T-knife Therapeutics Files CTA for Phase 1 ATLAS Trial of Supercharged PRAME-Targeted TCR-T in Solid Tumors

SAN FRANCISCO and BERLIN – November 17, 2025 — 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 initiate the Phase 1 ATLAS trial for its lead candidate, TK-6302.

TK-6302 is a Supercharged PRAME-targeted T cell receptor T cell (TCR-T) therapy aimed at solid tumors. PRAME is a validated target expressed in several high unmet need solid tumor indications, including non-small cell lung, ovarian, endometrial, skin, and triple negative breast cancers. The ATLAS trial is planned to begin in 2026 following CTA approval.

Preclinical Data Shows “Best-in-Class” Efficacy

Preclinical data for TK-6302 has demonstrated best-in-class anti-tumor efficacy, suggesting its potential to elicit deep and durable responses. The therapy incorporates pioneering innovations to enhance T cell fitness and overcome immune barriers:

• High Affinity TCR: Enhances cytotoxicity against tumor cells.
• Costimulatory CD8 Co-receptor: Engages CD4 T cells to boost T cell fitness and persistence.
• FAS-based Checkpoint Converter: Designed to promote engraftment and survival of T cells within the hostile tumor micro-environment.

“This milestone reflects the unwavering commitment of our employees to boldly innovate and redefine solutions in the service of solid tumor patients,” said Thomas M. Soloway, President and Chief Executive Officer of T-knife.

The preclinical results highlighted the superior potency of the therapy:

• Sustained Killing: TK-6302 demonstrated sustained serial killing and cytokine secretion in models mimicking the inhibitory ligand expression found in PRAME-expressing tumors.
• Superior Activity: In a complex 3-dimensional (3D) spheroid tumor model, TK-6302 eliminated multiple rounds of tumors and showed superior anti-tumor activity compared to controls.
• Manufacturing: The therapy is manufactured using a non-viral gene editing process for improved TCR expression and has been successfully produced at-scale using the clinical process.