic Updates and 2025 Corporate Guidance
• IDEAYA Biosciences has a strong financial position with $1.2 billion in cash, expected to fund operations into at least 2028.
• A Phase 3 registration-enabling trial for darovasertib in neoadjuvant UM is planned for initiation in the first half of 2025.
• Clinical program updates for IDE397 in combination with Trodelvy® in MTAP-deletion urothelial cancer are expected in 2025.
• IDEAYA targets three IND filings in 2025, expanding its precision medicine oncology programs.
Focused Ultrasound Shows Promise in Alzheimer's Treatment
• A clinical trial using focused ultrasound to treat Alzheimer’s disease has shown promising results, marking a potential new direction in treating this debilitating condition.
• The study, published in the Journal of Neurosurgery, highlights the noninvasive nature of focused ultrasound as a key advantage in Alzheimer's treatment.
• Researchers are optimistic about the potential of this approach to offer a new therapeutic avenue for patients suffering from Alzheimer's disease.
• Further research is needed to fully understand the long-term effects and optimal use of focused ultrasound in Alzheimer's treatment.
Enhertu Approved for HER2-Low and HER2-Ultralow Metastatic Breast Cancer
• The FDA has approved Enhertu for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer after endocrine therapy progression.
• DESTINY-Breast06 trial data showed a 36% reduction in disease progression or death risk compared to chemotherapy.
• Patients on Enhertu had a median progression-free survival of 13.2 months versus 8.1 months on chemotherapy.
• This approval expands Enhertu's use to an earlier treatment setting and a broader patient population.
FDA Approves Subcutaneous Opdivo Qvantig for Multiple Solid Tumors
• The FDA approved Opdivo Qvantig, a subcutaneous injection of nivolumab, for adult solid tumors previously approved for intravenous Opdivo.
• CheckMate-67T trial data showed non-inferior pharmacokinetic exposures, similar efficacy, and comparable safety to intravenous Opdivo.
• Opdivo Qvantig offers a faster 3-5 minute administration time, providing convenience and flexibility for patients.
• The approval helps Bristol Myers Squibb maintain market share amid patent expirations and increasing biosimilar competition.
IDEAYA Advances Oncology Pipeline with Novel Inhibitors and Gilead Collaboration
• IDEAYA Biosciences nominated IDE251, a first-in-class dual KAT6/KAT7 inhibitor, for cancer treatment, with IND submission planned for 2025, targeting breast and NSCLC.
• The company is collaborating with Gilead Sciences to evaluate IDE397, a MAT2A inhibitor, with Trodelvy in MTAP-deletion NSCLC, addressing a significant unmet need.
• IDEAYA nominated IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, with IND filing expected in mid-2025, enhancing its precision medicine oncology pipeline.
Merus' Petosemtamab Shows Promise in HNSCC and NSCLC Trials, Bolstering Investment Potential
• Merus' petosemtamab demonstrates a 42.5% overall response rate in Phase 2 trials for second-line or higher head and neck squamous cell carcinoma (HNSCC).
• In combination with pembrolizumab, petosemtamab shows a 60% objective response rate for first-line HNSCC treatment, aligning with optimistic analyst projections.
• MCLA-129 demonstrates efficacy in MET exon 14 EGFR NSCLC patients, achieving a 43.5% overall response rate, suggesting potential in specific genetic mutations.
• Analysts project revenue growth for Merus, with estimates of $112 million for 2025, driven by clinical trial successes and potential regulatory approvals.
Novel Treatment Landscape Expands for Uveal Melanoma with Multiple Promising Therapies in Development
• Recent FDA approvals of Kimmtrak and Hepzato mark significant breakthroughs in uveal melanoma treatment, offering new options for patients with metastatic disease.
• IDEAYA Biosciences' darovasertib-crizotinib combination enters phase 3 trials, potentially expanding treatment options for both HLA-A2 positive and negative metastatic uveal melanoma patients.
• Multiple innovative approaches are advancing through clinical development, including Roche's T-cell engager RO7293583 and iOnctura's novel PI3Kδ inhibitor IOA-244.
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