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 Denver, CO, that an intramuscular prime dose of VRON-0200 alone, its novel, first-in-class, immunotherapy for HBV Functional Cure, induced anti-HBV activity with continued HBsAg declines, without rebound, up to 2+ years post dosing, in all chronically HBV-infected treated patients. These data, presented as a late breaking oral presentation, by Dr. Grace Wong, M.D., from the Chinese University of Hong Kong, also highlighted VRON-0200’s favorable safety and tolerability profile, and viral biomarker data, through Day 360.

Professor Grace Wong, M.D., from the Chinese University of Hong Kong, one of the study investigators, commented: “What stands out from these VRON-0200 data is that no HBsAg rebound was observed in any patient, and we have observed continued declines in HBsAg levels in all patients during long-term follow-up. New antivirals being developed for HBV Functional Cure are changing the treatment landscape and providing new options for our patients with chronic hepatitis B virus infection. However, to-date, most patients who lose HBsAg during treatment will rebound following treatment discontinuation. Restoring a patient’s own immune responses against the virus with immune modulators and/or therapeutic vaccines is now considered an important strategy to help prevent rebound and improve treatment responses. These long-term VRON-0200 follow up data suggest that it has potential as a safe, easy to administer interferon-sparing immune modulator to address this issue.”

“Immune modulators and therapeutic vaccines have an important role in improving HBV Functional Cure responses. “What is remarkable is that not only was there no HBsAg rebound after 2+ years, but the addition of a prime VRON-0200 dose to suppressive antiviral therapy also resulted in a rate of HBsAg decline that was 5.6 times greater than the historical rate observed in patients on antiviral therapy alone,” said Dr. Sue Currie, Chief Operating Officer of Virion Therapeutics. “Its safety, ease of use, and durable anti-HBV activity provide the rationale for evaluating VRON-0200 in a broader range of HBV-infected patients; our SPARK-B Phase 2B study will evaluate off-treatment Functional Cure following nucleos(t)ide discontinuation and will include patients with baseline HBsAg levels up to 3,000 IU/mL. We are excited to advance the VRON-0200 program with the goal of improving Functional Cure rates for the almost 260 million people living with chronic HBV worldwide.”

Professor Ed Gane, M.D., from the University of Auckland, and one of the study investigators, noted: “The development of new HBV treatments that could produce durable loss of HBV DNA and HBsAg after a finite course of treatment has eluded the field for decades. Finally, we are seeing novel therapies, such as bepirovirsen, that will provide finite treatment options for some of our chronically HBV-infected patients. VRON-0200, with its ability to restore broad and durable anti-HBV immune responses, could become the key component of future combination regimens to both improve the rate of functional cure and also increase the size of the eligible patient population, simply through the addition of a single, well tolerated intramuscular injection. I look forward to continuing to follow VRON-0200’s progress as it advances into later stage clinical trials.”

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 a 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

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