PIPELINE
VesiculoVax™ Prophylactic Vaccines
for Public Health and Biodefense:

Profectus utilizes VesiculoVax™-vectored vaccines for emerging infectious disease indications where the rapid induction of neutralizing antibodies is needed to protect against the viruses causing hemorrhagic fevers (Ebola, Marburg, Lassa), encephalitic disease (VEE, EEE, WEE), and arthralgic disease (chikungunya). VesiculoVax™ vectors are negative-strand, non-segmented RNA viruses of the order Mononegavirales that have been modified to enable the delivery of vaccine immunogens. These vectors are particularly attractive because there is little pre-existing immunity in humans and they can be engineered to abundantly express the surface glycoproteins of targeted viruses in the authentic form that induces the immune system to produce the most effective antibody response. In addition, VesiculoVax™ vectors are replication competent and deliver the innate signals that induce the immune system to produce a potent and durable response. The Profectus prototype VesiculoVax™ vector (vesicular stomatitis virus, VSV) has demonstrated single dose protection of monkeys against lethal challenge with Ebola and Marburg viruses. A VesiculoVax™ VSV vectored HIV vaccine has completed a clinical trial that demonstrated safety, 100% vaccine take, and immunogenicity across a range of doses. A second immunologically distinct VesiculoVax™ vector has been developed to the point that it has demonstrated protective efficacy in an animal model of lethal encephalitic disease caused by VEE and EEE viruses.
PRECLINICAL-STAGE VESICULOVAX™ PROPHYLACTIC VACCINES
Ebola and Marburg Viruses
Profectus is developing vaccines for pre- and post-exposure protection against the hemorrhagic disease caused by Ebola and Marburg viruses.

Program Status:
Multiple studies conducted by a team from the NIAID, CDC, FDA, and DoD have shown that a single dose of the Profectus VesiculoVax™ vectored Ebola and Marburg vaccines provides 100% protection of non-human primates against challenge with 1,000 times the lethal dose of both Ebola and Marburg viruses. A trivalent VesiculoVax™ vectored vaccine to protect against all filoviruses has entered non-human primate testing with financial support from the NIAID.

Unmet Medical Need:
There are presently no approved active or passive interventions for exposure to Ebola and Marburg viruses as the result of natural outbreak, laboratory accident, or deliberate misuse. Public health concern is based on both the emerging infectious disease status of these viruses and their potential use as biologic weapons.

Venezuelan, Eastern, and Western Equine Encephalitis Viruses (EEVs)
Profectus is developing a prophylactic vaccine for protection against encephalitis caused by the Venezuelan, Eastern and Western Equine Encephalitis Viruses.

Program Status:
Preclinical studies have demonstrated single-dose protective efficacy of VesiculoVax™-vectored vaccines in an animal model of lethal encephalitic disease caused by the Venezuelan and Eastern equine encephalitis viruses.

Unmet Medical Need:
These mosquito-transmitted viruses are endemic to North, Central, and South America. Public health concern is based on the emerging infectious disease status of these viruses that is associated with climate change, and their potential use as biologic weapons.

Chikungunya Virus
A VesiculoVax™-vectored vaccine is under development to protect against the arthralgic disease caused by infection with chikungunya virus.

Program Status:
A prototype vaccine has demonstrated single dose protection against lethal infection in the mouse model of disease. With support from the NIAID, several vaccine candidates have been optimized and are undergoing immunogenicity testing for selection of the lead vaccine.

Unmet Medical Need:
This mosquito transmitted virus is historically endemic to tropical areas of Africa and Southeast Asia. However, the mosquito vector is now widely distributed in Europe and the Americas, with recent outbreaks having spread to Europe and individuals returning to the United States from endemic areas.

Lassa Virus
Profectus is developing a VesiculoVax™-vectored vaccine to protect against Lassa hemorrhagic fever.

Program Status:
Several vaccine candidates have been constructed and are undergoing optimization prior to entering small animal immunogenicity testing.

Unmet Medical Need:
This rodent-borne virus infects up to 3 million humans per year in West Africa. Public health concern is based on both the emerging infectious disease status of this virus and its potential use as a biologic weapon.

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