Stainwei Granted Patent for anti-VEGF Monoclonal Antibody and its anti-PD-1 mAb

Stainwei Biotech announced it received a patent certificate (Patent No. US9,580,498) issued by the United States Patent and Trademark Office for its novel humanized anti-VEGF monoclonal antibody (mAb code name: hPV19). This patent was issued through a pathway of PCT application (PCT/CN2013/086542) filed by Stainwei in 2013. Prior to receiving the US patent, Stainwei already received two patent certificates for this antibody from China Intellectual Property Office in 2015 and 2016.

A phase I clinical trial evaluating the safety and efficacy of hPV19 in cancer patients is ongoing in China. According to the data released by the company, hPV19 has a unique antigen recognition site (epitope), composed of amino acid sequences different from other commercially available antibodies targeting the same antigen. In both in-vitro and in-vivo experiments, hPV19 showed a 6-8 times higher biological activity than Avastin.

"In pre-clinical animal studies and early stage clinical trials in cancer patients, hPV19 has also demonstrated an excellent safety and tolerance profile," Dr. Qunmin Zhou, the company's co-founder said. "We are excited to test its efficacy in the ongoing clinical trials. We are also excited to hopefully bring to the market a unique, non-biosimilar, and stronger therapeutic agent that can benefit our patients."

Meanwhile, Stainwei has filed a PCT patent application for a new formulation of hPV19 mAb intended for the treatment of age-related macular degeneration (AMD), diabetic macular edema (DME) and other eye-disorders associated with VEGF-mediated vascular over-growth. Stainwei has completed preclinical experiments and an application for Investigational New Drug (IND) in AMD and DME will be submitted to China-FDA soon.