T-knife Therapeutics announced that it will present four posters showcasing preclinical data on its lead TCR-T cell therapy program, TK-6302, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting taking place November 7-9, 2025, in National Harbor, MD. The presentations will highlight product characterization and manufacturing data for this supercharged PRAME-targeted therapy as the company advances toward clinical trials.
Novel Engineering Approach Addresses Solid Tumor Challenges
TK-6302 represents a next-generation TCR-T cell therapy designed to overcome key barriers that have limited the success of T cell therapies in solid tumors. According to Peggy Sotiropoulou, Ph.D., Chief Scientific Officer of T-knife, "These data highlight the innovative engineering advances underpinning TK-6302 with the aim of broadening the clinical benefit of T cell therapy across diverse solid tumor cancers. By addressing key barriers such as T-cell fatigue, limited persistence, and an immunosuppressive tumor microenvironment, our approach is designed to generate more durable and meaningful responses for patients."
The therapy incorporates several novel enhancements, including a high-affinity TCR, a costimulatory CD8 coreceptor, and a FAS-based switch receptor. These modifications are designed to improve T cell fitness and persistence while overcoming the immunosuppressive tumor microenvironment to enhance durability of response.
Comprehensive Preclinical Data Package
The four poster presentations will cover multiple aspects of TK-6302 development:
PRAME Target Validation: One poster (Abstract #27) will analyze PRAME expression in advanced and metastatic solid tumors, demonstrating homogeneous expression and stability between lesions across treatment lines and upon exposure to checkpoint inhibitors.
Preclinical Efficacy and Safety: Abstract #329 will present data on TK-6302's preclinical safety and efficacy profile, showcasing the supercharged TCR-T cell therapy's performance in laboratory studies.
Manufacturing Characterization: The third presentation (Abstract #347) will provide in-depth characterization of TK-6302 manufactured at scale from both healthy donors and patients, addressing critical manufacturing considerations for clinical development.
CRISPR Safety Assessment: Abstract #330 will focus on genome editing safety in the CRISPR-engineered PRAME-targeting cells, demonstrating editing precision and safety profiles.
Broad Target Opportunity Across Multiple Cancer Types
PRAME represents a validated target expressed across a wide range of solid tumors, including cancers of the skin, uterus, ovaries, lungs, breasts, esophagus, kidneys, cervix, and head & neck. This broad expression profile positions TK-6302 as a potential therapy for multiple cancer indications.
Clinical Development Timeline
T-knife plans to submit a Clinical Trial Application (CTA) in Q4 2025, with initiation of a Phase 1 clinical study of TK-6302 planned for 2026. This timeline positions the company to begin human testing of its supercharged TCR-T therapy within the next two years.
The biopharmaceutical company, founded by leading T cell and immunology experts utilizing technology developed at the Max Delbrück Center for Molecular Medicine together with Charité – Universitätsmedizin Berlin, is supported by international investors including Andera Partners, EQT Life Sciences, RA Capital Management, and Versant Ventures.
