TK-8001 is under clinical development by T-Knife and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how TK-8001’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

TK-8001 overview

TK-8001 (T-1367) is under development for the treatment of solid tumors including gastrointestinal tumor, lung cancer (pulmonary tumor), gynecological cancer, urogenital tumor (urinary tract cancer). It comprises CD8 type of T-cells modified to express T-cell receptors (TCRs) targeting MAGE-A1. It is developed based on T-knife’s proprietary humanized T-cell receptor (HuTCR) mouse platform. It was also under development for the treatment of multiple myeloma

T-Knife overview

T-Knife is a biopharmaceutical company developing tumor-specific T cell receptor (TCR) therapies to treat cancer. The company utilizes its proprietary transgenic HuTCR (human TCR) mouse platform, where HuTCR mice are vaccinated with human tumor antigens to generate safe human TCRs. The company leverages fully human TCRs to manufacture patient-derived T cell products targeting tumor-specific antigens in the treatment of myeloma, solid tumors and hematologic cancer. T-knife was funded by Andrea Partners and Boehringer Ingelheim International GmbH. The company is a spin-off from Max-Delbruck Center for Molecular Medicine. T-knife is headquartered in Berlin, Germany.

For a complete picture of TK-8001’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.