Highlights from the Data Presentation
- VRON-0200 was safe and well tolerated, with no serious treatment-related adverse events, treatment discontinuations, or treatment-related clinical laboratory abnormalities reported
- In the majority of patients (83%; 19/23), a single intramuscular VRON-0200 dose, added to standard of care antiviral therapy, induced anti-HBV immune activation and restoration, with HBsAg declines beginning at Day 28; these HBsAg declines were sustained and/or continued to decline up to one year after VRON-0200 treatment, with 47% of patients (9/19) achieving greater than a 50% reduction (4 patients had a 1 log10 IU/mL or greater decline) at Day 360
- A single VRON-0200 prime dose, followed by the addition of monthly doses of investigational antivirals initiated 28 days later, produced rapid and profound HBsAg declines (<2 IU/mL) in all patients (n=7); at Week 20, three of six patients achieved complete HBsAg loss, one within 7 days of the first combination dose
- The “Spark and Fan” model where an upfront VRON-0200 “spark” dose “primes” an anti-HBV immune response which is then “fanned” (aka boosted) by an antiviral regimen that removes the virus (e.g., HBsAg), could make VRON-0200 the foundational backbone agent to a wide range of future Functional Cure treatments
Virion Therapeutics, LLC, a clinical-stage biotechnology company, developing novel T cell-based immunotherapies that utilize checkpoint modifiers, today announced at AASLD’s The Liver Meeting®, in Washington DC, that a single intramuscular dose of VRON-0200, its novel, first-in-class, immunotherapy for HBV Functional Cure, induced HBV-specific immune activation, restoration, and HBsAg declines, that were sustained and/or continued up to one-year post dosing, in the majority of chronically HBV-infected treated patients. The data, presented as an oral presentation, by Dr. Grace Wong, M.D., from the Chinese University of Hong Kong, also highlighted VRON-0200’s ongoing favorable safety and tolerability profile, and rapid and profound HBsAg declines when VRON-0200 was combined with an investigational antiviral regimen.
Professor Grace Wong, M.D., from the Chinese University of Hong Kong, and one of the study investigators commented: “Current and investigational HBV Functional Cure treatments have been limited by their inability to restore a patient’s own immune responses against the virus. As a result, once treatment is discontinued, and the antiviral agents are no longer present, viral rebound typically occurs. What makes these data so exciting is that not only was a single, well tolerated VRON-0200 dose, alone, able to restore broad anti-HBV immune responses in the majority of chronically HBV-infected patients, but these responses were sustained, and/or improved, up to one year after end of treatment. VRON-0200’s ability to restore a patient’s own anti-HBV responses, with the potential for sustained viral control after antiviral treatment ends, is a significant advance for the field and opens up a wide range of possible future Functional Cure treatment options.”
“These new VRON-0200 clinical study data highlight its potential as a key component in future HBV Functional Cure regimens,” said Dr. Sue Currie, COO of Virion, and one of the study authors. “Off treatment viral rebound has been the “Achilles heel” for every HBV Functional Cure regimen to date. A single VRON-0200 dose alone was able to “Spark” a new and sustained anti-HBV response that could offer a solution to treatment rebound. This novel and exciting approach, where a patient’s own immune response is “sparked” (i.e. primed) with VRON-0200, and then “fanned” (aka boosted) by the removal of the HBV virus, position VRON-0200 to be the foundational backbone agent for new combination therapies that could produce meaningful Functional Cure rates for the almost 260 million persons living with chronic HBV worldwide. A Phase 2b SPARK-B trial for HBV Functional Cure is in development and will use the “Spark and Fan” approach to evaluate VRON-0200 in combination with an investigational antiviral.”
Professor Ed Gane, M.D., from the University of Auckland, and one of the study investigators, noted: “Sustained viral control after finite treatment is difficult to achieve with current HBV Functional Cure regimens, including those containing pegylated interferon. What is particularly exciting about these VRON-0200 data are that, in the majority of patients, most infected at birth, VRON-0200 was not only able to activate and restore an HBV-specific immune response, but also, these HBsAg responses were sustained and further reduced even one year after end of VRON-0200 dosing. These sustained anti-HBV immune responses, after finite treatment, could provide a solution for long-term prevention of viral rebound and ultimately get us closer to meaningful Functional Cure rates.”
