T-knife Therapeutics to Present Preclinical Data on PRAME-Targeted TCR-T Therapy TK-6302 at SITC 2025
Key Insights
T-knife Therapeutics (search) will present four posters on TK-6302 (search), a supercharged PRAME (search)-targeted TCR-T cell therapy, at the Society for Immunotherapy of Cancer (search) Annual Meeting in November 2025.
TK-6302 (search) incorporates novel engineering features including a high-affinity TCR, costimulatory CD8 (search) coreceptor, and FAS (search)-based switch receptor to address key barriers in solid tumor (search) treatment.
The company plans to file a Clinical Trial Application in Q4 2025 and initiate Phase 1 clinical studies in 2026 for this therapy targeting multiple solid tumor (search) types.
T-knife Therapeutics (search) announced that it will present four posters showcasing preclinical data on its lead TCR-T cell therapy program, TK-6302 (search), at the Society for Immunotherapy of Cancer (search) (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 (search)-targeted therapy as the company advances toward clinical trials.
Novel Engineering Approach Addresses Solid Tumor Challenges
TK-6302 (search) 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 (search) 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 (search) coreceptor, and a FAS (search)-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 (search) development:
PRAME (search) 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 (search)'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 (search) 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 (search)-targeting cells, demonstrating editing precision and safety profiles.
Broad Target Opportunity Across Multiple Cancer Types
PRAME (search) 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 (search) 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 (search) 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 (search) together with Charité – Universitätsmedizin Berlin, is supported by international investors including Andera Partners (search), EQT Life Sciences (search), RA Capital Management (search), and Versant Ventures (search).