Medicago is First in the World to Report Positive Interim Results for its H7N9 Pre-Clinical Trial

Medicago is First in the World to Report Positive Interim Results for its H7N9 Pre-Clinical Trial
06/06/2013

- The H7 VLP vaccine candidate induces an antibody response after a single dose in mice-

QUEBEC CITY, June 6, 2013 /CNW/ - Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a preclinical trial for an H7N9 Avian Influenza VLP vaccine candidate ("H7 vaccine"). The data show that three micrograms of the H7 vaccine administered with and without adjuvant induced high antibody titers after one dose.

"These results are very significant as there is a general concern that H7 vaccines will be of low immunogenicity in humans should a pandemic be declared.  However, our results indicate that our plant-based H7 vaccine is able to generate a high immune response in animal models.  To our knowledge, this is the first report of preclinical results for an H7 vaccine developed for the recent H7N9 virus, further demonstrating that Medicago is well positioned to be a first responder in the face of a pandemic," said Andy Sheldon, President and CEO of Medicago.

"This is an important first step in our H7N9 program. Previous H7N3 and H7N1 avian vaccines derived from eggs have been tested in humans without achieving significant antibody levels even at doses as high as 2x90 micrograms or 2x24 micrograms mixed with alum.  Previous vaccines from other technologies also induced very low antibody levels in the mouse model, whereas Medicago's results indicate that our H7 vaccine developed for the emerging H7N9 strain elicits a solid antibody response in mice after a single dose," said Nathalie Landry, Vice-President of Product Development at Medicago. "Results from challenge studies will be available in the coming month."

The plant-made H7N9 vaccine was developed for the H7N9 virus that is responsible for the recent influenza outbreak in China that killed 37 of the 133 reported cases as of May 29, 2013. The first vaccine lots were available at Medicago on May 9th only 19 days after Medicago had received the DNA gene from the DNA sequence in GISAID EpiFlu™ Database. This emerging H7N9 strain causes a lot of concerns to the vaccine community as it is rapidly evolving being a very few mutations away of being fully transmissible to humans. Moreover, it has been shown to be transmissible between ferrets under certain conditions.  Contrary to highly pathogenic H5N1 viruses, this H7N9 virus does not kill the bird population limiting the ability to control the source of infection.

The hemagglutinin (HA) sequence used for the development of the H7 VLP vaccine was obtained from the GISAID EpiFlu™ Database. Medicago would like to thank  Dr. Jun Li and the Hangzhou Center for Disease Control and Prevention (China), respectively author and originating and submitting laboratory for the sequence of HA of the isolate A/Hangzhou/1/2013 (sequence ID EPI_ISL_138977). 

The H7N9 vaccine contains the adjuvant component, GLA (glucopyranosyl lipid A). This is a novel synthetic TLR4 agonist that is supplied by Immune Design Corp. GLA has been shown in multiple pre-clinical studies and in over 700 human subjects to be a safe and potent activator of humoral and cellular Th1 immune responses. In clinical trials it has been shown to be immunogenic, provide dose sparing features, and cross protection against drifted influenza strains.

About Medicago
Medicago is a clinical-stage biopharmaceutical company developing novel vaccines and therapeutic proteins to address a broad range of infectious diseases worldwide. The Company is committed to providing highly effective and competitive vaccines and therapeutic proteins based on its proprietary VLP and manufacturing technologies. Medicago is a worldwide leader in the development of VLP vaccines using a transient expression system which produces recombinant vaccine antigens in plants. This technology has potential to offer more potent vaccines with speed and cost advantages over competitive technologies, enabling the development of a vaccine for testing in approximately one month after the identification and reception of genetic sequences from a pandemic strain. This production time frame has the potential to allow vaccination of the population before the first wave of a pandemic, and supply large volumes of vaccine antigens to the world market. Medicago also intends to expand development into other areas such as biosimilars and biodefense products where the benefits of our technologies can make a significant difference. Additional information about Medicago is available at www.medicago.com.

Forward Looking Statements
This news release includes certain forward-looking statements or forward-looking information for the purposes of applicable securities laws and such statements and information are based upon current expectations, which involve risks and uncertainties associated with Medicago's business and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions "anticipate", "believe", "plan", "estimate", "expect", "intend", and similar expressions to the extent they relate to Medicago or its management. The forward-looking statements are not historical facts, but reflect Medicago's current expectations regarding future results or events. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations, including the matters discussed under "Risk Factors and Uncertainties" in Medicago's Annual Information Form filed on March 28, 2013, with the regulatory authorities. Medicago assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.