– 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 (generic name: bevacizumab, Roche/Genentech’s anti-VEGF mAb, the world’s first and so far still the only FDA-approved anti-VEGF mAb drug on the market). “In pre-clinical animal studies and early stage clinical trials in cancer patients, hPV19 has also demonstrated an excellent safety and tolerance profile,” said Dr. Qunmin Zhou, the company’s co-founder. “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.
The company’s another promising product is a novel anti-PD-1 monoclonal antibody named hAb21 (humanized IgG4-kappa version). hAb21 binds to human PD-1 antigen at a unique site (epitope), which is different from that of Keytruda (Merck) and Opdivo (Bristol-Myers Squibb). hAb21 has shown a remarkable anti-tumor activity in human PD-1 gene knock-in mouse models.
As illustrated in the above figure, syngenic MC38 tumors implanted in the PD-1 gene knock-in mice were completely rejected within 7-10 days without re-growth thereafter in all 6 mice in the group treated with hAb21. Furthermore, repeated MC38 tumor inoculation was performed to those mice on day 30, and tumors were again completely rejected within 10-14 days without further hAb21 treatment. All 6 mice survived to day 60 and received MC38 inoculation for the third time (experiment on-going). In the same knock-in mice treated with Keytruda (pembrolizumab), complete tumor rejection was observed in only 1 out of 6 mice, while initial tumor regression followed by re-growth after the completion of Keytruda treatment were found in the other 5 mice, which all died of tumor progression.
Based on these encouraging results, Stainwei has filed a patent application for hAb21, and is currently carrying out IND-enabling studies. An IND indication for advanced solid tumors is expected to be submitted to China-FDA and US-FDA in the second-half of 2017.
About Stainwei Biotech, Inc.
Stainwei (www.stainwei.cn) was founded in May 2007 at Suzhou-Biobay, China. It currently has more than 10 monoclonal antibodies in the pipeline, targeting either well-known antigens such as VEGF, PD-1/PD-L1, PD-1H (VISTA), CTLA-4, SOST or other potential targets not to be disclosed at this time.
Since its inception, Stainwei has received VC-funding of more than 100 million RMB from a number of institutions, which include Cowin Venture (Suzhou), Xiangtang Venture (Suzhou), Fortune-link (Shanghai) and Comway Capital (An-hui). Its therapeutic antibody program has also been supported by research grants from the Chinese government, Jiangsu province, Suzhou municipal city and Singapore-China Suzhou Industrial Park (SIP-Suzhou).
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