Enliven Therapeutics Reports Positive Results for CML Drug

Enliven Therapeutics, Inc. (NASDAQ: ELVN) has recently announced positive proof of concept data from the phase 1 clinical trial of elvn-001, a potent, highly selective, small molecule kinase inhibitor designed to specifically target the bcr-abl gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML).

As of the cutoff date of March 18, 2024, 27 patients had enrolled in the ongoing phase 1 clinical trial across five dose levels of elvn-001, ranging from 10mg once daily (qd) to 120mg qd. Of the enrolled patients, 16 were evaluable for molecular response by 12 weeks.

The preliminary data from the trial revealed that elvn-001 achieved a cumulative major molecular response (MMR) rate of 44% (7/16) by 12 weeks and demonstrated responses in patients with prior exposure to asciminib and/or who were TKI-resistant. Among post-asciminib patients, elvn-001 achieved a cumulative MMR rate of 44% (4/9) by 12 weeks. Furthermore, among TKI-resistant patients, elvn-001 achieved a cumulative MMR rate of 40% (4/10) by 12 weeks.

Importantly, all response-evaluable patients had improved or stable bcr::abl1 transcript levels by 12 weeks. These results compare favorably to precedent phase 1 cumulative MMR rates for approved bcr::abl1 TKIs, particularly given the shorter time frame for response assessment and a more heavily pre-treated patient population.

The preliminary safety data indicated that elvn-001 has been well tolerated, with no ≥ grade 3 non-hematologic treatment-related adverse events (TRAE) reported, and no dose reductions were necessary.

The pharmacokinetic (PK) profile of elvn-001 supports once-daily dosing with flexible administration requirements and showed superior target coverage at doses equal to or greater than 40mg qd compared to 1st and 2nd generation TKIs. At 80mg qd, elvn-001 achieved similar target coverage compared to asciminib.

Enliven Therapeutics' co-founder and CEO, Sam Kintz, expressed excitement about elvn-001's initial phase 1 data and the potential for elvn-001 to become the best-in-class active-site bcr::abl1 TKI. The company is also hosting a virtual event with key opinion leaders to discuss the phase 1 initial proof of concept data and how elvn-001 could fit into the CML landscape.

The phase 1 clinical trial of elvn-001 is a dose escalation trial designed to evaluate the safety and tolerability, and determine the recommended dose for further clinical evaluation of elvn-001 in patients with CML with and without T315I mutations who are relapsed, refractory, or intolerant to TKIs.

Elvn-001 has been 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.

Enliven Therapeutics aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being.

This press release signifies a significant step forward in the field of CML treatment and demonstrates promising results from the phase 1 clinical trial of elvn-001, offering hope for patients with relapsed, refractory, or intolerant CML. Today the company's shares have moved 19.0% to a price of $23.59. For more information, read the company's full 8-K submission here.

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