Phase II trial results with hepatitis B vaccine VVX001

Viravaxx, a global leader in antiviral vaccine development is happy to announce, that a Phase II study ( identifier NCT03625934) has been successfully completed with its first in class therapeutic hepatitis B vaccine VVX001. The study was designed to demonstrate an immune response specific for the PreS component of the large surface antigen of the hepatitis B virus (HBV). Another important aspect was the demonstration of virus neutralization capability of these antibodies and their potential to reduce viral DNA and viral antigen in serum. A major objective of the trial was to evaluate the potential of achieving a functional cure in patients with chronic hepatitis B, allowing discontinuation of life-long antiviral treatment.

Excellent results from a Phase II trial with the innovative therapeutic hepatitis B vaccine VVX001.

In this trial, four different cohorts were included and randomized 3:1 to either VVX001 or placebo: (1) vaccination naïve healthy subjects, (2) non-responders to conventional vaccination, (3) inactive HBV carriers and (4) patients on long-term treatment with direct antivirals. A total of 64 subjects participated in the trial.

The study reached its primary endpoint: it was observed that a regimen of five monthly injections of 20 µg of VVX001 statistically significantly elicited PreS specific IgG antibodies in actively treated subjects in all four cohorts. (p<0.0001 vs placebo overall).

Sera obtained from subjects treated with VVX001 demonstrated a potent inhibition of infection of HepG2-NTCP cells by HBV in a cell culture model, which validates the virus neutralization capacity of the vaccination. Encouragingly, more than half of the chronically infected patients in the study had a >50% reduction of serum HbSAg at 8 months after the end of treatment, which points to the potential of achieving a functional cure with a finite course of treatment with VVX001.

The treatment was safe and very well tolerated. Most side-effects were local injection site reactions, were mild to moderate and resolved within a short period after drug application. Moreover, direct antivirals could be safely stopped in most chronically infected patients after three VVX001 injections without a virus flare.

Walter Baumann, CEO of Viravaxx commented: „This study provides a successful validation of our peptide carrier fusion technology platform towards achievement of a functional cure for the more than 250 million patients living with chronic hepatitis B and may help to support the important WHO goal of HBV eradication. We now will work to expeditiously to move VVX001 into expanded trials.”

The complete data set obtained in this trial will be presented in due course at an international conference and will be published in a leading peer reviewed journal.

About VVX001 and peptide carrier fusion vaccines:

VVX001 is a first in class therapeutic hepatitis B vaccine based on recombinant peptide carrier technology invented in the lab of Prof. Rudolf Valenta at the Medical University of Vienna. The peptide carrier fusion proteins are constructed from the PreS component of the large surface antigen of the hepatitis B virus (HBV) with peptidic extensions at the C- and N-terminus. This design leads to a focussing of the IgG immune response to the binding site of PreS for its hepatocyte receptor NTCP. These antibodies potently block virus entry into hepatocytes; VVX001 therefore has the potential to achieve a functional cure by breaking the infection cycle in chronically infected patients.