Our goal is to start clinical trials for the first hypoallergens in 2019. If the trials are completed successfully and the regulatory authorities give their approval, we aim to start the production and sales. Each allergy requires its own hypoallergen, so the product line will be expanded as we manufacture new modified hypoallergens.
The R&D program for our immunotherapeutic hypoallergens is featured in the pdf below. Click the image to view the program.
The technologies we use allow us to precisely characterize hypoallergen structure and interaction, design targeted modifications to them and evaluate potential product candidates.
Native mass spectrometry is an emerging technology that allows the topological investigation of protein complexes with high sensitivity. This unique tool provides us complementary information to established technologies in structural biology. It also provides additional information on exact protein complex-compositions, structures and dynamics. This technology is extremely useful for determining the correct folding and structure of hypoallergen candidates. It also provides useful information on allergen-IgE antibody complexes.
Crystallisation of proteins and protein complexes is one way to study the structure of proteins. Protein crystals are exposed to X-rays in unique synchrotrons and the diffraction spectrum received in this kind of analysis provides us valuable information about the primary, secondary, tertiary and even quaternary structures of proteins under investigation. This method gives us a very precise way to design changes in allergen molecules in order to achieve the hypoallergenic properties we aim at.
HRA Histamine Release Assay
The biological activity of the hypoallergen candidates can be analysed in a so called histamine release assay. In this assay stripped basophil cells are challenged with allergen and hypoallergen molecules and the subsequent release of histamine is measured. The amount of histamine released by a hypoallergenic product candidate opposed to a wild type allergen tells us if the hypoallergen has a potential to be used as an immunotherapeutic product.