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http://www.pharma-planta.net

Prof. Julian Ma,

Prof. Rainer Fischer,Fraunhofer IME, Aachen

Dr. Julia Boyle,University of SurreyClinical Research Centre, Guildford

Prof. Maurice Moloney,Rothamsted Research, Harpenden

Pharma-Planta

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Recombinant Pharmaceuticals fromPlants for Human HealthA public consortium comprising

28 Academic Institutes and 3 Small/medium companies.

Funding period 2004 2009.12M Euros of EU public funding.

http://www.pharma-planta.net

The Pharma-Planta Project

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In 2009, 23M infants worldwidewere not reached by routine

immunization services

1.7M children under the age of 5 diedfrom vaccine-preventable diseases in2008

(WHO Global Immunisation Data; 2010)

The drive for the Pharma-Planta projectcomes from the need to produce modernmedicines economically and in sufficientquantities to meet global demand.

Global access to medicine

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An unprecedented opportunity to produce valuable medicinesaffordably and on a massive scale.

Molecular Farming

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Good manufacturing practice (GMP) is part of a quality systemcovering the manufacture and testing of pharmaceuticals.GMP regulations require (by law) that drug manufacturers ensuretheir products are safe, pure and effective.

Manufacturing processes must be clearly defined, controlled andconsistent.

GMP regulations are designed to minimize or eliminate

contamination and errors. This protects the consumer fromproducts that are dangerous or ineffective.

The challenge of making approvedpharmaceuticals from plants

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Mammalian cells current industrystandard.

Cell culture. A highly controlled and defined,sterile process

High-tech and expensive

Limited scalability

Plants

Cultivation of whole plants

A variable biological system

Non-sterile

Low-tech and inexpensive

Massive scalability

Manufacture of monoclonal antibodies

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To move beyond proof of concept anddevelop candidate products for clinicalevaluation in Phase I human trials

Monoclonal antibodies against two major diseases:HIV (passive immunization and microbicidal use)

Rabies (passive immunization)

Pharma-Planta Primary Objective

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Greenhouse

29 d

26 d

33 d

Scaled-up production

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41 d 44 d

Harvested tobacco

Scaled-up production

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DisruptionFiltration

Filtered tobaccoextract

Downstream processing

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Greenhouse Production of rAb 2G12 in Tobacco

Cultivation transgenic tobacco plantscultivated for 45 days in greenhouse

Harvesting leaves chopped andshredded in 250-kg batches

GMP downstream processing using acustom process, >5 g of pure antibody

Toxicology product non toxic in rabbits Clinical trial phase I trial in humans

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Double-blind, placebo controlled, first in woman Dose escalation: 7, 14 and 28 mg

Objectives:

Evaluate safety: clinical safety tests, local

reactions, adverse events

Evaluate P2G12 concentration in blood and

vaginal secretions

A Phase I study of P2G12 as a vaginal microbicide

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Phase I P2G12 safety trial

Study schedule

Dosing

7 mg, 28th June 2011.

3 subjects (2x P2G22, 1x placebo)

14 mg, 19th July 2011.

3 subjects (2x P2G12, 1x placebo)

28 mg, 30th August 2011.

5 subjects (4x P2G12, 1x placebo) Preliminary results 17th October 2011

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The Significance of Monoclonal Antibodies

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The Significance of Monoclonal Antibodies

Major products in biotechnology and clinical care

Injectable, topical and oral applications

Licensed products already available for:

Cancers (avastin, herceptin)

Infectious disease (Synagis)

Chronic diseases (infliximab, rituximab)

Many pipeline products

Typical costs 10-15,000 /patient/yr

S

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Pharma-Planta a publicly funded academicconsortium.

A unique plant biotechnologymanufacturing facility in Aachen, Germany.

The GMPmonoclonal antibody drug product from

plants has been approved in UK.

-derived Mab.

Opening the potential of plants to manufacture a range ofdrugs for the developed and developing world.

Our thanks to the European Union Framework 6 Programme forfunding this work.

Summary

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