GAITHERSBURG, MD, USA I July 27, 2015 I 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 HepatitisHepatitis 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 VaxinVaxin
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.
SOURCE:
Vaxin