Barinthus Bio to Present VTP-300 Clinical Data Updates at EASL Congress 2024

Rhea-AI Summary

Barinthus Biotherapeutics (NASDAQ: BRNS) will present clinical data for its hepatitis B immunotherapy candidate, VTP-300, at the EASL Congress 2024 in Milan, Italy, from June 5-8. The presentations will include a poster on June 5 and an oral presentation on June 6. The poster will discuss how VTP-300 combined with nivolumab continues to show reductions in HBsAg levels without serious adverse events. The oral presentation will highlight that VTP-300, when administered after imdusiran, maintains lower HBV surface antigen levels and allows more subjects to discontinue NUC therapy. CEO Bill Enright expressed optimism about the potential for a functional cure for hepatitis B.

Positive

• VTP-300 combined with nivolumab shows meaningful reductions in HBsAg levels.
• No treatment-related serious adverse events observed with VTP-300.
• VTP-300 maintains lower HBV surface antigen levels when used after imdusiran therapy.
• More subjects qualified to discontinue NUC therapy with VTP-300 than with placebo.
• Presentations at a prestigious conference like EASL can increase visibility and credibility.

Negative

• Data presented are interim and may change with further analysis.
• The effectiveness of VTP-300 is still under investigation and not yet confirmed.
• Dependence on conference presentations may not translate to immediate stock price gains.

• Two abstracts highlighting the Company's lead hepatitis B-focused asset will be presented as poster and oral presentations.
  
• More mature interim data to be presented at EASL following abstract data cuts earlier in the year may indicate potential rates of functional cure.

OXFORD, United Kingdom, May 22, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS) (the Company), a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer, today announced clinical data from the Company's hepatitis B-focused immunotherapeutic candidate, VTP-300, will be highlighted in poster and oral presentations at the European Association for the Study of the Liver (EASL) Congress, taking place June 5-8, 2024, in Milan, Italy.

“We are pleased to present the latest data on our immunotherapeutic candidate, VTP-300, at EASL 2024 updated from the data cut we made in January for the abstracts,” said Bill Enright, CEO of Barinthus Bio. “Hepatitis B is considered to be a 'silent epidemic' because most people are asymptomatic while infected, allowing the disease to slowly damage the liver. We understand chronic HBV profoundly impacts the quality of life for people living with the disease, and we are excited to share our ongoing research efforts with the overall goal of a working towards a functional cure.”

Abstract Acceptances:

Abstract number: 2823
Presentation type: Poster presentation
Title: VTP-300 immunotherapeutic, plus low dose PD-1 inhibitor, nivolumab, continues to show meaningful, sustained reductions in HBsAg levels.
Presentation time: Wednesday, 05 June, 08:30-18:00 CET.
Authors: MF. Yuen, WL. Chuang, CJ. Liu, A. Leerapun, P. Tangkijvanich, L. Bussey, R. Kolenovska, M. Downs, K. Anderson, A. Vardeu, D. Tait.
Key Findings: Preliminary data suggest VTP-300 in combination with nivolumab has been generally well tolerated, with no observed treatment-related serious adverse events, and contributed to declines in hepatitis B surface antigen (HBsAg) across all groups. Additional interim data, including NUC discontinuation, Hepatitis B Virus (HBV) markers, immunology and safety data will be presented in the poster.

Abstract number: 505
Presentation type: Oral presentation
Title: Imdusiran (AB-729) administered every 8 weeks for 24 weeks followed by the immunotherapeutic VTP-300 maintains lower HBV surface antigen levels in NUC-suppressed CHB subjects than 24 weeks of imdusiran alone.
Presentation time: Thursday, 06 June, 17:00-18:15 CET
Authors: K. Agarwal, MF. Yuen, S. Roberts, GH. Lo, CW. Hsu, WL. Chuang, CY. Chen, PY. Su, S. Galhenage, SS. Yang, EP. Thi, K. Anderson, D. Antoniello, E. Medvedeva, T. Eley, T. Varughese, L. Bussey, C. Davis, A. Vardeu, CL. Espiritu, SC. Ganchua, C. Iott, E. Eill, T. Evans, KD. Sims.

Key Findings: Imdusiran administered for 24 weeks followed by VTP-300 was generally well-tolerated and resulted in lower HBsAG levels than placebo at week 60. Additionally, more subjects that received VTP-300 qualified to stop NUC therapy than placebo. On-treatment, follow-up and NUC discontinuation data including HBV parameters and immunology data will be included in the oral presentation.

About VTP-300
VTP-300 is an immunotherapeutic candidate consisting of an initial dose using the ChAdOx vector and a secondary dose(s) using the MVA vector, both encoding multiple hepatitis B antigens, including full-length surface, modified polymerase, and core antigens. VTP-300 is the first antigen-specific immunotherapy that has been shown to induce sustained reductions in HBsAg. Barinthus Bio is studying VTP-300 in combination with other agents, including siRNA and low-dose anti-PD-1 antibodies, to control the infection and counterbalance the immune suppression and T cell exhaustion in the liver caused by chronic HBV infection.

About HBV
Globally it is estimated that there are approximately 254 million people, including up to 2.4 million in the U.S. and 10.6 million in Europe, living with chronic HBV infection, with the highest prevalence in East Asia and Africa.^1,2 Approximately 1.1 million people died from HBV and related complications in 2022, such as liver cirrhosis and hepatocellular carcinoma.¹ Due to low HBV diagnosis rates, only 13% of people living with chronic hepatitis B are aware of their infection and less than 3% had received antiviral treatment at the end of 2022.¹

About Barinthus Biotherapeutics
Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a broad pipeline, built around three proprietary platform technologies: ChAdOx, MVA and SNAP, Barinthus Bio is advancing a pipeline of four product candidates across a diverse range of therapeutic areas, including: VTP-300, an immunotherapeutic candidate designed as a potential component of a functional cure for chronic HBV infection; VTP-200, a non-surgical product candidate for persistent high-risk human papillomavirus (HPV); VTP-1000, an autoimmune candidate designed to utilize the SNAP-Tolerance Immunotherapy (TI) platform to treat patients with celiac disease; and VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer. Barinthus Bio’s proven scientific expertise, diverse portfolio and focus on pipeline development uniquely positions the company to navigate towards delivering treatments for people with infectious diseases, autoimmunity and cancers that have a significant impact on their everyday lives. For more information, visit www.barinthusbio.com.

References

1. WHO, Global hepatitis report 2024.
2. Hepatitis B Foundation, What is Hepatitis B?, 2023.

Forward Looking Statements
This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding: our product development activities and clinical trials, including timing for readouts of any interim data or next steps for any of our programs, including VTP-300, or the HBV003 and AB-729-202 trials, the tolerability or potential benefits of VTP-300, and our ability to develop and advance our current and future product candidates and programs. Any forward-looking statements in this press release are based on our 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, risks and uncertainties related to the success, cost and timing of our pipeline development activities and planned and ongoing clinical trials, our ability to execute on our strategy, regulatory developments, our ability to fund our operations and access capital, the risk that interim or topline data may not reflect final data or results, global economic uncertainty, including disruptions in the banking industry, the conflict in Ukraine, the conflict in Israel and Gaza, and other risks identified in our filings with the Securities and Exchange Commission (the SEC), including our Annual Report on Form 10-K for the year ended December 31, 2023, our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We expressly disclaim 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.

IR contacts:
Christopher M. Calabrese 
Managing Director 
LifeSci Advisors
+1 917-680-5608
ccalabrese@lifesciadvisors.com

Kevin Gardner
Managing Director
LifeSci Advisors
+1 617-283-2856
kgardner@lifesciadvisors.com

Media contact:
Audra Friis
Sam Brown, Inc.
+1 917-519-9577
audrafriis@sambrown.com

Company contact:
Jonothan Blackbourn
IR & PR Manager
Barinthus Bio
ir@barinthusbio.com

FAQ

What is the main focus of Barinthus Bio's EASL Congress 2024 presentations?

Barinthus Bio will present clinical data on its hepatitis B immunotherapy candidate, VTP-300, focusing on its effectiveness and safety.

What significant findings will Barinthus Bio present about VTP-300 at EASL 2024?

Barinthus Bio will present findings showing VTP-300's combination with nivolumab reduces HBsAg levels without serious adverse events, and VTP-300 maintains lower HBV levels post-imdusiran therapy.

When and where will Barinthus Bio present VTP-300 data?

Barinthus Bio will present the data at the EASL Congress 2024 in Milan, Italy, on June 5-8, 2024.

How did VTP-300 perform in combination with nivolumab?

VTP-300 combined with nivolumab showed meaningful, sustained reductions in HBsAg levels without treatment-related serious adverse events.

What are the implications of VTP-300's clinical data for hepatitis B treatment?

The data suggest potential for a functional cure by maintaining lower HBV surface antigen levels and enabling more patients to discontinue NUC therapy.