EvolveImmune Therapeutics Presents New Preclinical Data Demonstrating Improved Anti-Tumor Potential of Novel Costimulatory T Cell Engager Platform at Festival of Biologics Immunotherapy World Congress

Company Unveils EVOLVE-105 Program, A Best-in-Class CD20xCD3 Multispecific Antibody Designed to Concurrently Drive CD2 Costimulation to Improve the Treatment of B cell Malignancies

Expanding Portfolio of First-in-Category Costimulatory T Cell Engagers Highlights Ability of Modular EVOLVE Platform to Target Diverse Range of Tumor Antigens in Solid and Hematological Cancers

BRANFORD, Conn., March 22, 2023 (GLOBE NEWSWIRE) — EvolveImmune Therapeutics, an immuno-oncology company developing first-in-category, multifunctional biotherapeutics to overcome cancer-driven immunodeficiency, today announced that new preclinical data on EVOLVE^™, the company’s novel costimulatory T cell engager platform, were featured in an oral presentation at the Festival of Biologics Immunotherapy World Congress. The presentation highlighted the potential of the company’s innovative integrated CD2 costimulatory strategy to overcome treatment limitations of current immunotherapies. Additionally, the company disclosed the first data for EVOLVE-105, its best-in-class CD20xCD3 multispecific T cell engager that also selectively mediates CD2 costimulation.

Most current immunotherapies rely on the presence of pre-existing tumor-reactive T cells, which are absent or at low levels in many tumors. Moreover, they do not provide coordinated costimulatory receptor activation to overcome T cell dysfunction and drive more effective and longer lasting anti-tumor responses. Despite important therapeutic progress being made with CD3 bispecific antibodies, concerns remain regarding the depth and durability of response achieved with these therapeutics when not paired with costimulation. The EVOLVE platform was created to unleash potent, selective, and integrated T cell costimulation to bypass low tumor immunogenicity, conditionally activate adaptive immunity, and reduce T cell exhaustion, in order to address unmet needs for the treatment of solid and hematologic tumors.

The Festival of Biologics presentation, entitled, “A novel costimulatory T cell engager platform engineered for the treatment of immune suppressive tumors,” included key new findings for the company’s EVOLVE platform and its growing costimulatory T cell engager portfolio.

EVOLVE Therapeutic Platform

Presented findings showcased several differentiating features of the EVOLVE platform, including its ability to:

• Optimize CD8 T cells and improve their tumor killing activity ex vivo and in vivo, when compared to matched CD3 bispecific antibody controls.
• Rejuvenate exhausted T cells to drive more potent tumor cell killing than matched CD3 bispecific antibody controls.
• Finely tune T cell activation to drive optimal costimulation without increasing cytokine release, as compared to matched CD3 bispecific antibody controls.
• Demonstrate superiority of CD2 as a costimulation target as evidenced by increased promotion of cytolytic activity, T cell cytokine production and T cell expansion, as well as greater CD2 receptor expression in tumor infiltrating lymphocytes across a range of tumor types, as compared to other costimulatory targets CD28 and 4-1BB.

“As we continue to gain experience with immunotherapy treatments in cancer, it is becoming clear that the addition of targeted costimulation is needed to overcome T cell dysfunction to improve the durability of patient responses. EvolveImmune has built a compelling case for CD2 as the preferred pathway for effective T cell costimulation and the data presented at this conference strongly support this approach,” said Nils Lonberg, Ph.D., an executive in residence with Canaan and a member of EvolveImmune’s scientific advisory board. “Importantly, the company has translated this strategy into a modular drug discovery and development platform that can efficiently create novel multifunctional therapeutics that incorporate CD2 costimulation to target a diverse range of tumor antigens in both solid and hematological cancers.”

EVOLVE-105

As part of the presentation, EvolveImmune also reported the first data for EVOLVE-105, which is designed to advance the treatment of B cell malignancies by addressing the durability and tolerability challenges that have emerged with other CD20xCD3 Tell cell engager therapies.

The company evaluated EVOLVE-105 in several preclinical experiments, comparing it with CD20-targeting clinical benchmarks. Data demonstrated superiority for EVOLVE-105 in inducing T cell proliferation and maintaining effector T cell activity compared to the most potent benchmarks, suggesting potential durability benefits afforded by CD2 costimulation. Assessments in multiple tumor-killing assays demonstrated EVOLVE-105 to possess similar anti-tumor activity to the most potent CD20 clinical benchmarks with reduced cytokine release, highlighting a potentially important tolerability advantage. Furthermore, in an in vivo model of B cell leukemia, EVOLVE-105 treatment achieved a complete response, which also represented a statistically significant decrease in tumor volume as compared to the clinical benchmark.

With these findings suggesting an encouraging therapeutic and safety profile for EVOLVE-105, the company expects to select a development candidate for further advancement in the coming month.

“Despite their therapeutic benefits, the current class of CD20xCD3 bispecific antibodies may contribute to T cell dysfunction and exhaustion, as well as elevated cytokine release, highlighting two significant issues that limit their overall therapeutic impact. In EVOLVE-105, we believe we have a next generation CD20xCD3 multispecific that can address these durability and tolerability issues by selectively mediating CD2 costimulation. Our newly reported data support this belief, showing that EVOLVE-105 provides potent anti-tumor activity with lower cytokine release and does so without inducing T cell dysfunction,” stated Jeremy Myers, Ph.D., senior vice president, research and development at EvolveImmune. “We look forward to nominating our EVOLVE-105 development candidate in the near-term and continuing to advance this promising program toward the clinic.”

In addition to EVOLVE-105, the company’s pipeline includes EVOLVE-104 which targets a unique tumor antigen present on bladder and other solid tumors, EVOLVE-106, a best-in-class approach for selected solid tumors, and EVOLVE-101, which recognizes a novel tumor antigen present on B cell malignancies and acute myeloid leukemia. The company expects to nominate a development candidate from its EVOLVE-104 program in mid-2023.

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. The company is rapidly advancing two first-in-category programs, with first-in-human clinical trials anticipated in 18 months. 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

CONTACT: 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