Shenzhen, April 16, 2021 – Shenzhen Chipscreen Biosciences, a China headquartered biopharmaceutical company developing and marketing novel drugs based on its unique technology of Chemical Genomics Drug discovery platform, today announces that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with a Phase 1b/2 clinical trial of Chiauranib/CS2164, a potential treatment for multiple oncological indications including Small Cell Lung Cancer (SCLC), Ovarian Cancer, Liver Cancer, and Breast Cancer, etc. Chiauranib is the third novel drug candidate discovered and developed by Chipscreen to be marketed, submitted NDA or in the late-stage phases of clinical studies.
Chiauranib is an innovative, 3-pathway targeted kinase small molecule inhibitor with high selectivity against Auroa B /VEGFRs/CSF1R currently entering Phase III clinical trials in China. Its treatments to SCLC and Ovarian Cancer have been just designated as “breakthrough therapies” by National Medical Products Administration (NMPA) of China in the past months. The molecular mechanism of Chiauranib is to inhibit the rapid proliferation of tumor cells via targeting novel DNA replication pathway, as well as enhancement of antitumor immunity and inhibition of tumor angiogenesis concomitantly.
The primary objective of this Phase Ib/2 study in the USA is to demonstrate safety, tolerability and efficacy of Chiauranib as a monotherapy in 24 to 36 patients with SCLC.
"With this clearance of US FDA IND application for CS2164, it will certainly increase success of our global development strategy based on early efficacy and safety data obtained from China trials." said Dr.Xianping Lu , Chairman and President of Chipscreen.