It gives me great pleasure to (re)trumpet the news that – at long last – a monoclonal antibody made in plants that neutralizes a wide range of HIV-1 variants, is going into Phase 1 clinical trial.
The MAb 2G12 is made in transgenic tobacco plants: these are grown in batches of 250 kg, harvested, and the MAb extracted under conditions of Good Manufacturing Practice (GMP). Simple enough…yet it took years, a great deal of money, and significant exchanges with the regulatory authorities to get the clinical trial of plant-made pharmaceuticals approved. From the Fraunhofer Institute news website:
Antibodies that have been produced in tobacco plants will now for the first time be tested in a clinical study. The decision was announced at a press conference in London on Tuesday July 19th 2011.
UK regulators have approved Europe’s first clinical trial of a monoclonal antibody produced from genetically modified plants. This landmark decision sets the stage for the testing, in humans, of an anti-HIV product made from genetically modified tobacco plants. It will open the door for trials of additional plant-derived medicines treating a range of diseases.
The trial will test the safety of a plant-derived antibody designed to stop the transmission of HIV between sexual partners when applied directly to the vaginal cavity. If proven safe in the 11 participants, the researchers can then go on to test the effectiveness of the product.
The clinical trial marks the culmination of the EU Framework 6 Pharma-Planta project, which was launched by a consortium of 30 academic and industrial partners in 2004 with €12 million in funding from the European Union. The primary goal was to develop an approved manufacturing process for recombinant pharmaceutical proteins made in plants and take one such product through all the development stages including the pivotal clinical trial.
This also represents a reward for years of perseverance by Professor Rainer Fischer, coordinator of the Pharma-Planta FP6 project and Director of the Fraunhofer IME. From the press release:
Professor Julian Ma, scientific coordinator for Pharma-Planta and Professor of Molecular Immunology at St George’s, University of London, said: “This is a red letter day for the field. The approval from the MHRA for us to proceed with human trials is an acknowledgement that monoclonal antibodies can be made in plants to the same quality as those made using existing conventional production systems. Many people did not ever believe that it could be achieved.”
Amen to that, brother Julian…! Readers of this blog will know we are big fans of farmed pharmaceuticals – and this is another big step along that road.