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. ClearB Therapeutics was co-founded in 2017 by Morningside Ventures in collaboration with Professor Stephen Locarnini and the Victoria Infectious Diseases Reference Laboratory in Melbourne, Australia. ClearB is working to develop therapeutic vaccines designed to drive functional cure of hepatitis B. The work is grounded in proprietary insights derived from studying rare-event infection resolution in patients who suffer from chronic hepatitis B. For more information, please visit https://clearbtherapeutics.com/.

Global Hepatitis Report 2017. World Health Organization. https://www.who.int/hepatitis/publications/global-hepatitis-report2017/en/ Accessed on November 29, 2019 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.

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The B-Clear phase IIb trial investigated the efficacy and safety of 12 or 24 weeks of treatment with bepirovirsen in people with CHB on stable NA treatment or not-on-NA treatment at study start. Bepirovirsen, with a loading dose at day 4 and 11, and at a dose of 300mg per week for 24 weeks (treatment arm 1) resulted in 9% of patients on-NA and 10% of patients not-on-NA achieving the primary outcome of HBsAg levels below the Lower Limit of Detection (LLOD) and HBV DNA levels below the Lower Limit of Quantification (LLOQ). Patients with low baseline hepatitis B surface antigen levels 3 responded best to treatment with bepirovirsen in treatment arm 1 with 16% of patients on-NA and 25% of patients not-on-NA achieving the primary outcome. 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). We are excited to continue to share new preclinical data with the Hepatitis B medical community at this important conference as we progress our therapeutic vaccine candidate, CLB-3000, toward the clinic,” said Aileen Rubio, PhD., CEO for the company. “Chronic Hepatitis B continues to be a significant global disease and we believe these data provide clear rationale for the choice antigens that comprise CLB-3000.” Extensions: Extensions can store data on your computer or in your Google Account. Learn how to uninstall an extension. 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.

Search history & other Google activity: Searches and other activity on Google services are saved to your Google Account. Learn how to delete Google activity. In the NA-naïve group (n=12), average [SD] reduction reached -1.56 [1.38] log 10 IU/ml vs. placebo 0.00 [0.11], n=6, p=0.001. Three of these patients had reductions ≥3.0 log 10 IU/mL by Day 29. Using pioneering antisense technology GSK’836 delivered anti-viral activity, marking a potential step forward toward the goal of assessing a functional cure for people with chronic hepatitis B. Abstract Title : Therapeutic vaccination with CLB-3000 in a mouse model of chronic Hepatitis B induces anti-HBs responses associated with functional cure For the selected 300mg dose of GSK’836, reductions in HBsAg were observed in NA-treated (HBeAg negative) and NA-naïve patients (HBeAg positive and negative):

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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.” 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] Chronic hepatitis B is a major global health problem caused by the hepatitis B virus. It is a long-lasting infection that occurs when the body’s immune system is unable to fight off the virus enabling it to persist in the blood and liver. Current treatment options, which include nucleoside/nucleotide analogues, can suppress but not clear the virus, so need to be taken for life.

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.Hepatitis B Fact sheet. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b.Updated on July 18, 2019. Accessed on November 29, 2019 Professor Man-Fung Yuen, Principal Investigator and Chief of Division of Gastroenterology and Hepatology, Queen Mary Hospital, The University of Hong Kong, said: “Chronic hepatitis B affects millions of people worldwide and is notoriously difficult to treat. The promising data from the B-Clear study offer the potential for a chance of functional cure for the millions for people who are chronically infected with the virus, particularly for those with low baseline HBsAg levels.” GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principal risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic.