Virion Therapeutics Presents VRON-0200 Preclinical Data Showing Direct Correlations Between Intrahepatic CD8+ T cells and Hepatitis B Virus Declines (HBV) at EASL 2023

VIENNA, June 21, 2023 /PRNewswire/ -- Virion Therapeutics, LLC, a clinical stage company developing T cell-based immunotherapies for cancer and chronic infectious diseases, today, presented data entitled "Intrahepatic CD8⁺ T cells correlate with significant declines in HBV viral load and S antigen following a single vaccination with VRON-0200 in an AAV mouse model" at the European Association for the Study of Liver Diseases (EASL) annual Congress. These data were recognized as one of the Top 77 posters (out of 1,700 plus presentations) by the meeting organizers.

Chronic HBV infection impairs CD8⁺ T cell functions resulting in the loss of virus control. VRON-0200 is a therapeutic vaccine being developed for HBV Functional Cure that contains key HBV antigens, coupled to glycoprotein D (gD), a checkpoint modifier of early T cell activation.

Top line results, following a single intramuscular injection of VRON-0200, versus the same treatment without the checkpoint modifier, gD, include:

• Significantly enhanced frequencies of CD8⁺ T cells in the blood and livers, as well as a doubling of breadth of responses in spleens, in VRON-0200 treated mice
• Reproducible HBV DNA declines in blood of >3 log₁₀ copies/mL versus <1.5 log₁₀ copies/mL in VRON-0200 and non-gD treated mice, respectively
• HBV DNA declines in blood were strongly inversely correlated with the frequency of IFN-gamma CD8⁺ T cells in the liver (r² = -0.83)

"A treatment for chronic HBV infection whereby a patient's own immune system can control the infection, without the need for life-long antiviral therapies has been highly sought after," said Andrew Luber, Pharm.D., President, and Chief Executive Officer of Virion. "These data show a direct correlation between vaccine-induced T cells in the liver, where HBV replicates, and HBV declines in the blood; this, to our knowledge, is the first time that this has been observed for an immune-modulator or a vaccine. We believe this further support the potential role that VRON-0200 can play, for use alone, or in combination regimens, to achieve a functional cure and look forward to evaluating its potential in chronically HBV-infected persons starting this summer."

"VRON-0200 is unique in its ability to stimulate broad and sustained HBV-specific CD8⁺ T cell responses. Due to the gD checkpoint modifier adjuvant, which allows for T cell stimulation to weaker antigens that are normally not triggered by a natural infection, we expect to achieve activation of new HBV-specific T cells rather than recall of already activated and potentially impaired T cells which failed when a patient was first exposed to the virus. That makes VRON-0200 so promising," said Hildegund Ertl, MD, Professor, Vaccine & Immunotherapy Center, at The Wistar Institute in Philadelphia PA and Scientific Founder of Virion Therapeutics. 

PRESENTATION DETAILS
Presentation Title: "Intrahepatic CD8⁺ T cells correlate with significant declines in HBV viral load and S antigen following a single vaccination with VRON-0200 in an AAV mouse model
Abstract: #1285; TOP-107
Presenting Author: Andrew Luber
Presentation Date: June 23, 2023 

The above presentation is available via the EASL-ILC Meeting Site at: https://www.easlcongress.eu, and on Virion's website at https://www.viriontx.com/science/presentations-publications/.

ABOUT VRON-0200

VRON-0200 is 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. Our preclinical data support the hypothesis that VRON-0200 can mitigate this exhaustion through checkpoint modification by lowering the activation threshold and stimulating T cells to regions of the virus that are not normally activated during a chronic HBV infection (known as sub-dominant epitopes), which promotes further CD8⁺ T cell expansion and viral control. A Phase 1b study in chronically HBV-infected patients is scheduled to begin enrollment in Summer 2023.

ABOUT VIRION THERAPEUTICS, LLC

Virion Therapeutics, LLC, is a science driven company whose mission is to cure cancer and chronic infectious diseases through the development of novel and accessible CD8⁺ T cell-based immunotherapies. Our proprietary technologies combine genetically encoded checkpoint modifiers with selected and optimized target-specific antigens that are inserted into viral vectors to promote potent, prolonged, and broad CD8⁺ T cell responses. Founded in early 2018 to advance technology licensed from The Wistar Institute, an international leader in biomedical research with special expertise in vaccine, cancer and infectious disease research, Virion has built a best-in-class, experienced biotechnology management team, augmented by its advisory board that has extensive domain knowledge in antiviral, vaccine, and oncology therapeutic arenas. 

www.VirionTx.com

Media contact:
Dr. Sue Currie, Ph.D.
[email protected]
Phone: 1-800-841-9303

SOURCE Virion Therapeutics, LLC