EvolveImmune Therapeutics Presents New Preclinical and Translational Data on Novel CD2 Costimulatory T Cell Engager Platform at 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

EV-104 and EV-106 Programs Demonstrate Potential for A Differentiated Precision Immunotherapy Approach Built on Novel Insights Into Solid Tumor Features

BRANFORD, Conn., Nov. 06, 2023 (GLOBE NEWSWIRE) -- EvolveImmune Therapeutics, an immuno-oncology company developing first-in-category, multifunctional biotherapeutics to overcome the therapeutic challenges of cancer cell resistance to current immune therapy agents, today announced that new preclinical and translational data highlighting EV-104 and EV-106, two programs utilizing EVOLVE, the company’s proprietary costimulatory T cell engager platform were presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). The company shared for the first time its pioneering insights into the regulation of tumor antigen expression in specific solid tumor lineages and the association of those lineages with immune infiltration. In addition, presented data highlighted the robust anti-tumor efficacy exhibited by lead molecules for the EV-104 and EV-106 programs in patient-derived solid tumor models. These findings illustrate the potential of the EVOLVE platform to enable a novel precision immunotherapy strategy for selecting patients who are most likely to benefit by treatment with each of these molecules.

The EVOLVE platform uniquely unleashes potent, selective and integrated T cell costimulation, which amplifies and sustains the tumor killing capacity of these T cells. This approach bypasses low tumor immunogenicity, conditionally activates adaptive immunity and reduces T cell dysfunction to address unmet needs for the treatment of solid and hematologic tumors. The platform also takes advantage the company’s understanding of specific tumor cell characteristics to guide tumor antigen prioritization and program differentiation. By pairing its distinctive costimulation strategy with these critical tumor-intrinsic attributes, EvolveImmune is developing an innovative pipeline of first-in-category precision immuno-oncology agents with an enhanced likelihood of clinical success.


In a poster presentation at SITC, EvolveImmune spotlighted advances to the company’s first-in-class EV-104 program, a novel multi-functional T cell engager with integrated CD2 costimulation which conditionally targets ULBP2.

Researchers found that ULBP2 expression is markedly enriched in cancers displaying molecular features of the basal-squamous tumor lineage and that these tumors show high levels of immune infiltrates. This profile is favorable to optimize clinical anti-tumor responses with EV-104 in these sizeable patient subpopulations which continue to experience high unmet needs despite current therapies. The expression pattern of ULBP2 is distinct from that of the solid tumor targets for a number of approved or investigational immunotherapies, suggesting opportunities for meaningful clinical differentiation. EV-104 showed robust single-agent anti-tumor activity in patient-derived tumor models of bladder and lung cancer and demonstrated promising activity in combination with anti-PD1 therapy in pre-clinical models with patient-derived tumors, providing rationale for combination treatment approaches with checkpoint inhibitors.


In a second SITC poster presentation, researchers shared the latest data on EV-106, a proprietary multi-functional T cell engager with integrated CD2 costimulation which conditionally targets B7-H4. EvolveImmune has identified advanced candidate leads for this best-in-class solid tumor program.

The presentation unveiled new observations showing that B7-H4 expression is elevated in breast tumors that are estrogen receptor (ER)-low and in triple-negative breast cancers (TNBCs). New clinical, genetic and pharmacologic evidence indicates that a range of clinically relevant breast cancer therapeutics such as CDK4/6 inhibitors, selective estrogen receptor modulators (SERMs) and selective estrogen receptor degraders (SERDs) strongly induce surface B7-H4 levels following treatment. This profile suggests significant therapeutic potential for a B7-H4-targeting immunotherapy such as EV-106 to overcome therapeutic resistance in both breast cancer patient subpopulations, which are notable by their high unmet need. New findings demonstrated robust single-agent anti-tumor activity by EV-106 lead molecules in three different preclinical breast cancer cell assay systems that was superior to B7-H4-targeted CD3 T cell engagers being advanced by competitors which do not employ integrated CD2 costimulation. Additionally, combining EV-106 with either estrogen therapies (SERD + CDK4/6 inhibitor) or an anti-PD-1 antibody further heightened the anti-tumor activity of EV-106, suggesting the potential for effective combination therapy in these patient segments.

“EvolveImmune’s intentional focus on integrating CD2 costimulation in their T cell engager platform continues to be a highly appealing approach to address the therapeutic challenges which result from impaired T cell effector function and T cell exhaustion in the solid tumor setting. With their new and unexpected observations describing the association of high levels of expression of their drug targets with specific cancer cell features, the company has broken new ground to enable a patient selection strategy to identify patients who may benefit most from these treatments. I look forward to closely following the progress of EvolveImmune’s programs, which have the potential to address unmet medical needs in the significant proportion of patients whose cancers do not respond to currently available immunotherapies,” said Susan Kaech, Ph.D., professor and director, NOMIS Center for Immunobiology and Microbial Pathogenesis at the Salk Institute for Biological Studies, and NOMIS Foundation Chair.

“These new translational data presented at SITC build upon the strong pipeline and platform advances we have made at EvolveImmune, and provide a glimpse into the potential of EV-104 and EV-106, as well as other EVOLVE programs to come, to represent a next generation of differentiated precision immunotherapies,” said Jeremy Myers, Ph.D., senior vice president, research and development at EvolveImmune. “We are highly driven to continue our quest to leverage our team’s innovativeness and know-how to quickly bring our solid tumor programs to patients in need, and we remain on track to meet this goal.”

Additional information on the 38th Annual Meeting of SITC is available through the conference website at: https://www.sitcancer.org/2023/home.

About EvolveImmune Therapeutics

EvolveImmune Therapeutics, Inc. is an immunotherapy platform company developing first-in-category, multifunctional biotherapeutics designed to overcome cancer-driven immunodeficiency in a range of solid tumors and hematological cancers. First-in-human clinical trials are anticipated in 2024. The company is supported by a syndicate of top-tier life science industry investors including Pfizer Ventures, Solasta Ventures, Takeda Ventures, Yonjin Ventures and Elm Street Ventures.

For more information, please visit: www.evolveimmune.com


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