ModeX Therapeutics' Epstein-Barr Vaccine Candidate Begins Phase I Trial with Merck

ModeX Therapeutics Inc., aligned with OPKO Health, has initiated the first phase of clinical trials for a groundbreaking Epstein-Barr virus (EBV) vaccine, marking a significant step forward in addressing a virus that currently lacks any approved treatments or vaccines. The Phase I trial, undertaken in conjunction with Merck (known as MSD outside North America), involves the administration of an experimental vaccine to its inaugural participant. This progression has led to an undisclosed financial milestone payment from Merck to ModeX.

EBV is a prevalent virus, notorious for causing infectious mononucleosis, commonly referred to as mono. More critically, it is linked to various forms of cancer and autoimmune conditions like multiple sclerosis. The absence of FDA-approved vaccines or therapies for EBV makes the development of a vaccine a critical public health goal.

ModeX's investigational vaccine, MDX2201, utilizes its innovative ferritin nanoparticle technology, which can present multiple recombinant antigens to stimulate a comprehensive immune response. This novel approach involves four viral proteins crucial for EBV's entry into host cells, effectively targeting both B cells and epithelial cells. The vaccine's design intends to offer robust and lasting immunity, in contrast to earlier attempts that concentrated solely on the gp350 protein.

Gary Nabel, President and CEO of ModeX and Chief Innovation Officer of OPKO, highlights the vaccine's potential to mitigate the severe health risks posed by EBV, including its long-term implications such as cancer and autoimmune disorders. The collaboration with Merck harnesses their clinical expertise alongside ModeX's unique vaccine technology, aiming to develop a preventive solution against EBV.

The Phase I study, identified as NCT06655324, will assess the safety and tolerability of MDX2201 in up to 200 healthy adult participants. Elias Zerhouni, President and Vice Chairman of OPKO, expressed gratitude towards the participants and healthcare professionals involved in this collaborative venture with Merck, underlining the potential global impact of a successful EBV vaccine.

ModeX Therapeutics is a pioneering force in the biopharmaceutical sector, focusing on developing multispecific biologics for both cancer and infectious diseases. With a pipeline that targets some of the most urgent viral threats globally, ModeX's innovative approach integrates multiple biologics into single molecules, creating potent and versatile antibodies and vaccines.

Based in Weston, Massachusetts, ModeX operates under OPKO Health, a multinational company emphasizing strategic positions in rapidly expanding markets. OPKO leverages its expertise in discovery, development, and commercialization to address significant medical challenges.

As ModeX advances with its EBV vaccine trials, the scientific community remains hopeful that MDX2201 will pave the way for effective prevention strategies against EBV-related health issues. The ongoing research and clinical evaluations aim to provide a breakthrough in combatting a virus that affects a vast majority of the global population.