Virion Therapeutics Reports Broad and Sustained Anti-HBV Immunity Following a Single VRON-0200 Dose in the Majority of Chronically HBV-Infected Patients From its Phase 1b Study at CROI 2026

PHILADELPHIA--(BUSINESS WIRE)--Virion Therapeutics, LLC, a clinical-stage biotechnology company developing novel T cell-based immunotherapies that utilize checkpoint modifiers, today announced at the 33^rd 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.

"VRON-0200 is the first new HBV immune modulator since pegylated interferon to show durable clinical activity with sustained and/or improving anti-HBV responses up to one year (360 days) following a single dose ..." Dr. Sue Currie, Virion Therapeutics

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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 with sustained 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).

About Chronic Hepatitis B
Despite a preventative vaccine, cases of chronic hepatitis B (CHB) continue to rise, with an estimated 254 million persons infected worldwide and 1.1 million deaths per year from HBV-related liver complications. Chronic HBV remains a global health issue with a high unmet medical need since there is no cure available. The current standard of care requires lifelong antiviral therapy to maintain control of the virus. 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. As a result, immune modulators are now considered necessary for future cure treatment strategies.

About VRON-0200
VRON-0200 is an investigational therapeutic immunotherapy designed with the goal of providing a functional cure for chronic HBV infection. Clinical data from an ongoing Phase 1b trial have shown VRON-0200 to be safe and well tolerated, and, when given as a single intramuscular dose, was immunogenic, and able to “Spark” anti-HBV activity in chronically HBV-infected patients on nucleos(t)ide therapy alone, and, also, when given with combination antiviral therapies. These results suggest the potential of VRON-0200 to be the key backbone immune modulator for HBV functional cure treatments.

About Virion Therapeutics (Virion)
Virion Therapeutics, LLC is a clinical-stage company developing novel immunotherapies that utilize proprietary checkpoint modifiers to enhance/restore, broaden, and elicit sustained immune responses, with the goal to cure cancer and chronic infectious diseases. Virion’s pipeline now includes its lead VRON-0200 clinical program, and several additional IND-enabling programs, such as its VRON-0300 oncology program for advanced solid tumors, leveraging its proprietary platform technologies.

To learn more, visit www.VirionTx.com