Desentum Reports Strong Safety and Immunological Data From Phase 1 Clinical Study With Investigational Birch Pollen Allergy Vaccine DM-101PX

Desentum Oy, a clinical-stage biopharmaceutical company developing novel immunotherapies for treating allergies, announces positive clinical data with birch pollen allergy vaccine DM-101PX. The short-course treatment was found to be safe and well tolerated in birch pollen allergic patients and to induce a very strong and sustained allergen-specific IgG4 response. DM-101PX-induced immunoglobulins were found to efficiently block IgE-mediated basophil activation endorsing the product’s potential to induce a protective immune response.

The randomised, double-blind, placebo-controlled study evaluated three dose escalation regimens, each consisting of ten subcutaneous injections over 10 weeks with DM-101PX or placebo in a total of thirty birch pollen allergic adults. No serious or severe adverse events occurred, and most adverse events were local injection-site reactions that are typically seen in subcutaneous allergen immunotherapy. Nearly all patients reached their targeted maximum dose. The treatment induced a robust allergen-specific IgG4 response, which was found to be associated with effective blocking of IgE-mediated basophil activation. Elevated allergen-specific IgG4 levels and IgE-blocking activity were still detectable in patients’ blood samples at a follow-up visit 28–37 weeks after completion of the treatment indicating that DM-101PX induces a sustained immune response, which is expected to protect against allergic symptoms.

“We are very excited to see that a short treatment with DM-101PX is safe and able to induce a very strong protective immune response, which exceeds that of marketed AIT products”, says Pekka Mattila, CEO of Desentum. “The results endorse Desentum’s approach to design highly efficient allergy vaccines. Based on the positive data from Phase 1, we have decided to advance the product into Phase 2 clinical trials in which the clinical effects of treatment with DM-101PX will be investigated.”

About DM-101PX

DM-101PX is an investigational medicinal product intended for immunotherapeutic treatment of birch pollen allergy. The active ingredient is DM-101, a recombinant variant of major birch pollen allergen Bet v 1, which is genetically engineered to reduce its allergenicity while retaining the desired immunological properties. In DM-101PX, it is formulated into a thermosensitive hydrogel to support the controlled release of the active ingredient after subcutaneous injection.

About Desentum

Desentum Oy is a clinical-stage biopharmaceutical company based in Espoo, Finland, leveraging high-resolution protein engineering and drug delivery technologies for designing allergy vaccines that enable short-course treatment to restore long-term tolerance. Desentum, founded in 2011, is a spin-off company from VTT Technical Research Centre of Finland Ltd. With its product development, Desentum targets both respiratory and food allergies.

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