Ocean Biomedical Congratulates Joint Venture Partner, Virion Therapeutics, on Positive Immunogenicity Results

Ocean Biomedical, Inc. congratulated its JV partner Virion Therapeutics, LLC, a clinical-stage biotechnology company developing novel T cell-based immunotherapies, on its late breaker presentation highlighting the first-ever human immunogenicity data from its novel checkpoint modifier immunotherapy for HBV functional cure (VRON-0200), at the EASL 2024 Congress in Milan, Italy.

The late breaker Phase 1b data presented, which includes Virion’s first checkpoint modifier, glycoprotein D (gD), demonstrated that VRON-0200 was not only safe and well tolerated, but immunogenic in the majority of chronically HBV-infected patients, following a single intramuscular injection.

“Chronic HBV infection severely impairs a patient’s ability to clear the virus. A single low dose injection of VRON-0200 was able to stimulate T cell responses in the majority of patients, most of whom had little, to no, documented HBV immunity prior to treatment” said Virion’s CEO, Dr. Andrew Luber. “VRON-0200 is our lead clinical program and these clinical safety and immunogenicity data will further support our proprietary platform technologies and other pipeline programs in development, including VRON-0300, which is for patients with advanced solid tumors.”

Unlike monoclonal antibody checkpoint inhibitors which attempt to “rescue” already activated, but exhausted, CD8⁺ T cells, Virion’s checkpoint modifiers alter T cell activation to amplify and broaden a patient’s own immune response; this may include regions of a tumor or infectious disease that are not normally stimulated during a chronic disease, thereby potentially producing a “new” immune response. Additionally, after it is administered through an intramuscular injection, the checkpoint modifiers act locally, at the injection site, and not throughout the body, thereby limiting the risk for serious adverse events such as those seen following the intravenous administration of monoclonal antibody checkpoint inhibitors.

Ocean Biomedical co-founder and Executive Chairman Dr. Chirinjeev Kathuria said “We congratulate Virion on these exciting data, as they continue to advance VRON-0200, not only as a safe, well tolerated, and easy to administer treatment, but also, now with positive clinical immunogenity data, which is advancing their goal of an interferon-sparing treatment option for the 300 million persons worldwide infected with Chronic HBV. Treatments for chronic HBV are in high demand and could capture an estimated global market of $6.5+ billion by 2032. Ocean is pleased to partner with Virion and we look forward to helping accelerate this, and other programs, in development.”

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. This includes almost 100 million persons in China who are affected by this disease. 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.

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 which may include T cells that are not normally activated during a chronic HBV infection, which results in improved viral control.

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. In early Fall 2023, Virion and Ocean Biomedical entered a joint venture to accelerate and expand Virion’s pipeline of novel immunotherapies. For more information, visit www.VirionTx.com.

Ocean Biomedical, Inc. is a Providence, Rhode Island-based biopharma company with an innovative business model that accelerates the development and commercialization of scientifically compelling assets from research universities and medical centers. Ocean Biomedical deploys the funding and expertise to move new therapeutic candidates efficiently from the laboratory to the clinic to the world. Ocean Biomedical is currently developing five promising discoveries that have the potential to achieve life-changing outcomes in lung cancer, brain cancer, pulmonary fibrosis, and the prevention and treatment of malaria. The Ocean Biomedical team is working on solving some of the world’s toughest problems, for the people who need it most. For more information, visit www.oceanbiomedical.com.