9.15 - 16.00 EST | 6.15 - 13.00 PST
8:45 am Opening Remarks from Chairperson
Combining Therapies for Curative Effects
9:00 am Targeting the Farnesoid X Receptor for the Treatment of Chronic Hepatitis B
Synopsis
- FXR agonists disrupt the host FXR-HBV interaction at the cccDNA level
- The combination of Vonafexor with interferon α2a shows a synergistic antiviral effect with in CHB patients likely immune mediated therapeutic flares
- This host targeting strategy could be an attractive option for combinational anti HBV therapies
9:30 am Strategy of Building HBV Pipeline Leading to Functional Cure
Synopsis
- Cornerstone drug/drug candidate: Marketed Pegasys® and Phase 2, subcutaneously injected PD-L1 antibody – ASC22
- In-house developed drug candidates against novel targets in combination with marketed Pegasys®
- In-house developed drug candidates against novel targets in combination with phase 2, PD-L1 antibody ASC22
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10:00 am Role of a Vaccine Immunotherapeutic in Combination Therapy to Achieve Functional Cure for Chronic HBV Infection
Synopsis
- In addition to current NUCs and next-generation therapies, consensus is building that a functional cure for chronic HBV will also require the use of an immunotherapeutic to break immunological tolerance and restore long-term immunologic control over the virus.
- VBI’s vaccine immunotherapeutic candidate, VBI-2601 has been designed to restore and enhance T cell & B-cell immunity and impact the extracellular steps of the HBV life cycle: to clear circulating virus, block viral entry, and eliminate infected hepatocytes.
- VBI-2601 includes S, Pre-S1 and Pre-S2 in a novel therapeutic formulation. Pre-S1 is a key factor and target for HBV vaccination, as high levels of Pre-S1 are correlated with more severe disease, and is the key binding ligand for infectious HBV particles (vs non-infectious subviral particles). Published data demonstrates that T cell responses
to Pre-S1 further boost responses to the S antigen, which may help break tolerance to the HBV S antigen and result in a more immunogenic response. We are assessing VBI-2601 in an ongoing Phase 1b/2a study and expect to announce initial immunologic data from the program in Q4 2020, with additional data forthcoming through early 2021. We would plan to discuss early data from this program during our presentation
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10:30 am Roundtable Discussion: Establishing the Scientific Rationale and Evidence which will Give Confidence that a Combination Will be Successful
Synopsis
- What Factors Make Up a Feasible Combination?
- Conducting Clinical Studies of a Combination Therapy to Reduce HBV Surface Antigens
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11:00 am Combination Therapy for HBV Cure
Synopsis
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- Combination therapy is used primarily to address HBV resistance to oral antivirals. Multiple experimental approaches such as combining interferon alpha with an oral antiviral have been in clinical trials focused on finite therapy and functional cure
11:30 am Virtual Speed Networking Break
12:00 pm HBsAg, Subviral Particles and Their Clearance in Establishing Functional Cure of Chronic HBV Infection
Synopsis
- HBsAg is the dominant circulating antigen in chronic HBV infection, derived almost entirely from non-infectious subviral particles (SVP)
- Circulating HBsAg blocks immune function and must be cleared during therapy to achieve functional cure of HBV
- A review of HBsAg / SVP biology and recent advances in understanding how antisense / siRNA and nucleic acid polymers affect SVP production to achieve functional cure will be presented
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12:30 pm Development of a Therapeutic Vaccine for Hepatitis B
Synopsis
- Vaccine to achieve functional cure through induction of CD8+ T cells
- In Phase 1/2a
- Based on consensus genotype C
To read full session information – download the event guide here.
1:00 pm Targeting HBV Core Protein to Improve Treatment for Chronic Hepatitis B Patients
1:30 pm Virtual Speed Networking Break
1:45 pm
Recruiting Chronic HBV Patients and Running Successful Clinical Trials from East to West
2:00 pm Global Barriers to a HBV Cure Roll-Out
Synopsis
- HBV Industry Landscape in the First Second and Third Worlds
- Diagnostic and Lexicon Unmet Needs
- Lessons learned and Opportunities for rapid roll out
2:30 pm The Patient Perspective on Hepatitis B Treatment, Cure & Clinical Trial Participation
Synopsis
- Provide an overview of treatment-related experiences of people living with hepatitis B, including current challenges
- Discuss the patient perspective on administration and outcomes of future treatments for hepatitis B
- Understand patient perceptions of clinical trials for hepatitis B, including wants, needs and challenges
To read full session information – download the event guide here.
3:00 pm Panel Discussion: Discuss How We Can Identify Patient Populations for a Variety of Chronic HBV Therapeutic Trials
Synopsis
- Explore a variety of geographies that hold large populations of patients with Chronic HBV, discuss the difficulties that could come with running trials in these untapped areas and find ways industry, academia and government bodies could collaborate to overcome these challenges
- How do we maintain patient compliance with trials?
- Separate the challenges that will come with conducting combination trials over monotherapy trials
- Breaking ground in new geographies to conduct new clinical trials
To read full session information – download the event guide here.