Ascletis negotiated rights to develop Medivir’s MIV-802 nucleotide polymerase inhibitor candidate for hepatitis C virus (HCV) therapy for development in the greater China region, including mainland China, Hong Kong, Macau, and Taiwan. Financial details were not disclosed, other than to confirm that Medivir will receive an up-front payment, plus development and commercialization milestones, and tiered royalties of marketed products containing MIV-802. Ascletis will fund and carry out all MIV-802 clinical development, manufacturing, and commercialization activities for its designated territories.
MIV-802 is a nucleotide-based NS5B polymerase inhibitor, which has been designed to selectively target the liver. In August 2016, Trek Therapeutics acquired exclusive rights to develop and commercialize the drug globally, excluding the greater China region. Medivir’s former subsidiary, BioPhausia, which is now part of Karo Pharma, holds option rights to commercialize MIV-802-containing products in the Nordic countries and other specified western European countries.
Ascletis is focused on developing liver disease therapies for the Chinese market. The firm’s clinical pipeline includes four candidates licensed in for development and commercialization within greater China. In November 2014, Ascletis negotiated a license to Presidio’s HCV HS5A inhibitor PPI-668 (ravidasvir; ASC-16). The drug has since completed a Phase II study.
During April 2013, Ascletis separately negotiated rights to develop Janssen’s next-generation human immunodeficiency virus (HIV) protease inhibitor TMC310911 (ACS-09), which has since completed a Phase IIa study, and Roche’s investigational HCV therapy danoprevir (ASC-08). In March 2017, the Chinese Food and Drug Administration granted priority review designation to Ascletis’ danoprevir New Drug Application (NDA).
Back in mid 2012, Ascletis and Alnylam Pharmaceuticals’ established a strategic collaboration to develop the latter’s RNA interference (RNAi) therapeutic ALN-VSP (ASC-06) for treating liver cancers. The agreement gives Ascletis exclusive rights to the drug in China, Hong Kong, Macau, and Taiwan.
Ascletis completed a $100 million Series B round of fundraising in January. With operations in Hangzhou and Shaoxing, China, the firm also has a U.S. facility in Research Triangle Park, NC.
Medivir is exploiting its protease inhibitor and nucleotide/nucleoside platforms primarily for the development of treatments for cancer. Separately today, the firm reported starting a Phase I study evaluating therapy with its birinapant candidate combined with Merck & Co’s programmed cell death protein 1 (PD-1) inhibitor Keytruda® in patients with refractory solid tumors. The open-label, dose-escalation trial aims to evaluate safety, tolerability, and preliminary efficacy.
Birinapant is a parenterally administered bivalent peptidomimetic of the protein SMAC (second mitochondria-derived activator of caspases). The drug is designed to bind to and degrade inhibitors of apoptosis proteins (IAPs), to enable apoptosis in tumor cells, and activate the immune system to attack the tumor.