8:25 am Chair’s Opening Remarks
Striving for Functional Cure: Advancing Combination Therapies to Attain Effective & Durable Treatment>
8:30 am Panel Discussion: What, When & How? Pursuing Combination Therapy to Improve Durable Efficacy & Decrease Viral Breakthrough
Synopsis
• Sequencing multiple mechanisms of action acting on immune and viral targets to optimize therapeutic effect
• Identifying effective combinations to achieve treatment with finite durations
• Measuring toxicity and adverse events in combination therapy for HBV
9:00 am Interrogating Therapeutic Agents with Additive or Synergistic Activity against HBV for Combination Therapy
Synopsis
• Advancing combinations exploring a core inhibitor with multiple other mechanisms
• Combining three or more therapeutic candidates with differing mechanisms of action in cross-company collaborations
• Exploring opportunities for future development to attain finite and curative treatment
9:30 am Drawing Comparisons with Hepatitis C: Breaking New Ground or Following in the Footsteps?
Synopsis
• Hepatitis C cure: 25 years to get there and viral resistance was the key
• HBV cure: is it the virus or the immune system that is the key? • How does HCV cure help us understand duration and stopping rules for HBV
• Considering similarities and differences between hepatitis B and hepatitis C to inform the next generation of trials
10:00 am In Person Structured Networking
Synopsis
This session is the ideal opportunity to (finally!) take advantage of face-to-face networking time, and understand who is also prioritizing and overcoming challenges within HBV drug development.
10:30 am Morning Break & Networking
11:00 am Clinical Trial Design Considerations for a Combination Therapy with Multiple Mechanisms of Action to Achieve a Functional Cure
Synopsis
• What can we learn from existing clinical collaborations and clinical data to inform combination therapy for chronic HBV?
• Establishing effective biomarkers to measure efficacy
• Constructing multi-arm trials to evaluate different combinations
11:30 am The Potential Role of an Anti-HBs Antibody in Combination Therapy to Achieve Functional Cure in Chronic HBV
Synopsis
• Discuss how combination therapy is likely needed to achieve functional cure of chronic HBV by suppressing the virus and stimulating/enhancing the immune system
• Evaluate how VIR-3434 is an HBV-neutralizing monoclonal antibody with multiple potential mechanisms of action including cross-presentation and stimulation of T cells (vaccinal effect)
• Review in vitro, in vivo and clinical data on VIR-3434 and the vaccinal effect of antibodies and how it may play a role in combination therapy
12:00 pm Lunch & Networking
Developing & Standardizing Predictive Biomarkers to Understand Disease Course & Shape Treatment Strategy
1:00 pm From HBV RNA to Core-Related Antigen: Novel Viral Biomarkers to Guide Treatment Management & Clinical Outcome Prediction
Synopsis
• Assessing the development of novel serum markers that can assess the replicative and transcriptional activity of HBV
• Exploring the use of viral biomarkers in treatment stopping criteria
• Understanding the role of viral biomarkers in predicting clinical outcomes
1:30 pm Emerging & Established Non-Invasive Biomarkers for Predicting & Evaluating Efficacy of HBV Therapeutics
Synopsis
• Reviewing the role of circulating HBs, HBe, Core Related Ag, HBsAb
• Understanding the role of circulating viral nucleic acids (RNA and DNA)
• Uncovering new circulating markers of immunological restoration
Developing Reflective Models to Improve Mechanstic Understanding & Predict Efficacy of Antiviral Drugs & Novel Immunotherapies for HBV
2:00 pm Utility of Animal Models for Evaluating Preclinically Novel HBV Therapeutics
Synopsis
• Why doesn’t HBV infect mice and how can the barrier be overcome?
• Analyze advances in development of (immunocompetent) humanized mice
• Discuss emerging NHP models for modeling chronic HBV
2:30 pm Afternoon Break & Networking
Enhancing Patient Recruitment & Stratification to Tailor Treatment to Subgroups
3:00 pm Translation of Antivirals & Immunostimulants in HBV: From Bench to Bedside
Synopsis
• Characterizing the anti-HBV immune response in preclinical studies and understanding mechanisms of viral replication
• Assessing the interplay between viral replication and the immune response
• Translating learnings to clinical trials and establishing synergistic combination regimens
3:30 pm Rethinking Treatment Thresholds & Patient Subgroups to Implement Targeted Clinical Trials
Synopsis
• Studying the host immune response to overcome barriers to broaden treatment candidacy
• Are clinical trials justified in those outside current treatment guidelines?
• Which special population should be prioritized for trials of novel therapies?
4:00 pm Chair’s Closing Remarks
4:10 pm Scientific Poster Session
Synopsis
After the formal presentations have finished, the learning and networking carries on. The Poster Session allows you to connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships. During this session scientific posters will be presented on the very latest advancements in next generation therapies for HBV with a focus on better understanding and overcoming translational challenges to inform the direction of future drug development efforts.