PHILADELPHIA, PA — Virion Therapeutics LLC reported data showing its experimental hepatitis B immunotherapy VRON-0200 generated sustained immune responses in chronically infected patients following a single dose, the company announced at the 33rd Conference on Retroviruses and Opportunistic Infections in Denver.
The data come from an ongoing Phase 1b trial evaluating VRON-0200, an investigational T cell-based immunotherapy intended to help achieve a functional cure for chronic hepatitis B virus infection.
According to the company, a single intramuscular dose of VRON-0200 triggered HBV-specific immune activity in a majority of patients with chronic infection. Reductions in hepatitis B surface antigen, or HBsAg, were sustained or deepened through Day 360 of follow-up.
The results were presented by Sue Currie, Ph.D., of Virion Therapeutics during a late-breaking session at the conference.
Currie said current and investigational HBV treatments often fail to restore the patient’s immune response against the virus, which can allow the virus to return after therapy stops.
“We are now at a pivotal point in the development of potential functional cures for chronic HBV,” Currie said. “These treatments, however, are limited by their inability to restore a patient’s own immune responses against the virus.”
She added that VRON-0200 has shown “durable clinical activity with sustained and/or improving anti-HBV responses up to one year following a single dose,” which could reduce the need for additional medications after antiviral treatment ends.
The therapy is also being studied in combination with investigational antiviral agents designed to reduce viral antigens. Currie described the approach as a “spark and fan” model, in which VRON-0200 primes the immune response while antivirals reduce viral levels to enhance the effect.
Andrew Luber, Pharm.D., chief executive officer of Virion Therapeutics, said the therapy uses checkpoint modifiers designed to strengthen immune responses while limiting broader immune-related side effects.
“Locally acting checkpoint modifiers enhance, broaden, and prolong immune responses to chronic infections and cancer,” Luber said.
He said the company is preparing a Phase 2b trial, known as SPARK-B, to test VRON-0200 in combination with investigational antivirals for potential HBV functional cure strategies.
Virion is also evaluating whether its checkpoint modifier technology could be applied to other chronic viral diseases, including HIV, hepatitis D virus, herpes simplex virus type 2, and Epstein-Barr virus, as well as oncology treatments through its VRON-0300 program for advanced solid tumors.
More information about the VRON-0200 study is available at ClinicalTrials.gov under identifier NCT06070051. The conference presentation can be downloaded from www.VirionTx.com.
Chronic hepatitis B remains a major global health issue. Despite the availability of a preventive vaccine, an estimated 254 million people worldwide are living with chronic HBV infection, and about 1.1 million deaths occur annually from related liver complications, according to global health estimates.
Current standard treatment relies on lifelong antiviral therapy to control the virus, but no cure is available. Researchers are increasingly exploring immune-modulating therapies as part of strategies to achieve long-term control or functional cure of the disease.
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