A large part of the AllergyVAX project consisted of a First-in-Human (FIH) clinical study of DM-101. During the first half of the project, a regulatory package was compiled for the clinical study. It was submitted to a local regulatory authority and independent ethics committee for evaluation. Preparations for the clinical study were completed and an ethics approval as well as regulatory authorisation was gained. The randomised, double-blinded, placebo-controlled, dose escalation study was designed to evaluate the safety and tolerability of subcutaneous immunotherapy with DM-101 in birch pollen allergic adults. Immunological markers such as allergen-specific IgE and IgG were also analysed. For the study, 27 adults with documented birch pollen allergy were enrolled and randomised into four cohorts. The volunteers received either a single dose or five ascending doses of DM-101 or placebo.
The clinical study was launched in early 2020. In March 2020, the study was temporarily halted due to the Covid-19 pandemic and approaching pollen season. The study was resumed in November 2020, and dosing was completed before the 2021 birch pollen season. The results were analysed and the outcome of the study was positive. The highest of the tested dosing regimens, a biweekly dosing regimen of DM-101 involving five ascending doses was safe and well-tolerated and immunological marker results indicated a favourable change in the markers associated with a protective response.
Desentum's business model is based on performing preclinical product development, taking the product candidates through early clinical trials and partnering with a larger pharmaceutical company to perform late-stage clinical trials and commercialisation. Clinical results are important for partnering negotiations, so the temporary halt of the clinical study that has delayed clinical results, has also prevented full deployment of partnering efforts during the project lifespan. However, activities were still conducted to establish relationships for commercial partnering. Nearly 7 M€ of new capital was also raised for further preclinical and clinical development. With the support from the clinical results, these activities can now be continued and ramped up right after the project conclusion.
Project progress has been communicated to public in press releases and online news updates, and content marketing has been performed to build awareness of the company, especially during the clinical study. Newsletters and presentations have been created for existing and potential new investors and partners.
An unexpected result derived from the project was new information regarding the impact of formulation on the potency of allergens. In parallel to the AllergyVAX project, formulation development work (not funded by the H2020 grant) has been conducted to exploit this information and produce an improved formulation of DM-101 for the next clinical study. Potential new formulations are being tested to select the best one.
