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 Phase 2a Clinical Data 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 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