Abstract title: A humanized monoclonal antibody 4G2 exhibits anti-viral activity in a mouse model of persistent hepatitis B virus (HBV) infection Professor Locarnini is a past director of the World Health Organisation (WHO) Regional Reference Laboratory for Hepatitis B and D for the Western Pacific Region (WPRO). His current major research interests include viral hepatitis, hepatitis vaccines and antiviral chemotherapy with an emphasis on the basic virology of the various agents of hepatitis, the molecular pathogenesis of hepatitis, as well as prevention and public health control measures. In addition to the full study results for the B-Clear trial, GSK will share updates on its specialty and vaccines pipeline at the AASLD meeting in Washington DC, including: Chronic hepatitis B is a major global health threat that can progress to liver complications including cirrhosis and liver cancer, with approximately 900,000 people dying each year. 1, 2 Functional cure means that the virus is at levels that are low enough to be undetectable in blood and can be controlled by the immune system without medication. Current treatment options have limited success in achieving functional cure. The mainstay of therapy includes nucleoside/nucleotide analogues (NA) which are often taken for life because they suppress but rarely clear the virus. Hepatitis B is a viral infection, caused by the hepatitis B virus (HBV), in the liver that can cause both acute and chronic liver disease. [2] Chronic hepatitis B (CHB) is a long-lasting infection and occurs when the body’s immune system is unable to fight off the virus and it persists in the blood and liver. [3] It is estimated that there are 257 million people globally with CHB. [3] Even when treated, CHB can progress to liver failure and liver cancer, which results in nearly 900,000 deaths per year. [4] Around 22 million people get diagnosed and of these only 1.7 million (8%) get treated. [3]

The World Health Organization defines hepatitis B as a “potentially life-threatening liver infection caused by Hepatitis B virus (HBV). It is a major global health problem. It can cause chronic infection and puts people at high risk of death from cirrhosis and liver cancer.” Approximately 2 billion people are infected with HBV and ~250 million living with CHB. Viral hepatitis is the 7 th ranked cause of human death and liver cancer is the 3 rd most common cause of cancer related death globally. In the NA-naïve group (n=12), average [SD] reduction reached -1.66 [1.48] log 10 IU/ml vs. placebo 0.00 [0.47], n=6, p<0.001.

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UK based test Laboratories have completed the latest Gold Standard COVID-19 testing in October 2020, in which our product achieved Log4, resulting in a 99.99% virucidal kill. External scientific engagement on the start of the phase IIb study of GSK4532990 in adults with nonalcoholic steatohepatitis (NASH). CONCORD, Mass.--( BUSINESS WIRE)-- ClearB Therapeutics, Inc., now a clinical-stage biotechnology company committed to developing therapies to drive functional cure in patients with chronic hepatitis B (CHB) infection, announced that the first patient has been dosed in the Phase 1b clinical study evaluating the therapeutic vaccine CLB-3000 ( ACTRN1263000841673). Satisfactory review of safety data for this patient supported opening enrollment for the remainder of the cohort. These data from the 31 patients participating in the phase 2a study will be virtually presented at The Digital International Liver Congress (ILC) 2020. [1] Across both treatment groups, of the six patients with HBsAg reductions >3.0 log 10 IU/ml, four patients had levels falling below the limit of quantification (0.05 IU/ml). Prolonged HBsAg loss was observed in one-NA treated patient (from Day 36 to Day 113) and one NA-naïve patient (from Day 23 to Day 126).

Bepirovirsen is an investigational antisense oligonucleotide (ASO) designed to specifically recognise the RNA that the hepatitis B virus uses to replicate itself in the infected liver cells (hepatocytes) and make the viral antigens (proteins) which facilitate chronicity of the disease by helping to avoid clearance by the immune system. The ASO recruits the liver’s own enzymes to eliminate the RNA by digesting it to an inactive form. The subsequent reduction in the levels of the RNA results in a decrease in both the virus and the production of viral antigen (HBsAg) by the hepatocytes, which can be measured by a drop in the HBV DNA and antigen levels in the circulating blood. Bepirovirsen has an additional property of stimulating immune responses via Toll-like receptor 8 (TLR8) which may help the immune system to achieve durable clearance of the virus from circulating blood. GSK today announced that GSK’836 (GSK3228836), an investigational antisense oligonucleotide, showed marked reductions in hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA compared with placebo after four weeks treatment in people with chronic hepatitis B on stable nucleoside or nucleotide analogue (NA) therapy and in patients who were NA-naïve. The aerosol disinfectant disperses a high-performance disinfectant-Alcohol solution that is suitable for use on all types of surfaces, ideal for areas such as food preparation areas, gyms, offices, homes, trains planes and automobiles. Providing a highly effective sanitisation eradicating the virus even in the hard to get to places. The phase 2a dose-ranging study investigated GSK’836 at doses of 150mg and 300mg compared to placebo, administered by subcutaneous injection over a four-week treatment period in 31 patients. After the last treatment dose, all patients received tenofovir or entecavir (two available antivirals recommended as first-line monotherapies for chronic hepatitis B) for six months and were observed to determine if HBsAg loss was sustained. Primary endpoints included safety and tolerability. The main efficacy analysis included the change in serum HBsAg and plasma hepatitis B virus DNA from baseline to the end of the 4-week treatment period (Day 29). Other endpoints included additional antiviral parameters and pharmacokinetics. Abstract Title: Impact of various expression systems on efficacy of HBsAg therapeutic vaccines to achieve clearance in a mouse model of chronic hepatitis BPhase IIb trial of bepirovirsen in sequential combination with pegylated interferon (PegIFN) treatment; Deleting info from a device will delete it everywhere it's synced. To delete the data from one device without removing it everywhere: We are also excited to continue to showcase new preclinical data on an additional novel immune based serotherapy approach at the upcoming AASLD The Liver Meeting,” Dr. Rubio added. For more information regarding AASLD The Liver Meeting 2023, please visit The Liver Meeting | AASLD.

Chris Corsico, SVP, Development, GSK, said: “Today’s results from the B-Clear study are a promising step forward for the approximately 300 million people living with chronic hepatitis B. We look forward to confirming these findings for bepirovirsen in our phase III study starting next year, as well as exploring potential sequential therapy options with the aim of helping more people living with CHB achieve functional cure.” Phase II trials ongoing to explore potential sequential treatment options with the aim of increasing functional cure rate GSK3228836 is an investigational antisense oligonucleotide (ASO) that has been designed to specifically recognise the messenger RNA (mRNA) that the Hepatitis B virus uses to make viral antigens (disease-causing protein) in infected cells (hepatocytes) in the liver. It helps to destroy the mRNA by recruiting the liver’s own enzymes to digest it to an inactive form. The subsequent reduction in the levels of the mRNA results in a decrease in the production of viral antigen (HBsAg) by the hepatocytes, which can be measured by a drop in the antigen levels in the circulating blood. CLB-3000 is a bivalent subunit therapeutic vaccine comprised of CLB-405 and CLB-505 proteins, adjuvanted with Alhydrogel®. CLB-405 and CLB-505 were designed to over-represent clearance profile epitopes that were identified from the functional cure patients. The Phase 1b study is an open label dose escalation design enrolling up to 36 CHB patients in as many as 3 cohorts. The objectives of the study are safety, tolerability, and anti-viral activity of CLB-3000. Results from the two ascending dose cohorts are expected in 2H 2024.Yuen MF et al. Hepatitis B virus (HBV) surface antigen (HBsAg) inhibition with ISIS 505358 in chronic hepatitis B (CHB) patients on stable nucleos(t)ide analogue (NA) regimen and in NA -naive CHB patients: phase 2a, randomized, double-blind, placebo-controlled study. Abstract No. AS067. The Digital International Liver Congress 2020. ClearB Therapeutics was co-founded in 2017 with Professor Stephen Locarnini and the Victoria Infectious Diseases Reference Laboratory in Melbourne, Australia. ClearB is working to develop immune based therapies designed to drive functional cure of hepatitis B infection. The work is grounded in proprietary insights derived from studying rare-event infection resolution in patients who suffer from CHB. For more information, please visit https://clearbtherapeutics.com/. CONCORD, Mass. & MELBOURNE, Australia--( BUSINESS WIRE)--ClearB Therapeutics, Inc., a company developing a therapeutic vaccine designed to drive functional cure of hepatitis B, announced today that its abstract titled “Impact of various expression systems on efficacy of HBsAg therapeutic vaccines to achieve clearance in a mouse model of chronic hepatitis B” was accepted for poster presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2021, taking place virtually November 12-15, 2021. Phase 2a data to be presented at The Digital International Liver Congress suggests potential of investigational drug (GSK3228836) to suppress hepatitis B virus after four weeks of treatment.