SAN DIEGO, Oct. 24, 2017 — Vical Incorporated (Nasdaq:VICL) announced today that it is pursuing early stage development of a novel treatment for chronic hepatitis B virus (CHB) infection based on its DNA and lipid-delivery technologies. This development effort is being conducted in collaboration with Vical’s strategic partner, AnGes, Inc of Osaka, Japan. The initial stage of this program will be to demonstrate preclinical proof of concept for inhibiting HBV infection in a human liver model in the second half of 2018. The ultimate aim of this program would be to demonstrate eradication of persistent HBV infection in CHB patients.
AnGes has provided partial funding for the initial stage of this program and, if successful, Vical expects that AnGes will continue to participate in the funding of the program. AnGes has been granted the right of first refusal to negotiate with Vical for an exclusive license to develop and commercialize this therapy in Japan.
Vical intends to first establish in vitro proof of concept against HBV infection using an HBV-producing cell line followed by in vivo testing in an elaborate preclinical model of HBV infection which enables human hepatocytes to be infected with HBV and then treated and monitored for suppression of several virologic markers including reduction in covalently-closed circular (ccc) DNA levels in the livers. Should Vical establish in vivo proof of concept, it intends to advance the product towards Phase 1 testing, ideally in CHB patients, to achieve clinical proof of concept at an early stage of development. Results of the preclinical proof of concept studies are anticipated in the second half of 2018.
About chronic HBV infection
Chronic HBV infection affects nearly 250 million people worldwide and an estimated 786,000 deaths are attributed annually to CHB infection worldwide. People with CHB infection are at increased risk for severe liver disease, with 15% to 40% developing cirrhosis or hepatocellular carcinoma. Although currently-available antiviral drugs effectively inhibit the HBV reverse transcriptase and suppress viral replication while the drugs are taken, they typically lead to only a 1% to 3% per year cure rate. The persistence of cccDNA in infected liver cells is not altered by the antiviral drugs so novel treatments are necessary to eliminate this reservoir and produce a long term cure, thereby reducing the need for lifelong antiviral drug use. Vical’s approach is intended to address the underlying cause of persistent HBV infection – cccDNA– by targeting hepatocytes and using molecular interventions to inactivate the cccDNA harbored within hepatocyte nuclei.
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. Additional information on Vical is available at www.vical.com.