- The IMAG1NE Phase 1/2 trial is an accelerated dose-titration, open-label, multi-center Phase 1/2 trial to evaluate TK-8001 in patients with MAGE-A1 positive solid tumors
- TK-8001 targets a MAGE-A1 epitope presented on HLA-A*02:01
- IMAG1NE utilizes biomarker-guided patient selection criteria to enroll those patients that have the highest potential for safe, deep, and durable responses
- MAGE-A1 is an attractive therapeutic target that is highly cancer specific and demonstrates significant consistency of expression between primary tumor and metastases
San Francisco, CA and Berlin, Germany – October 20, 2022 – T-knife Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to developing T cell receptor-based immunotherapies that deliver transformational benefits to cancer patients, today 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.
“We believe our MyT Platform is distinct in its ability to identify TCRs that have been naturally optimized for affinity, specificity and sustaining long-term T cell function, making TK-8001 a promising new therapy to target MAGE-A1 positive solid tumors,” stated Eugen Leo, M.D., Ph.D., Chief Medical Officer of T-knife. “Our IMAG1NE trial combines a TCR with best-in-class potential, manufacturing designed to select the most potent T cells, and biomarker-guided patient selection criteria that seeks to enroll those patients that we believe have the highest likelihood of safe, deep and durable responses to TK-8001.”
“We are excited to bring our first MyT Platform derived product candidate into the clinic,” added Thomas M. Soloway, Chief Executive Officer of T-knife. “This is a significant milestone representing the rapid progress at T-knife, and we are thankful for the support and trust we have received from our many collaborators, investigators and the patient community as we pursue our goal to build a global company focused on bringing the power of TCR-based therapies to cancer patients.”
In preclinical studies, the MAGE-A1-directed TCR incorporated in TK-8001 exhibited high binding affinity and specificity to a MAGE-A1 epitope presented on HLA-A*02:01. Importantly, T cells incorporating the MyT Platform derived TK-8001 TCR demonstrated in vitro serial killing activity and enhanced in vivo anti-tumor activity compared to T cells engineered with TCRs derived from human donors.
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.