On May 14, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported updated, positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) in an abstract accepted for an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress taking place June 12-15 in Milan, Italy, and virtually (Press release, Enliven Therapeutics, MAY 14, 2025, View Source [SID1234653093]). Updated data will be presented during an oral presentation at the conference on Friday, June 13, at 5 p.m. CEST/11 a.m. ET. Enliven management will host a webcast and conference call to discuss the data on Friday, June 13, at 7:30 p.m. CEST/1:30 p.m. ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with CML. Data presented at EHA (Free EHA Whitepaper) will be from the ongoing ENABLE Phase 1a/1b clinical trial, which enrolled patients with CML that have failed, are intolerant to, or are not a candidate for, available therapies known to be active for treatment of their CML (NCT05304377).

"We are strongly encouraged by the consistent efficacy, safety and tolerability data from the ongoing ENABLE trial in heavily pretreated patients with CML," said Helen Collins, M.D., Chief Medical Officer of Enliven. "These data continue to demonstrate the potential for ELVN-001 to achieve a best-in-class profile compared to the available active-site TKIs. We look forward to providing additional updates at the EHA (Free EHA Whitepaper) Congress in June."

Abstract Highlights

Patient Demographics

As of the cutoff date of January 21, 2025, 74 patients have been enrolled in the ongoing Phase 1 trial across dose levels from 10-160 mg daily and the vast majority of patients (82%) remain on study with a median treatment duration of ~26 weeks.
Patients enrolled continue to be heavily pretreated, with 66% having received three or more prior tyrosine kinase inhibitors (TKIs), including ponatinib (45%) and asciminib (57%).
Updated Efficacy

Of the enrolled patients, 36 with typical transcripts and without T315I mutations were evaluable for molecular response by 24 weeks.
16 of 36 (44%) evaluable patients were in major molecular response (MMR) by 24 weeks, with 7 of 27 (26%) achieving and 9 of 9 (100%) maintaining MMR.
Of those resistant to their last TKI, 10 of 25 (40%) were in MMR by 24 weeks.
Of those previously treated with asciminib or ponatinib, 9 of 25 (36%) were in MMR by 24 weeks, including one with a known asciminib resistance mutation (A337T).
All patients who achieved or maintained MMR were still in MMR at the time of data cutoff.
These data continued to compare favorably to precedent Phase 1 MMRs for approved BCR::ABL1 TKIs, particularly given the more heavily pre-treated patient population in the ELVN-001 clinical trial.
Updated Safety

ELVN-001 remains well-tolerated across all doses, consistent with its selective kinase profile.
Dose interruptions and reductions occurred in less than 10% and less than 5% of patients, respectively.
The maximum tolerated dose was not reached.
Details of the oral presentation are as follows:
Title: ENABLE: A Phase 1a/1b Study of ELVN-001, a selective active site inhibitor of BCR::ABL1, in patients with previously treated CML
Presenter: Andreas Hochhaus, M.D.
Session Title: s425 Novel approaches of CML treatment
Location: Coral 2
Abstract Number: S165
Presentation Date/Time: June 13, 5 p.m. CEST / 11 a.m. ET

The abstract is available on the EHA (Free EHA Whitepaper) website. Following the presentation, a copy will be available on the "Program Presentations & Publications" section of the Company’s website at www.enliventherapeutics.com.

Webcast and Conference Call Information
Enliven will host a conference call with management on June 13, 2025, at 7:30 p.m. CEST/1:30 p.m. ET. To access the call, please dial +1 (800) 803-6955 (domestic) or (240) 220-9050 (international), and reference participant ID 631-128-259 at least 10 minutes prior to the start time and ask to be joined to the Enliven call. Accompanying slides and a link to the webcast will be available in the Investors section of the Enliven website at View Source To participate in the live event, please register using this link. An archived webcast will be available following the event.

About the ENABLE Trial
The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. The trial is currently in Phase 1a/1b development and is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to TKIs. Secondary endpoints include pharmacokinetics, MMR by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response. Enliven is preparing for the potential start of a pivotal trial for ELVN-001 in 2026.

About ELVN-001
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. As a highly selective active site inhibitor, ELVN-001 has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was also designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.