Horizon 2020 – AllergyVAX

Next generation allergen immunotherapy based on specifically modified recombinant hypoallergens

Desentum’s goal is to set a new industry standard on allergy treatment by developing novel immunotherapeutic hypoallergens – so-called allergy vaccines. In the AllergyVAX project, we will test a birch pollen hypoallergen rBet v 1 dm in a Phase I/IIa clinical trial to evaluate its safety and potential to induce a desired immunological effect, and to obtain a roadmap for further clinical trials. We will also develop a business strategy for partnering and commercialization of rBet v 1 dm and the platform technology.

Background

Allergy is a rapidly increasing, global problem that already affects 1 billion people and causes significant social and economic burden. In Europe, allergic rhinitis and asthma cause more than 100 million missed work and school days per year. Allergy is usually managed by avoiding the allergen or by medication that temporarily alleviates the symptoms.

The only disease-modifying treatment available to date is allergen immunotherapy (AIT) where long-term symptom relief is achieved by training the immune system to tolerate allergens. However, typical AIT takes 3-5 years, involves monthly injections or daily drops/tablets and has the risk of serious allergic reactions during treatment. Thus, the popularity of AIT is still relatively low compared to symptomatic drugs.

We have developed a platform technology for creating modified hypoallergens to be used in AIT. It is based on making small, highly targeted modifications to allergen proteins that reduce their ability to trigger allergic reactions during treatment without compromising their efficacy in building tolerance to natural allergens. With these modified hypoallergens, we expect to shorten the injectable AIT treatment from dozens of injections over 3 years to just 3-6 injections over a few months. From the clinically important major birch pollen allergen Bet v 1 we have created rBet v 1 dm hypoallergen. In preclinical tests it has shown 100-fold reduction in histamine release compared to natural allergens and induced similar immunological responses in mice that are desired in human AIT.

 

Project tasks and objectives

In the AllergyVAX project we will test rBet v 1 dm for maximum tolerated dose and immunogenicity in allergic patients in a phase I/IIa clinical trial. The project will facilitate seamless transition to phase IIb-III clinical development, establishing a basis for product launch with selected partners and advancing other hypoallergens in the pipeline, including product candidates for grass pollen, dog, horse and peanut allergies.

 

Primary project objectives are:

  • Demonstrating the safety and immunogenicity of rBet v 1 dm in a clinical setting
  • Aligning financial and business development strategies to support market access
  • Increase awareness of Desentum’s technology among the allergy community

Primary tasks for achieving the objectives are:

Regulatory procedures
Preparation of a regulatory package for clinical trial authorization; discussion with regulatory authorities to ensure compliance
Phase I/IIa clinical trial
Testing the safety, tolerability and immunogenicity of Bet v 1 dm in a first-in-human clinical study
Business development
Building partnering relationships and market access strategy to ensure seamless late-phase clinical development and commercialisation
Communication Communicating the project progress and results to educate the stakeholders and support the business development goals

 

AllergyVAX project started on Dec 1, 2018. Project duration is 32 months.

 

Project news

29.10.2018 Desentum wins a 1.9 M€ EU grant for first-in-human clinical trials

 

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 829933.