Full Press Release Details
Barinthus Bio Presents Interim Data from Phase
2b HBV003 Trial and Phase 2a AB-729-202 Trial in Collaboration with Arbutus Biopharma in Chronic HBV Patients at AASLD
OXFORD, United Kingdom, Nov. 9, 2023 (GLOBE NEWSWIRE) - Barinthus
Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today announced the presentation of data from two HBV clinical trials at The
American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting 2023. The presentations include an oral presentation
of data from HBV003, an ongoing Phase 2b trial designed to further evaluate the safety and efficacy of VTP-300 when combined with a low-dose
anti-PD-1 antibody, and standard-of-care (SoC) nucleos(t)ide analogue (NUC) therapy. Alongside this, a
late-breaking poster presentation with interim data
from patients with chronic hepatitis B (CHB) from the Phase 2a AB-729-202 trial combining Arbutus
Biopharma Corporation's (NASDAQ: ABUS) RNAi therapeutic candidate, imdusiran (AB-729), with Barinthus Bio's T-cell stimulating
immunotherapeutic candidate, VTP-300, and SoC NUC therapy. 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.
"We believe these early data are very encouraging. In HBV003,
VTP-300 in combination with nivolumab continues to show meaningful and sustained HBsAg declines across all treatment groups, with the
most prominent declines occurring in patients with lower baseline HBsAg levels at screening," said Bill Enright, Chief Executive
Officer of Barinthus Bio. Regarding the combination trial imdusiran with VTP300, Bill added "Although these are preliminary data,
we can already see that VTP-300 appears to show a meaningful impact in sustaining low HBsAg in patients after imdusiran treatment, with
clear differences shown between placebo and VTP-300. It's very positive that we are seeing that all participants treated with imdusiran
and VTP-300 have qualified to stop NUC therapy, which really highlights VTP-300's potential as an important component of a functional
Study HBV003: VTP-300 and Low-dose Nivolumab
HBV003 is designed to obtain critical information on treatment dosing
regimen with patients receiving VTP-300 and low-dose nivolumab. All Groups received ChAdOx at Day 1, Groups 1 & 2 received MVA with
nivolumab at Day 29 with Group 2 being dosed again at Day 85, Group 3 received only MVA at Day 29, followed by nivolumab at Day 36 and
a second MVA dose at Day 85 to evaluate PD-1 inhibition timing. Seventy-four out of a planned 120 virally-suppressed CHB patients on stable
NUC therapy have been enrolled in the trial and 57 have reached Day 113. VTP-300 in combination with nivolumab led to HBsAg declines in
all treatment groups, particularly in participants with screening HBsAg levels 200 IU/mL.
The HBV003 trial protocol is currently being amended to include only
participants with screening HBsAg 200 IU/mL. Participants with screening HBsAg 200 IU/mL have been observed to benefit
the most in the preliminary data, with the trial protocol amendment being focused on improving the overall risk/benefit ratio. People
with thyroid auto-antibodies, family history of auto-immune thyroiditis, or abnormal thyroid levels will be excluded from trial eligibility
to minimize the risk of thyroiditis.
Study AB-729-202: VTP-300 in Combination with Imdusiran (AB-729)
Clinical trial AB-729-202 enrolled forty non-cirrhotic, virally suppressed
CHB patients that were on stable NUC therapy. The patients initially received imdusiran (60mg every 8 weeks) for 24 weeks and were then
randomized to receive either VTP-300 or placebo at week 26 and 30 (and conditionally at week 38 if they experienced a >0.5 log10
decline in HBsAg between Weeks 26 and 34), in addition to ongoing NUC therapy. The preliminary data include a subset of patients that
received the two dose VTP-300 regimen (28/40 patients) and available follow-up data to Week 48 (12/40 patients) and showed the following:
The preliminary safety data from this trial demonstrated that imdusiran
and VTP-300 were both generally well-tolerated. There were no serious adverse events, Grade 3 or 4 adverse events or treatment discontinuations.
Dr. Karen Sims, Chief Medical Officer of Arbutus Biopharma, commented,
"Imdusiran consistently delivers compelling efficacy and safety data in multiple Phase 2a populations and combinations. In this
trial, all but one patient reached surface antigen levels below 100 IU/mL and one reached <LLOQ (lower limit of quantification) with
24 weeks of imdusiran plus NUC therapy alone, which is a meaningful achievement as we believe lowering surface antigen is key to promoting
host HBV-specific immune reawakening. As we continue to dose and follow these patients, I look forward to seeing the potential that imdusiran,
VTP-300 and NUC therapy can have on achieving a functional cure for patients with CHB."
The presentation for HBV003 and poster for AB-729-202 can be found
on the Barinthus Bio website at https://investors.barinthusbio.com/events-presentations.
About Barinthus Bio's 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 imdusiran (AB-729), Arbutus' Lead RNAi Therapeutic
Imdusiran is an RNA interference (RNAi) therapeutic specifically designed
to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable
reawakening of a patient's immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus' novel covalently
conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. Clinical data generated thus far has shown
single and multiple doses of imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis
B surface antigen and hepatitis B DNA. Imdusiran is currently in multiple Phase 2a clinical trials.
About Hepatitis B Virus (HBV)
Globally it is estimated that there are more than 300 million people,
including up to 2.4 million in the U.S. and 14 million in Europe, living with chronic HBV infection, with the highest prevalence in East
Asia and Africa. Approximately 820,000 people die each year from HBV and related complications, such as liver cirrhosis and hepatocellular
carcinoma. Due to low HBV diagnosis rates of about 10.5% aware of their infection coupled with strict treatment eligibility guidelines,
only 6.6 million (2.2%) people with chronic HBV are receiving treatment and less than 10% will achieve a functional cure with existing
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 four proprietary platform technologies: ChAdOx, MVA, SNAP-TI, and
SNAP-CI; Barinthus Bio is advancing a pipeline of five 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-TI
platform to treat patients with celiac disease; VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent
prostate cancer; and VTP-1100, a preclinical cancer candidate designed to utilize the SNAP-CI platform to treat patients with HPV-related
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.
Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical
company leveraging its extensive virology expertise to identify and develop novel therapeutics with distinct mechanisms of action, which
can be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). Arbutus believes the key to success in
developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Arbutus'
pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729), and an oral PD-L1 inhibitor,
AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific
immune response. Imdusiran is currently in two Phase 2a combination clinical trials. AB-101 is currently
being evaluated in a Phase 1a/1b clinical trial. Additionally, Arbutus has identified compounds in its internal PD-L1 portfolio that could
also be used in oncology indications. For more information, visit www.arbutusbio.com.
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: Barinthus Bio's plans and strategy with respect
to its pipeline and product candidates, including VTP-300 and the HBV003 clinical trial, and the potential benefits of VTP-300 for the
treatment of chronic HBV. Any forward-looking statements in this press release are based on Barinthus Bio 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 Barinthus Bio's pipeline development activities and planned and ongoing
clinical trials, Barinthus Bio's ability to execute on its strategy, regulatory developments, the risk that Barinthus Bio may not