San Francisco, CA and Berlin, Germany \u2013 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.<\/p>\n
\u201cWe 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,\u201d stated Eugen Leo, M.D., Ph.D., Chief Medical Officer of T-knife. \u201cOur 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.\u201d<\/p>\n
\u201cWe are excited to bring our first MyT Platform derived product candidate into the clinic,\u201d added Thomas M. Soloway, Chief Executive Officer of T-knife. \u201cThis 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.\u201d<\/p>\n
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.<\/p>\n
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.<\/p>\n","protected":false},"excerpt":{"rendered":"
San Francisco, CA and Berlin, Germany \u2013 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…<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[123],"class_list":["post-17352","post","type-post","status-publish","format-standard","hentry","category-biodiscovery-en"],"acf":[],"yoast_head":"\n