EvolveImmune Therapeutics Highlights Progress for Lead Asset EVOLVE104 and EVOLVE T Cell Engager Platform in Multiple Presentations at 2026 AACR Annual Meeting
Phase 1 Clinical Trial of EVOLVE104 Continues to Advance According to Plan
Oral Minisymposium Presentation Demonstrates That EVOLVE T Cell Engagers Drive Greater T Cell Activation, Proliferation and Differentiation Compared to Conventional Bispecific T Cell Engagers
Poster Presentation Highlights Enhanced Formation of an Immune Interface Between T Cell and Tumor Cell by EVOLVE Platform that Strengthens T Cell Signaling and Tumor Killing
BRANFORD, Conn., April 22, 2026 (GLOBE NEWSWIRE) -- EvolveImmune Therapeutics, a clinical-stage immuno-oncology company developing a new class of multi-specific T cell engagers with integrated CD2 costimulation, today announced the presentation of new data highlighting its novel EVOLVE T cell engager platform and an update on its lead asset, EVOLVE104, at the 2026 American Association for Cancer Research (AACR) Annual Meeting. The results presented included findings from collaborative research conducted in partnership with Michael L. Dustin, Ph.D., Kennedy Trust Professor of Molecular Immunology at the University of Oxford, UK. The AACR conference is being held April 17-22, 2026, in San Diego, California.
The 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.
“Our presentations at AACR share an impressive collection of first-in-class scientific findings for the EVOLVE platform and the continued clinical progress of our EVOLVE104 program. We are unlocking new insights into the mode of action of our EVOLVE platform which are catalyzing new and impactful prospects for our pipeline growth,” said Stephen Bloch, M.D., Chief Executive Officer of EvolveImmune. “Our focus remains on efficiently executing our ongoing clinical study for EVOLVE104, while advancing further differentiated innovation opportunities for our EVOLVE technology.”
Highlights from the company's presentations at the AACR conference are as follows:
EVOLVE104:
EvolveImmune spotlighted its ongoing phase 1 clinical trial of EVOLVE104, the first molecule from the company’s EVOLVE platform to enter clinical development (presentation #CT079). The compound targets a novel set of tumor-associated antigens, ULBP2/5/6, which are expressed on bladder cancers and squamous cell carcinomas. Notably, EVOLVE104 is the first T cell-redirecting therapeutic candidate targeting ULBP2/5/6 to enter clinical development.
The phase 1a/1b study, EIU-104101 (NCT07217171), is evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of EVOLVE104. The trial, began enrolling in December 2025, is designed with an initial phase 1a dose escalation portion, to be followed by phase 1b dose expansion, enrolling up to 160 subjects with locally advanced or metastatic bladder cancer and squamous cell carcinomas of the lung, esophagus, skin, tongue, and anogenital region who have relapsed from or are refractory to standard of care therapies. The study is currently open at nine US sites, with additional sites expected to open during the remainder of 2026.
EVOLVE T Cell Engager Platform:
In an oral minisymposium presentation (presentation #4055), EvolveImmune shared updated results from preclinical studies demonstrating that EVOLVE’s integrated CD2 co-stimulation approach shows superiority to conventional CD3-bispecific T cell engagers. Chronic in vitro human T cell stimulation with EVOLVE demonstrated sustained activation and proliferation, as well as enhanced differentiation into more effective effector-memory T cells. This activity correlated with improved tumor-dependent cytotoxicity compared to conventional CD3-bispecific T cell engagers. Notably, this superior profile for EVOLVE was observed with primary human tumor-infiltrating lymphocytes as well.
The enhanced T cell activity driven by EVOLVE led to greater tumor growth inhibition in an in vivo lung tumor xenograft model, when compared to bispecific T cell engagers. These findings add to the growing collection of evidence demonstrating that integrated T cell CD2 costimulation mediated by EVOLVE molecules results in superior human T cell performance compared to conventional CD3-bispecific T cell engagers.
A second poster presentation (presentation #5594) described experimental results conducted in collaboration with the laboratory of Professor Dustin. These findings showed that the EVOLVE platform functionally mimics the naturally occurring processes involved in human T cell recognition of target cells for their activation. This includes the active generation of an immune interface, or immune synapse, between T cells and target cells, which includes the positioning of CD2 to the corolla of the synapse, a hallmark feature of this interface. This activity correlated with increased T cell receptor signaling, improved T cell fitness and greater tumor killing. These findings provide further insight into the fundamental mechanistic activity that mediates the ability of EVOLVE to enhance T cell-mediated anti-tumor activity.
“It is remarkable how well EVOLVE mimics synaptic patterns generated by natural CD58 in a target membrane,” said Professor Dustin.
About EVOLVE104
EVOLVE104 is a next-generation trispecific T cell engager that binds CD3 and CD2 on T cells and the tumor-associated antigens ULBP2/5/6, which have limited expression in normal human tissues and are found on a number of epithelial-derived malignancies, including urothelial carcinoma and a broad array of squamous cell carcinomas. In preclinical studies, EVOLVE104 has demonstrated compelling single-agent activity and combination activity with anti-PD-1 therapy, the ability to reinvigorate dysfunctional T cells, and a promising safety profile. EVOLVE104 is currently being studied in a first-in-human phase 1 clinical trial in subjects with advanced, relapsed or refractory solid tumors (NCT07217171).
About EvolveImmune Therapeutics
EvolveImmune Therapeutics, Inc. is an immuno-oncology company developing first-in-class, multi-specific 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. The EVOLVE platform has generated a pipeline of internal and partnered programs, the most advanced of which, EVOLVE104, is in active clinical development. For more information, please visit: www.evolveimmune.com.
Contacts: EvolveImmune Therapeutics Stephen Bloch, M.D. Chief Executive Officer 860-856-7104 info@evolveimmune.com Stellar Red PR (on behalf of EvolveImmune Therapeutics) Tim Brons (Media) 646-319-8981 tbrons@stellarredPR.com
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