Epstein-Barr Virus Vaccine Candidate Launches Phase 1 Study

ModeX Therapeutics Inc. today announced the dosing of the first participant in the Phase I clinical trial of an Epstein-Barr virus (EBV) vaccine candidate, MDX2201.

The U.S. CDC says EBV, a member of the herpes virus family (human herpesvirus 4), is one of the most common human viruses. Most people (90%) are infected with EBV at some point during their lives. EBV infection can affect a person's brain, spinal cord, and nerves.

As of January 8, 2025, there are no U.S. FDA-approved vaccines or treatments for EBV or herpes infections.

This EBV vaccine is based on ModeX’s ferritin nanoparticle platform. Its surface can express as many as 24 copies of a recombinant antigen, enhancing the presentation of key virus components and stimulating 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 and an antigen derived from gp350.

This combination, using ModeX’s multi-targeted approach, inhibits infection in two cell types: B and epithelial cells. This contrasts with efforts previously focused on gp350 alone.

“EBV infection can cause serious illness and pose long-term risks of cancer and autoimmunity..... 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, in a press release on January 7, 2025.

This study's (V350-001) estimated completion date is November 18, 2026.

MDX2201 is being developed in collaboration with Merck.