Ocean Biomedical Inc (OCEA)

[INV4]

Virion Therapeutics, Ocean Biomedical begin patient dosing in phase 1b trial of VRON-0200 immunotherapy for chronic HBV infection

Philadelphia
Friday, October 27, 2023

Virion Therapeutics, LLC, a clinical-stage biotechnology company developing novel T cell-based immunotherapies, and its Joint Venture partner, Ocean Biomedical, Inc., announced that the first patients have been dosed in the phase 1b clinical trial of its investigational VRON-0200 immunotherapy, which is being evaluated as a functional cure for patients with chronic Hepatitis B virus (HBV) infection.

VRON-0200, a first-in-class treatment, using one of Virion's proprietary checkpoint modifiers, was specifically designed to enhance and broaden a patient's own immune response. This novel mechanism of action may help overcome one of the key problems faced in treating chronic HBV - immune exhaustion. The international, first-in-human VRON-0200 phase 1b study is currently enrolling patients in Hong Kong and New Zealand, with additional sites planned in the United States. Initial clinical data from this study are expected in early 2024.

"The initiation and dosing of patients in this VRON-0200 study is a critical first step in evaluating its impact on chronically HBV-infected patient's immune responses to the virus, with the ultimate goal of finding a cure for this insidious disease. The mechanism by which VRON-0200 works is a totally new approach to anything previously investigated or currently in development by others – we are looking forward to evaluating the first clinical data from this program, early next year," said Dr. Sue Currie, COO of Virion.

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 as there is no cure available. The current standard of care requires lifelong antiviral therapy to keep the virus in check.

Grace Wong, MD, Professor of Medicine at the Chinese University at Hong Kong (CUHK), and a principal investigator in the VRON-0200 study, commented, "Novel treatments that can control or potentially cure chronic HBV infection, that are easy to administer, and are well tolerated, alone, or in combination with other treatments, are in high need." Wong added, "VRON-0200, with its potential to expand a patient's own immune response to control the infection, coupled with how it is given - as a single (prime), or double (prime and boost) injection into the arm muscle, has the potential to be an innovative therapy to address this high global unmet medical need for patients with chronic HBV."

"The dosing of these first patients, in our lead VRON-0200 chronic HBV Phase 1b study, represents a major milestone in Virion's mission of bringing innovative immunotherapies to patients with cancer and chronic infectious diseases," said Virion's CEO, Dr. Andrew Luber. "Targeting T cell activation, via checkpoint modification, is unique to Virion. This first study, using our first checkpoint modifier, gD, not only benefits patients with chronic hepatitis B, but also, provides useful information for our proprietary platform technologies and pipeline, including VRON-0300, which is in development for patients with advanced solid tumours," Luber added.

Ocean Biomedical co-founder and executive chairman Dr. Chirinjeev Kathuria, commented: "This is another major clinical and business value inflection point for our company. Treatments for chronic HBV are in high demand and could capture an estimated global market of $6.5+ billion by 2032. Companies at a similar stage as our JV's VRON-0200 study, have seen large steps up in value. For example, VIR Biotechnology's value increased by over $3.6 billion dollars after they reported their initial 8 patient phase 1 data. Ocean is pleased to partner with Virion in bringing this high-need, high-value treatment – aiming for a functional cure - to patients with chronic HBV around the world."

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 to 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 (CPMs) to enhance and broaden CD8+ T cell responses to a tumour or chronic infection.

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 centres.

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