ModeX Therapeutics Inc., an OPKO Health company, announces dosing of the first participant in the phase I study (NCT06655324) of an Epstein-Barr virus (EBV) vaccine candidate being developed in collaboration with Merck, known as MSD outside the United States and Canada. This development triggers an undisclosed cash milestone payment from Merck to ModeX.
“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,” said Gary Nabel, M.D., Ph.D., president and chief executive officer of ModeX and chief innovation officer of OPKO.
The investigational vaccine based on MDX2201 is being evaluated for safety and tolerability in up to 200 healthy adults against EBV.
“We are grateful to the participants and physicians who are actively engaged with Merck in our joint efforts to explore the potential of MDX2201 as a novel vaccine against EBV,” said Elias Zerhouni, M.D., president and vice chairman of OPKO. “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.”
MDX2201 is based on ModeX’s ferritin nanoparticle vaccine platform, which can express as many as 24 copies of a recombinant antigen on its surface to enhance the presentation of key components of the virus and stimulate durable protective immunity. MDX2201 presents antigens from four viral proteins involved in viral entry into host cells. These include a recombinant antigen designed from the proteins gH, gL and gp42, as well as an antigen derived from gp350. By using ModeX’s multi-targeted approach, this combination inhibits infection in two cell types, B cells and epithelial cells, which contrasts from efforts that previously focused on gp350 alone. This EBV vaccine technology was the subject of preclinical data published in May 2022 in Science Translational Medicine.
Epstein-Barr virus (EBV), a member of the herpes virus family, is one of the most common human viruses. Most people are infected with EBV at some point during their lives. EBV can cause infectious mononucleosis, also called mono, and is associated with other illnesses, including some specific types of cancer and multiple sclerosis. There are currently no FDA approved vaccines or treatments for EBV infection.
ModeX Therapeutics is a clinical-stage biopharmaceutical company developing innovative multispecific biologics for cancer and infectious disease.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies.
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