for Public Health and Biodefense:
Ebola/Marburg | EEVs | Chikungunya | Lassa | RSV | CCHFV
Auro Vaccines 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, CCHFV), encephalitic disease (VEE, EEE, WEE), arthralgic disease (chikungunya) and respiratory disease (RSV). VesiculoVax™ vectors are negative-strand, non-segmented RNA viruses that have been modified to enable the safe 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 Auro Vaccines’ 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 and a VesiculoVax™ VSV vectored Ebola vaccine have both completed phase I clinical evaluation demonstrating safety, 100% vaccine take, and immunogenicity across a range of doses. A series of immunologically distinct VesiculoVax™ vectors have been developed to the point that they have demonstrated protective efficacy in animal models of lethal disease caused by VEE, EEE, and WEE viruses.
CLINICAL-STAGE VESICULOVAX™ PROPHYLACTIC VACCINES
Filoviruses
Auro Vaccines has developed VesiculoVax™-vectored vaccines for pre- and post-exposure protection against the hemorrhagic disease caused by multiple species of filovirus (i.e. Zaire ebolavirus, Sudan ebolavirus and Marburg virus).
Program Status:
Multiple studies conducted by a team from the NIAID, CDC, FDA, and DoD have shown that a single dose of the Auro Vaccines’ tri-valent VesiculoVax™ vectored filovirus vaccine provides 100% rapid-onset protection of non-human primates against challenge with 1,000 times the lethal dose of Zaire ebolavirus, Sudan ebolavirus and Marburg virus. A mono-valent VesiculoVax™ vectored Ebola vaccine has completed phase I clinical evaluation demonstrating safety, 100% vaccine take, and immunogenicity across a range of doses. Auro Vaccines has out-licensed the VesiculoVax™-vectored Zaire ebolavirus, Sudan ebolavirus and Marburg virus vaccines to Emergent BioSolutions for further clinical development and licensure.
Unmet Medical Need:
Confirmed outbreaks of Ebola virus disease (EVD) have been documented since the 1970s, primarily in areas of sub-Saharan Africa, where the virus is always present at low levels in certain infected wild animals. On rare occasions, people become sick with EVD after coming into direct contact with infected animals, which can then lead to EVD outbreaks when the virus spreads between people.
An outbreak in three West African countries (Guinea, Liberia and Sierra Leone) from 2014 to 2016 resulted in more than 28,000 cases of EVD and more than 11,000 deaths that were caused by Zaire ebolavirus. In 2019, The U.S. Food and Drug Administration (FDA) approved Merck’s Ebola vaccine rVSV-ZEBOV (tradename “Ervebo”). The rVSV-ZEBOV vaccine has been found to be safe and protective against only the Zaire ebolavirus species of ebolavirus. In 2020, the European Commission granted Marketing Authorization for Janssen’s two-dose (Ad26.ZEBOV and MVA-BN-Filo) Ebola vaccine regimen.
PRECLINICAL-STAGE VESICULOVAX™ PROPHYLACTIC VACCINES
Chikungunya Virus
Auro Vaccines has developed a VesiculoVax™-vectored vaccine to protect against the arthralgic disease caused by infection with Chikungunya virus.
Program Status:
The vaccine has demonstrated single dose protection against lethal infection in the mouse model of disease. Pre-IND discussions have been held with the FDA and pre-clinical safety studies (i.e repeat dose toxicology, neurovirulence and biodistribution) have been completed. The candidate is scheduled to enter Phase I clinical evaluation in 2021.
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.
Venezuelan, Eastern, and Western Equine Encephalitis Viruses (EEVs)
Auro Vaccines has developed prophylactic vaccines 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.
Lassa Virus
Auro Vaccines has developed a VesiculoVax™-vectored vaccine to protect against Lassa hemorrhagic fever.
Program Status:
The vaccine candidate has demonstrated efficacy in a non-human primate challenge and has completed IND-enabling toxicology studies. The program has been out-licensed to Emergent BioSolutions and is scheduled to enter Phase I clinical evaluation in 2021.
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.
Respiratory Syncytial Virus
Auro Vaccines is developing a VesiculoVax™-vectored vaccine to protect against infection with respiratory syncytial virus (RSV) infection.
Program Status:
Multiple VesiculoVax™-vectored vaccine candidates have been developed and are being screened for immunogenicity and efficacy in various small animal models.
Unmet Medical Need:
In the USA approximately 4-5 million children <4 years are infected per year, with more than 57,000 requiring hospitalization. Globally, >30 million children <5 years are infected per year, with more than 3.4 million hospitalized.
Crimean Congo Hemorrhagic Fever Virus
Auro Vaccines in collaboration with the US National Institutes of Health and the University of Texas Medical Branch at Galveston are developing a VesiculoVax™-vectored vaccine to protect against infection with Crimean Congo hemorrhagic fever (CCHF) virus infection.
Program Status:
Multiple VesiculoVax™-vectored vaccine candidates are being developed and will be screened for immunogenicity and efficacy in various animal models.
Unmet Medical Need:
CCHF is endemic in Africa, the Balkans, the Middle East and western and south-central Asia. The main vector transmitting the virus, the Hyalomma marginatum tick, is widely distributed across southern and eastern Europe. Humans may also become infected through direct or indirect contact with the blood or organs of infected animals. As a result of its high case fatality rate (10-40%), ability to spread easily by human-to-human contact, and potential for aerosol release, CCHFV is classified by the National Institute of Allergy and Infectious Diseases (NIAID) as a Category A priority pathogen. The World Health Organization (WHO) has also recently placed CCHFV on their list of top 10 priorities for emerging virus research.