Plant-Derived Influenza Virus-Like Particles: A Unique Combination of Highly Effective Product and Cost-Effective Manufacturing

Transcription

1 Plant-Derived Influenza Virus-Like Particles: A Unique Combination of Highly Effective Product and Cost-Effective Manufacturing Nathalie Charland, PhD GHSI Workshop on Public Health Emergency Medical Countermeasures November 5, 2009

2 Forward-Looking Statements All statements, other than statements of historical facts, included in this presentation regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words believe, anticipate, estimate, plan, expect, intend, may, project, will, would and similar expressions are intended to identify forward-looking statements, although not all forwardlooking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated or implied by forward-looking statements, including the factors discussed under Risk Factors and in other sections of the prospectus. These factors and the other cautionary statements made in the prospectus should be read as being applicable to all related forward-looking statements wherever they appear in this presentation. Our statements of belief in respect of our product and partner product candidates are based primarily upon our results derived to date from our research and development program. We believe that we have a reasonable scientific basis upon which we have made such statements. It is not possible, however, to predict, based upon studies in vitro and animal studies whether a new therapeutic agent or technology will be proved to be safe and/or effective in humans. We cannot assure that the particular results expected by us will occur. Any forward-looking statements and statements of belief represent our estimates only as of the date of the prospectus and should not be relied upon as representing our estimates as of any subsequent date. Except as required by law, we do not assume any obligation to update any forward looking statements or statements of belief. We disclaim any intention or obligation to update or revise any forward-looking statements or statements of belief, whether as a result of new information, future events or otherwise.

3 Medicago today Focus Offices + cgmp facility Manufacturing technology Vaccine technology Products Vaccines Quebec City, QC Transient expression in plants Virus-like particles Pandemic (TRL 6B) and seasonal (TRL 3C) influenza Employees 60 Publicly-traded company TSX-V: MDG

4 Significant unmet needs in this market WHO scenarios vs. true pandemic months * M 0 M 0M Nb of vaccine doses accumulated after a pandemic influenza outbreak 3 0M 0 M 0M 4 20M 0 M 50M 5 60M 3M 160M 6 60M ~ 40M 250M * As estimated for US, Canada, France, UK, Germany, Italy, Spain, Japan & Australia for October 2009 Sebelius calls for updated vaccine-making process Los Angeles Times, October 22 nd, 2009

5 Medicago pandemic vaccine = First responder solution 3 months 6 months It doesn't matter if there is a dose for everybody if it doesn't get to them before they become ill. Cases Mike Osterholm, former Minnesota public health official & expert on pandemic preparedness at the University of Minnesota Reuters, October 28 th, 2009 Medicago plant-based vaccine supply Egg-based vaccine supply A/H1N1 strain identified First wave begins Second wave begins

6 Technology Proprietary platform for the production recombinant proteins based on a transient expression technology in plants (N. benthamiana) Plants in greenhouse Infiltration Transient expression Purification Fast, inexpensive and easily scalable: From plants to vaccines in 5 days Start production of any new pandemic vaccine in 1 month Substrate easy to supply (plants in greenhouses) Simple process and manufacturing facilities

7 Real-life scenario with influenza A (H1N1) April 24 : Identification of genetic sequence of A (H1N1) May 4: Genetic material introduced into plants May 4 8: Plants incubated in greenhouse for vaccine production May 15: First purified vaccine lot June 30: Positive preclinical results (mice)

8 Vaccine Influenza virus-like particles in plants using only one gene of the influenza virus (Hemagglutinin) Medicago VLP Influenza virus These particles resemble the influenza virus but with no genetic material, meaning that they are not infectious Best compromise between safety and efficacy: Activate both humoral (antibodies) and cellular (T-cells) immune responses and provide strong and broad protection against the virus

9 Cross protection against different strains of influenza Type A Subtype or lineage Clade H1, H2, H3, H5 clade 1 H5 clade 2 Medicago s vaccine is formulated with this strain Subclade Viet-Nam H5 clade 2.1 Indonesia H5 clade 2.2 Turkey H5 clade 2.3

10 Lethal challenge study in ferrets with Viet-Nam strain Phase I ongoing as we talk 100 % survival rate Day after challenge

11 Immunogenicity of A/H1N1 candidate vaccine produced in plants HI titers measured in sera form mice immunized with H1-VLP from strain A/California/4/2009. Titers are expressed as reciprocal of the highest dilution of serum that inhibits hemagglutination of turkey red blood cells. After prime immunization After boost immunization Whole live virus strain A/California/4/2009 A/California/7/2009 Dose Mean GMT Mean GMT 5 µg µg + alhydrogel µg µg + alhydrogel Protective level = 40

12 Manufacturing facility & capacity Current setting: 1400 sq meters 1000 sq. meters BL2+ greenhouses (growth of non-transgenic plant & incubation after Agrobacterium vacuum-infiltration) 300 sq. meters purification (Control rooms) $7M investment for M doses/year (5 µg/dose) Similar setting in Maryland estimated at $12M by SNC-Lavalin Commercial setting (2011) Additional 3000 sq. meters BL2+ greenhouses w/ 1500 sq. meters offices & warehouse $10M additional investment for M doses/year 2 1

13 Location of 90% of influenza vaccine manufacturing Medicago s solution

14 Medicago strategy Clinical development of pandemic and seasonal Influenza vaccines Complete Phase I (H5 candidate) Leverage clinical results of pandemic to accelerate development of seasonal or other pandemic candidate(s) Partner with major vaccine company in clinical phases to gain expertise and access to markets Execute agreements with target countries to enable domestic vaccine production infrastructure Europe (France Genopole) India (Ajanta Pharma) MENA (Tabuk) Asia (China) USA, Russia, Mexico, etc.

15 Thank you! TSX-V: MDG