Vaccitech Doses First Patients in Phase 2b Clinical Trial of VTP-300 Immunotherapeutic Candidate
Vaccitech plc recently announced the dosing of the first patients in HBV003, a Phase 2b clinical trial designed to further evaluate the safety and efficacy of VTP-300 when combined with a low-dose anti-PD-1 antibody in patients with chronic hepatitis B infection. The study plans to assess and enable the selection of one of three different multi-dose regimens and to enroll 120 patients in countries across the Asia-Pacific region.
VTP-300 includes Vaccitech’s prime-boost platform, which utilizes 2 nonreplicating viral vectors, ChAdOx1 and MVA. Each viral vector encodes HBV antigens to elicit an immune response against HBV. At interim analyses of the phase 1b/2a HBV002 study, VTP-300 demonstrated not only 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 and significant, but also sustained reductions in Hepatitis B surface Antigen (HBsAg), which is a surrogate marker of ongoing virus replication.
“We have been very encouraged by data emerging from our open-label HBV002 study, which shows that VTP-300 induced significant and sustained HBsAg declines in some patients with chronic HBV. We are excited to now advance VTP-300 into a Phase 2b study, to both select a regimen for the combination and evaluate the potential for achieving functional cures” said Bill Enright, Chief Executive Officer of Vaccitech.
“We are proud to have administered the first dose in this important Phase 2b HBV003 study here at the Queen Mary Hospital, Hong Kong,” added Professor Man-Fung Yuen, Chair and Endowed Professor of Medicine, The University of Hong Kong, Hong Kong. “We hope that this study will help bring us closer to finding a potential regimen for a functional cure for the 250 million patients currently living with chronic HBV, for which there is currently no curative treatment.”
Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development primarily of novel immunotherapies for the treatment of chronic infectious diseases, cancer, autoimmunity and diseases where the T cell arm of the immune system is believed to play an important role. The company’s proprietary platforms include modified simian adenoviral vectors (ChAdOx1 and ChAdOx2), other viral vectors including the well-validated Modified Vaccinia Ankara (MVA) and synthetic nano-particle technologies (SNAPvax and Syntholytic). The combination of different technologies in a mix and match approach (heterologous prime-boost) consistently generates significantly higher magnitudes of T cells compared with other technologies and approaches. The company has a broad pipeline of both clinical and preclinical stage therapeutic programs to treat solid tumors, chronic viral infections, as well as prophylactic viral vaccine programs. Vaccitech co-invented a COVID-19 vaccine with the University of Oxford, now approved for use in many territories and exclusively licensed worldwide to AstraZeneca through Oxford University Innovation, or OUI. Vaccitech is entitled to receive a share of all milestones and royalty income received by OUI from AstraZeneca.
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