TK-8001 / T-knife Therap - LARVOL DELTA

IMAG1NE: A Phase 1/ 2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 in Patients With HLA-A*02:01 Genotype and Advanced-Stage/ Metastatic MAGE-A1+ Solid Tumors (clinicaltrials.gov) - P1/2 | N=23 | Terminated | Sponsor: T-knife GmbH | N=48 ➔ 23 | Trial completion date: Jun 2037 ➔ Jan 2024 | Suspended ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Jan 2024; Sponsor decision.

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor • HLA-A

IMAG1NE: A Phase 1/ 2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 in Patients With HLA-A*02:01 Genotype and Advanced-Stage/ Metastatic MAGE-A1+ Solid Tumors (clinicaltrials.gov) - P1/2 | N=48 | Suspended | Sponsor: T-knife GmbH | Recruiting ➔ Suspended

Metastases • Trial suspension • Oncology • Solid Tumor • HLA-A

T-knife Therapeutics Presents Preclinical Data on the Anti-Tumor Activity of TK-8001 at ISCT Annual Meeting (GlobeNewswire) - "T-knife Therapeutics, Inc...announced presentation of a poster...at the International Society for Cell & Gene Therapy (ISCT) Annual Meeting being held from May 31 – June 3, 2023 in Paris, France....The data demonstrated that T cells expressing TCR 8001, the TCR in our lead program TK-8001, performed better than human donor-derived TCRs in all evaluated metrics, including: Higher peptide sensitivity, a measure of affinity; Longer cytotoxic capacities upon repeated antigen stimulation; Long-term cytotoxic capacity, in a variety of different tumor types, at very low effector-to-target ratio; Superior T cell engraftment, leading to significantly enhanced relapse-free survival in a challenging tumor model; And higher IFN-γ secretion upon tumor cell recognition, even in instances with low levels of MAGE-A1 expression."

Preclinical • Oncology • Solid Tumor

T-knife Therapeutics Announces Dosing of First Patient with TK-8001 in the IMAG1NE Phase 1/2 Clinical Trial (GlobeNewswire) - "T-knife Therapeutics, Inc...announced it has dosed the first patient in the IMAG1NE Phase 1/2 clinical trial. The IMAG1NE trial is designed to evaluate the safety and preliminary efficacy of TK-8001, a T cell receptor (TCR) engineered T cell therapy (TCR-T) specific for the Melanoma-associated Antigen Gene-A1 (MAGE-A1), in patients with solid tumors....The IMAG1NE Phase 1/2 trial is an accelerated dose-titration, open-label, multi-center Phase 1/2 trial designed to evaluate the safety and preliminary efficacy of TK-8001 in patients with MAGE-A1 positive solid tumors. The Phase 1 part of the study is focused on the selection of a dose to advance into the Phase 2 part of the study. The Phase 1 dose escalation part is designed to enroll approximately 6 to 18 patients to assess the safety and tolerability of TK-8001 at various doses. Once the recommended Phase 2 dose has been identified, TK-8001 will then be evaluated in an expansion part of the trial."

Trial status • Melanoma • Oncology • Solid Tumor

IMAG1NE: A Phase 1/2, First-in-Human, Open-Label, Two-Part Clinical Trial of TK-8001 in Patients With HLA-A*02:01 Genotype and Advanced-Stage/Metastatic MAGE-A1+ Solid Tumors (clinicaltrials.gov) - P1/2 | N=48 | Recruiting | Sponsor: T-knife GmbH

New P1/2 trial • Oncology • Solid Tumor • HLA-A

A first-in-human, phase 1/2 clinical trial of TK-8001, a MAGE-A1 directed T cell receptor in patients with advanced-stage solid tumors (The „IMAG1NE“-trial) (SITC 2021) - "Part 2 of the trial will enroll up to 30 subjects with advanced-stage, MAGE-A1 positive cancer to confirm safety and efficacy.The study is expected to open for enrolment in Q4/2021. For further information please contact T-knife GmbH at info@t-knife.com."

Clinical • IO biomarker • P1/2 data • Melanoma • Oncology • Solid Tumor • CD8 • HLA-A • IFNG • MAGEA1

T-knife Therapeutics Reports Preclinical Efficacy Data Induced by TK-8001, a Novel MAGE-A1-Specific TCR-T (GlobeNewswire) - "T-knife Therapeutics, Inc...reported preclinical data demonstrating that its novel MAGE-A1-specific T cell receptor (TCR) induced meaningful anti-tumor activity and enhanced engraftment as compared to human donor derived TCRs. In vivo data presented at the SITC annual meeting highlight the potential of T-knife’s lead product candidate TK-8001, a TCR engineered T cell therapy (TCR-T) that is being developed to treat MAGE-A1 positive solid tumors. The company plans to initiate a first-in-human, Phase 1/2 trial in early 2022."

New P1/2 trial • Preclinical • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Lung Cancer • Oncology • Solid Tumor

T-knife Therapeutics Announces Upcoming Presentations at Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting (GlobeNewswire) - "T-knife Therapeutics, Inc...announced that three abstracts highlighting its lead product candidate TK-8001, a T cell receptor (TCR) engineered T cell therapy (TCR-T) being developed to treat MAGE-A1 positive solid tumors, will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting taking place November 10-14, 2021."

Clinical data • Oncology

T-knife Therapeutics Announces $110 Million Series B Financing to Advance Pipeline of T-cell Receptor Therapies (GlobeNewswire) - "T-knife’s lead program, TK-8001, is a novel TCR-T product candidate targeting MAGE-A1 positive cancers. T-knife plans to begin enrolling patients in the TK-8001 IMAG1NE Phase 1/2 clinical study in the fourth quarter of 2021 and is planning to submit INDs/CTAs for additional product candidates in 2022."

IND • New P1/2 trial • Oncology