Cothera Bioscience was formed by the founding core members of CrownBio, a well-known Contract Research Organization specializing in translational oncology, to develop innovative, targeted cancer therapies. Cothera Bioscience has developed its proprietary i-CR® technology platform, which is a powerful method for providing individualized drug screening and new drug development. The platform combines a high content screening system with the conditional reprogramming of primary cultured tumor cells, which enables the efficient and undifferentiated expansion of primary patient-derived tumor cells in vitro, while also preserving the tumor’s heterogeneity. Through its collaboration with leading oncology medical centers, Cothera Bioscience has carried out prospective clinical trials and demonstrated that the i-CR® system can effectively predict the actual clinical response of a drug, with potential to significantly improve both clinical efficacy and success rate in anticancer drug development.

In terms of pipeline progress, Cothera Bioscience has developed a series of new product pipelines for cancer in the areas of synthetic lethality and immunotherapy, and has filed a number of international and domestic patents for its R&D results. PC-002, its main project, is a first-in-class small-molecule drug targeting MYC-mutated tumors. Currently, it has been approved by the U.S. Food and Drug Administration and South Korea’s Ministry of Food and Drug Safety, and has entered clinical phase II.

The second compound Cothera Bioscience has developed to treat MYC-mutated tumors is zotiraciclib (ZTR/TG02). ZTR is a highly potent oral CDK9 inhibitor which can cross the blood–brain barrier and degrade proteins with short half-lives and anti-apoptotic oncogenes such as McL-1 and Myc. The compound is being developed for the treatment of high-grade glioma (HGG) and diffuse intrinsic pontine glioma (DIPG). A Phase 1b clinical trial of ZTR sponsored and conducted by the National Cancer Institute (NCI) in the US has just completed, which has initially confirmed the safety and efficacy of ZTR in combination with temozolomide (TMZ) in the treatment of patients with relapsed high-grade glioma, and a Phase II international multi-center clinical trial is about to begin. Another important pipeline product, CTB-02, currently in a phase 1b / 2a clinical trial in Australia, is for pan-KRAS variant bowel cancer and non-small cell lung cancer.