Partnership for producing mites recombinant allergens

 

Partnership agreement between STALLERGENES and PROTEIN’EXPERT

STALLERGENES S.A and Protein’eXpert S.A. announce they have signed a partnership agreement for developing and pharmaceutically producing mites recombinant¹ allergens.

The partnership is part of the STALLERGENES “Enhanced Allergens” innovation programme for a recombinant protein treatment for sublingual desensitisation of allergy to mites.  This second-generation treatment is made up of the recombinant allergens Der p 1 and Der p 2 in the form of a fusion protein, combined with an adjuvant and/or a mucoadhesive formulation for facilitating recognition of the allergen by the immune system.

Protein’eXpert will handle:

• developing processes aimed at optimising the existing production protocol;
• developing and scaling up fermentation, renaturation, and purification processes;
• producing preclinical and clinical batches.

“This partnership enables us to accelerate the development of our “Enhanced Allergens” programme, and to envisage moving rapidly on to humans in a phase I study,” emphasizes Philippe Moingeon, Scientific Director of STALLERGENES.  Protein’eXpert has indeed recognised know-how in the field of process development and cGMP² biomanufacturing.

“Protein’eXpert is very pleased to be taking part in an innovative development programme in the specific field of respiratory allergy immunotherapy,” declares Nicolas Mouz, Chief Scientific Director at Protein’eXpert.  “’This partnership offers us an opportunity to propose our expertise in protein engineering and therapeutic protein development, and to widen our knowledge of allergens.”

About the “Enhanced Allergens” programm

The combination of molecular biology tools and of formulation/adjuvanting strategies makes it possible to target better the immune system of the sublingual mucous membrane, and to improve the efficacy of desensitisation treatments.  It is on this major concept that the “Enhanced Allergens” programme is based.

The active ingredient being considered is a combination of the major allergens of Dermatophagoides pteronyssinus, Der p 1 and Der p 2, expressed as a single recombinant molecule.  The use of recombinant allergens makes it possible to develop products that are fully characterised, quantifiable, and reproducible.

In January 2007, a first range of product candidates was selected and underwent pharmaceutical and preclinical development.  Going on to humans is scheduled for 2009, and several product candidates will be tested in parallel so as to identify, in 2010, the final prototype.  A clinical development phase is scheduled for 2011.

 

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1 Recombinant allergen: allergen produced by genetic engineering, unlike a natural allergen.
2 cGMP: current Good Manufacturing Practices.