Enliven Therapeutics (ELVN) Jefferies 2024 Global Healthcare Conference summary

Program overviews and leadership

• Two lead clinical programs: ELVN-001 (BCR-ABL inhibitor for CML) and ELVN-002 (HER2 inhibitor).

• Leadership team includes experienced oncology drug developers with backgrounds at Array BioPharma and Five Prime Therapeutics.

Clinical data and study updates

• Initial proof-of-concept data for ELVN-001 in heavily pretreated CML patients showed favorable safety, tolerability, and efficacy.

• Data compared favorably to prior Phase I studies of bosutinib and SCEMBLIX, despite a more resistant patient population.

• Maintenance of MMR in highly resistant patients is seen as a significant achievement; all such patients remain on study.

• Next data update expected later in 2024, with a major inflection point anticipated in 2025 as more patients and longer follow-up accrue.

Study design and regulatory plans

• Enrollment continues in Phase Ia, with dose escalation complete for the broader population; Phase Ib to start in Q2.

• Phase Ib will include 60-100 patients, combining data from both Ia and Ib for regulatory discussions.

• Main goal for Phase Ib is dose alignment with FDA under Project Optimus; a T315I arm will be opened.

• Plan to use the full Phase I dataset for FDA discussions on registrational trial design by end of 2025.