Vaxin enrolls first patient in Phase I trial of HepTcell to treat hepatitis B virus

HepTcell is a peptide-based immunotherapeutic which includes the company’s proprietary Densigen technology.

The product candidate includes nine long peptides covering conserved regions of core, polymerase and surface proteins from HBV, each linked to a fluorocarbon tail which acts to improve immune responses.

Around 72 patients with chronic HBV infection will be enrolled in this randomized, double-blind, placebo-controlled dose-escalation trial, which will be conducted at seven sites within the UK.

The trial’s primary endpoints are safety and tolerability, while secondary endpoints include immunogenicity and antiviral factors.

During the trial, HepTcell will be tested as an add-on treatment to the patient’s standard of care.

The existing 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.

Vaxin CEO Bill Enright said: "This is a continuation of the exciting work we obtained through the acquisition of Immune Targeting Systems earlier this year.

"Pre-clinical development and manufacturing was co-funded through the UK’s innovation agency, Innovate UK (formerly Technology Strategy Board) for £2m ($3.1m), and a parallel funding commitment of $16m from Vaxin investors."

The company noted that 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 from the Phase I trial of HepTcell are expected to be reported in the fourth quarter of next year.

HepTcell, which uses a bioinformatics platform, 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.