-- Comprehensive TK-6302 data demonstrate preclinical efficacy and safety, supporting clinical readiness, alongside established scalable manufacturing
--TK-6302 Clinical Trial Application planned in Q4 2025 for initiation of the Phase 1 ATLAS trial in 2026
SAN FRANCISCO and BERLIN, Nov. 07, 2025 (GLOBE NEWSWIRE) -- T-knife Therapeutics, Inc., a biopharmaceutical company developing T cell receptor (TCR) engineered T cell therapies (TCR-T) to fight cancer, today announced multiple presentations on TK-6302 were featured at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. TK-6302 is a differentiated, PRAME-targeted TCR-T that incorporates leading innovations, including a high-affinity TCR, a chimeric CD8 co-receptor that engages CD4 T cells and provides co-stimulation upon TCR engagement, and a FAS checkpoint converter that boosts T cell fitness and survival.
“We have conducted numerous preclinical studies evaluating TK-6302, our supercharged PRAME targeting TCR-T,” stated Peggy Sotiropoulou, Ph.D., Chief Scientific Officer of T-knife. “The competitively differentiated and consistent performance demonstrated across all analyses positions us with confidence as we prepare for the initiation of the ATLAS Phase 1 clinical trial. With the totality of the data, we have demonstrated preclinically that TK-6302 shows best-in-class anti-tumor efficacy and T cell fitness compared to peer company PRAME TCR-T approaches. Additionally, we have established our clinical manufacturing process with scalable production to support clinical development.”
Data Overview
A poster titled “Analysis of PRAME in advanced/metastatic solid tumors shows homogeneous expression and stability between lesions, across treatment lines, and upon exposure to checkpoint inhibitors” (Abstract 27) demonstrated that PRAME is expressed in multiple solid tumors and minimally present in healthy tissues, supporting its potential as a therapeutic target capable of driving deep, durable responses with a low risk of antigen-negative relapse.
A poster titled “TK-6302, a supercharged PRAME TCR-T cell therapy containing a high affinity TCR, a costimulatory CD8 coreceptor and a FAS-based switch receptor, demonstrates preclinical safety and efficacy,” (abstract 329) showcased preclinical studies demonstrating the anti-tumor activity, polyfunctionality, T cell fitness and favorable safety profile of TK-6302. TK-6302’s multi-mechanistic mode of action was further characterized through key observations:
- Supercharged PRAME CD4 and CD8 T cells directly kill tumor cells via the high-affinity TCR and chimeric CD8 co-receptor that engages CD4 T cells and provides co-stimulation upon TCR engagement (co-stim CD8 CoR).
- Supercharged PRAME CD4 T cells secrete cytokines to support CD8 T cell function and trigger global immune responses by recruiting and activating other immune cells, driving tumor control through antigen spreading, beyond HLA and target constraints.
- The co-stim CD8 CoR mediates TCR-T fitness and durable functional activity through optimal co-stimulation.
- The FAS-TNFR checkpoint converter enhances TCR-T cell engraftment and persistence via activation in the lymph nodes and prevention of FAS-L induced cell death in the tumor.
A poster titled “In-depth characterization of TK-6302, a supercharged PRAME TCR-T therapy, manufactured at-scale from healthy donors and patients,” (abstract 347) presented data demonstrating potent anti-tumor activity of TK-6302 across multiple assays, including physiologically relevant 3D tumor models that mimic solid tumor barriers, with high yield manufacturing performance. Additionally, transcriptomic profiling at harvest and following co-culture with cancer cells revealed a TK-6302 gene expression signature consistent with broad immune activation, enhanced tumor homing and sustained T cell fitness.
A poster titled “Preclinical assessment of genome editing safety in CRISPR-engineered PRAME-targeting TK-6302 TCR-T cells demonstrates editing precision and safety,” (abstract 330) reviewed comprehensive analyses of TK-6302 drug products manufactured at-scale with the clinical process, which showed high editing precision with full and correct integration of the transgene, and without concerning off-target or chromosomal aberrations.
Copies of the poster presentations can be found at: https://www.t-knife.com/technology/scientific-publications.
About T-knife Therapeutics
T-knife is a biopharmaceutical company dedicated to developing T cell receptor (TCR) engineered T cell therapies (TCR-Ts) to deliver broad, deep and durable responses to solid tumor cancer patients. The company’s unique approach leverages its proprietary platforms and synthetic biology capabilities to design the next-generation of supercharged TCR-Ts with best-in-class potential.
The company’s lead program, TK-6302, is a supercharged PRAME targeting TCR-T that includes novel enhancements to improve T cell fitness and persistence, to overcome the immunosuppressive tumor micro-environment, and to improve durability of response. The company plans to submit a Clinical Trial Application (CTA) in Q4 2025 and to initiate the ATLAS Phase 1 clinical trial of TK-6302 in 2026.
T-knife was 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 led by an experienced management team, and is supported by a leading group of international investors, including Andera Partners, EQT Life Sciences, RA Capital Management and Versant Ventures. For additional information, please visit the company’s website at www.t-knife.com.
T-knife Therapeutics, Inc.
Camille Landis
Chief Business Officer / Chief Financial Officer
media@t-knife.com
