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T-knife Therapeutics Announces Upcoming Presentations at Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting

— Presentations to cover preclinical data for lead TCR-T candidate, TK-8001, and the protocol design for a Phase 1/2 trial of TK-8001 to treat MAGE-A1 positive solid tumors

T-knife Therapeutics, Inc., a biopharmaceutical company dedicated to developing novel therapeutics to fight cancer, today 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.

“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 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

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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.

About T-knife Therapeutics

T-knife Therapeutics is a biopharmaceutical company dedicated to developing novel therapeutics to fight cancer, initially focused on T cell receptor (TCR) engineered T cell therapies (TCR-Ts), a promising modality that holds the potential to generate transformative responses in patients with solid tumors. The Company’s unique approach leverages its proprietary HuTCR mouse platform, a next-generation T cell receptor and epitope discovery engine that produces fully human, tumor-specific TCRs, naturally selected in vivo for optimal affinity and high specificity.

T-knife is advancing a portfolio of TCR-T product candidates against targets with high unmet medical need, including cancer testis antigens, oncoviral antigens and commonly shared tumor-driving neoantigens. T-knife was founded by leading T-cell and immunology experts using technology developed at the Max Delbruck Center for Molecular Medicine together with Charité – Universitätsmedizin Berlin. For additional information, please visit the company’s website at www.t-knife.com.