ChAdOx1-HBV

Barinthus Bio is a UK-based T cell therapy specialist. Image credit: Shutterstock / ymart. Much like the mythological navigator from which it takes its name, Barinthus Biotherapeutics is steering a new course of pipeline prioritisation and restructuring by shelving its prostate cancer candidate and a major workforce reduction. Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Top Guide for Drug Delivery Systems The UK-based T cell specialist – formerly known as Vaccitech – said it will prioritise its pipeline to focus on two of its immunotherapy candidates, VTP-300 and VTP-1000, in chronic hepatitis B and coeliac disease indications respectively. Shares in the Nasdaq -listed Barinthus opened 4.7% lower when the market opened on 13 June following the company announcement on 12 June. Barinthus’ market cap is $73m. As part of the pipeline shuffle, the biopharma said that it expects to undergo a restructuring which will include reducing its employee number by around a quarter. The company currently has a headcount of around 130 employees, according to GlobalData. GlobalData is the parent company of Pharmaceutical Technology. See Also: Takeda signs option agreement with Ascentage for CML drug UK’s new Netflix-style funding model for antibiotics goes live Barinthus also plans to extend its cash runway into Q2 of 2026, further down the road it previously projected its coffers to reach which was until Q4 2025. The decision for VTP-300’s focus comes on the back of recent positive interim data from a pair of Phase II trials. The results, unveiled at the European Association for the Study of the Liver (EASL), demonstrated the drug’s potential to “significantly reduce and maintain hepatitis B surface antigen (HBsAg) levels and achieve undetectable HBsAg levels in patients with chronic hepatitis B.” Barinthus’ CEO Bill Enright said: “We believe that VTP-300 has great potential to do so as part of a functional cure regimen for Hepatitis B. With this pipeline prioritisation, we put the company in a strong position to maximise the probability of success.” VTP-1000’s prioritisation meanwhile was based on “encouraging” preclinical data. Barinthus’ candidate is designed to induce gluten-specific T regulatory cells and reduce gluten-specific T effector cell responses, thereby dampening the immune response seen in coeliac patients. A Phase I trial is expected to commence in Q3 2024. As VTP-300 and VTP-1000 advance, the company’s prostate cancer candidate VTP-850 appears to be getting sidelined. While a Phase I trial with the immunotherapeutic candidate will be completed, Barinthus did not reveal any further plans.  VTP-850 appears on the company’s website alongside infectious disease candidate VTP-200, which has just been evaluated in a Phase Ib/II trial. The trial reached its primary safety endpoint but fell short of efficacy, based on results announced in April this year . Barinthus is not the only company to trim its workforce this year. Senti Bio cut 37% of its employees in January in an attempt to extend its cash runway, followed by Xilio firing 21% of its workforce in a pipeline reprioritisation effort. Most recently, Erasca reduced its headcount by around 18% after shutting down three clinical programmes.

The development of VTP-300 in chronic Hepatitis B (CHB) and VTP-1000 in celiac disease will be prioritized. The pipeline prioritization is expected to result in a reduction in workforce of approximately 25% and an estimated extension to the cash runway into the second quarter of 2026. OXFORD, United Kingdom, June 12, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates, today announced plans to prioritize its pipeline to focus on the development of VTP-300 in CHB and VTP-1000 in celiac disease. The decision follows the positive interim data from the two ongoing Phase 2 clinical trials presented at the European Association for the Study of the Liver (EASL) Congress on June 6, 2024. The data from the ongoing HBV003 and IM-PROVE II trials demonstrated VTP-300’s potential to significantly reduce and maintain Hepatitis B surface antigen (HBsAg) levels and achieve undetectable HBsAg levels in patients with CHB. Additionally, the strategic focus on Barinthus Bio’s proprietary SNAP-TI platform and lead candidate VTP-1000 in celiac disease, follows encouraging pre-clinical data demonstrating mode of action and disease amelioration being observed in a number of disease models​. Celiac disease is a chronic autoimmune disorder affecting approximately 1% of people in Western countries that currently has no FDA or EMA approved treatments.1 VTP-1000 aims to balance the immune response by inducing gluten-specific T regulatory cells and reducing gluten-specific T effector cell responses. Initiation of the Phase 1 clinical trial is expected in the third quarter of 2024. The development of VTP-300 in CHB and VTP-1000 in celiac disease will be prioritized and the ongoing Phase 1 clinical trial of VTP-850 in prostate cancer will be completed. The Company expects to undergo a restructuring to align resources with the streamlined pipeline, which will include a workforce reduction of approximately 25% and an estimated extension of the cash runway into the second quarter of 2026. “Barinthus Bio remains focused on advancing immunotherapies to transform patients’ lives, and we believe that VTP-300 has great potential to do so as part of a functional cure regimen for HBV. With this pipeline prioritization, we put the Company in a strong position to maximize the probability of success, particularly given the encouraging VTP-300 Phase 2 interim data presented at EASL earlier this month and the compelling differentiation of our novel SNAP-TI platform to treat autoimmune diseases. In line with our pipeline prioritization, we have made the difficult decision to reduce our workforce. I would like to thank our talented employees for their contributions to the Company’s achievements. We will continue to execute well on advancing our promising pipeline and are excited about upcoming key clinical milestones in our HBV and celiac programs,” said Barinthus Bio’s Chief Executive Officer, Bill Enright. 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 focused pipeline, built around three proprietary platform technologies: ChAdOx, MVA and SNAP, Barinthus Bio is advancing product candidates in infectious disease and autoimmunity, including: VTP-300, an immunotherapeutic candidate designed as a potential component of a functional cure for chronic HBV infection and VTP-1000, an autoimmune candidate designed to utilize the SNAP-Tolerance Immunotherapy (TI) platform to treat patients with celiac disease. Barinthus Bio also has a Phase 1 clinical trial for 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 . References Al-Toma, A., et al. (2019) United European Gastroenterol J. 7(5), 583-613. Barinthus Bio's 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, our cash runway, our pipeline prioritization, including the corporate restructuring and planned reduction in headcount, 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 corporate restructuring, the risk that we may not achieve the anticipated benefits of our pipeline prioritization, including the risk that our estimates of our cash runway are incorrect, 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