EvolveImmune’s EVOLVE104 T-Cell Engager Program Approved for Clinical Trials

BRANFORD, Conn. — August 14, 2025 — Leads & Copy — EvolveImmune Therapeutics announced that the FDA has cleared the IND application for EVOLVE104, a novel trispecific T cell engager targeting ULBP2/5/6 for solid tumor treatment. A phase 1 clinical trial is slated for 2025.

According to Stephen Bloch, M.D., CEO of EvolveImmune, this IND clearance is a transformational milestone for the company, paving the way for it to advance as a clinical-stage developer of trispecific T cell engagers. The company believes that the integrated CD2 costimulation strategy underpinning EVOLVE has differentiated potential to deliver best-in-class T cell engagers.

EvolveImmune’s EVOLVE platform co-opts key mechanisms for efficient immune synapse formation and T cell effector function. In preclinical studies, EVOLVE104 has demonstrated single-agent and combination activity with anti-PD-1 therapy, reinvigorating dysfunctional T cells and demonstrating a promising nonclinical safety profile.

Stephen Bloch, M.D., Chief Executive Officer, 860-856-7104, info@evolveimmune.com

Source: EvolveImmune Therapeutics

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