8:25 am Chair’s Opening Remarks

  • Herbert Virgin Chief Scientific Officer & Executive Vice President of Research, Vir Biotechnology

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

  • Patricia Mendez Head HBV Cure, Gilead Sciences
  • David Anderson Chief Scientific Officer, VBI Vaccines
  • Carey Hwang Senior Vice President, Clinical Research, Head of Chronic Infection, Vir Biotechnology
  • Luisa Stamm Chief Medical Officer, Assembly Biosciences

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

  • Luisa Stamm Chief Medical Officer, Assembly Biosciences

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?

  • Nezam Afdhal Chief of the Division of Gastroenterology, Hepatology & Nutrition, Beth Israel Deaconess Medical Center

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

  • Carey Hwang Senior Vice President, Clinical Research, Head of Chronic Infection, Vir Biotechnology

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

  • Katie Kitrinos Vice President, Clinical Virology, Assembly Biosciences

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

  • Alexander Ploss Associate Professor of Molecular Biology, Princeton University

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

  • Patrick Kennedy Clinical Professor of Translational Hepatology, Queen Mary University Of London

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

  • Herbert Virgin Chief Scientific Officer & Executive Vice President of Research, Vir Biotechnology

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.