Enliven Therapeutics Shifts Focus to Leukemia Drug, Abandons HER2 Solid Tumor Program

Enliven Therapeutics, a Colorado-based biotech company, has announced a strategic shift in its drug development pipeline, prioritizing its promising leukemia candidate while discontinuing further development of its solid tumor program. This decision, revealed in the company's first-quarter earnings release, marks a significant change in direction for the pharmaceutical firm.

ELVN-002 Program Discontinued

Enliven has decided to halt the development of ELVN-002, its HER2 pathway inhibitor for solid tumors, beyond 2025. The drug was being evaluated in two phase 1 trials:

1. A combination study with AstraZeneca and Daiichi Sankyo's antibody-drug conjugate Enhertu for HER2-positive breast cancer.
2. A combination study with Roche's Herceptin for patients with HER2-positive colorectal cancer.

The company plans to explore strategic alternatives for the ELVN-002 program, effectively ending its pursuit of the solid tumor market in the near term.

Focus Shifts to ELVN-001 for Chronic Myeloid Leukemia

With resources now redirected, Enliven is doubling down on ELVN-001, a small molecule kinase inhibitor designed to target the BCR-ABL gene fusion, the primary driver of chronic myeloid leukemia (CML). The company is preparing for a pivotal trial of ELVN-001, scheduled to potentially begin in 2026.

Recent phase 1 trial results for ELVN-001 have been encouraging:

• 44% of 36 evaluable patients with previously treated CML experienced a major molecular response by 24 weeks.
• A major molecular response is defined as a reduction in the BCR-ABL1 gene level to 0.1% or less.

Sam Kintz, Enliven's CEO, expressed optimism about the program, stating, "We continue to gain confidence and momentum in the program as the efficacy, safety and tolerability data consistently compare favorably to the approved BCR::ABL inhibitors."

Financial Outlook and Market Competition

The strategic realignment is expected to extend Enliven's financial runway. With $289.6 million in cash reserves at the end of March, the company now projects its funds to last into late 2027.

ELVN-001 will enter a competitive market for CML treatments, which includes established drugs such as:

• Novartis' Gleevec and Tasigna
• Bristol Myers Squibb's Sprycel
• Pfizer's Bosulif

However, Enliven believes its candidate shows promise, particularly given the more heavily pre-treated patient population in its clinical trial compared to those of its competitors.