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?

  • Mark Dybul Chief Executive Officer, Enochian BioSciences

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

  • Michael Newman Founder & Chief Scientific Officer, Indaptus Therapeutics

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

  • Kees Melief Chief Scientific Officer, ISA Pharmaceuticals

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

  • Rajan George Founder, President & Chief Executive Officer, Akshaya Bio

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

4:30 pm Chair’s Closing Remarks & End of Conference