Vaccitech Doses First Patients in HBV003, a Phase 2b Clinical Trial of VTP-300 immunotherapeutic candidate for Chronic HBV Patients
Vaccitech plc (NASDAQ: VACC) announced the commencement of dosing in the HBV003 Phase 2b clinical trial, evaluating the safety and efficacy of VTP-300 combined with a low-dose anti-PD-1 antibody for chronic hepatitis B patients. The trial aims to enroll 120 patients across the Asia-Pacific region. VTP-300 demonstrated promising results in the prior HBV002 study, showing significant reductions in Hepatitis B surface Antigen levels and robust activation of immune cells. The study seeks to identify an optimal treatment regimen and progress towards a functional cure for millions affected by chronic HBV.
- Initiation of HBV003 Phase 2b trial, expanding on prior positive results.
- VTP-300 showed significant and sustained HBsAg declines in previous studies.
- Potential to offer a functional cure for chronic hepatitis B, impacting millions globally.
- None.
OXFORD, United Kingdom, Oct. 31, 2022 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines, today announced the dosing of the first patients in HBV003. HBV003 is 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,” said 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.”
About Vaccitech plc
Vaccitech (“the Company”) 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.
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding: the Company’s business plans and objectives, including the clinical trials of ChAdOx1-HBV and the ChAdOx1-HBV/MVA-HBV (VTP-300) and low-dose nivolumab combination, the continued development of VTP-300 and the potential therapeutic effects and expected patient population of VTP-300. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “future,” “potential,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: the success, cost and timing of the Company’s product development activities and planned and ongoing clinical trials, the Company’s ability to execute on its strategy, regulatory developments, the Company’s ability to fund its operations and the impact that the current COVID-19 pandemic will have on the Company’s clinical trials and preclinical studies and other risks identified in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2021 and its Quarterly Report on Form 10-Q for the first quarter of 2022 and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward- looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Vaccitech Media contacts:
Katja Stout, Scius Communications (EU)
Direct: +44 (0) 7789435990
Email: katja@sciuscommunications.com
Katie Larch / Robert Flamm, Ph.D., Burns McClellan, Inc. (U.S.)
Email: klarch@burnsmc.com / rflamm@burnsmc.com
Jonothan Blackbourn, Investor Relations & Public Relations Manager, Vaccitech
Email: IR@vaccitech.co.uk
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