Profectus gets $9.5m Department of Defense funding to manufacture trivalent vesiculoVax-vectored Vaccine

In addition, the USACC has contracted for clinical evaluation of the VesiculoVax Zaire-Ebola virus vaccine to meet the current outbreak in West Africa.

The $9.5 million award has been made with Battelle Memorial Institute through the Chemical, Biological, Radiological, & Nuclear Defense Information Analysis Center (CBRNIAC) contract, a Defense Technical Information Center (DTIC) owned, Indefinite Delivery Indefinite Quantity (ID/IQ) contract vehicle for providing comprehensive scientific and technical research and analysis supporting the Department of Defense CBRN and Homeland Defense communities.

Battelle has contracted with Profectus for manufacturing and clinical evaluation and with Charles River Laboratories and Biologics Consulting Group for preclinical testing and IND preparation, respectively.

"While the urgent need today is for a vaccine that protects against the current Ebola Zaire outbreak, we are also anticipating the needs for tomorrow. We are continuing to develop a trivalent vaccine that will protect our service members and DoD civilians against the major filovirus threats: Ebola Zaire, Ebola Sudan, and Marburg viruses," said LTC Victor Suarez, MCS-JVAP Joint Product Manager.

"The available evidence suggests that a trivalent vaccine, such as the one under development by Profectus, is the desired end point as it would simultaneously offer protection against the current Ebola Zaire outbreak and also meet the long-term goals of preventing future infections by the Ebola Sudan and Marburg viruses. The DoD is optimistic that its long-term commitment to identifying and supporting safe and effective trivalent filovirus vaccines is coming to fruition and remains supportive to advancing the Profectus BioSciences trivalent Ebola/Marburg vaccine into human clinical trials as rapidly as possible."

"We are gratified that the Department of the Defense has recognized the potential of Profectus’ VesiculoVax Zaire-Ebola virus vaccine to combat the current outbreak in West Africa, and the potential of our multi-component vaccine to protect civilians and military personnel against all strains of filoviruses, whether from natural outbreak or deliberate misuse." said John Eldridge, PhD, Chief Scientific Officer of Profectus.

"More than 15 years have been invested in developing the genetically attenuated rVSVN4CT1 VesiculoVax vaccine delivery platform and demonstrating its safety in multiple clinical trials. To date, it is the only vaccine to demonstrate single-dose protection of monkeys against lethal challenge with highly virulent low-passage Ebola and Marburg viruses."

Profectus began development of VesiculoVax rVSVN4CT1 vectored Ebola and Marburg vaccines approximately 5 years ago in collaboration with Dr. Thomas Geisbert at the UTMB Galveston National Laboratories (GNL) and Dr. Heinz Feldmann at the NIH Rocky Mountain Laboratories. The initial studies demonstrated that a single dose of the rVSVN4CT1-Z-Ebola vaccine protected guinea pigs and rhesus macaques against morbidity and mortality when challenged with a lethal dose of Zaire-Ebola virus.

Subsequently, Profectus provided rVSVN4CT1 vectored Ebola and Marburg vaccine candidates into studies conducted by the Filovirus Animal Non-clinical Group (FANG). This team includes members from the National Institute for Allergy and Infectious Diseases (NIAID), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the U.S. Department of Defense (DoD), and is charged with identifying and filling knowledge gaps in the areas of assays, animal models, challenge material, and human clinical data in support of advanced development licensure studies for Ebola and Marburg vaccines.

In the FANG studies a single dose of the Profectus VesiculoVax rVSVN4CT1-vectored Ebola vaccine provided 100% protection of non-human primates against challenge with 1,000 times the lethal dose of highly pathogenic low passage Zaire-Ebola virus. In addition, a single dose of the Profectus VesiculoVax rVSVN4CT1-vectored Marburg vaccine provided 100% protection against challenge with 1,000 times the lethal dose of low passage Angola-Marburg virus.

Based on these results, Profectus has partnered with the NIAID, the Department of Defense’s Joint Vaccine Acquisition Program (JVAP), and the Biomedical Advanced Research and Development Authority (BARDA) in the development of rVSVN4CT1-vectored Ebola and Marburg vaccines. Currently funded efforts under these partnerships include:

• In April 2012, Profectus BioSciences and the GNL received a five-year $5.4 M grant from the NIAID supporting development of a trivalent Ebola/Marburg vaccine to protect against systemic exposure with all major strains of Ebola and Marburg viruses.
• In March 2014, the GNL, Profectus Biosciences, Tekmira Pharmaceuticals, and the Vanderbilt University Medical Center were awarded $26 million by the NIAID to advance combination treatments for Ebola and Marburg infection.
• In July 2014, Profectus BioSciences and the GNL were awarded a 3 year $8.5M grant from the DOD/JVAP to support development of a lyophilized trivalent VesiculoVax -vectored vaccine to protect against all major strains of Ebola and Marburg viruses delivered as aerosols. The lyophilized trivalent vaccine is being tested in both pre-exposure and post-exposure studies to confirm protection of non-human primates from aerosol exposure to Ebola and Marburg viruses.
• In October 2014, Profectus BioSciences was awarded a 1 year $5.8M contract with BARDA to manufacture the company’s novel VesiculoVax Zaire-Ebola vaccine candidate for use in Phase 1 clinical studies. The contract can be extended to a total of 13 months and $8.6 million. Profectus will apply to the U.S. Food and Drug Administration for an Investigational New Drug (IND) designation that would allow initiation of human clinical trials of the vaccine’s safety and immunogenicity in humans.

This most recent contract award for $9.5M from the JVAP through Battelle will support manufacture of the trivalent rVSVN4CT-vectored Ebola/Marburg vaccine, and phase 1 clinical evaluation of rVSVN4CT1-Zaire-Ebola virus vaccine for safety and immunogenicity. A rapid follow up trial of the trivalent vaccine is in planning.