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GUELPH, Ont., Canada, April 16, 2018— AntoXa Corporation has obtained a license from Defence Research & Development Canada (DRDC), an Agency of the Canadian Department of National Defence, to develop and produce an anti-ricin monoclonal antibody for sale in markets worldwide.

The licensing agreement follows work AntoXa and the J.C. Hall laboratory at the University of Guelph conducted with DRDC to develop and produce the plant-made antibody PhD9 as a medical countermeasure for ricin exposure, a program that has received more than $600,000 (CAD) from the Government of Canada since 2014.

“We anticipate market entry for the PhD9 anti-ricin antibody within two to three years, a timeline that is dependent on raising the necessary funds for scale up and other activities necessary to obtain regulatory approvals,” said Ashley Meyers, AntoXa Chief Technical Officer.

“This antibody will be produced in the vivoXPRESS® plant-based manufacturing system licensed from PlantForm Corporation, which uniquely addresses the critical need for cost-effective, large-scale production of antidotes for ricin and other potential terrorism threats.”

Ricin is a naturally occurring protein from the castor-bean plant, Ricinus communis. It is extremely toxic to humans when inhaled or injected and is listed as a Category B threat agent by the U.S. Centers for Disease Control and Prevention due to its ease of production, worldwide availability, relative stability and extreme lethality. There is currently no approved antidote against ricin poisoning. It acts very quickly and leaves a short window for administering therapeutic antibodies.

The PhD9 antibody drug candidate prevents ricin from penetrating cells. DRDC conducted in vitro and in vivo studies that found the plant-made version of the antibody showed therapeutic efficacy against ricin intoxication. The findings were presented at the Antibody Engineering and Therapeutics Conference in December 2015.

Next steps for the commercialization of PhD9 are transitioning to large-scale GMP manufacturing, product characterization, animal safety and efficacy studies, and a Phase 1 human clinical trial. Medical countermeasures do not require Phase 2 and Phase 3 human efficacy trials for ethical reasons, therefore the path to regulatory approval is shorter than for other pharmaceuticals.

About AntoXa Corporation (www.antoxacorp.com)

AntoXa Corporation is a Canadian biopharmaceutical company developing medical countermeasures to protect military and civilian personnel from biological and chemical agents, as well as outbreaks of naturally occurring infectious diseases.

A wholly-owned subsidiary of PlantForm Corporation, AntoXa holds an exclusive licence to the vivoXPRESS^® biopharmaceutical manufacturing platform to produce countermeasures for ricin, sarin, soman and Ebola Sudan, as well as other defence-related therapeutics.

vivoXPRESS^® technology uses genetically engineered plants to produce biopharmaceuticals in less than six weeks at a significantly lower cost of goods compared to industry standard fermentation systems.

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For more information, please contact:

Don Stewart
President and CEO, AntoXa Corp.
[email protected]
+1 416-452-7242

Stacey Curry Gunn
Director of Communications, AntoXa Corp.
[email protected]
+1 519-827-1131

PhD9 to neutralize ricin

AntoXa is using the vivoXPRESS^® system to produce an innovator antibody (PhD9) being studied by Defence Research and Development Canada (DRDC) as an antidote to ricin exposure.

Ricin is a naturally occurring toxin from the Castorbean plant. It is considered a category B threat agent by the U.S. Centers for Disease Control and Prevention due to its accessibility, ease of production and extreme lethality. No therapeutic antibody or vaccine is currently available to counteract its deadly effects. The PhD9 antibody drug candidate developed by DRDC prevents ricin from penetrating cells.

DRDC has conducted in vitro and in vivo studies that found the plant-made version of the antibody showed therapeutic efficacy against ricin intoxication that was comparable to hD9 produced using mammalian cell technology. The findings were presented at the Antibody Engineering and Therapeutics Conference in December 2015.

Butyrylcholinesterase (BuChE) to protect against nerve agents

AntoXa and the Government of Canada are co-developing butyrylcholinesterase (BuChE) as a next-generation therapeutic and prophylactic countermeasure to organophosphate toxins such as sarin and soman.

BuChE is a naturally occurring plasma enzyme that provides broad-spectrum protection against all nerve agents. Purified human BuChE has been proven efficacious in animal models; however, its development has been limited by relatively low production yield compared to very high cost as well as the inherent risk of human pathogen transmission from the plasma derived product. AntoXa has produced a high-yield, low-cost recombinant BuChE using the vivoXPRESS^® platform and successfully evaluated the safety of the product in an animal model.

Antibodies against Ebola

Antibodies produced using the vivoXPRESS® biopharmaceutical manufacturing system have been shown to neutralize the Sudan strain of Ebola as well as antibodies produced using other systems, according to analyses performed by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) with funding support and technical advisory services from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP).

Building upon the USAMRIID project, our team worked with University of New Mexico scientists to advance Ebola research and improve existing vaccines by inducing more effective immune responses to infection. The project employed the vivoXPRESS^® system to express glycoproteins found on Filoviridae, the family of viruses that cause Ebola and Marburg disease, two severe and often fatal viral hemorrhagic fevers that afflict humans and non-human primates.