RAS(ON) inhibitors

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Revolution Medicines Announces Key Leadership Additions, including Alan Sandler, M.D. as Chief Development Officer
Globenewswire· 2025-09-29 13:00
Core Insights - Revolution Medicines, Inc. has appointed Alan Sandler, M.D. as the chief development officer to enhance its leadership in developing targeted therapies for RAS-addicted cancers [1][2] - The company has also appointed Alicia Gardner and Gerwin Winter as regional general managers for the U.S. and Europe, respectively, to strengthen its global commercial capabilities [3] Company Overview - Revolution Medicines is a late-stage clinical oncology company focused on developing novel targeted therapies for patients with RAS-addicted cancers [4] - The company's R&D pipeline includes RAS(ON) inhibitors such as daraxonrasib (RMC-6236), elironrasib (RMC-6291), and zoldonrasib (RMC-9805), which are currently in clinical development [4] - The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be the next to enter clinical development, with additional opportunities focusing on RAS(ON) mutant-selective inhibitors [4]
Revolution Medicines(RVMD) - 2025 Q2 - Earnings Call Presentation
2025-08-06 20:30
Pipeline and Clinical Development - Daraxonrasib, a multi-selective RAS(ON) inhibitor, is being evaluated in a Phase 3 trial for 2L metastatic PDAC and has planned Phase 3 initiations for 1L metastatic and adjuvant resectable PDAC [15] - Elironrasib, a G12C-selective inhibitor, shows promising antitumor activity in previously treated RAS G12C NSCLC, with an objective response rate (ORR) of 56% (20 out of 36 patients) and a disease control rate (DCR) of 94% (34 out of 36 patients) at 200 mg BID [40] - Zoldonrasib, a G12D-selective inhibitor, demonstrates initial activity in previously treated KRAS G12D NSCLC, with an ORR of 61% (11 out of 18 patients) and a DCR of 89% (16 out of 18 patients) at 1200 mg QD [72] Daraxonrasib Clinical Data - In 2L PDAC patients treated with daraxonrasib at 300 mg daily, the median PFS was 85 months in RAS mutant patients, and the OS rate at 6 months was 97% [24] - In 2L/3L RAS G12X NSCLC patients treated with daraxonrasib at 120-220 mg daily, the median PFS was 98 months and the median OS was 177 months [28] - Daraxonrasib combined with pembrolizumab +/- chemotherapy in 1L RAS mutant NSCLC showed an ORR of 60% and a DCR of 90% in patients with TPS < 50%, and an ORR of 86% and a DCR of 100% in patients with TPS ≥ 50% [32] Financial Position - The company has a strong financial position with $21 billion in cash, cash equivalents, and marketable securities as of June 30, 2025 [119] - The company anticipates a 2025 GAAP Net Loss of $103 - $109 Billion [119]
Revolution Medicines Reports Second Quarter 2025 Financial Results and Update on Corporate Progress
Globenewswire· 2025-08-06 20:02
Core Insights - Revolution Medicines, Inc. reported significant advancements in its clinical trials for targeted therapies aimed at RAS-addicted cancers, particularly focusing on daraxonrasib for metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) [1][2][3] Clinical Development Progress - The company is executing pivotal trials with daraxonrasib, with the RASolute 302 trial for PDAC nearing completion of U.S. enrollment and continuing globally, expecting data readout in 2026 [1][2] - Daraxonrasib has received Breakthrough Therapy Designation from the FDA for previously treated metastatic PDAC with KRAS G12 mutations [2][8] - A registrational trial for daraxonrasib as a first-line treatment for metastatic PDAC is set to initiate this year, comparing it against chemotherapy [3][4] - The company plans to initiate a Phase 3 trial in 2026 for daraxonrasib combined with pembrolizumab for RAS mutant NSCLC [5][7] Financial Highlights - As of June 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $2.1 billion, including a $250 million tranche from Royalty Pharma [16] - Research and development expenses increased to $224.1 million for Q2 2025, up from $134.9 million in Q2 2024, primarily due to clinical trial and manufacturing costs [17] - General and administrative expenses rose to $40.6 million in Q2 2025 from $21.7 million in Q2 2024, driven by personnel-related costs and commercial preparation activities [18] - The net loss for Q2 2025 was $247.8 million, compared to a net loss of $133.2 million in Q2 2024 [19] Strategic Partnerships and Funding - The company entered a $2 billion flexible funding agreement with Royalty Pharma to support its global development and commercialization efforts [8][13] - A collaboration with Iambic Therapeutics aims to enhance drug discovery through AI capabilities [12][15] Pipeline and Future Directions - The company is advancing its pipeline with mutant-selective inhibitors elironrasib and zoldonrasib, with plans for pivotal trials in 2026 [6][10] - RMC-5127, a RAS(ON) G12V-selective inhibitor, is on track for clinical readiness in 2025 [11][22]
Revolution Medicines to Report Financial Results for Second Quarter 2025 After Market Close on August 6, 2025
Globenewswire· 2025-07-30 20:05
Core Insights - Revolution Medicines, Inc. is a late-stage clinical oncology company focused on developing targeted therapies for RAS-addicted cancers [3] - The company will report its financial results for Q2 2025 on August 6, 2025, after market close, followed by a webcast to discuss these results and corporate progress [1] Company Overview - Revolution Medicines is developing RAS(ON) inhibitors aimed at suppressing various oncogenic variants of RAS proteins [3] - The current R&D pipeline includes daraxonrasib (RMC-6236), elironrasib (RMC-6291), and zoldonrasib (RMC-9805), which are in clinical development [3] - The company plans to advance RMC-5127, a RAS(ON) G12V-selective inhibitor, into clinical development next [3] - Additional pipeline opportunities focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C) [3]
Revolution Medicines Announces Publication of a Peer-Reviewed Research Paper in Science on the Discovery and Development of Zoldonrasib, a RAS(ON) G12D-Selective Inhibitor
Globenewswire· 2025-07-24 20:00
Core Insights - Revolution Medicines, Inc. has published a peer-reviewed research paper in Science detailing the discovery and development of zoldonrasib (RMC-9805), a selective covalent inhibitor targeting RAS(ON) G12D mutations in cancers [1][3] Group 1: Drug Development and Mechanism - Zoldonrasib targets RAS G12D mutations, which are prevalent in various cancers, including 92% of pancreatic ductal adenocarcinoma, 50% of colorectal cancer, and 30% of non-small cell lung cancer [2] - The drug employs a novel mechanism as a tri-complex inhibitor, successfully forming covalent bonds with RAS(ON) G12D proteins by utilizing a unique protein-protein interface [2][3] - Preclinical data indicate that zoldonrasib can drive significant tumor regressions in models with KRAS G12D mutations, showcasing its therapeutic potential [2][3] Group 2: Clinical Trials and Future Prospects - Zoldonrasib is currently in clinical trials, including a Phase 1 study (RMC-9805-001) evaluating its efficacy in patients with advanced solid tumors harboring KRAS G12D mutations [4] - Results from the NSCLC and PDAC studies have been presented at notable cancer research meetings, indicating ongoing evaluation and interest in the drug's performance [4] - The company is also developing additional RAS(ON) inhibitors, including daraxonrasib (RMC-6236) and elironrasib (RMC-6291), with plans for RMC-5127 (G12V-selective) to enter clinical development next [5]
Revolution Medicines and Summit Therapeutics Enter into Clinical Collaboration to Evaluate Combinations of Three RAS(ON) Inhibitors with Ivonescimab in RAS Mutant Tumors
Globenewswire· 2025-06-30 12:00
Core Insights - Revolution Medicines and Summit Therapeutics have entered a clinical collaboration to evaluate the safety and efficacy of RAS(ON) inhibitors in combination with Summit's ivonescimab across multiple solid tumor types [1][2][3] Company Overview - Revolution Medicines is a late-stage clinical oncology company focused on developing targeted therapies for RAS-addicted cancers, with a pipeline that includes daraxonrasib (RMC-6236), elironrasib (RMC-6291), and zoldonrasib (RMC-9805) [4] - Summit Therapeutics is a biopharmaceutical oncology company dedicated to developing patient-friendly therapies aimed at improving quality of life and addressing unmet medical needs [5][6] Clinical Collaboration Details - The collaboration will assess combinations of RAS(ON) inhibitors with ivonescimab in three priority tumor types: RAS mutant non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC) [2] - Under the agreement, Summit will provide ivonescimab for clinical research, while Revolution Medicines will act as the study sponsor, with both companies retaining commercial rights to their respective compounds [2] Drug Development Insights - Initial evidence suggests that daraxonrasib and elironrasib can provide additive antitumor activity when combined with a PD-1 antibody in first-line treatment for RAS mutant non-small cell lung cancer [2] - The collaboration aims to explore the therapeutic potential of combining investigational drugs from Revolution's RAS(ON) inhibitor portfolio with Summit's advanced PD-1 / VEGF bispecific inhibitor [3]
Revolution Medicines Presents Initial Data from Zoldonrasib (RMC-9805) Study in Patients with KRAS G12D Mutant Non-Small Cell Lung Cancer at the 2025 AACR Annual Meeting
Globenewswire· 2025-04-27 16:05
Core Insights - Zoldonrasib, a RAS(ON) G12D-selective inhibitor, shows acceptable tolerability and promising initial antitumor activity in patients with KRAS G12D mutant non-small cell lung cancer (NSCLC) [1][2] Group 1: Clinical Data - New clinical data for zoldonrasib was presented at the American Association for Cancer Research (AACR) Annual Meeting, highlighting its potential as a treatment for NSCLC [1][2] - The Phase 1 study (RMC-9805-001) involved 90 solid tumor patients treated with 1200 mg once daily, demonstrating an acceptable safety profile consistent with previous data in pancreatic cancer [3] - The most common treatment-related adverse events (TRAEs) included nausea (39%), diarrhea (24%), vomiting (18%), and rash (12%), primarily Grade 1 or 2 in severity [3] Group 2: Efficacy Results - Preliminary antitumor activity was assessed in 18 efficacy-evaluable NSCLC patients, showing an objective response rate of 61% (11 patients) and a disease control rate of 89% (16 patients) [4] - The data indicates a high unmet need for new treatments in this patient population, as there are currently no approved targeted therapies for RAS G12D mutant cancers [5] Group 3: Company Overview - Revolution Medicines is focused on developing targeted therapies for RAS-addicted cancers, with a pipeline that includes multiple RAS(ON) inhibitors [6] - The company is advancing zoldonrasib as a monotherapy and in combination therapies, aiming to provide innovative treatment options for hard-to-treat cancers [2][6]