On December 19, RemeGen Co., Ltd. (688331.SH/09995.HK) announced that its independently developed ADC RC88 targeting MSLN has applied for a phase 2 clinical trial for gynecological tumors. It has been approved by US FDA, and will be performed in the US, China, European Union, and other countries and regions.

This is an open-label, dose-optimized phase 2 study for the treatment of patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. It aims to evaluate the optimal dose, safety and efficacy of RC88 monotherapy in the target population.

Epithelial ovarian cancer (including epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer) is one of the leading causes of cancer death in women. Due to the lack of effective screening methods, more than 70% of patients with epithelial ovarian cancer when diagnosed are at an advanced stage, and most patients will relapse within 2 years. As the interval between relapses gradually shortens, these patients eventually progress from platinum-sensitive relapses to platinum-resistant relapses. For patients with platinum-resistant recurrent ovarian cancer (PROC), once platinum resistance occurs, the currently available treatment methods are non-platinum chemotherapy. The treatment response rate of these regimens is still very low, and more effective treatment regimens are needed to improve patient quality of life

RC88 is an ADC drug targeting MSLN independently developed by RemeGen. It was approved to conduct phase 1 clinical trials in China in November 2018 and is currently in Phase 2 clinical trials. In addition, the application for a phase 1 or phase 2 clinical study of RC88 combined with Sintilimab in the treatment of patients with advanced malignant solid tumors was approved by CDE in March this year, and the first patient has been enrolled.