PlantForm Corporation

Transcription

1 PlantForm Corporation Professor J. Christopher Hall CSO PlantForm Corporation Canada s Top10 Winner Life Sciences 2008/9 Innovator of the Year Guelph, Canada, 2010

2 Opportunity The introduction of more affordable, biosimilar, versions of already approved treatments is a priority to health care providers to reduce costs and increase the availability of life saving medicines.

3 Biologic Drugs A substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases. (National Cancer Institute, USA) Category Method of Production Biologic Drug Class Biological Drug Biotechnolog y Monoclonal Antibodies Natural Process Proteins Vaccines

4 Opportunity!!!"#$%&'()*+(',*&"-.+/& '(012*'1*3345*'-*6&$ :";&+ Production of the anti-breast cancer therapeutic drug Herceptin using tobacco plants as bioreactors.

5 Trastuzumab (Herceptin )!!!"#$%&'()*+(',*&"-.+/& '(012*'1*3345*'-*6&$ :";&+! Humanized mouse antibody! Manufactured by Genentech Inc.! FDA approval date: 1998! Treatment of early-stage and metastatic breast cancer! 25% - 30% of all breast cancers are HER2 overexpressors

6 Opportunity! PlantForm uses its proprietary platform to produce drugs at ultra low cost in plants.! PlantForm s current and future products are manufactured at only 5 to 10% of the cost of name brand equivalents.! PlantForm s first product is a biosimilar Herceptin, a $5.8 billion/year breast cancer drug

7 Manufacturing Platform Production Platform 1. Cloning platform (IP position) 2. Tobacco plant expression Transient system Transgenic system (IP position) 3. Production 4. Extraction and Recovery 5. Purification (IP position) "#Formulation & Fill-finish Overall process (IP position) (Two other patent families)

8 Antibody Production Systems Expression System Mammalian cell culture Time to Milligrams of Antibody Time to Grams of Antibody 2-6 months 6-12 months Transgenic animals >12 months >12 months Stable transgenic plants 12 months >24 months Plant Magnifection 14 days days

9 Whole-Plant Transfection 4

10 Whole-Plant Transfection Leaf #4 #5 # dpi

11 Biosimilar Herceptin % activity Activity analysis Percent Cell Growth Activity analysis demonstrates that the PlantForm biosimilar drug has the same efficacy as the name brand drug Time (days) Breast cancer cell line growth inhibition Genentech Herceptin PlantForm biosimilar Herceptin Negative control

12 Potential Downsides of Plants! Time to create stable transgenic! Quantity of expressed protein! Purification! Glycosylation issues

13 Large-Scale Production Strategy! Contract Partnerships o Bayer oicon Genetics, Germany okbp, USA o Dalton, Canada! Supporting o Clinical trial production o Commercial production! Advantages o No capital costs o Flexibility o Expertise

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19 Current Technical Objectives 2010: Scale manufacturing 2011: Animal efficacy study 2012: Phase I clinical trial 2013: Phase III clinical trial 2014: License submission

20 Manufacturing Advantage Name brand ($3,500) Standard biosimilar ($2,500) PlantForm biosimilar ($2,500) Name brand profits at biosimilar pricing ($1,000) ($1,000) ($100)

21 PlantForms Timeline Advantage

22 Production Process Comparison Mammalian Fermentation! 5,000L mammalian process based facility to produce 400kg of antibodies per year! Facility Costs! High capital costs ($450M)! Complex equipment! Extensive environmental control! Large staffing requirement Plants! 12-acre greenhouse process facility to produce 400kg of antibodies per year! Facility Costs! Low capital costs ($80M)! Simple greenhouse equipment! Simple environmental control! Reduced staffing requirements

23 PlantForm is the only producer of SEBs at ultra-low-cost with short development timelines focused on monoclonal antibodies.

24 Development Approach and Results Activity Status % activity Percent Cell Growth Trastuzumab activity Time (days) Roche PlantForm Negative control (Breast cancer cell line growth inhibition) Grohs BM et al (2010), J. Agric. Food Chem., 58, 10056

25 PlantForm Advantage! Biosimilar drugs o Development time advantage! 6-12 years reduction! Plant based production o Manufacturing cost advantage! fold cost reduction o Capital cost advantage! $450 million for traditional process (500 kg antibody)! $80 million for plant facility (500 kg antibody) o Manufacturing risk advantage! Process variability minimized o Patent advantages! Manufacturing patents not applicable

26 Marketing Strategy! Potential Partners o Pharma companies o Biotech companies o Generic companies! Examples include! Supporting o Clinical trials o Marketing and sales! Advantages o Platform technology o Ultra low cost drugs o Fast turn around o IP position

27 Business Summary! Technology o Platform drug manufacturing technology company o Antibody drug focus! Sales and marketing o Partner with experts in marketing and sales of generic drugs o Partner will support cost of clinical trials! Global Market o Established o Expanding! Risk profile o Established production system low risk o Established product low risk

28 PlantForm Corporation THANK YOU