TK-6302 / T-knife Therap - LARVOL DELTA

T-knife Therapeutics Files Clinical Trial Application for Phase 1 ATLAS Trial for TK-6302, a Supercharged PRAME-targeted T Cell Receptor Therapy (GlobeNewswire) - "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."

New P1 trial • Preclinical • Solid Tumor

T-knife Therapeutics Presents Preclinical Data on PRAME-Targeted TK-6302 Highlighting its Potential as a Promising, Category-leading Therapy at the Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "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."

New P1 trial • Preclinical • Solid Tumor

In-depth characterisation of TK-6302, a supercharged PRAME TCR-T therapy, manufactured at-scale from healthy donors and patients (SITC 2025) - "Gene expression analysis using bulk RNA-Sequencing is ongoing, with early data indicating T cell fitness-associated gene signatures.Conclusions The non-viral genome-editing manufacturing process of TK-6302 consistently yields TCR-T product at therapeutically relevant doses. Comprehensive characterization of healthy donor- and patient derived DP showed characteristics associated with improved clinical outcomes, supporting the potential for broad, deep and durable responses in hard-to-treat indications."

Clinical • IO biomarker • Melanoma • Oncology • Sarcoma • Solid Tumor • CD4 • CD8 • IFNG • LAG3 • PD-1 • PRAME

Preclinical assessment of genome editing safety in CRISPR-engineered PRAME-targeting TK-6302 TCR-T cells demonstrates editing precision and safety. (SITC 2025) - "Data collection for chromosomal integrity using full scale runs using healthy donors is ongoing and data will be presented.Conclusions Comprehensive preclinical evaluation supports the safety of the genome editing process used to engineer TK-6302, with no concerning off-target activity or evidence of genomic instability observed. These findings provide a robust foundation for the clinical development of TK-6302 across PRAME-expressing solid tumor indications."

Preclinical • Oncology • Solid Tumor • CD4 • CD8 • PRAME

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. (SITC 2025) - "The FAS-SwR expression protected TK-6302 from FAS-ligand induced cell death, but did not result in aberrant activation of TK-6302 in the absence of antigen. Importantly, TK-6302 showed robust anti-tumor activity against a variety of cancer cell lines derived from various indications, as demonstrated using cytokine secretion, cytotoxicity upon long-term and repeated stimulation, and upon co-culture with multi-cellular tumor spheroids mirroring the plethora of challenges raised by solid tumors.Conclusions TK-6302 demonstrates a favorable preclinical safety profile and robust functional activity supporting its advancement to clinical evaluation in multiple PRAME-expressing cancer indications."

Preclinical • Oncology • Solid Tumor • CD4 • CD8 • FASLG • IFNG • PRAME

T-knife Therapeutics Presents Preclinical Data at the American Association for Cancer Research (AACR) Annual Meeting Demonstrating a Potential Best-in-Class PRAME Targeted TCR-T Therapy (GlobeNewswire) - "T-knife Therapeutics...announced multiple data presentations at the American Association for Cancer Research (AACR) Annual Meeting. Preclinical data demonstrated that TK-6302, T-knife’s supercharged PRAME targeting TCR-T, outperformed other clinical-stage approaches. The company plans to submit a Clinical Trial Application (CTA) for TK-6302 in the fall of 2025 and to initiate a Phase 1 clinical study of TK-6302 in early 2026....detailed data showing best-in-class potential for TK-6302. Through the incorporation of 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 in the periphery and prevents apoptosis in the tumor, TK-6302 demonstrated higher in vitro anti-tumor activity compared to known clinical-stage PRAME TCR-T approaches."

New P1 trial • Preclinical • Oncology

TK-6302, a supercharged PRAME TCR-T cell therapy containing a high affinity TCR, an activating CD8 coreceptor (costimCD8 CoR) and a Fas-based switch receptor, drives sustained anti-tumor responses (AACR 2025) - "Supercharged PRAME TCR-T therapy demonstrates best-in-class preclinical anti-tumor efficacy and T cell fitness compared to current clinical stage PRAME TCR-T approaches, providing the potential for deep and durable responses in hard-to-treat indications."

IO biomarker • Melanoma • Oncology • Sarcoma • Solid Tumor • CD40 • CD8 • FAS • FASLG • PRAME

T-knife Therapeutics Announces Five Presentations at American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "T-knife Therapeutics...announced that five abstracts highlighting its PRAME-targeted TCR-T therapy, TK-6302, and its platform technologies will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting....Multiple presentations demonstrate that T-knife’s proprietary next-generation technologies address important challenges with current cell therapy constructs, including boosting T cell fitness and persistence within an immunosuppressive tumor microenvironment. TK-6302, a supercharged PRAME T cell therapy, is rapidly advancing towards a Clinical Trial Application (CTA) filing in the fourth quarter of 2025."

New trial • Preclinical • Solid Tumor