Virion Therapeutics Announces Positive Phase 1b Immunogenicity Data for VRON-0200 at EASL Congress

Virion Therapeutics, a biotechnology firm at the clinical-stage, has unveiled encouraging immunologic and safety results from its innovative checkpoint modifier immunotherapy, VRON-0200, aimed at achieving a functional cure for chronic hepatitis B virus (HBV). The data was presented by Professor Ed Gane, M.D., from the University of Auckland, during the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy.

In this groundbreaking Phase 1b trial, 13 patients with chronic HBV, who were already on antiviral therapy, each received a single low dose of VRON-0200 via intramuscular injection. Over a period encompassing 870 patient days on treatment, VRON-0200 demonstrated a strong safety profile, with no serious adverse events, patient withdrawals, or significant laboratory anomalies, including liver function tests, being reported.

Among the nine patients who had at least 28 days of immunologic follow-up, five exhibited notable increases in CD8+ T cell responses post-vaccination. Remarkably, several of these patients maintained T cell responses above their pre-treatment levels up to day 91. This indicates that VRON-0200 can stimulate immune responses even in patients with minimal pre-existing immunity.

Professor Gane highlighted the significance of these findings: "Chronic HBV patients typically suffer from immune exhaustion. Traditional immunomodulatory therapies, like therapeutic vaccines, have failed to elicit strong HBV-specific T- and B-cell responses. The fact that a single intramuscular injection of VRON-0200 could induce T cell responses in the majority of patients is very promising. This immunotherapy's ease of administration and favorable safety profile are crucial for potential HBV treatments."

Dr. Sue Currie, COO of Virion Therapeutics, emphasized the importance of these initial results. "Immune-based treatments are essential for achieving a functional cure for chronic HBV. These data from VRON-0200, the first checkpoint modifier T cell vaccine, show that even a single low dose can induce immune responses in chronically HBV-infected patients. Building on these positive outcomes, we are now examining VRON-0200 further, both alone and in combination with other investigational agents. More data will be forthcoming soon."

The Phase 1b VRON-0200 study is a multi-center, open-label trial involving dose escalation and both prime-only and prime-plus-boost therapeutic vaccination strategies. The trial includes non-cirrhotic, HBeAg positive or negative chronic HBV patients already on nucleos(t)ide antiviral therapy with specific HBV DNA and HBsAg levels. Cohort 1 involves a low dose of VRON-0200, while Cohort 2 involves a higher dose. Patients in each cohort are randomized to receive either a single prime vaccination or a prime and boost regimen. Cohort 3, set to start later this year, will explore VRON-0200 in combination with other investigational agents.

Chronic HBV remains a significant global health issue, with an estimated 296 million infected individuals worldwide and approximately 820,000 deaths annually due to HBV-related liver complications. Despite the availability of a preventative vaccine, there is no cure for chronic HBV, and current treatments require lifelong antiviral therapy.

VRON-0200 is designed to provide a functional cure for chronic HBV by enhancing CD8+ T cell responses, which are typically exhausted in chronic infection. Preclinical data suggest that VRON-0200 can modify checkpoints to amplify and broaden T cell responses, potentially leading to improved viral control.

Virion Therapeutics, established in 2018, focuses on developing T cell-based immunotherapies for cancer and chronic infectious diseases. The company leverages proprietary genetically encoded checkpoint modifiers to enhance CD8+ T cell responses. Virion's pipeline includes the VRON-0200 program for chronic HBV and the VRON-0300 program for advanced solid tumors. In 2023, Virion formed a joint venture with Ocean Biomedical to accelerate the development of its innovative immunotherapies.

These promising VRON-0200 results mark a significant step toward a functional cure for chronic HBV, offering hope to millions affected by the virus worldwide. Additional data and studies will further clarify the potential of this novel immunotherapy in combating chronic HBV infection.

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