IDE-892 / Ideaya Biosci - LARVOL DELTA

A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=260 | Not yet recruiting | Sponsor: IDEAYA Biosciences

Monotherapy • New P1 trial • Bladder Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Genito-urinary Cancer • Lung Adenocarcinoma • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Peritoneal Mesothelioma • Pleural Mesothelioma • Solid Tumor • Urothelial Cancer

IDEAYA Biosciences Announces IND Submission for IDE892, a Potential Best-In-Class PRMT5 Inhibitor for MTAP-Deletion Solid Tumors (PRNewswire) - "The company is targeting to begin a Phase 1 dose escalation trial of IDE892 in MTAP-deleted lung cancer in the fourth quarter of 2025, with the goal of advancing into combination trials with IDE397...in the first half of 2026....Preclinical profile of IDE892 and mechanistic combination rationale with IDE397...inhibitor, will be presented at the 10-Year Anniversary R&D Day on September 8th."

IND • New P1 trial • Preclinical • Solid Tumor

IDEAYA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides Business Update (PRNewswire) - "IDE892: a potential best-in-class MTA-cooperative PRMT5 inhibitor to enable wholly-owned combination with IDE397. IND filing targeted for mid-year 2025....IDE034: a potential first-in-class B7H3/PTK7 TOP1i bispecific ADC with combination potential with IDE161. IND filing targeted for the second half of 2025. IDE574: a potential first-in-class KAT6/7 dual inhibitor development candidate with combination opportunities with multiple programs in the Company's pipeline. IND filing targeted for the second half of 2025."

IND • Oncology

IDEAYA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides Business Update (PRNewswire) - "IDEAYA plans to enable the wholly-owned IDE397 and IDE892 (PRMT5MTA) combination in patients with MTAP-deletion non-small cell lung cancer (NSCLC) in the second half of 2025....Initiation of evaluation of IDE849 and IDE161 combination targeted in the second half of 2025....Targeting to present preclinical combination mechanism and synergy efficacy data of IDE161 with TOP1-payload based ADCs at a medical conference in the third quarter of 2025."

New trial • Preclinical • Non Small Cell Lung Cancer

IDEAYA Biosciences Announces Phase 1/2 Expansion for IDE397 and Trodelvy Combination in MTAP-Deletion Urothelial Cancer (PRNewswire) - "IDEAYA Biosciences...announced the initiation of a Phase 1/2 expansion in the clinical trial evaluating IDE397, its investigational, potential first-in-class, small molecule methionine adenosyltransferase 2a (MAT2A) inhibitor, in combination with Gilead's Trodelvy (sacituzumab govitecan-hziy), a Trop-2 directed antibody-drug conjugate (ADC), in methylthioadenosine phosphorylase (MTAP)-deletion urothelial cancer (UC) based on preliminary safety and clinical efficacy data....A clinical program update on the IDE397 and Trodelvy combination is planned in 2025. In addition to the clinical trial program evaluating IDE397 in combination with Trodelvy, IDEAYA is has a monotherapy expansion study in MTAP-deletion NSCLC and UC and is expecting to initiate a wholly-owned clinical combination trial of IDE397 and IDE892, IDEAYA's potential best-in-class, MTA-cooperative PRMT5 inhibitor in the second half of 2025."

New P1/2 trial • New trial • Non Small Cell Lung Cancer • Urothelial Cancer

IDEAYA Announces Further Gilead Sciences Clinical Study Collaboration Evaluating Combination of Trodelvy and IDE397 in MTAP-Deletion NSCLC (PRNewswire) - "IDEAYA Biosciences...announced it has entered into an additional clinical study collaboration and supply agreement with Gilead Sciences, Inc...to evaluate the efficacy and safety of IDE397, its investigational, potential first-in-class, small molecule MAT2A inhibitor, in combination with Gilead's Trodelvy (sacituzumab govitecan-hziy), a Trop-2 directed antibody-drug conjugate (ADC), in methylthioadenosine phosphorylase (MTAP)-deletion non-small cell lung cancer (NSCLC)...'look forward to providing clinical program updates in 2025,'...In addition to the Phase 1/2 trial evaluating IDE397 in combination with Trodelvy in UC and NSCLC, IDEAYA is actively enrolling patients into a monotherapy expansion in MTAP-deletion NSCLC and urothelial cancer and is expecting to initiate a wholly-owned clinical combination trial of IDE397 and IDE892, IDEAYA's potential best-in-class, MTA-cooperative PRMT5 inhibitor in the second half of 2025."

Commercial • New trial • Trial status • Non Small Cell Lung Cancer • Urothelial Cancer

IDEAYA Biosciences Announces Participation at the 43rd Annual J.P. Morgan Healthcare Conference and 2025 Corporate Guidance (PRNewswire) - "3 IND-filings targeted in 2025, representing IDEAYA's 7th, 8th, and 9th potential clinical stage precision medicine oncology program targeting solid tumors; IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, in mid-year 2025. Combination potential with IDE397; IDE034, a potential first-in-class B7H3/PTK7 TOP1i bispecific ADC, in the second half of 2025. Combination potential with IDE161; IDE251, a potential first-in-class KAT6/7 dual inhibitor development candidate, in the second half of 2025. Combination potential with multiple programs in IDEAYA's pipeline..."

IND • Solid Tumor

IDEAYA Announces Agenda for Investor R&D Day Webcast on December 16, 2024 (PRNewswire) - "The presentations by IDEAYA management and key opinion leaders will showcase scientific insights and clinical development opportunities across IDEAYA's precision medicine oncology pipeline. In addition, IDEAYA will highlight its next-generation precision medicine pipeline programs, including IDE275 / GSK959, a potential first-in-class and best-in-class Phase 1 Werner Helicase inhibitor, IDE892, a potential best-in-class MTA-cooperative PMRT5 inhibitor, IDE034, a potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC), and a potential first-in-class lysine acetyltransferase 6/7 (KAT6/7) development candidate."

Clinical • Oncology • Solid Tumor

IDEAYA Biosciences Announces Development Candidate Nomination of IDE892, a Potential Best-in-Class MTA-cooperative PRMT5 Inhibitor (PRNewswire) - "IDE892 was discovered through IDEAYA's iterative physics-based ligand design and optimization platform, and is a highly potent and selective MTA-cooperative PRMT5 inhibitor with best-in-class potential and favorable drug-like properties. IDE892 has demonstrated exceptionally selective antiproliferative activity in MTAP-deleted tumor cell models and durable complete responses in combination with MAT2A inhibitor IDE397 in challenging MTAP-deletion preclinical models. IND-enabling studies for IDE892 are ongoing to support an Investigational New Drug (IND) filing to the U.S. Food and Drug Administration (FDA) in mid-2025, subject to satisfactory completion of ongoing preclinical and IND-enabling studies."

IND • New molecule • Oncology