IDE-397
- Generic Name
- IDE-397
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.
Amgen and Ideaya Terminate Cancer Combination Trial for PRMT5 and MAT2A Inhibitors
• Amgen and Ideaya Biosciences have mutually agreed to discontinue their clinical collaboration testing the combination of AMG 193 and IDE397 for solid tumors.
• Ideaya will pivot to studying IDE397 in combination with its own PRMT5 inhibitor IDE892 for non-small cell lung cancer treatment.
• Amgen continues development of AMG 193 monotherapy, which showed 21.4% objective response rate across multiple tumor types, and has initiated Phase II trials in NSCLC.
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 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.
Ideaya Biosciences Faces Stock Lows Amidst Pipeline Developments and Analyst Optimism
• Ideaya Biosciences' stock hit a 52-week low, reflecting broader biotech sector challenges despite a strong financial position and ongoing R&D efforts.
• The company is advancing its pipeline with a Phase 1 trial for IDE161 plus KEYTRUDA in endometrial cancer and plans for SHR-4849 in lung cancer.
• Despite a Leerink Partners downgrade, analysts from UBS, Cantor Fitzgerald, and Goldman Sachs remain optimistic about Ideaya's drug candidates.
• Upcoming milestones include filing a US IND application for SHR-4849 in H1 2025 and advancing IDE251, a potential first-in-class dual inhibitor.
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.
IDEAYA Biosciences, Inc. (IDYA) BCG Matrix Analysis 2024
IDEAYA Biosciences, Inc. (IDYA) is analyzed through the Boston Consulting Group Matrix, revealing its strategic positioning in 2024. With a strong pipeline in precision oncology and significant cash reserves, IDEAYA faces challenges including an accumulated deficit and reliance on external financing. The analysis covers the company's Stars, Cash Cows, Dogs, and Question Marks, highlighting its future potential and current challenges.
IDEAYA Biosciences Navigates Oncology Landscape with Precision Medicine Approach
• IDEAYA Biosciences focuses on precision medicine in oncology, highlighted by a strong pipeline of product candidates and collaborations with major pharmaceutical companies.
• The company's financial health is supported by significant cash reserves of $1.2 billion as of September 30, 2024, primarily from equity issuance and collaboration agreements.
• IDEAYA faces challenges, including an accumulated deficit of $492.5 million and reliance on external financing due to the absence of approved products generating revenue.
• Early-stage clinical candidates like darovasertib and IDE397 represent potential future revenue streams, contingent on successful clinical trial outcomes and regulatory approvals.
IDEAYA Biosciences Navigates Oncology Landscape with Precision Medicine Approach
• IDEAYA Biosciences focuses on precision medicine in oncology, leveraging molecular diagnostics to develop targeted therapies for specific patient populations.
• The company's pipeline includes candidates like darovasertib (IDE196) and IDE397 (MAT2A), with darovasertib currently in Phase 2/3 trials.
• IDEAYA has collaborations with major pharmaceutical companies like GSK and Pfizer, enhancing research capabilities and providing financial support.
• As of September 30, 2024, IDEAYA reported cash reserves of $1.2 billion, supporting ongoing clinical development and operational activities.
IDEAYA Biosciences Advances Precision Medicine Pipeline with Multiple Clinical Programs
• IDEAYA Biosciences reports positive progress in multiple clinical programs, including darovasertib for uveal melanoma and IDE397 for MTAP-deletion cancers.
• The company is targeting the initiation of a Phase 3 registration-enabling trial for darovasertib in neoadjuvant uveal melanoma in the first half of 2025.
• IDE397 demonstrates confirmed objective response rates (ORR) of 40% in urothelial cancer and 38% in squamous non-small cell lung cancer.
• IDEAYA is expanding clinical trials for IDE397 in combination with AMG 193 and Trodelvy, and for IDE161 with Keytruda in endometrial cancer.
Ideaya's IDE397 Shows Promise in MTAP-Deletion Cancers
• Ideaya Biosciences reports positive Phase 1 data for IDE397, a MAT2A inhibitor, in urothelial and non-small cell lung cancer patients with MTAP-deletion.
• The study showed a ~33% overall response rate and a ~93% disease control rate in heavily pre-treated patients at the 30mg once-daily dose.
• IDE397 demonstrated a manageable safety profile with no drug-related serious adverse events or discontinuations at the expansion dose.
• The company plans to advance IDE397 in combination with Trodelvy in urothelial cancer, with expansion targeted for Q4 2024.
IDEAYA Biosciences' IDE397 Shows Promise in MTAP-Deletion Cancers, Bolstering Optimistic Outlook
• IDEAYA Biosciences' IDE397 demonstrated a significant overall response rate in patients with MTAP-deletion lung and bladder cancers in a Phase 1 study.
• The disease control rate was notably high, further supporting IDE397's potential as an effective treatment option for these cancers.
• IDEAYA's strong financial position, with over $1 billion in cash reserves, supports ongoing research and development efforts.
• Analysts from Capital One Financial and LifeSci Capital have issued Buy ratings for IDEAYA, citing promising clinical data and financial stability.
IDEAYA Biosciences Presents Promising Phase 1 Results for IDE397 in MTAP-Deleted Cancers
• IDEAYA Biosciences announced Phase 1 expansion results of IDE397, a first-in-class MAT2A inhibitor, in patients with MTAP-deletion urothelial and non-small cell lung cancer.
• The oral presentation at the EORTC-NCI-AACR Symposium highlighted IDE397's potential in treating cancers with methylthioadenosine phosphorylase (MTAP) deletions.
• IDEAYA also presented preclinical data for its MAT2A and PARG programs, showcasing combinatorial inhibition strategies and novel PARG inhibitors.
• These findings underscore IDEAYA's commitment to precision medicine oncology and targeted therapeutics for genetically defined patient populations.
IDEAYA Biosciences Announces Corporate and Portfolio Updates at J.P. Morgan Healthcare Conference
IDEAYA Biosciences, Inc. shared key corporate and portfolio updates at the J.P. Morgan 40th Annual Healthcare Conference, highlighting its strong financial position, progress in clinical trials, and future plans for its oncology-focused precision medicine developments.
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