EBV-001 vaccine prevents EBV infection in lab-grown human cells
Trials to test vaccine in humans expected to launch in 2024, per developer
EBV-001, a vaccine candidate being developed by EBViously to target the Epstein-Barr virus (EBV), triggered the production of potent antibodies against the virus in mice, and blood samples from these animals prevented EBV infection in lab-grown human cells.
That’s according to new data presented by the company, which is developing the vaccine as a way to prevent infections by EBV. Such infections are implicated in diseases such as infectious mononucleosis, known commonly as mono, multiple sclerosis (MS), and some cancers.
The new preclinical data was presented at the World Vaccine Congress West Coast 2023, held Nov. 27-30 in Santa Clara, California. The presentation was given by Sebastian Goy, PhD, designated chief operating officer at EBViously.
The company, which is a spinoff from Helmholtz Munich, part of a German government research network, says it expects to start clinical trials in 2024 to test its EBV vaccine candidate in humans. The first trial will aim to prevent mononucleosis due to EBV infection, which also has been linked to a higher risk of MS.
“In addition to a strong preclinical data package, we now have everything in place for the start of clinical trials,” Axel Polack, MD, EBViously’s designated CEO, said in a company press release. “Following further confirmation of our preclinical efficacy data, we will apply for regulatory clearance to proceed towards a Phase I study.”
Even at low levels, EBV vaccine leads to strong B-cell response in mice
EBV is a member of the herpes virus family that’s estimated to affect nearly everyone — up to 95% of people — in the world’s population. Although the infection usually doesn’t cause symptoms, some patients may develop infectious mononucleosis, marked by fever, headaches, and swollen lymph nodes.
Following infection, the virus remains inactive inside B-cells — cells of the immune system responsible for producing antibodies, or blood proteins that can counteract specific bacteria.
There, the virus is thought to increase the cells’ activation, raising the risk of MS or certain B-cell cancers.
To date, EBV infection is believed to be one of the strongest risk factors for MS, with a study including more than 10 million U.S. adults showing that it increased the risk of developing MS by 32 times. The mechanisms aren’t fully understood, but it seems that certain viral proteins resemble some brain proteins, so an immune response directed against the virus also may target brain tissue.
EBV-001 is an experimental vaccine that mimics the original virus, carrying in its shell more than 50 viral proteins that can be recognized by the immune system to launch an attack when in contact with the actual virus. However, it does not contain any viral genetic material, so it cannot cause an infection.
EBViously reported previously that the vaccine generated an immune response in animal models, which included cellular immunity and the production of antibodies against the virus. These reactions reflect the broad spectrum of antiviral immunity in humans.
The new data presented by the company demonstrates that even at low levels, EBV-001 induces a specific and strong B-cell response in mice, leading to the production of high levels of antibodies against several viral proteins.
Based on our very favorable preclinical proof-of-concept data on the immunogenicity of the vaccine, we are confident that EBV-001 can effectively prevent the development of infectious mononucleosis.
Researchers also collected sera — the fluid component of the blood that contains antibodies — from these animals. It was able to prevent EBV infection of human B-cells and skin cells in lab cultures.
“Based on our very favorable preclinical proof-of-concept data on the immunogenicity of the vaccine, we are confident that EBV-001 can effectively prevent the development of infectious mononucleosis,” said Wolfgang Hammerschmidt, PhD, EBViously’s designated chief scientific officer.
To ensure the vaccine is ready to enter clinical trials, the company already has worked with an external contract manufacturing organization to establish optimized protocols to have the treatment consistently produced according to quality standards.
“We have established a scalable and robust manufacturing process and have set up all necessary immune monitoring tools to study the [antibody-based] and cellular immune response during clinical trials,” Polack said.
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