Barinthus Bio Completes Enrollment for HBV003 and PCA001 Clinical Trials

Barinthus Biotherapeutics, a clinical-stage biopharmaceutical company listed on NASDAQ under BRNS, has announced the completion of participant enrollment for two significant clinical trials. The trials involve HBV003, a Phase 2b study of VTP-300 targeted at adults with chronic hepatitis B (CHB), and PCA001, a Phase 1 study of VTP-850 aimed at men experiencing increased prostate-specific antigen (PSA) levels following local therapy for prostate cancer.

Bill Enright, CEO of Barinthus Bio, expressed satisfaction with the progress, highlighting the challenges of recruiting participants for studies focused on CHB and prostate cancer. The completion of enrollment in these trials signifies key milestones, aligning with the company's timeline for data readouts: HBV003 results are expected in the fourth quarter of 2024, while PCA001 data are anticipated in the first half of 2025.

The HBV003 trial (NCT05343481) has enrolled 121 participants and aims to gather crucial dosing information for a potential functional cure regimen for CHB. This involves administering VTP-300 along with low-dose (LD) nivolumab. Previously, the HBV002 study provided positive monotherapy results for VTP-300, both alone and combined with LD nivolumab. Interim data from HBV003, presented at the European Association for the Study of the Liver (EASL) Congress, showed that the combination of VTP-300 and LD nivolumab was generally well-tolerated and resulted in a sustained reduction in Hepatitis B surface antigen (HBsAg) levels. According to the study criteria, 76% of participants who reached Day 169 were deemed eligible for discontinuing NUC therapy, with 19% of those eligible achieving undetectable HBsAg levels, and two patients maintained these undetectable levels for over 16 weeks.

On the other hand, the PCA001 Phase 1 trial (NCT05617040) has 22 participants and aims to establish the recommended Phase 2 dosing regimen for VTP-850. This study will also evaluate the safety and efficacy of VTP-850 through PSA and T cell response measurements. VTP-850 represents an advanced prostate cancer immunotherapy candidate utilizing Barinthus Bio’s ChAdOx/MVA platform, involving two proprietary nonreplicating viral vectors administered sequentially.

Globally, approximately 254 million people are living with chronic hepatitis B infection. This includes up to 2.4 million individuals in the U.S. and 10.6 million in Europe, with the highest prevalence rates in East Asia and Africa. In 2022, around 1.1 million people died due to hepatitis B virus infection and its complications, such as liver cirrhosis and hepatocellular carcinoma. Despite the high prevalence, diagnosis rates are low, with only 13% of those infected being aware of their condition, and less than 3% receiving antiviral treatment by the end of 2022.

Prostate cancer continues to be a prevalent health issue, ranking as the fourth most common cancer globally in 2020, with 1.4 million new cases. In the United States, approximately 13 out of every 100 men are expected to develop prostate cancer during their lifetime. In the UK, it remains the most common cancer among men, with over 52,000 diagnoses annually. Post-local therapy recurrence, marked by rising PSA levels, occurs in 20-30% of patients, indicating incomplete eradication of the disease. Among those experiencing biochemical recurrence, there is a 1 in 9 chance of developing metastases.

Barinthus Bio focuses on creating novel immunotherapeutic candidates aimed at guiding the immune system to combat chronic infectious diseases and autoimmunity. Their pipeline includes VTP-300, designed as a potential component of a functional cure for chronic HBV, and VTP-1000, intended to treat celiac disease using their SNAP-Tolerance Immunotherapy platform. Barinthus Bio is also conducting a Phase 1 trial for VTP-850, targeting recurrent prostate cancer. The company's advanced technology platforms and therapeutic strategies, combined with deep scientific expertise and a focus on clinical development, uniquely position them to deliver treatments that significantly improve the lives of patients with chronic infectious diseases and autoimmunity.