Vaxin First-in-Man Phase I Clinical Trial Initiated in Chronically Infected Hepatitis B Patients

GAITHERSBURG, MD--(Marketwired - Jul 27, 2015) - Vaxin Inc., a clinical stage vaccine and immunotherapeutics company, today announced that it has enrolled the first patient into a phase I clinical trial of HepTcell™ (FP-02.2), the company's immunotherapeutic compound to treat people chronically infected with the hepatitis B virus (HBV). The multi-center trial will be conducted at seven sites within the United Kingdom, and aims to recruit 72 patients with chronic HBV infection.

The trial is a randomized, double-blind, placebo-controlled dose-escalation study. The primary endpoints are safety and tolerability. Secondary endpoints include immunogenicity and antiviral factors. HepTcell will be tested as an add-on treatment to the patient's standard of care. Current therapy standards include treatment with antiviral drugs which act to control virus replication but are unable to eliminate the virus and therefore require long-term treatment. The combined treatment strategy aims to stimulate immune responses to a level that would increase the low clinical cure rates observed in patients treated with antiviral therapy alone. Initial results are expected in Q4 2016.

HepTcell is a peptide-based immunotherapeutic incorporating Vaxin's proprietary Densigen™ technology. This product candidate comprises nine long peptides covering conserved regions of core, polymerase and surface proteins from HBV, each linked to a fluorocarbon tail which acts to enhance immune responses. Using a bioinformatics platform, HepTcell has been designed to elicit T cell responses to each of the major infecting HBV genotypes, as well as in an ethnically diverse population, thereby allowing applicability across a world-wide market. Treatment with HepTcell aims to restore functional T cell immune responses to the hepatitis virus in HBV-infected subjects where the natural immune responses are lacking or poor.

Professor Mark Thursz, MD PhD, a world expert in the treatment of hepatitis from Imperial College London, and chief investigator, said, "We are very excited to start this multi-center clinical study. Treatments like HepTcell that are designed to restore the immune response, offer a long-term treatment solution to chronically-infected hepatitis B patients, potentially allowing them to stop their antiviral medication."

"This is a continuation of the exciting work we obtained through the acquisition of Immune Targeting Systems earlier this year," said Bill Enright, CEO of Vaxin. Enright continued, "Pre-clinical development and manufacturing was co-funded through the UK's innovation agency, Innovate UK (formerly Technology Strategy Board) for £2.0 million ($3.1 million), and a parallel funding commitment of $16 million from Vaxin investors."

About Chronic Hepatitis
Hepatitis B virus (HBV) has infected >2 billion people worldwide, of whom more than 360 million people (5 percent of the world's population) remain chronically infected. HBV is the tenth leading cause of death worldwide, with over 600,000 HBV-related deaths per year and >36,000 in Europe. Life-threatening liver disease (cirrhosis, liver failure and hepatocellular carcinoma) occurs in as many as 40 percent of patients with chronic hepatitis B (CHB). Even though prophylactic vaccination programs have led to declines in new HBV infections in many countries, CHB infection is a rapidly growing problem in Europe due to immigration of HBV carriers from endemic areas, and transmission from mother to child. The treatment of CHB has improved dramatically in the last 10 years, owing to the development of new antiviral compounds, including polymerase inhibitors or pegylated alpha-interferon. Despite significant retardation in HBV-related disease progression and reduction in mortality, those treatments rarely achieve clinical cure.

About Vaxin
Vaxin Inc. is a clinical stage biotechnology company developing next-generation vaccines and immunotherapeutics to address significant public health and biodefense needs. By leveraging specific attributes of its two independent and complementary platform technologies, Vaxin can rapidly design product candidates against a wide range of disease targets, including respiratory diseases, chronic infections, and cancer. Our Densigen™ T-cell platform technology is uniquely suited to direct the immune response against traditionally difficult disease targets, including chronic infections and cancer, by directing an individual's immune system against multiple target antigens instead of just one. Vaxin's RespirVec™ platform utilizes convenient needle-free intranasal delivery to achieve broad immunity against disease pathogens more rapidly than conventional vaccines. Vaxin's product candidates are easily manufactured, highly stable, and provide a safe, effective alternative to current products. www.vaxin.com.