8:25 am Chair’s Opening Remarks
Delineating Meaningful Endpoints & Stopping Points to Attain Durable Finite Treatment & Functional Cure
8:30 am Panel Discussion: Defining Clinical Endpoints & Exploring Surrogates for HBV Functional Cure
Synopsis
• Reflecting cccDNA activity and assessing durability of hepatitis B surface antigen seroclearance
• Outlining parameters for acceptable and clinically meaningful hepatitis B surface antigen loss and opportunities to implement alternative surrogate endpoints
• Future directions: looking towards a sterilizing cure
9:00 am Surface Antigen Loss & Transaminase Flares – Critical Milestones for Achieving Functional Cure
Synopsis
• Understand how a surface antigen (subviral particles) is produced independently from viral replication and blocks restoration of immune function
• Discuss why surface antigen clearance is required for efficient targeting of infected hepatocytes
• Demonstrate how transaminase flares signal recovery of immune function and removal of hepatocytes containing integrated HBV DNA – a critical event for functional cure
9:30 am Eliminating HBV for Sterilizing Cure: Is it Possible?
Synopsis
• Can infected hepatocytes be eliminated?
• Is it possible to prevent relapse?
• Would adjuvant immunotherapy be beneficial?
10:00 am Morning Break & Networking
Paving the Way to Immunotherapeutics to Enhance Therapeutic Response in Combination Therapies
11:00 am Exploring Immunotherapies in Development to Achieve a Functional Cure for Chronic HBV
Synopsis
• Assessing mechanisms of action currently in development for chronic HBV
• What can we learn from progress in developing immunotherapies to inform future directions of dug development?
• Creating synergy while balancing therapeutic response and safety in combination therapies
11:30 am Bepirovirsen Implying Potential Dual Mechanism of Action
Synopsis
• Bepirovirsen is an unconjugated ASO targeting HBV mRNA
• Review data suggesting that Bepirovirsen has dual mechanism of action to reduce HBsAg and to stimulate immune responses
12:00 pm Driving Pre-Clinical Anti-HBV Activity With a Novel Multi-TLR Agonist Therapeutic Vaccine
Synopsis
• Ensuring safe induction of innate and adaptive immune pathways
• Exploring the inhibition of plasma and liver viral DNA loads, as well as HBsAg and HBeAg
• Discussing the potential safe synergy with standard of care
12:30 pm Lunch & Networking
1:30 pm Achieving Sustained Treatment Response: The Need for Immunotherapy in Chronic HBV
Synopsis
• Evaluating the role of T-cells in clearing virus infections, including HBV epitope targets for CD4+ and CD8+ T cells
• Understanding the analogy between HPV and HBV chronic infections with attention to the special role of the liver
• Reviewing the synthetic Long Peptide vaccine technology in HBV
• Exploring the relationship between immune response and clinical response
2:00 pm HepTcell as Immunotherapy to Achieve Functional Cure for Chronic HBV
Synopsis
• Chronic hepatitis B is characterized by immune tolerance, and functional cure can only be achieved by restoring T cell function
• T cell epitopes from Core and Polymerase antigens, conserved across HBV genotypes represent attractive targets for the development of safe and effective HBV immunotherapeutic
• An immunotherapeutic agent will be effective at an HBsAg level at which immune tolerance is reduced (below 100 IU/mL). Combination therapy with one of the new direct acting agents may achieve this starting point for treatment
2:30 pm Targeted Immunotherapy for Chronic Hepatitis B (CHB-TI)
Synopsis
- Importance of de novo induction of antigen specific adaptive immunity to CHB
- Development of novel CHB-TI regimens
- Status of CHB-TI clinical program and development of synergistic combination modalities
3:00 pm Afternoon Break & Networking
Clinical Updates to Influence the Next Generation of Trials & Inform Pipeline Decisions
3:30 pm Active Site Polymerase Inhibitor Nucleotides (ASPINs) for Chronic Hepatitis B Infection
Synopsis
- ASPINs target the HBV polymerase in a mechanistically unique way from nucleoside analogues
- ASPINs have demonstrated preclinical and clinical sustained suppression of HBV viremia
- ASPINs may be an integral component of curative regimens
4:00 pm VVX001: A Candidate Vaccine Which Enhances HBV Virus-Specific Immunity In Vivo
Synopsis
• VX001 is studied in an ongoing, prospective double-blind, placebo-controlled trial with four groups of patients
• Induction of preS-specific IgG response is an exploratory primary endpoint supporting decision making on discontinuing NUC therapy in selected patient groups
• In the ongoing trial, VVX001 is studied in vaccine naïve subjects, in subjects having failed to seroconvert upon vaccination with a licensed HBV vaccine, in patients who are chronically infected with HBV, but are classified as inactive carriers, and in patients with active chronic HBV infection who are HBeAg negative and chronically treated with NUCs
4:30 pm Chimigen® HBV: An Immunotherapy for Chronic Hepatitis B
Synopsis
• Exploring Chimigen®: Novel Immunotherapy Technology Platform
• Breaking immune tolerance to HBV and restoring anti-HBV T cell immunity
• Attaining durable “functional cure” of hepatitis B by restoring antiviral T cell immunity