-- Preclinical data with TK-6302 has shown best-in-class anti-tumor efficacy, demonstrating its potential to elicit deep and durable responses in diverse solid tumor indications with high unmet need
-- Following CTA approval, Phase 1 ATLAS trial planned to begin in 2026
SAN FRANCISCO and BERLIN, Nov. 17, 2025 (GLOBE NEWSWIRE) -- T-knife Therapeutics, Inc., a biopharmaceutical company developing next-generation T cell therapies to fight cancer, today announced the filing of a Clinical Trial Application (CTA) to begin the Phase 1 ATLAS trial for TK-6302, a Supercharged PRAME-targeted TCR T cell therapy in solid tumors. PRAME is a validated target expressed in multiple solid tumor indications with high unmet need, including squamous non-small cell lung, ovarian, endometrial, skin, and triple negative breast cancers.
"The filing of this clinical trial application is a notable achievement, both for the development of TK-6302 and for our company," stated Thomas M. Soloway, President and Chief Executive Officer of T-knife. "This milestone reflects the unwavering commitment of our employees to boldly innovate and redefine solutions in the service of solid tumor patients. We have pioneered novel technologies with TK-6302 that demonstrate best-in-class preclinical results in enhancing T cell fitness, persistence and anti-tumor activity, while overcoming immune barriers. Empowered by these novel advances, we are excited by the prospect of initiating the ATLAS trial to evaluate the potential of TK-6302."
TK-6302 is a PRAME-targeted TCR-T that has been "supercharged" by the inclusion of key differentiating innovations: a high affinity TCR to enhance cytotoxicity; a costimulatory CD8 coreceptor to engage CD4 T cells and enhance T cell fitness and persistence; and a FAS-based checkpoint converter designed to boost engraftment and promote T cell survival in the hostile tumor micro-environment. Preclinical data with TK-6302 demonstrated sustained serial killing and cytokine secretion in a model mirroring the inhibitory ligand expression in PRAME-expressing tumors. In a complex 3-dimensional (3D) spheroid tumor model, TK-6302 eliminated multiple rounds of tumors and demonstrated superior anti-tumor activity compared to controls. TK-6302 is manufactured with a non-viral gene editing process for improved TCR expression, and it has been successfully manufactured at-scale using the clinical process.
About T-knife Therapeutics
T-knife is a biopharmaceutical company dedicated to developing T cell therapies 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 T cells 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. Following CTA approval, the company plans 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
