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Immune Design Corporation and Medicago, Inc. Announce License Agreement and Collaboration to Develop Novel Adjuvanted Pandemic Influenza Vaccines


6/28/2013 10:06:36 AM

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SEATTLE and QUEBEC CITY, June 27, 2013 /PRNewswire/ - Immune Design, a leader in the field of therapeutic vaccines for cancer, infectious diseases and allergy, and 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 announced that they have entered a license agreement providing Medicago the use and commercialization of Immune Design's proprietary synthetic Toll-like Receptor 4 agonist, Glucopyranosyl Lipid A (GLA). Medicago has the option to use Immune Design's molecular adjuvant in its vaccines for various pandemic influenza strains.

Under the terms of the agreement, Immune Design has granted Medicago a worldwide, nonexclusive license to research, develop, and commercialize GLA as a component of its VLP-based vaccines in the field of pandemic influenza. Other terms were not disclosed.

"We are pleased to enter into this collaboration with Medicago and allow for our proprietary adjuvant to be utilized in their vaccine candidates for pandemic influenza," states Carlos Paya, MD, PhD, Immune Design's President and Chief Executive Officer. "Medicago has demonstrated a track record to date, of rapid and successful vaccine candidates design and production which have them at the forefront of next generation vaccine development."

"The established clinical safety and immunogenicity profile of Immune Design's synthetic TLR4 agonist, GLA, make it an ideal adjuvant for our VLP-based influenza vaccine candidates," said Andy Sheldon, Medicago's President and Chief Executive Officer. "We will further investigate the use of both formulated GLA and alum in our Phase II H5N1 trial which was recently initiated with results expected during the summer of 2013."

Medicago's first vaccine candidate in the field, which targets the H5N1 influenza strain, completed a successful U.S. Phase I study which was conducted with the Infectious Disease Research Institute (IDRI), earlier this year. In that study, all three configurations of adjuvant and route of administration (I.D., Alum, and GLA-AF) for 20ug of the H5N1 vaccine candidate induced a solid immune response against the H5N1 viral strain that exceeded the CHMP immunogenicity criteria for licensure of influenza vaccines. Medicago recently initiated a Phase II study of its H5N1 VLP in combination with both the GLA and alum adjuvants with results expected in the summer of 2013.

Medicago also recently announced the production of a H7N9 VLP vaccine candidate which includes formulated GLA or alum, making Medicago the first company to successfully produce a VLP vaccine candidate against the emerging strain. Medicago and Immune Design are collaborating to conduct preclinical studies of the H7N9 VLP-GLA combination.

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.

About Immune Design:
Immune Design is a privately held, clinical stage biotechnology company based in Seattle, WA. Immune Design brings together some of the world's leaders in the field of molecular immunology to develop next generation, therapeutic, and preventative vaccines for malignant, infectious and allergic diseases. The company employs leading edge technologies which target dendritic cells for more precise activation of the immune response. These include a novel lentiviral vector engineered to deliver antigen-encoding nucleic acids directly to dendritic cells in vivo and a TLR-4 agonist that activates dendritic cells by up-regulating key molecules for efficient antigen presentation, and produces cytokines of the Th1 type to enhance the immune response. The TLR-4 agonist is licensed from the Infectious Disease Research Institute, or IDRI, for worldwide exclusive rights in a number of indications, including influenza. For more information, go to www.immunedesign.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.

SOURCE Medicago Inc.



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