Profectus BioSciences, Inc. 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, according to a 2 Oct press release.
The base period of the contract, with a value of $6.96 million, will support a proof-of-concept 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.
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 1, 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.
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.
The Profectus VesiculoVax™ vaccine delivery technology is based on the discovery that replication competent vesiculoviruses are uniquely suited for use as vaccine vectors. This discovery was made in the laboratory of Dr. John Rose and patented by Yale University.
Building on these discoveries, Profectus scientists have introduced multiple non-reversible genetic modifications into the prototype vesicular stomatitis virus (VSV) that render it safe for human use. The VesiculoVax™ platform consists of a growing family of attenuated, non-cross-reactive vaccine vectors.
This project has received funding from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract HHHSN272201700077C “Advanced Development of Multivalent Vaccine Candidates for Filoviruses and Lassa Fever”.
