ModeX teams up with Merck to develop MDX-2201 vaccine for EBV

Epstein-Barr virus is thought to be strongest risk factor for MS

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by Patricia Inacio, PhD |

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A new collaboration between ModeX Therapeutics and Merck, known as MSD outside North America, is expected to advance the development of ModeX’s MDX-2201, an investigational vaccine targeting the Epstein-Barr virus (EBV).

A history of infection with EBV — known for causing infectious mononucleosis, or mono, and certain types of cancer — is believed to be the strongest risk factor for multiple sclerosis (MS). Indeed, a study last year showed it may increase a person’s risk of developing MS by more than 30 times.

Under the agreement, the two companies will work together to continue the preclinical development of MDX-2201. They also will collaborate to file an investigational new drug (IND) application with the U.S. Food and Drug Administration requesting clearance to test the vaccine candidate for EBV in clinical trials.

After the IND filing, Merck will become solely responsible for the vaccine’s clinical development and regulatory activities, as well the therapy’s potential commercialization, pending approval by regulatory agencies.

“We are delighted to enter this collaboration with Merck to develop a vaccine against EBV, a virus that takes a profound toll on human health worldwide,” Gary Nabel, MD, PhD, president and CEO of ModeX, said in a press release.

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Merck already has developed vaccines with the potential to help protect against certain cancers. Now, the company is setting its sights on a vaccine for EBV.

“We look forward to working with the ModeX Therapeutics team to apply our experience and expertise to evaluate the potential of MDX-2201 to help protect against EBV infection and other, potentially related, conditions,” said Tarit Mukhopadhyay, PhD, vice president of infectious diseases and vaccine discovery at Merck Research Laboratories.

EBV mainly infects and replicates in two cell types: epithelial cells, which line most surfaces in the body, and B-cells, a type of immune cell implicated in MS.

After infection, the virus remains in a dormant state inside these cells. Prior research has shown that infected immune cells may be involved in initiating the autoimmune attack that drives neurodegeneration in MS.

We look forward to working with the ModeX Therapeutics team to apply our experience and expertise to evaluate the potential of MDX-2201 to help protect against EBV infection and other, potentially related, conditions.

MDX-2201 is an experimental vaccine developed with ModeX’s ferritin nanoparticle vaccine platform, which can load up to 24 copies of an antigen — a molecule capable of triggering an immune response — into a ferritin nanoparticle. By carrying more antigen molecules at the nanoparticle’s surface, these vaccines may have greater potency in fighting disease.

This vaccine candidate, in particular, is made of a nanoparticle carrying four types of viral proteins — gp350, gH, gL, and gp42 — that are important for the entry of EBV into cells. A preclinical study confirmed that this multitarget approach elicited a potent immune response in mice, ferrets, and nonhuman primates.

“Targeting four proteins used by EBV to infect cells, this vaccine candidate embodies the novel multitargeting approach developed by ModeX scientists,” said Nabel, who also is chief innovation officer of OPKO, the company that acquired ModeX last year.

ModeX Therapeutics is harnessing the power of its platform to develop vaccines for infectious diseases and cancer.

“We founded ModeX to develop innovative multispecific biologics for cancer and infectious diseases that target multifactorial pathways that cause illness,” said Elias Zerhouni, MD, president and vice chairman of OPKO.

“This first collaboration leverages our scientific excellence and innovative platforms along with Merck’s discovery and clinical development expertise with the goal of benefiting patients around the world,” Zerhouni added.

Under the terms of the agreement, OPKO will receive an upfront payment of $50 million from Merck. The company also is eligible for up to $872.5 million in additional payments pending certain development and commercialization milestones, as well as royalties on global sales if the therapy ultimately is approved.

“Merck represents the ideal partner to develop and commercialize a new vaccine candidate, and we are particularly proud to enter into this high-potential agreement,” said Phillip Frost, MD, chairman and CEO of OPKO.