Prostate cancer is the fourth most common cancer worldwide while over one million die from hepatitis B and related complications annually. Credit: Nemes Laszlo via Shutterstock.com.

Barinthus Biotherapeutics (formerly Vaccitech) has completed enrolment for its vaccine trials in chronic hepatitis B (CHB) and prostate cancer.

The UK-based T cell specialist’s Phase IIb randomised, open-label Phase IIb HBV003 trial (NCT05343481) is evaluating VTP-300 in 121 adults with CHB.

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The trial is seeking optimum dosing for a functional cure regimen for CHB. Patients will receive the experimental vaccine VTP-300 with a low dose of Bristol Myers Squibb’s Opdivo (nivolumab).

Enrolment for the trial kicked off in June 2023 across multiple sites in the Asia-Pacific region following positive topline final data from a Phase Ib/IIa trial (NCT04778904). In the Phase Ib/IIa trial, VTP-300 was observed to induce meaningful, sustained reductions of hepatitis B surface antigen (HBsAg) in patients with CHB.

VTP-300 is a vaccine comprised of chimpanzee adenovirus Oxford 1-vectored hepatitis B virus immunotherapeutic (ChAdOx1-HBV) and modified vaccinia Ankara-vectored hepatitis B virus immunotherapeutic (MVA-HBV).

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Research estimates that approximately 254 million people are living with HBV globally, with the highest prevalence in East Asia and Africa. In 2022, approximately 1.1 million people died from hepatitis B and related complications.

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Prostate cancer vaccine trial also fully enrolled

Barinthus’ PCA001 is a Phase I open-label trial (NCT05617040) of the VTP-850 vaccine in men with rising prostate-specific antigen (PSA) following treatment for prostate cancer.

The trial has enrolled 22 participants and is designed to determine the recommended Phase II dosing regimen of VTP-850 and will evaluate safety and efficacy as measured by prostate-specific antigen (PSA) and T-cell response.

VTP-850 is a prostate cancer immunotherapeutic candidate that uses Barinthus’ ChAdOx/MVA platform of two proprietary nonreplicating viral vectors.

Barinthus’ CEO Bill Enright commented: “We continue to execute our strategy and are pleased to complete the enrolment in two different trials in CHB and prostate cancer, two diseases where recruitment can be a real challenge.”

In 2020, prostate cancer became the fourth most common cancer worldwide, with 1.4 million new cases diagnosed.

Barinthus said it anticipates data readouts from the HBV003 and PCA001 trials in Q4 2024 and H1 2025 respectively.

In April 2024, the company’s VTP-200 vaccine for human papillomavirus (HPV) met its primary safety endpoint in its Phase Ib/II APOLLO trial (NCT04607850).

The biotech announced in June 2024 that it would be slashing its headcount by 25% and said at the time that it would be refocusing its pipeline on prioritising VTP-300 and VTP-1000 in coeliac disease.