Enliven reports positive Phase 1 trial data for ELVN-001 in CML

Published 14/05/2025, 15:08
Enliven reports positive Phase 1 trial data for ELVN-001 in CML

BOULDER, Colo. - Enliven Therapeutics, Inc. (NASDAQ: ELVN), a biopharmaceutical company valued at approximately $978 million, has shared encouraging results from its ongoing ENABLE Phase 1 clinical trial of ELVN-001, a treatment for chronic myeloid leukemia (CML). According to InvestingPro data, the company maintains a strong financial health score of 2.73 (GOOD), with analysts setting price targets between $33 and $42. The findings, set to be presented at the European Hematology Association (EHA) 2025 Congress in June, suggest that ELVN-001 could offer a new therapeutic option for patients with CML, especially those who have not responded to other treatments.

As of January 21, 2025, 74 patients have been enrolled in the trial, with a median treatment duration of approximately 26 weeks. A significant number of these patients, 66%, had previously been treated with three or more tyrosine kinase inhibitors (TKIs), indicating a heavily pre-treated population. The company’s strong financial position, with a current ratio of 19.99 and more cash than debt on its balance sheet (as noted by InvestingPro), suggests robust capability to support ongoing clinical development. The data reveals that 44% (16 of 36) of evaluable patients achieved a major molecular response (MMR) by 24 weeks, and all patients who reached or maintained MMR were still in this state at the time of the data cutoff.

The safety profile of ELVN-001 appears favorable, with dose interruptions and reductions occurring in less than 10% and less than 5% of patients, respectively. The maximum tolerated dose was not reached, indicating a potential for higher dosing without compromising safety.

Enliven’s Chief Medical Officer, Helen Collins, M.D., expressed optimism about the trial’s consistency in efficacy, safety, and tolerability, suggesting that ELVN-001 has the potential to be best-in-class compared to available active-site TKIs. The company is preparing for a possible pivotal trial for ELVN-001 in 2026.

ELVN-001 is a potent, highly selective small molecule kinase inhibitor designed to target the BCR::ABL gene fusion, the oncogenic driver in CML. It is also designed to be effective against the T315I mutation, which often confers resistance to approved TKIs, and other mutations that cause resistance to allosteric BCR::ABL1 inhibitors.

The abstract for the presentation at the EHA Congress is available on the EHA website, with a full copy to be posted on Enliven’s website following the event. Additionally, Enliven will host a webcast and conference call on Friday, June 13, at 1:30 p.m. ET to discuss the data in detail.

This report is based on a press release statement and contains forward-looking statements regarding Enliven’s research and potential treatments. These statements are predictions and are subject to risks and uncertainties. For comprehensive financial analysis and additional insights, including 6 more exclusive ProTips, visit InvestingPro.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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