Vaccitech announced the dosing of the first patient in HBV002. HBV002 is a Phase 1b/2a clinical trial designed to evaluate the safety and preliminary efficacy of VTP-300 both with and without a low-dose anti-PD-1 antibody in patients with chronic hepatitis B (CHB) infection. The study plans to enroll 64 patients in South Korea, Taiwan, China Region of China and the UK.

VTP-300 will utilize Vaccitech’s ChAdOx1-MVA prime-boost combination to elicit an immune response against HBV. The HBV DNA sequence contained in the viral vectors is derived from a genotype C sequence, which is the most common genotype circulating worldwide. The platform has demonstrated robust activation of cytotoxic CD8+ T cells (immune cells associated with clearance of HBV infected cells), which are believed to have the potential to lead to a functional cure in combination with current anti-viral therapy and a low-dose checkpoint inhibitor.

“HBV infection is a serious chronic viral infection of the liver that affects an estimated 257 million people worldwide, including more than two million in the U.S. and 13 million in Europe, and results in approximately 880 thousand deaths per year,” said Bill Enright, Chief Executive Officer of Vaccitech. “Prophylactic vaccines cannot treat HBV infection, and there are no highly effective curative regimens. VTP-300, which we designed as a potential functional cure of chronic HBV, represents an opportunity to address this serious unmet need. We are looking forward to the results of this trial, and if successful, advancing VTP-300 into later clinical development.”

“By targeting the HBV genotype C, which is the most prevalent worldwide and is particularly common where the virus is endemic, we have designed an immunotherapeutic to address a very broad population of patients. We also believe it may induce T cell responses against other common genotypes, and given the promising preclinical results, we are very excited to see the first patient treated in this latest clinical trial,” Prof. Ellie Barnes, from University of Oxford, and Chief Investigator on the HBV002 trial said.