Announced positive data from the Phase 1 clinical trial of ELVN-001 in CML, reporting a cumulative MMR rate of 47% with 32% of patients achieving MMR by 24 weeks and demonstrating a favorable safety and tolerability profile across all dose levelsStrong balance sheet with $491 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into the first half of 2029BOULDER, Colo., Aug. 13, 2025 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ...

Core Insights - Enliven Therapeutics announced positive data from the Phase 1 ENABLE clinical trial for ELVN-001, a treatment for chronic myeloid leukemia (CML), showing a cumulative major molecular response (MMR) rate of 47% and an achieved MMR rate of 32% by 24 weeks [1][11] - The trial demonstrated a favorable safety and tolerability profile, with only 3.4% of patients experiencing dose reductions due to treatment-emergent adverse events (TEAEs) and 4.6% discontinuing treatment due to TEAEs [11] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics aimed at improving the quality of life and survival for patients [13] - The company is based in Boulder, Colorado, and aims to address unmet needs in precision oncology [13] Clinical Trial Details - The ENABLE trial is a Phase 1 study evaluating ELVN-001 in previously treated CML patients, with a focus on safety, tolerability, and determining the recommended dose for further evaluation [9] - As of April 28, 2025, 90 patients were enrolled, with a median treatment duration of approximately 29 weeks [5] Efficacy Data - Among 53 evaluable patients, 25 (47%) achieved MMR by 24 weeks, with 13 of 41 (32%) achieving and 12 of 12 (100%) maintaining MMR [5][11] - The trial included heavily pretreated patients, with 67% having received three or more prior TKIs [5] Safety Profile - ELVN-001 was well tolerated across all evaluated doses, with low levels of dose reductions and discontinuations [11] - The maximum tolerated dose was not reached, and the pharmacokinetic profile supports once-daily dosing [11][12] Future Outlook - Enliven plans to initiate a head-to-head Phase 3 pivotal trial for ELVN-001 in 2026, leveraging insights from historical Phase 1 data to guide regulatory pathways [7][9]

Core Insights - Enliven Therapeutics announced positive data from the Phase 1 ENABLE clinical trial of ELVN-001 for chronic myeloid leukemia (CML), showing a cumulative major molecular response (MMR) rate of 44% by 24 weeks [1][5] - The trial included 74 patients with a median treatment duration of approximately 26 weeks, demonstrating a favorable safety and tolerability profile [1][5] - The updated data will be presented at the European Hematology Association (EHA) Congress in June 2025, with a webcast and conference call scheduled for the same day [1][7] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics, particularly for oncology [10] - The company aims to address unmet medical needs through a precision oncology approach, enhancing patient survival and well-being [10] Product Details - ELVN-001 is a selective small molecule kinase inhibitor targeting the BCR::ABL gene fusion, which is the oncogenic driver in CML [2][9] - The ongoing ENABLE trial is designed to evaluate the safety, tolerability, and recommended dose of ELVN-001 in patients who have failed or are intolerant to existing therapies [8] Clinical Trial Insights - As of January 21, 2025, 74 patients were enrolled in the ENABLE trial, with 66% having received three or more prior tyrosine kinase inhibitors [5] - Among evaluable patients, 44% achieved MMR by 24 weeks, with 100% of those maintaining MMR at the data cutoff [5] - The trial's results are favorable compared to previous Phase 1 trials of approved BCR::ABL1 TKIs, particularly given the heavily pretreated patient population [5] Upcoming Events - The oral presentation at the EHA Congress will be led by Dr. Andreas Hochhaus, focusing on the ENABLE trial results [6] - Following the presentation, additional data will be available on the company's website [6]