Virion Therapeutics, LLC, a clinical-stage biotechnology company developing novel T cell-based immunotherapies that utilize checkpoint modifiers, today announced at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI), in Denver, CO, that a single intramuscular dose of VRON-0200, its novel, first-in-class, immunotherapy for HBV Functional Cure was able to “spark” and re-awaken durable HBV-specific immunity in the majority of chronically HBV-infected patients – with HBsAg declines that were sustained or deepened through Day 360. These data, presented as a late breaker presentation, by Dr. Sue Currie, PhD., Virion Therapeutics, also highlighted VRON-0200’s ongoing favorable safety and tolerability profile, and its rapid and profound synergy when combined with antigen lowering antiviral agents.
Dr. Currie commented: “We are now at a pivotal point in the development of potential functional cures for chronic HBV, with exciting progress being made, with different classes of HBV treatments. These treatments, however, are limited by their inability to restore a patient’s own immune responses against the virus. As a result, once treatment is discontinued, viral rebound typically occurs in a large proportion of patients. The field now believes that immune modulators are necessary to mitigate this virological rebound. VRON-0200 is the first new HBV immune modulator since pegylated interferon to show durable clinical activity withsustained and/or improving anti-HBV responses up to one year (360 days) following a single dose – which has the potential to prevent the need for rescue medications after HBV treatment discontinuation, and improve overall functional cure rates.” Currie added, “Additionally, the rapid HBsAg declines seen when combined with investigational antivirals, the “fan” to the VRON-0200 “spark”, has the added future potential of shortening combination treatment regimens, and also expansion to other populations such as those with higher baseline HBsAg levels (e.g., >3,000 IU/mL) and co-infected patients (e.g., HIV/HBV, HDV/HBV). This “Spark and Fan” model, where an upfront VRON-0200 “spark” dose “primes” one’s own anti-HBV immune response, then is “fanned” (boosted) by an antiviral regimen(s) that removes the virus (e.g., HBsAg), could make VRON-0200 a foundational backbone agent to a wide range of future Functional Cure strategies.”
“Locally acting checkpoint modifiers (CPM) enhance, broaden, and prolong immune responses to chronic infections and cancer, and by mechanism, minimize the risks for serious “off target” adverse events,” said Dr. Andrew Luber, Pharm.D., CEO of Virion. Luber added, “VRON-0200, Virion’s first CPM-containing immunotherapy, with its favorable safety and tolerability profile, documented durable clinical activity, and convenient single i.m. administration, along with its potential for increased accessibility due to its ease of scalabilty and distribution, make it ideal for global public health initiatives. 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 investigational antivirals. The benefits of CPM for other chronic viral diseases such as HDV/HBV, HIV/HBV, HIV Cure, HSV-2, EBV, are being considered, and the lessons learned from the VRON-0200 program are being applied to our VRON-0300 program for advanced solid tumors. We look forward to sharing more data from the current Phase 1b VRON-0200 trial at future meetings.”
The presentation is available for download at www.VirionTx.com and more details of this study can be found at ClinicalTrials.gov (Identifier: NCT06070051).
