HBsAg

Arbutus Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, February 29, 2024
LNP, HBV, Court, PD, Research, Virology, Expert witness, CFBV, AASLD, Construction, Nivolumab, Investment, Arbutus, HBsAg, EASL, Vaccine, Interim, Safety, COVID-19, Pharmacokinetics, Roivant Sciences, Patient, Clinical trial, Congress, RNA interference, DNA, Pharmaceutical industry

Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.

Key Points: 
  • Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.
  • Arbutus plans to announce end-of-treatment data from this portion of the trial in the first half of 2024.
  • Arbutus is advancing AB-101 into part two of this clinical trial which involves dosing healthy subjects with multiple-ascending doses of AB-101.
  • Roivant Sciences Ltd. owned approximately 23% of the Company’s outstanding common shares as of December 31, 2023.

Precision BioSciences Receives Pre-IND Feedback from US FDA for PBGENE-HBV as it Advances Towards Clinical Readiness

Retrieved on: 
Wednesday, February 14, 2024
Infectious Diseases, FDA, Genetics, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Oncology, HBV, University College London, FRCS, Toxicology, Precision BioSciences, Gene editing, MD, Food, HBsAg, Precision, Feedback, CccDNA, FCP, Patient, IND, Trial of the century, CTA

Receipt of this regulatory feedback provides alignment and clarity on Precision’s final IND/CTA-enabling preclinical plans and clinical strategy for PBGENE-HBV prior to advancement into Phase 1 clinical studies.

Key Points: 
  • Receipt of this regulatory feedback provides alignment and clarity on Precision’s final IND/CTA-enabling preclinical plans and clinical strategy for PBGENE-HBV prior to advancement into Phase 1 clinical studies.
  • “Based on this feedback, we have initiated the final preclinical studies as well as site selection efforts as we move towards clinical readiness.
  • The pre-IND meeting with FDA provided feedback on overall design for the proposed first-in-human clinical study as well as feedback on the toxicology and specificity assessments.
  • “Given the constructive feedback from the FDA and other regulatory agencies worldwide, I look forward to seeing this novel modality progressing to further assessment in the clinic.”

Arbutus Announces 2024 Corporate Objectives and Provides Financial Update

Retrieved on: 
Monday, January 8, 2024
LNP, RNA interference, AASLD, Virology, HBV, Vaccine, Court, Nivolumab, Congress, Clinical trial, Pharmacokinetics, PD, Expert witness, Arbutus, COVID-19, EASL, CFBV, Interim, Investment, Patient, Safety, HBsAg, PD-L1, Pharmaceutical industry

Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.

Key Points: 
  • Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.
  • Arbutus plans to announce end-of-treatment data from this portion of the trial in the first half of 2024.
  • Arbutus expects to report preliminary data from the healthy subject portion of this clinical trial, including target engagement and receptor occupancy data, in the first half of 2024.
  • With respect to the Moderna lawsuit, fact discovery is currently on-going with the claim construction hearing scheduled for February 8, 2024.

Aligos Therapeutics Presents Positive Data at the AASLD Liver Meeting® 2023 Demonstrating that Treatment with ALG-000184 (CAM-E) Results in Significant Multi-log Reductions in Hepatitis B Antigens (HBsAg, HBcrAg and HBeAg)

Retrieved on: 
Friday, November 10, 2023
Hepatology, Safety, DNA, SAN, Therapy, PEI, HBsAg, AASLD, Emory University, Liver, Week, Doctor of Philosophy, B, CccDNA, Liver cancer, Hepatitis B virus, CHB, Entecavir, MBA, University, Hepatitis, Hong Kong, Physician, Poster, ETV, RNA, Vaccine, Pharmaceutical industry, HBeAg, Boston, New York University, Gastroenterology, Jacob Aligo

SOUTH SAN FRANCISCO, Calif., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that emerging hepatitis B antigen lowering data for its capsid assembly modulator – empty (CAM-E) drug, ALG-000184, are available as a late breaking poster at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD), being held in Boston, Massachusetts, November 10 – 14, 2023.

Key Points: 
  • The data will be presented by Dr. Man-Fung Yuen, Chair and Professor of Gastroenterology and Hepatology at the University of Hong Kong, in Poster Hall C on Monday November 13 from 1-2 pm ET.
  • “ALG-000184 appears to have best-in-class antiviral properties which are also unique compared to other drug classes being evaluated for the treatment of chronic hepatitis B (CHB).
  • If the trends observed to date continue, ALG-000184 has the potential to become a cornerstone therapy in the treatment of CHB.
  • The antiviral effects of ALG-000184 presented at AASLD indicate that this drug is achieving significant viral suppression, likely via inhibition of cccDNA synthesis.

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

Retrieved on: 
Thursday, November 9, 2023
Group 3, Hepatology, Safety, Immune system, Thyroiditis, RNA interference, AASLD, Risk, MVA, NUC, Patient, HBV, Clinical trial, Non-cirrhotic portal fibrosis, Liver, SOC, Autoimmune thyroiditis, CHB, Cancer, Nivolumab, Hepatitis, Group 2, Autoimmunity, Thyroid disease, Șaeș, Vaccine, Pharmaceutical industry, HBsAg

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.

Key Points: 
  • 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.
  • Preliminary immunology data suggests HBV-specific T cell IFN-γ production was enhanced in patients receiving imdusiran plus VTP-300 compared to placebo.
  • 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.

Arbutus Biopharma and Barinthus Bio Present Preliminary Data from Phase 2a Clinical Trial Combining Imdusiran with VTP-300 at AASLD - The Liver Meeting®

Retrieved on: 
Thursday, November 9, 2023
Hepatology, Virology, Immune system, University of Hong Kong, AASLD, Patient, HBV, Clinical trial, Division, Non-cirrhotic portal fibrosis, Liver, University, Cancer, Autoimmunity, CFBV, Vaccine, Pharmaceutical industry, HBsAg, Gastroenterology

WARMINSTER, Pa. and OXFORD, United Kingdom, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a cure for people with chronic hepatitis B virus (cHBV) infection, and Barinthus Biotherapeutics plc (Nasdaq: BRNS), formerly Vaccitech plc, 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 a late breaking poster presentation at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023. The poster contains preliminary data from the Phase 2a clinical trial (AB-729-202) combining Arbutus’ RNAi therapeutic, imdusiran (AB-729), with Barinthus Bio's T-cell stimulating immunotherapeutic, VTP-300, and standard-of-care nucleos(t)ide analogue (NA) therapy.

Key Points: 
  • The poster contains preliminary data from the Phase 2a clinical trial (AB-729-202) combining Arbutus’ RNAi therapeutic, imdusiran (AB-729), with Barinthus Bio's T-cell stimulating immunotherapeutic, VTP-300, and standard-of-care nucleos(t)ide analogue (NA) therapy.
  • Preliminary immunology data suggests HBV-specific T cell IFN-γ production is enhanced in patients receiving imdusiran plus VTP-300 compared to placebo.
  • The preliminary safety data from this trial demonstrate that imdusiran and VTP-300 were both safe and well-tolerated.
  • 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.

VBI Vaccines Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 14, 2023
Biotechnology, FDA, Other Health, Health, Pharmaceutical, Oncology, Research, Infectious Diseases, Science, COVID-19, Clinical Trials, Shekel, MLE, High-net-worth individual, Hepatitis B vaccine, GMT, HBsAg, Net, AASLD, Bank statement, Disease, GBM, Government, Administration, Patient, HBV, Research and development, Prison, Allergy, Fast track (FDA), Autoimmune disease, InSight, Liver, VBI, Messenger, Internationalized domain name, GAAP, Vaccine, Cancer, Partnership, R, Seroconversion, Growth, Infection, Israeli new shekel, Pharmaceutical industry, Video game, Rare-earth element, Cryptocurrency, Bank

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended September 30, 2023.

Key Points: 
  • VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended September 30, 2023.
  • Cost of Revenues: Cost of revenues was $2.5 million in the third quarter of 2023 as compared to $2.7 million in the third quarter of 2022.
  • Research and Development (R&D): R&D expenses for the third quarter of 2023 were $1.5 million as compared to $5.0 million for the third quarter of 2022.
  • Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results.

Precision BioSciences Presents Late-Breaking Data Highlighting Preclinical Efficacy and Safety of PBGENE-HBV for Chronic Hepatitis B at AASLD’s The Liver Meeting 2023

Retrieved on: 
Monday, November 13, 2023
Research, Infectious Diseases, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, Webcast, ID, Safety, DNA, Gene editing, Entrepreneurship, HBsAg, AASLD, IND, HBeAg, HBV, Conference call, Liver, CccDNA, Conference, CHB, Hepatitis, CTA, Precision BioSciences, Vaccine, Broadcasting, Boston

The poster highlights preclinical data demonstrating PBGENE-HBV’s ability to eliminate cccDNA and inactivate hepatitis B virus (HBV) DNA, meriting further investigation as a potentially curative treatment for chronic hepatitis B (CHB).

Key Points: 
  • The poster highlights preclinical data demonstrating PBGENE-HBV’s ability to eliminate cccDNA and inactivate hepatitis B virus (HBV) DNA, meriting further investigation as a potentially curative treatment for chronic hepatitis B (CHB).
  • The final clinical candidate nuclease demonstrated no detectable off-target editing at doses that maximized on-target editing.
  • In multiple HBV disease models, PBGENE-HBV demonstrated ability to inhibit viral markers and eliminate cccDNA in HBV-infected primary human liver cells.
  • These data are further supported by a high level of viral engagement and a 95% reduction in hepatitis B surface antigen (HBsAg) in an episomal HBV mouse model.

Vir Biotechnology to Present New Data from Its Ongoing Phase 2 Chronic Hepatitis Delta and B Trials Today at AASLD’s The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Hepatology, INSERM, Immunity, Interferon, Immune system, ALT, HDV, HBsAg, AASLD, Clinical trial, Viral hepatitis, EOT, Patient, Small RNA, Abstract, Week, Monoclonal antibody, Liver, Auckland City Hospital, CHB, University, Peginterferon-alfa, CHD, APHP, Hepatitis, Vir, RNA, Vaccine, Pharmaceutical industry, Communications satellite, Treatment, Medicine

To date, no participants receiving the combination therapy or VIR-3434 monotherapy have experienced ALT elevations relative to their baseline.

Key Points: 
  • To date, no participants receiving the combination therapy or VIR-3434 monotherapy have experienced ALT elevations relative to their baseline.
  • “Chronic hepatitis delta is the most aggressive form of viral hepatitis.
  • Vir will host an investor conference call to discuss the Phase 2 CHD & CHB AASLD data at 1:45 p.m. Pacific Time / 4:45 p.m. Eastern Time on November 13th.
  • A live webcast will be available on https://investors.vir.bio and will be archived on www.vir.bio for 30 days.

Brii Bio Presents New Data Highlighting Progress Towards Achieving HBV Functional Cure at AASLD's The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023
Hepatology, Grade 2, FAS, Plasma, AASLD, Biotechnology, Vaccination, Patient, HBV, EOT, Enzyme inhibitor, Week, Liver, Health, Liver cancer, CHB, MD, Trial of the century, PPS, Seroconversion, Hepatitis, Pharmaceutical industry, Vaccine, HBsAg, Boston

DURHAM, N.C. and BEIJING, Nov. 13, 2023 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today shared three posters at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® in Boston, MA, two of which were accepted as late-breakers providing new data from two Phase 2 assets, BRII-179 (VBI-2601) and BRII-835 (VIR-2218), within the chronic hepatitis B (CHB) clinical program.

Key Points: 
  • "We are pleased to share these data at The Liver Meeting that demonstrate the versatility of our HBV portfolio and critical insight in our search for a cure for HBV," said David Margolis, MD, Chief Medical Officer of Brii Bio.
  • "The important connection between HBsAg loss and antibody response provides a clear direction in further improving the functional cure rate and identifying patients who will most likely respond to curative treatments.
  • Highlights include:
    The PK characteristics of BRII-835 in patients with chronic HBV infection are generally similar to those in healthy volunteers.
  • In addition, Vir Biotechnology, Inc. ("Vir") is also investigating VIR-2218 and/or VIR-3434 for the treatment of HBV/HDV co-infection.