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BIOTEK2021-Bioteknologi for verdiskaping

Novel-type vaccine against food allergy (ALLERVACC)

Awarded: NOK 10.9 mill.

ALLERVACC Populær vitenskapelig sammendrag, engelsk 18.10.2017 ALLERVACC is a concept for immune specific treatment (immunotherapy) of food allergy. The molecule is a recombinant fusion protein that consists of (1) a ligand that inhibits the intrinsic immunologic reaction and (2) an allergen that directs the molecule to the specific cells that starts the allergic response. In an earlier project we obtained promising results with ALLERVACC for treatment of shrimp allergy. In the present project it is investigated whether ALLERVACC can be modified for treatment of peanut allergy. Peanut protein was chosen because it is the most common and most dangerous food allergen for children. The main objective of this project was to generate an IPR-secured ALLERVACC for the treatment of IgE-mediated food allergies. The main challenges were: (i) further improvement of the stability of ALLERVACC, (ii) generation of ALLERVACC against peanut allergy, and (iii) set-up of a strategy for the proof of concept vaccination studies in humans via animal-studies. Our collaborators have been Oslo University Hospital (discussion partner and patient blood sample collection), National Public Health Institute (animal studies) and Kjeller Innovasjon, the Technology Transfer Office, who assisted on the commercialization strategy and patenting. We have optimized the stability of the molecule for sub aim (i). For sub aim (ii) and (iii) we have prepared and tested different species- specific variants of the molecule and variations of allergen-ligand combinations. In the last year of the project, we observed that a double-conjugate variant of ALLERVACC provided best effects in our in vitro test-system (basofile activation test) compared to the original single conjugate. However, additional in vitro tests with human blood as well as animal studies did not gain any data that support these findings. We therefore conclude that the results are not convincing and that additional studies are needed in order to continue to a verification project. A patent on ALLERVACC was granted in USA, Australia and Europe, which also includes the double-conjugate variant. We are now investigating possibilities for a continuation of the project at our institute, and will evaluate whether other groups or entities are interested in continuing this project.

The prevalence of allergies has grown into an epidemic, affecting hundreds of millions of people, particularly children. The socio-econonic impact is immense and current therapies are primarily based on symptomatic relief. We have developed a concept for a novel type of vaccine for the treatment of food allergic diseases, ALLERVACC. ALLERVACC is a fusion protein consisting of an allergen of choice bound to a ligand that induces immunological tolerance. Here, the allergen will drive the vaccine to the cell s that need to be suppressed in food allergy, while the ligand will induce tolerance by anergy or apoptosis in these cells. More specifically, this will lead to a suppression of the acute reaction of mast cells and basophils, and a specific deletion of sp ecific B-cells and plasma cells and concomitant drop in specific IgE levels towards the allergen. Overall, this induces immunological tolerance to the allergen. Using a shrimp allergen as a model, we have shown that the vaccine is capable of inhibiting th e allergic responses in several in vitro tests with both human and mouse cells, and in human skin prick test in shrimp allergic persons. The main objective of this project is to generate an IPR-secured ALLERVACC for the treatment of IgE-mediated food all ergies. The main challenges will be: (i) further improvement of the stability of ALLERVACC, (ii) generation of ALLERVACC against peanut allergy, and (iii) set-up of a strategy for the proof of concept vaccination studies in humans via animal-studies. The ALLERVACC will then be presented to the marked by a novel Norwegian biotech firm, or to an already existing commercial actor. Our partners in the project will provide the human patients (Oslo Universitetssykehus) and animal resources (Nasjonalt Folkehel seinstitutt) needed to perform the appropriate investigations of the ALLERVACC.

Funding scheme:

BIOTEK2021-Bioteknologi for verdiskaping