EvolveImmune Therapeutics Announces FDA Clearance of Investigational New Drug Application for EVOLVE104, a Novel Trispecific T Cell Engager with Integrated CD2 Costimulation
First Program from EVOLVE T-Cell Engager Platform to Advance into Clinical Development
Phase 1 Clinical Trial of EVOLVE104 to be Initiated in 2025
BRANFORD, Conn., Aug. 14, 2025 (GLOBE NEWSWIRE) -- EvolveImmune Therapeutics, an immuno-oncology company developing next-generation T cell engager biotherapeutics to overcome cancer cell resistance to current immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for EVOLVE104, a novel trispecific T cell engager with integrated CD2 costimulation which targets the tumor-associated antigens ULBP2/5/6. EVOLVE104, the company’s lead T cell engager from its EVOLVE platform, is being developed for the treatment of solid tumors. EvolveImmune intends to initiate a phase 1 clinical trial of EVOLVE104 in 2025.
"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. “We have long believed that the integrated CD2 costimulation strategy underpinning EVOLVE has differentiated potential to deliver best-in-class T cell engagers that offer meaningful clinical benefits to patients with cancer. We are excited to evaluate this hypothesis in a clinical setting. We expect to initiate our first-in-human clinical trial for EVOLVE104 in the coming months.”
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.
In preclinical studies, EVOLVE104 has demonstrated compelling single-agent and combination activity with anti-PD-1 therapy in preclinical cancer models, the capability to reinvigorate dysfunctional T cells for improved tumor growth inhibition, and a promising nonclinical safety profile. These data together with its superior manufacturability profile support the further development of EVOLVE104 for the treatment of advanced solid tumors.
About EvolveImmune Therapeutics
EvolveImmune Therapeutics, Inc. is an immuno-oncology company developing first-in-category, trispecific T cell engagers derived from its EVOLVE platform, which have been inspired by a generation of discoveries in T cell immunology. EVOLVE molecules leverage the power of integrated CD2 costimulation to overcome the therapeutic challenges of cancer cell resistance to current immunotherapies in a range of solid tumors and hematological cancers. First-in-human clinical trials with EVOLVE104 are anticipated to commence in 2025.
For more information, please visit: www.evolveimmune.com.
Contacts: EvolveImmune Therapeutics Stephen Bloch, M.D. Chief Executive Officer 860-856-7104 info@evolveimmune.com Vida Strategic Partners (on behalf of EvolveImmune Therapeutics) Tim Brons (Media) 415-675-7402 tbrons@vidasp.com
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
