Máire Geoghegan-Quinn, European Commissioner for Research and Innovation, said: "This exciting news is a step forward in our global fight against AIDS. European research and innovation funding allows our scientific community to tackle very difficult challenges, such as this one. It brings the hope of a better future for our societies in the years to come."
Pharma-Planta's project achievements have been finalized just ahead of World AIDS Day on 1 December 2011, which marks the 30th anniversary of the first diagnosed AIDS case, a disease which has now claimed more than 25 million lives around the world. The aim of the clinical trial was to demonstrate that a monoclonal antibody drug manufactured in plants is safe for use in humans. The specific drug is an antibody that targets and neutralises the Human Immunodeficiency Virus (HIV), which could eventually be used as part of a topical vaginal preparation to prevent transmission of the infection. The drug was produced in genetically modified tobacco plants, extracted and purified to a quality and specification that was approved by European pharmaceutical regulatory authorities.
The results show that the plant derived monoclonal antibody is safe and well tolerated. This study opens the way for further development of this drug product into clinical trials to confirm clinical efficacy. They also pave the way for the manufacture of other important drug targets using the genetically modified plant manufacturing platform, a technology which will facilitate the economic production of important drugs at very large scale.
The ambitious project required expertise in plant genetics, physiology and breeding, molecular biology, chemical analysis, bio processing, immunology and clinical medicine to name just a few. A European effort was necessary to assemble such a multi-disciplinary team. The results of the project place Europe in a leading position to exploit an exciting new pharmaceutical production technology.
Background
The Pharma-Planta Consortium is a mixture of academic partners, SMEs and large industry partners comprising 40 research groups in 33 partner organizations from 12 European countries and South Africa.Pharma-Planta was launched in 2004 and its primary goal was to establish a manufacturing platform for recombinant medicines using plants.
Biologics – medicines that are made using biological processes – are achieving an increasingly significant impact on human health. However, most are currently made at great expense using fermentation vessels containing bacteria or mammalian cells. Plants have many advantages for the production of biologics, primarily because they are easy and inexpensive to grow, and because they can be cultivated on a very large scale.
The challenge for Pharma-Planta was to move the science of “Molecular Pharming” on, from laboratory proof of concept to clinical feasibility. The breakthrough moment for the project came when Pharma-Planta’s innovative manufacturing process was approved by national regulatory authorities in Germany and the UK, allowing the launch of the phase I human trial in June this year. The manufacturing process showed for the first time in Europe that monoclonal antibodies can be made in plants to the same quality as those made using existing conventional production systems. This milestone has been achieved with approval to carry out a clinical study of an antibody that neutralizes HIV, produced in and isolated from tobacco plants.
Other aspects of the Pharma-Planta research programme have also made important contributions to the field of Molecular Pharming, advancing our understanding of the underlying cellular mechanisms in plants and helping to achieve major improvements in product yield. A number of additional candidate pharmaceuticals have been developed, thereby establishing a pipeline of second-generation products for future clinical trials. The consortium has also worked to facilitate the future availability of plant-derived recombinant pharmaceuticals to the poor in developing countries.
More information about Pharma-Planta can be found at http://www.pharma-planta.net
Fraunhofer Institute for Molecular Biology and Applied Ecology IME