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IDEAYA Biosciences Announces Upcoming Presentations at AACR 2026 Highlighting Multiple Clinical Stage Pipeline Programs
Prnewswire· 2026-03-18 10:00
Core Insights - IDEAYA Biosciences is set to present three clinical stage pipeline programs at the AACR Annual Meeting, showcasing potential first-in-class therapies targeting various cancer types [1][2]. Group 1: Pipeline Programs - The three highlighted programs include IDE034, a bi-specific antibody-drug conjugate targeting PTK7 and B7H3; IDE574, a dual inhibitor of lysine acetyltransferases KAT6 and KAT7; and IDE892, a PRMT5 inhibitor [1][3]. - These programs are currently undergoing Phase 1 clinical studies to assess their safety, tolerability, pharmacokinetics, and efficacy across multiple solid tumor indications, including lung, colorectal, pancreatic, breast, and prostate cancers [1][3]. Group 2: Presentation Details - The poster presentations will cover the following topics: - IDE034's enhanced antitumor activity compared to mono-specific ADCs, scheduled for April 19, 2026 [3]. - IDE574's ability to disrupt tumor lineage identity and drug tolerance, scheduled for April 21, 2026 [3]. - IDE892's selective inhibition of PRMT5, also scheduled for April 21, 2026 [3]. Group 3: Company Overview - IDEAYA Biosciences focuses on precision medicine in oncology, aiming to develop transformative therapies through a combination of small-molecule drug discovery, structural biology, and bioinformatics [4]. - The company is committed to creating targeted therapies that align with the genetic drivers of cancer, emphasizing synthetic lethality and antibody-drug conjugates [4].
IDEAYA Biosciences Announces First-Patient-In for Phase 1 Trial of IDE892, a Potential Best-In-Class PRMT5 Inhibitor for MTAP-Deleted Solid Tumors, and Provides MTAP and CDKN2A Pipeline Update
Prnewswire· 2026-03-09 10:00
Core Insights - IDEAYA Biosciences has initiated a Phase 1 clinical trial for IDE892, a potential best-in-class PRMT5 inhibitor targeting MTAP-deleted solid tumors, including non-small cell lung cancer (NSCLC) and pancreatic cancer [1] - The company plans to deprioritize combination activities with Trodelvy to focus on its proprietary MTAP-deleted and CDKN2A pipeline, aiming for a first-in-class CDKN2A development candidate nomination in H2 2026 and an IND submission in H1 2027 [1] Group 1: IDE892 Development - The first patient has been enrolled in the Phase 1 trial evaluating IDE892, which will assess safety, tolerability, pharmacokinetics, and pharmacodynamics as a monotherapy and in combination with IDE397 [1] - IDE892 exhibits approximately 1,400-fold selective binding to MTA-PRMT5 versus SAM-PRMT5 complexes and demonstrates single-digit nanomolar potency in MTAP-deleted cell lines [1] - Preclinical studies show that dual inhibition of PRMT5 and MAT2A with IDE892 and IDE397 resulted in durable tumor regressions in MTAP-deleted tumor models [1] Group 2: CDKN2A Program - IDEAYA is advancing its CDKN2A-deficiency program, targeting a first-in-class development candidate selection in H2 2026 and an IND submission in H1 2027 [1] - CDKN2A deficiency is prevalent in over 80% of pancreatic cancer cases and is often co-deleted with MTAP, creating opportunities for rational combination therapies [1] - The company has demonstrated robust monotherapy efficacy with its CDKN2A lead in multiple preclinical models, including a KRAS mutation pancreatic model [1] Group 3: Strategic Prioritization - As part of its strategic focus, IDEAYA has deprioritized clinical combination activities with Trodelvy and will conclude enrollment in ongoing Phase 1/2 trials with Gilead [1] - The company may explore additional combinations between IDE397 and other TOP1 payload ADCs, including IDE034, in the context of MTAP-deleted cancers [1] - MTAP deletion occurs in 15-20% of NSCLC, up to 40% of pancreatic cancer, and approximately 15% of all solid tumors, highlighting the unmet need for targeted therapies [1]
IDEAYA Biosciences (NasdaqGS:IDYA) FY Earnings Call Presentation
2026-01-12 23:45
January 2026 Improving Lives Through Transformative Precision Medicines JPM 2026 | 44th Annual Healthcare Conference NASDAQ: IDYA Safe Harbor Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future financial performance of IDEAYA Biosciences, Inc. (the "Company") and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, perfor ...
IDEAYA Biosciences(IDYA) - 2025 FY - Earnings Call Transcript
2025-12-02 15:02
Financial Data and Key Metrics Changes - The company is approaching top line results for its lead program, darovasertib, with guidance for an accelerated approval filing in the U.S. by year-end this year to Q1 next year [3][4] - Historical median progression-free survival (PFS) for metastatic uveal melanoma is about 2-3 months, while the company has reported a PFS of approximately 7 months in its trials, indicating a significant improvement [6][7] Business Line Data and Key Metrics Changes - The company has eight programs in clinical development, with darovasertib being the lead program in a registrational trial for metastatic uveal melanoma [3] - The company has received breakthrough therapy designation for darovasertib in the neoadjuvant setting, indicating a strong pipeline and potential for accelerated development [4] Market Data and Key Metrics Changes - The market for darovasertib targets approximately 4,000-5,000 patients, with a significant portion being HLA negative, which the company aims to address [9] - The annual incidence of neoadjuvant uveal melanoma is estimated to be 10,000-12,000 patients, highlighting a substantial unmet need in this area [12] Company Strategy and Development Direction - The company is focusing on expanding its pipeline in the MTAP deletion space, with a phase two MAT2A inhibitor and a phase one PRMT5 inhibitor, aiming to position itself as a leader in this competitive area [36] - The company is also exploring the DLL3 program for small cell lung cancer, with plans to differentiate based on efficacy and durability compared to competitors [53] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts, particularly for darovasertib, and believes that the combination of strong efficacy data and a robust pipeline will position the company favorably in the market [19][20] - The company is optimistic about the potential for its adjuvant study to become a blockbuster opportunity, targeting patients earlier in their treatment journey [29] Other Important Information - The company is preparing to initiate an adjuvant study in collaboration with Servier, targeting high and high medium metastatic risk populations [27] - The company has a unique bispecific ADC targeting B7-H3 and PTK7, which is expected to amplify efficacy in dual expression populations [66] Q&A Session Summary Question: What is the expected timeline for the neoadjuvant study? - The company anticipates enrolling the study in roughly five quarters, with the first eye preservation data expected in about six months [19][20] Question: How does the company plan to differentiate its DLL3 program? - The company believes it can differentiate based on response rates and durability, leveraging a unique linker system that allows for higher dosing [53][54] Question: What is the competitive landscape for the MTAP deletion space? - The company sees itself as an industry leader in the MTAP deletion area, with a diverse pipeline that includes multiple clinical stage assets [36][37]
IDEAYA Biosciences Announces IND Submission for IDE892, a Potential Best-In-Class PRMT5 Inhibitor for MTAP-Deletion Solid Tumors
Prnewswire· 2025-09-03 10:00
Core Insights - IDEAYA Biosciences has submitted an IND application to the FDA for IDE892, a potential best-in-class MTA-cooperative inhibitor of PRMT5, targeting MTAP-deleted lung cancer [1][2] - The company plans to initiate a Phase 1 dose escalation trial for IDE892 in Q4 2025 and aims to start combination trials with IDE397 in H1 2026 [1][6] Company Overview - IDEAYA is focused on precision medicine in oncology, developing transformative therapies for cancer through small-molecule drug discovery, structural biology, and bioinformatics [4] - The company has a robust pipeline targeting synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications [4] Market Opportunity - Approximately 15-20% of non-small cell lung cancer (NSCLC) cases are MTAP-deleted, presenting a significant unmet need for targeted therapies [2] - The combination of IDE892 and IDE397 is expected to enhance anti-tumor activity, creating a promising combination therapy opportunity [2][3] Upcoming Events - IDEAYA will present the preclinical profile of IDE892 and its combination rationale with IDE397 at the 10-Year Anniversary R&D Day on September 8, 2025 [6]
IDEAYA Biosciences Announces Phase 1/2 Expansion for IDE397 and Trodelvy® Combination in MTAP-Deletion Urothelial Cancer
Prnewswire· 2025-04-10 10:00
Core Insights - IDEAYA Biosciences has initiated a Phase 1/2 expansion clinical trial for IDE397, a potential first-in-class MAT2A inhibitor, in combination with Gilead's Trodelvy for treating MTAP-deletion urothelial cancer based on preliminary safety and efficacy data [1][10]. Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, aiming to discover and develop targeted therapeutics using molecular diagnostics to identify patient populations that would benefit most from its therapies [8]. Clinical Development - The combination of IDE397 and Trodelvy is being explored due to the high unmet medical need in MTAP-deletion urothelial cancer, where no approved therapies currently exist [3]. - The prevalence of MTAP-deletion in urothelial cancer is estimated to be around 26% [2][10]. - A clinical program update regarding the IDE397 and Trodelvy combination is expected in 2025, alongside other studies for IDE397 as a monotherapy in MTAP-deletion non-small cell lung cancer (NSCLC) and urothelial cancer [5]. Collaboration and Rights - IDEAYA and Gilead retain commercial rights to their respective compounds under a clinical study collaboration and supply agreement, with IDEAYA acting as the study sponsor [6].