ModeX Therapeutics, an OPKO Health company, has announced the commencement of a Phase I clinical trial for its Epstein-Barr virus (EBV) vaccine candidate, MDX2201, in collaboration with Merck. The first participant has been dosed in the study, triggering an undisclosed milestone payment from Merck to ModeX. This trial marks a significant step forward in the development of a vaccine against EBV, a virus with no current FDA-approved preventive or therapeutic options.
The Phase I study (NCT06655324) is designed to evaluate the safety and tolerability of MDX2201 in up to 200 healthy adult volunteers. The investigational vaccine is based on ModeX’s ferritin nanoparticle platform, engineered to present multiple copies of recombinant antigens on its surface to enhance immune stimulation.
MDX2201: A Multi-Targeted Approach
MDX2201 distinguishes itself from previous EBV vaccine development efforts by targeting four viral proteins involved in host cell entry: gH, gL, gp42, and gp350. This multi-targeted approach aims to inhibit EBV infection in both B cells and epithelial cells, contrasting with earlier vaccine candidates that primarily focused on gp350 alone. Preclinical data published in Science Translational Medicine demonstrated the potential of this approach.
Gary Nabel, M.D., Ph.D., President and Chief Executive Officer of ModeX and Chief Innovation Officer of OPKO, stated, “EBV infection can cause serious illness and pose long-term risks of cancer and autoimmunity. Through our collaborators at Merck, human trials to advance a novel vaccine candidate have now begun. Our nanoparticle vaccine aims to stimulate protective immunity in patients and prevent these diseases.”
The Burden of EBV
EBV is one of the most common human viruses, with most individuals becoming infected at some point in their lives. While often asymptomatic, EBV can cause infectious mononucleosis and is associated with several types of cancer, including Burkitt's lymphoma and nasopharyngeal carcinoma, as well as autoimmune diseases like multiple sclerosis. The development of an effective EBV vaccine could have a significant global health impact.
Collaboration and Future Development
The collaboration between ModeX and Merck combines ModeX’s innovative vaccine platform with Merck’s expertise in clinical development and commercialization. The companies will jointly advance MDX2201 through the IND application process. Merck intends to develop MDX2201 for protection against EBV infection and potentially related conditions.
Elias Zerhouni, M.D., President and Vice Chairman of OPKO, expressed gratitude to the participants and physicians involved in the trial, adding, “Our Merck collaboration combines their discovery and clinical development expertise with our innovative and unique technology platform against this latent virus where an approved vaccine could have significant implications for the majority of people around the world.”
