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Barinthus Biotherapeutics PLC (NASDAQ: BRNS) is a pioneering clinical-stage biopharmaceutical company focused on developing advanced T cell immunotherapeutic candidates. These therapies are designed to guide the immune system in combating chronic infectious diseases, autoimmunity, and cancer. Founded by notable scientists Professor Adrian Hill and Professor Sarah Gilbert, Barinthus Bio emerged out of the prestigious University of Oxford’s Jenner Institute, leveraging decades of expertise in viral vector vaccine technology.
Barinthus Bio's core assets include innovative T cell immunotherapeutic candidates such as VTP-300, VTP-200, VTP-1000, and VTP-850. VTP-300, aimed at chronic Hepatitis B virus (HBV) infection, has shown promising results in ongoing clinical trials, demonstrating sustained reductions in hepatitis B surface antigen (HBsAg). Another key candidate, VTP-200, targets persistent high-risk human papillomavirus (HPV) infections, potentially offering a non-surgical solution to this prevalent issue. Additionally, VTP-1000 is being developed for celiac disease, utilizing the SNAP-TI platform, and VTP-850 focuses on recurrent prostate cancer.
Recent achievements include the presentation of encouraging data from two HBV clinical trials at The Liver Meeting® 2023, involving their flagship VTP-300 in combination with other agents like low-dose anti-PD-1 antibodies and RNAi therapeutic candidates. These results highlight Barinthus Bio’s potential to revolutionize treatment paradigms for chronic HBV infection, offering hope for a functional cure.
Financially, Barinthus Bio is well-positioned, having recently extended its cash runway to Q4 2025 through strategic phasing of manufacturing and focusing resources on progressing Phase 2 trials. The company also secured up to $35 million in future funding from the Coalition for Epidemic Preparedness Innovations (CEPI) for its MERS program, underscoring the continued confidence from stakeholders and investors.
Under the leadership of CEO Bill Enright and the recent addition of Dr. Leon Hooftman as Chief Medical Officer, Barinthus Bio is poised for significant growth in 2024. The company aims to present more clinical data, initiate new trials, and advance its robust pipeline to bring cutting-edge treatments to patients in need.
For more information, visit www.barinthusbio.com.
Barinthus Biotherapeutics (NASDAQ: BRNS) has promoted Geoffrey Lynn, M.D., Ph.D. to Chief Scientific Officer (CSO), effective December 1, 2024. Dr. Lynn, co-inventor of the SNAP-TI technology, succeeds Nadège Pelletier, Ph.D., who served as CSO since early 2023. The company has achieved notable progress with VTP-300 in chronic hepatitis B treatment and recently initiated a Phase 1 trial for VTP-1000 in celiac disease. Dr. Lynn previously led Avidea Technologies from 2017 until its acquisition by Barinthus Bio in 2021.
Barinthus Biotherapeutics announced significant results from its ongoing Phase 2b HBV003 clinical trial for chronic hepatitis B treatment. The study, involving 121 participants, evaluated VTP-300 combined with low-dose nivolumab. Key findings include: eight participants achieved complete HBsAg loss, two met functional cure criteria, and two participants who discontinued NUC therapy developed HBsAb positivity. Among 40 participants assessed for NUC discontinuation, 24 were eligible, and nine chose to discontinue. Six remained off NUC therapy, with five maintaining this status for over six months. The treatment was generally well-tolerated with no treatment-related SAEs reported.
Arbutus Biopharma and Barinthus Bio announced new preliminary data from Phase 2a IM-PROVE II trial showing enhanced results when combining imdusiran, VTP-300, and low-dose nivolumab in treating chronic hepatitis B virus. 23% of participants receiving this combination achieved HBsAg loss by Week 48, with significantly greater mean declines in HBsAg levels (p<0.017) compared to other cohorts. The trial included 22 non-cirrhotic participants in Group C, with 13 eligible for nivolumab treatment. The combination therapy was generally well tolerated with no immune-related adverse events reported.
Barinthus Bio (NASDAQ: BRNS) reported Q3 2024 financial results and corporate updates. The company completed enrollment in the HBV003 trial of VTP-300 for chronic hepatitis B with 121 participants, and initiated the Phase 1 AVALON trial of VTP-1000 for celiac disease. Financial highlights include $106.1M in cash as of September 30, 2024, $15M in revenue from Vaxzevria® royalties, and a net loss of $8.1M ($0.21 per share). R&D expenses were $11.1M, down from $11.7M in Q2. The company expects current resources to fund operations into Q2 2026.
Barinthus Biotherapeutics (NASDAQ: BRNS) announced that updated clinical data from its chronic hepatitis B program will be presented at The Liver Meeting® 2024 in San Diego. The late-breaking presentation will focus on VTP-300 combined with low-dose nivolumab and its association with HBsAg loss in specific chronic hepatitis B patients. The company will also participate in several medical congresses including the International Workshop on HBV Cure 2024 and the BSI Immune Therapies Summit. Additionally, management will attend investor conferences including Guggenheim's Healthcare Innovation Conference and Jefferies London Healthcare Conference for presentations and one-to-one meetings.
Barinthus Biotherapeutics plc (NASDAQ: BRNS) has announced the completion of enrollment for two clinical trials: HBV003, a Phase 2b trial of VTP-300 in chronic hepatitis B (CHB), and PCA001, a Phase 1 trial of VTP-850 in prostate cancer. The HBV003 trial enrolled 121 participants to evaluate VTP-300 and low-dose nivolumab as a potential functional cure for CHB. Interim data showed the treatment was generally well-tolerated and led to sustained declines in HBsAg levels, with 76% of participants meeting NUC therapy discontinuation criteria.
The PCA001 trial enrolled 22 participants to determine the recommended Phase 2 dosing regimen of VTP-850 for prostate cancer. Data updates are anticipated in Q4 2024 for HBV003 and H1 2025 for PCA001. CEO Bill Enright highlighted the company's execution of its strategy and the significance of completing enrollment in these challenging recruitment areas.
Barinthus Biotherapeutics plc (NASDAQ: BRNS) has initiated a Phase 1 clinical trial of VTP-1000, an investigational immunotherapy for celiac disease. The AVALON trial (NCT06310291) aims to enroll 42 adults with celiac disease to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VTP-1000.
The trial consists of two parts: a single ascending dose (SAD) and a multiple ascending dose part with a controlled gluten challenge. VTP-1000 utilizes Barinthus Bio's proprietary SNAP-TI platform to deliver gluten-derived peptide antigens and rapamycin in nanoparticles, aiming to promote immune tolerance to gluten.
Celiac disease affects an estimated 1 in 100 people globally and currently has no approved treatments. VTP-1000 seeks to restore immune system tolerance to gluten, potentially reducing inflammation in the small intestine following gluten exposure.
Barinthus Biotherapeutics plc (NASDAQ: BRNS) reported its Q2 2024 financial results and corporate developments. The company is prioritizing its HBV and celiac disease programs, with plans to initiate a Phase 1 trial for VTP-1000 in celiac disease in Q3. Key highlights include:
- Positive interim data from two Phase 2 trials of VTP-300 in chronic hepatitis B (CHB)
- Cash position of $117.8 million as of June 30, 2024
- R&D expenses of $11.7 million in Q2 2024
- Net loss of $16.9 million or $(0.43) per share in Q2 2024
- Expected cash runway into Q2 2026
The company anticipates updated interim data from HBV trials in Q4 2024 and continues to advance its pipeline in immunotherapeutics.
Barinthus Biotherapeutics announced plans to prioritize its pipeline, focusing on VTP-300 for Chronic Hepatitis B (CHB) and VTP-1000 for celiac disease, following positive interim data from ongoing Phase 2 trials. The company will restructure, reducing its workforce by 25%, and expects to extend its cash runway to Q2 2026. VTP-300 data showed significant reductions in Hepatitis B surface antigen levels, while pre-clinical data for VTP-1000 in celiac disease were promising. The Phase 1 trial for VTP-1000 is set to begin in Q3 2024, and the ongoing Phase 1 trial of VTP-850 in prostate cancer will be completed.
Barinthus Bio announced promising results from two clinical trials of its VTP-300 treatment for chronic hepatitis B (CHB). In the HBV003 trial, 67% of participants had HBsAg levels below 10 IU/mL, and 19% had undetectable HBsAg levels, with 76% becoming eligible to discontinue nucleos(t)ide analogue (NUC) therapy. Interim data from the IM-PROVE II trial, conducted with Arbutus Biopharma, showed a statistically significant difference in HBsAg levels between the VTP-300 and placebo groups 24 weeks post-treatment. VTP-300 treatment led 84% of participants to discontinue standard NUC therapy versus 53% in the placebo group. Both trials reported no serious adverse events, with the most common side effect being thyroid dysfunction. These findings suggest VTP-300's potential to be a critical component in functional cure regimens for CHB.
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