EvolveImmune Therapeutics announced that the U.S. Food and Drug Administration has cleared the company's Investigational New Drug application for EVOLVE104, a novel trispecific T cell engager with integrated CD2 costimulation targeting tumor-associated antigens ULBP2/5/6. The Connecticut-based immuno-oncology company plans to initiate a Phase 1 clinical trial of EVOLVE104 in 2025, representing the first program from its proprietary EVOLVE platform to advance into clinical development.
Regulatory Milestone Advances Novel T Cell Engager Platform
"This IND clearance represents a transformational milestone for our company, as it paves the way for our advancement into a clinical-stage developer of next-generation trispecific T cell engagers," said Stephen Bloch, M.D., chief executive officer of EvolveImmune. The company expects to initiate its first-in-human clinical trial for EVOLVE104 in the coming months.
EVOLVE104 is being developed for the treatment of solid tumors and represents what the company describes as a first-in-category approach. The therapeutic is designed to overcome cancer cell resistance to current immunotherapies through its integrated CD2 costimulation strategy.
Platform Technology Addresses T Cell Dysfunction
EvolveImmune's proprietary EVOLVE platform is designed to therapeutically co-opt key mechanisms central to efficient immune synapse formation and T cell effector function. This approach aims to bypass low tumor immunogenicity, conditionally activate adaptive immunity and reduce T cell dysfunction, allowing for amplified and sustained T cell tumor killing capacity to address unmet medical needs in solid tumors and hematologic malignancies.
The platform leverages integrated CD2 costimulation to overcome therapeutic challenges of cancer cell resistance to current immunotherapies across a range of solid tumors and hematological cancers.
Preclinical Data Supports Clinical Advancement
In preclinical studies, EVOLVE104 demonstrated compelling single-agent and combination activity with anti-PD-1 therapy in preclinical cancer models. The therapeutic showed the capability to reinvigorate dysfunctional T cells for improved tumor growth inhibition and exhibited a promising nonclinical safety profile.
These preclinical data, combined with EVOLVE104's superior manufacturability profile, support the further development of the therapeutic for the treatment of advanced solid tumors. The company believes the integrated CD2 costimulation strategy has differentiated potential to deliver best-in-class T cell engagers that offer meaningful clinical benefits to patients with cancer.
Clinical Development Timeline
EvolveImmune intends to initiate the Phase 1 clinical trial of EVOLVE104 in 2025, marking a significant transition for the company from preclinical development to clinical-stage operations. The trial will evaluate the safety and efficacy of this novel trispecific T cell engager approach in patients with solid tumors.
