Virion Therapeutics LLC, a US-based clinical-stage biotechnology company, announced on Wednesday initial safety data from the first-ever human data from its novel, first-in-class, checkpoint modifier immunotherapy, VRON-0200, for HBV functional cure.

The findings were presented at the 33rd Annual Meeting of APASL (The Asian Pacific Association for the Study of the Liver) in Kyoto, Japan.

These initial Phase 1B safety results, on the first 10 chronically infected hepatitis B patients on nucleos(t)ide antiviral therapy, all of whom received a single, low dose, intramuscular injection of VRON-0200, demonstrated that it was safe and well-tolerated, with no significant adverse events reported and no other clinically relevant abnormalities in laboratory tests, electrocardiograms (ECGs) or vital signs.

VRON-0200 is a therapeutic immunotherapy, administered by intramuscular injection, designed with the goal of providing a functional cure for chronic HBV infection.

Dr. Sue Currie, Virion COO, and one of the study authors, said: "Finding a treatment for chronic HBV-infected patients will almost assuredly require an immune-based component to help control the infection. To date, the best responses have been observed with regimens that contain pegylated interferon, which requires weekly injections and is often accompanied by high rates of adverse events. These VRON-0200 data -- the first ever for a checkpoint modifier containing T cell vaccine of any kind -- represent a critical first step in Virion's mission to bring a safe, well tolerated, and easy to administer interferon-sparing functional cure immunotherapy to HBV-infected patients worldwide. We look forward to sharing additional safety, and the first-ever immunogenicity data, from this trial later this year."