On October 1, 2021 T-knife Therapeutics, Inc., a biopharmaceutical company dedicated to developing novel therapeutics to fight cancer, reported 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) (Free SITC Whitepaper) 36th Annual Meeting taking place November 10-14, 2021 (Press release, T-Knife, OCT 1, 2021, View Source [SID1234591706]).
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"TK-8001 is a novel CD8 TCR-T targeting MAGE-A1, a tumor-specific antigen associated with aggressive cancers and poor clinical prognosis," stated Eugen Leo, Chief Medical Officer of T-knife. "The presentations at SITC (Free SITC Whitepaper) will cover important aspects of our work related with TK-8001, including favorable preclinical data comparing TK-8001 to human donor-derived TCRs, the potential benefits of MAGE-A1 as a cancer target, and the design of our forthcoming IMAG1NE Phase 1/2 study intended to evaluate the safety and efficacy of TK-8001 in select patients with MAGE-A1 expressing solid tumors."
Poster Presentation Details
Title: Optimal-affinity MAGE-A1-specific T cell receptors (TCRs) generated using the humanized TCR-transgenic mouse platform HuTCR are superior to human donor-derived TCRs
Abstract ID: 225
Date: Friday, Nov. 12, 2021
Time: 7:00 am – 5:00 pm
Title: MAGE-A1 protein expression pattern in > 5,000 tumor and healthy tissue samples: Validation of MAGE-A1 as an ideal target for TCR-based cell therapy
Abstract ID: 95
Date: Friday, Nov. 12, 2021
Time: 7:00 am – 5:00 pm
Title: 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)
Abstract ID: 499
Date: Friday, Nov. 12, 2021
Time: 7:00 am – 5:00 pm
About TK-8001 TCR-T
TK-8001 is a CD8 TCR-T specific for the Melanoma-associated Antigen Gene-A1, or MAGE-A1. MAGE-A1 is associated with hallmarks of aggressive cancers and poor clinical prognosis, and there is an emerging body of evidence indicating its involvement as a potential driver of tumorigenesis. MAGE-A1 represents an attractive therapeutic target given the high unmet need in MAGE-A1 expressing cancers, no reported protein expression in healthy tissues other than testis and significant consistency of expression between the primary tumor and metastases. As high affinity TCRs specific for MAGE-A1 peptides in humans are eliminated through central tolerance, we believe our HuTCR platform is a differentiated means to discover and select MAGE-A1 specific TCRs with an optimal affinity and high specificity profile.
About the IMAG1NE Phase 1/2 Trial
The IMAG1NE Phase 1/2 trial is an open-label, multi-center Phase 1/2 trial designed to evaluate the safety and efficacy of TK-8001 in patients with MAGE-A1 positive solid tumors. The Phase 1 portion of the IMAG1NE trial is planned to enroll approximately 6 to 18 patients to assess the initial safety and tolerability of ascending dose levels of TK-8001. A key outcome of the Phase 1 portion of the trial is to select a dose to be evaluated in the Phase 2 part of the study. The Phase 2 portion of the IMAG1NE trial is designed to enroll approximately 30 additional participants to assess the efficacy of TK-8001 across a range of tumor indications.