Cothera Bioscience Receives FDA Clearance to Initiate Global Phase 2 Trial of First-in-Class MYC Inhibitor PC-002 for Relapsed or Refractory High-Grade B-Cell Lymphoma

Recently, VCBeat learned that Kesarui Biopharma, the parent company of Zhikang Boyao, announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a global, multicenter Phase 2 clinical trial of PC-002, an inhibitor targeting MYC mutations, for the treatment of high-grade B-cell lymphoma that is resistant or relapsed after first- and second-line therapies.

PC-002 is a core product of Coseray Biosciences, representing a first-in-class small-molecule drug targeting tumors with MYC gene alterations. PC-002 targets MYC protein degradation through a unique mechanism of action (MOA), selectively inducing apoptosis in MYC-dependent tumor cells. The MYC protein is overexpressed in more than 50% of tumors, making it one of the most critical “undruggable” oncology targets. With its unique mechanism, PC-002 has successfully demonstrated selective killing of MYC-mutant tumors, positioning it as a potential blockbuster therapy for multiple types of cancer.

Dr. Wu Yue, Co-founder and CEO of Kaserui Bio, stated“The FDA’s approval of PC-002 to enter Phase II clinical trials marks a significant milestone for Coserui. This is a promising start, and the company will continue its efforts to sequentially launch late-stage clinical trials for additional oncology indications, delivering breakthrough and superior treatment options to more cancer patients.”

Kaisirui Biopharma was founded by core members of the founding team of CrownBio, a renowned CRO, along with serial successful entrepreneurs from Silicon Valley, focusing on the research and development of innovative targeted oncology drugs. Beijing Zhikang Boyao Oncology Medical Research Co., Ltd. is the R&D subsidiary of Kaisirui Biopharma.

Kesai Rui Bio’s competitive advantage lies in its independently developed i-CR.^®Technology PlatformBy integrating conditional reprogramming technology for primary tumor cell culture with a high-content drug screening system, this approach enables efficient and unbiased expansion of patient-derived primary tumor cells in vitro while preserving tumor heterogeneity. Furthermore, it facilitates high-throughput drug screening using these patient-derived cells in vitro, making it particularly suitable for personalized medicine and new drug development for clinical patients.

Through collaboration with leading oncology medical centers, multiple prospective comparative clinical trials have been conducted, providing preliminary evidence for i-CR^®The system can effectively predict the actual clinical responses to drugs, thereby promising a substantial increase in the efficiency and clinical success rate of new anti-tumor drug development. In terms of pipeline progress, Kesarui has developed a series of new drug candidates targeting cancer in the fields of synthetic lethality and immunotherapy, with multiple international and domestic patents filed for these R&D achievements.

In addition to the MYC mutation inhibitor PC-002, which has blockbuster potential,Another key pipeline product of the company, CTB-02, targets pan-KRAS-mutant colorectal cancer and non-small cell lung cancer, and is expected to enter Phase 1/2 clinical trials in Australia for the first time this year.