Cothera Receives Authorization from the FDA to Conduct a Phase 2 Clinical Trial to Test Its Targeted MYC Mutation Inhibitor PC-002 for the Treatment of High-Grade B-cell Lymphoma

Beijing, San Francisco, June 17, 2021–Cothera Bioscience today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a global multi-center phase 2 clinical trial for the treatment of high-grade B-cell lymphoma that is resistant or refractory to first-line and second-line treatments with PC-002, an inhibitor that targets MYC mutations.

PC-002 is a first-in-class small molecule drug targeting MYC- mutated tumors. With more than 50% of human cancers showing increased expression, MYC is regarded as one of the most important yet “undruggable” cancer targets. With a unique mechanism of action, PC-002 selectively induces MYC protein degradation and cell apoptosis in MYC-dependent tumors. PC-002 may potentially target multiple indications in cancer involving MYC dysregulation.

Dr. Alex Wu, Co-founder and CEO of Cothera Bioscience, said: “The FDA’s approval of PC-002 to initiate human phase 2 clinical trials is an important milestone for Cothera. I believe this is a good start, and the company will continue its effort to launch late-stage clinical trials for other cancer indications, bringing breakthroughs and better treatment options to more cancer patients.”

About Cothera Bioscience, Inc.

Cothera Bioscience was formed to develop innovative targeted cancer therapies by the core founding members of CrownBio, a well-known Contract Research Organization specialized in translational oncology. Cothera Bioscience developed a proprietary i-CR® technology platform, a powerful method for individualized drug screening and new drug development. The platform combines a high content screening system with conditional reprogramming of primary cultured tumor cells, which enables efficient and undifferentiated expansion of primary patient-derived tumor cells in vitro while preserving the tumor’s heterogeneity. Through 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 the clinical efficacy and success rate in anticancer drug development.

Leveraging the powerful translational science linking the i-CR® technology platform and clinical patient drug response, Cothera Bioscience has developed a number of innovative anticancer candidates in the field of synthetic lethality and immunotherapy. Cothera Bioscience has applied for multiple international patents covering the drug candidates as well as the i-CR® technology platform. Besides PC-002, the company has another important pipeline product, CTB-02, which targets colon cancer and non-small cell lung cancer with pan-KRAS mutations. CTB-02 is expected to enter Phase 1/2 clinical trial in Australia in 2021.