Virion Therapeutics Completes Enrollment of First 2 Cohorts of Phase 1b Chronic Hepatitis B Trial of VRON-0200 For HBV Functional Cure

• Twenty-seven patients with Chronic Hepatitis B Virus infection (CHB) have now been dosed with VRON-0200 as a single (Prime), or Prime and Boost, intramuscular (i.m.) injection

PHILADELPHIA, Jan. 10, 2025 /PRNewswire/ -- Virion Therapeutics, LLC, a clinical-stage biotechnology company, developing novel T cell-based immunotherapies that utilize first-in-class, checkpoint modifiers, today announced that its Phase 1b clinical trial, evaluating VRON-0200 for HBV Functional Cure has completed enrollment in its first two cohorts. Specifically, 27 chronically HBV-infected patients on nucleos(t)ide antiviral therapy, have now received a single (Prime), or Prime and Boost, i.m. injection of VRON-0200. Virion has previously presented data from this study that showed that a single VRON-0200 injection was safe and well tolerated and was able to induce immune responses and anti-HBV activity despite the fact that most patients had highly impaired HBV immunity prior to treatment. Additionally, a third Cohort, the first to investigate VRON-0200 in combination with several investigational anti-HBV agents, is now underway.

"The swift completion of enrollment of these two cohorts, in this Phase 1b trial, reflects the strong interest among both providers and patients for finding an effective immunotherapy for Chronic HBV that is safe, well tolerated, and easy to administer," said Sue Currie, PhD, COO of Virion and one of the study's authors. Currie added, "Results from recent trials have shown that the addition of pegylated interferon (Peg-IFN), an immunomodulatory agent, plus investigational agents that potently suppress HBV, when added to standard of care nucleos(t)ide antiviral therapy, can maintain viral suppression in a large percentage of patients after discontinuation of therapy. However, treatment with Peg-IFN has treatment challenges that can include high rates of adverse events, and convenience-related issues, such as a long duration of treatment (e.g., 24-48 weeks). What makes VRON-0200 so promising is its simplicity of administration (a single-, or two-injection regimen), its safety and tolerability profile, and now its documented anti-HBV activity, even in the most difficult CHB patient population - those infected at birth. These findings highlight the potential of VRON-0200 as an IFN-sparing immunotherapy, alone or in combination, for HBV functional cure, with the goal of bringing a cure to the almost 300 million persons living with chronic HBV. We look forward to sharing more VRON-0200 clinical data in 2025 and continuing to advance this clinical development program."

Summary of VRON-0200 Phase 1b clinical trial design

• VRON-0200 is a Phase 1b, multi-center, open-label, dose escalation, prime only, and prime plus boost, therapeutic immunotherapy study to evaluate the safety, tolerability, immunology, and other clinical measures:
  • Inclusion criteria: Non-cirrhotic, HBeAg positive or negative, chronic hepatitis B patients currently taking nucleos(t)ide antiviral therapy with HBV DNA < 40 IU/mL and HBsAg < 500 IU/mL (< 1,000 IU/mL for Cohort 3)
  • Dose: Cohort 1 (low dose) (ENROLLED); Cohort 2 (high dose) (ENROLLED)
  • Prime or Prime-Boost: Patients are randomized to receive either a prime dose only or a prime and boost regimen
  • Combination Cohort 3: Patients are randomized to receive VRON-0200 prime plus 6 monthly subcutaneous doses of elebsiran and tobevibart starting on Day 28, alone, or with a boost, at Day 196 (ENROLLING)

More details of the study can be found at ClinicalTrials.gov (Identifier: NCT06070051).

About Chronic Hepatitis B
Despite a preventative vaccine, cases of chronic hepatitis B (HBV) continue to rise, with an estimated 296 million persons infected worldwide and 820,000 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.

About VRON-0200
VRON-0200 is a therapeutic immunotherapy, administered by intramuscular injection, designed with the goal of providing a functional cure for chronic HBV infection. While the virus itself stimulates HBV-specific CD8+ T cells, for those patients that can't clear the initial infection, their T cells soon become exhausted, placing limits on their ability to proliferate and control the virus. Preclinical data support the hypothesis that VRON-0200, through checkpoint modification, can amplify, broaden, and enhance T cell responses that may include T cells that are not normally activated during a chronic HBV infection, which results in improved viral control. An ongoing Phase 1b trial has shown VRON-0200 to be safe, well tolerated, and immunogenic, with anti-HBV activity, in chronically HBV-infected patients on nucleos(t)ide therapy. 

About Virion Therapeutics (Virion)
Virion Therapeutics, LLC is a clinical-stage company developing novel T cell-based immunotherapies to cure cancer and chronic infectious diseases that utilize proprietary genetically encoded checkpoint modifiers to enhance and broaden CD8+ T cell responses to a tumor or chronic infection. Founded in early 2018 to advance technology licensed from The Wistar Institute, an international leader in biomedical research, Virion has since developed a robust pipeline, including its lead VRON-0200 clinical program, and several additional IND-enabling programs, including its VRON-0300 oncology program for advanced solid tumors, leveraging its proprietary platform technologies.

To learn more, visit www.VirionTx.com

Contact:
Virion Therapeutics, LLC, Dr. Sue Currie, Chief Operating Officer
[email protected]

SOURCE Virion Therapeutics, LLC