On March 3, 2026 T-knife Therapeutics, Inc., a biopharmaceutical company developing next-generation T cell therapies to fight cancer, reported the authorization of its Clinical Trial Application (CTA) to begin the Phase 1 ATLAS trial of TK-6302 in Europe. TK-6302 is a multi-armored PRAME-targeted T cell therapy specifically engineered to overcome the challenges associated with treating solid tumor cancers. The ATLAS trial, which is poised to begin this year, is an adaptive, first-in-human, open-label, Phase 1 trial of TK-6302 in patients with advanced PRAME-positive solid tumors.
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"We are proud to achieve this important milestone, which enables the initiation of the Phase 1 ATLAS clinical trial and our transition to becoming a clinical-stage company," stated Thomas M. Soloway, President and Chief Executive Officer of T-knife. "TK-6302 is a highly differentiated therapy, engineered for greater potency against PRAME, a clinically validated target with attractive commercial potential. PRAME is highly prevalent across multiple high unmet-need solid tumor indications, including squamous non-small cell lung, ovarian, endometrial, skin, and triple-negative breast cancers. Today’s announcement reflects the dedication, expertise, and urgency our team brings to transforming innovative science into life-changing therapies."
Peggy Sotiropoulou, Ph.D., Chief Scientific Officer of T-knife, added, "The CTA was supported by a comprehensive and compelling preclinical data package demonstrating TK-6302’s best-in-class anti-tumor efficacy. By bolstering T-cell fitness and persistence while overcoming challenging tumor mediated immune barriers, TK-6302 has the potential to deliver meaningful clinical benefit, including deep, durable responses across a range of solid tumor cancers. Bringing a first-of-its-kind multi-armored, CRISPR gene-edited T cell therapy into the clinic underscores our commitment to pushing scientific boundaries in the service of delivering transformative therapies to patients."
About TK-6302
TK-6302 is a PRAME-targeted T cell therapy that has been "supercharged" by the inclusion of multiple armoring innovations: a high affinity PRAME targeting receptor 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 T cell receptor expression, and it has been successfully manufactured at-scale using the clinical process.
(Press release, T-Knife, MAR 3, 2026, View Source [SID1234663274])