Profectus BioSciences has received a contract for up to $22.25 million from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. The base period of the contract, with a value of $6.96 million, will support a proof-of-concept (POC) study in non-human primates (NHP) and preparations for manufacture under Good Manufacturing Processes (GMP) of a vaccine designed to protect against Zaire ebolavirus, Sudan ebolavirus, Marburgvirus and Lassa viruses. The contract also includes $15.29 million in options that may be exercised by the NIAID to support GMP manufacture and clinical evaluation of the multi-component vaccine. The vaccine is being developed in lyophilized form to allow distribution without a cold chain and enable routine mass immunization.
Ebola and Marburg viruses belong to the filovirus family of viruses, which cause periodic outbreaks of a highly contagious and lethal human infectious disease marked by a hemorrhagic fever, with a mortality rate that ranges between 25% and 90%. The infection typically affects multiple organs in the body and is often accompanied by severe bleeding (hemorrhage). The virus is transmitted to people from wild animals and spreads in the human population through human-to-human transmission.
Lassa virus is endemic to West Africa, where it infects up to 300,000 individuals per year, resulting in 60,000 cases of severe multisystem disease and 5,000 deaths. Among those who survive, about one in eight suffer permanent deafness. The main reservoir of this virus is the multimammate rat, which lives in close proximity to humans and sheds the virus in its urine and feces.
At present, there are no FDA-approved pre- or post-exposure interventions available in the event of natural outbreak, laboratory accident, or deliberate misuse of these viruses. The filoviruses and Lassa viruses are classified as Category A Priority Pathogens by the NIAID, Centers for Disease Control (CDC), and U.S. Department of Defense because they can be easily transmitted from person to person and have the potential for major health impact. Working with these viruses requires specialized containment procedures, and the Profectus NHP POC study will be conducted in the biosafety level 4 (BSL-4) containment laboratories at the Galveston National Laboratories of the University of Texas Medical Branch at Galveston.
Preclinical studies have demonstrated that a three-component vaccine using the Profectus VesiculoVax platform provides rapid and durable protection of NHP against lethal disease caused by the Ebola and Marburg viruses. In addition, a phase I, placebo-controlled, dose-escalation study of the Ebola Zaire VesiculoVax vaccine demonstrated a low rate of side effects and a 100% response rate in vaccine recipients. The average response magnitude seen at the top dose of vaccine exceeded that associated with complete protection in previously published studies in NHP.
"We are gratified to enter into this co-development contract with the NIAID," said John Eldridge, Ph.D., Chief Scientific Officer of Profectus. "Our Lassa vaccine has shown excellent immunogenicity when combined with the multi-component Ebola/Marburg vaccine. We look forward to the clinical testing of a vaccine designed to prevent the annual burden of Lassa fever and the sporadic, but increasing, severe outbreaks of Ebola and Marburg."