Periodic Reporting for period 1 - AllergyVAX (Next generation allergen immunotherapy based on specifically modified recombinant hypoallergens)
Reporting period: 2018-12-01 to 2020-03-31
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. The goal is to develop safe, effective and reproducible AIT that is convenient for the patients, thus improving treatment compliance and cost-efficiency. The recombinant allergens have a native 3D structure to preserve immunogenicity and contain highly targeted modifications to reduce allergic reactions during treatment. Recombinant production enables reproducibility and standardisation important for regulatory compliance. From the clinically important major birch pollen allergen Bet v 1 we have created DM-101 (rBet v 1 dm) hypoallergen. The aim of AllergyVAX project is to test DM-101 for safety and immunogenicity in a First-in-Human clinical study. The project is expected to facilitate seamless transition to Phase II–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, peanut, dog and horse allergies.
Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far
A large part of the project consists of a First-in-Human clinical study to evaluate the safety and tolerability of DM-101 and to evaluate the possible immunological effects of repeated dosing of DM-101 in birch pollen allergic individuals. During the first seven months of the project, a regulatory package was compiled for the First-in-Human clinical study. It was submitted to a local regulatory authority and independent ethics committee for evaluation. During the next seven months, preparations for the clinical study were completed and an ethics approval as well as regulatory authorisation was gained. The clinical study was launched in early 2020. At the end of the first reporting period, it was ongoing, although temporarily halted due to the Covid-19 pandemic.
Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)
If successful, at the end of the project we will have a clinical proof-of-concept for the DM-101 birch pollen hypoallergen. The clinical results are expected to facilitate partnering that will allow late-phase clinical development and commercialisation of DM-101. The expected socio-economic impact of the new immunotherapy is setting off a change in allergy management – from treating the symptoms to treating the disease – which is possible with an allergen immunotherapy that goes beyond the state-of-the-art of currently approved AIT in standardisation, safety and efficacy.