EBViously, a spin-off from Helmholtz Munich (HMGU), is led by world-leading experts in Epstein-Barr virus biology, genetics, and immunity and was founded to develop a safe and highly effective preventive vaccine against a range of diseases caused by Epstein-Barr virus (EBV), including infectious mononucleosis, immune disorders, multiple sclerosis, and various cancers. The spin-off is based on a project of HMGU supported by the German Center for Infection Research (DZIF). The project leading to the spin-off was co-funded by the DZIF to enable GMP manufacturing allowing the start of clinical trials in 2024. EBViously will present its approach and technology at the World Vaccine Congress 2023 (April 4-6, 2023) in Washington, DC, USA.
The first vaccine candidate, named EBV-001, is based on non-infectious EBV-derived virus-like particles (VLPs). It is a highly immunogenic, multi-antigen vaccine that mimics the original viral pathogen and its complexity, delivering more than 50 viral antigens in their native conformation. EBViously has generated positive preclinical proof-of-concept data on the immunogenicity of the vaccine candidate. Moreover, the induction of a broad humoral and cellular immune response has already been demonstrated in animal models, reflecting the spectrum of antiviral immunity in humans.
VLPs resemble actual virus particles, but do not contain any viral genetic material. With the authentic structure of the virus, these empty shells signal an EBV infection to the immune system and elicit a highly specific immune response from both the humoral and the cellular parts of the immune system.
“Based on our very favorable preclinical proof-of-concept data regarding the immunogenicity of the vaccine, we are confident that EBV-001 can effectively prevent the development of infectious mononucleosis and the often associated chronic fatigue syndrome,” says Axel Polack, M.D., designated CEO of EBViously. “A GMP process has been established by a commercial CMO and our goal is to begin clinical trials in 2024.”
“As a primary indication, we are targeting the prevention of infectious mononucleosis, also known as kissing disease or glandular fever, and post-infectious fatigue/chronic fatigue (ME/CFS), a common, long-COVID-like protracted disease following infectious mononucleosis,” says Prof. Wolfgang Hammerschmidt, designated CSO of EBViously. “Other potential indications include the prevention of post-transplant lymphoproliferative disease (PTLD) and EBV-associated cancers. As infectious mononucleosis is a known risk factor for multiple sclerosis, there is great hope that our vaccine may also reduce the incidence of this chronic neurodegenerative autoimmune disease.”
EBViously specialises in novel vaccines based on next-generation virus-like particles. The Company is a spin-off from Helmholtz Munich (HMGU) and is led by a group of renowned experts in the field of Epstein-Barr virus research. EBViously has so far received €9.6 million in funding from Helmholtz Validierungs Fonds (HVF) and the German Center for Infection Research (DZIF). Additional collaboration partners are Ludwig-Maximilians-Universität München (LMU) and University Hospital rechts der Isar (TUM MRI).
Epstein-Barr virus is one of the nine known herpesviruses and one of the most common viruses found in humans. It is estimated that approximately 90% of the world´s population is infected with EBV. Infections typically occur in early childhood and are usually asymptomatic. However, when infections occur later in life, they frequently cause infectious mononucleosis (“glandular fever”) and other serious complications. The virus is also associated with certain cancers – approximately 200,000 cancer cases worldwide, including several types of lymphoma, are attributed to EBV. In 2022, a large study documented that EBV infection is by far the most important risk factor for multiple sclerosis. A history of infectious mononucleosis further increases the risk.