ModeX’s MDX-2201 is being developed to treat Epstein-Barr Virus. Credit: Liza Gross / Wikimedia.

OPKO Health’s ModeX Therapeutics has signed an exclusive global licence and collaboration deal with Merck to develop a vaccine candidate for Epstein-Barr Virus (EBV), a leading cause of infectious mononucleosis.

Under the deal, ModeX and Merck will advance ModeX’s preclinical nanoparticle vaccine candidate targeting EBV, MDX-2201, to file an Investigational New Drug (IND) application.

Later, Merck will handle the clinical and regulatory activities, along with the commercialisation works of the product.

A joint steering committee of representatives from both companies will guide the pre-IND filing activity.

According to the deal, OPKO Health will receive a $50m upfront payment and is also eligible for up to $872.5m in development and commercialisation milestone payments, along with royalties on worldwide sales.

OPKO Health chief innovation officer and ModeX president and CEO Gary Nabel said: “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.

“Targeting four proteins used by EBV to infect cells, this vaccine candidate embodies the novel multitargeting approach developed by ModeX scientists.”

MDX-2201 is developed using the ferritin nanoparticle vaccine platform of ModeX that can express 24 recombinant antigen copies on its surface for improving the presentation of virus key components and stimulating durable protective immunity.

It presents antigens from four viral proteins, gp350, gH, gL, and gp42 that are involved in viral entry into host cells.

The vaccine candidate uses the company’s biologics platform for targeting multiple proteins of EBV.

Last month, Merck reported a 12.9% increase in its net sales to €22.23bn in fiscal 2022

NATICK, Mass. – September 28, 2023 – ModeX Therapeutics Inc., an OPKO Health, Inc. company (NASDAQ: OPK), has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services (HHS), to advance a platform and specific candidates designed to address a range of public health threats in viral infectious diseases.

The awarded funding will enable research, development and clinical evaluation of potent multispecific antibodies, based on ModeX proprietary MSTAR technology. MSTAR is a flexible plug-and-play platform able to incorporate four to six independent antibody binding sites into a single molecule, dramatically expanding their therapeutic potential while enabling rapid responses to emerging infections and their viral variants, including COVID-19, influenza, and other pathogens.

The SARS-CoV-2 program is supported by HHS’ Project NextGen, which is dedicated to advancing a pipeline of innovative vaccines and therapeutics against COVID-19. The BARDA contract includes an initial $59 million for the development, manufacturing, and execution of a Phase 1 clinical trial for a next-generation MSTAR multispecific antibody with broad neutralizing activity against known variants of SARS-CoV-2. Such antibodies have the potential for both treatment and prevention of COVID-19.

This initiative builds on a collaboration between ModeX and the Vaccine Research Center of the National Institutes of Health (NIH) for the discovery and characterization of novel therapeutic antibodies against SARS-CoV-2. Additional funding of up to $109 million may be available from BARDA upon achieving particular milestones to develop multispecific antibodies targeting other viral pathogens such as influenza. As part of the research program, gene-based delivery methods for the multispecific antibodies will be developed using mRNA or DNA vectors to leverage the body’s natural protein production processes.

“We are excited to partner with BARDA to advance the potential of our MSTAR multispecific antibody platform as a versatile solution to major viral threats,” said Drs. Gary Nabel and Elias Zerhouni, Co-Founders of ModeX and, respectively, President, Chief Executive Officer of ModeX and President of OPKO. “This support allows ModeX to evaluate promising candidates in clinical trials to treat or prevent SARS-CoV-2 infection and explore the utility of the platform against diverse viruses. We eagerly anticipate working closely with BARDA to explore and further advance this innovative platform.”

“This BARDA award represents the second major collaboration this year built on the strength of ModeX’s research and development programs,” added Dr. Phillip Frost, Chief Executive Officer of OPKO. “In March 2023, ModeX entered into an exclusive worldwide license and collaboration agreement with Merck to develop MDX2201, its nanoparticle vaccine candidate for Epstein-Barr virus. With BARDA’s support, ModeX is poised to advance another exciting new technology with high potential to benefit patients.”

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00056.

About ModeX Therapeutics

ModeX Therapeutics is a clinical-stage biopharmaceutical company developing innovative multispecific biologics for cancer and infectious disease. Its platforms unite the power of multiple biologics in a single molecule to create multispecific antibodies and vaccines with unprecedented versatility and potency in fighting complex disease. The ModeX pipeline includes candidates against both solid and hematologic tumors, as well as several of the world’s most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is an OPKO Health company based in Natick, Massachusetts. For more information, please visit www.modextx.com.

About OPKO Health, Inc.

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. For more information, visit www.opko.com.