The first study, published with collaborators from Madrid in Frontiers in Immunology, validates Allero’s SOMIT approach of addressing the oral mucosa as an immune privilege and an important target for the treatment of patients with Celiac disease (CD). Celiac disease is a chronic autoimmune disease characterized by an immune-triggered enteropathy upon gluten intake. The study compared mRNA patterns and immunohistological parameters of the oral mucosa of patients with CD (both chronic and newly diagnosed) and healthy subjects. All CD patients were characterized by a significant decrease in the expression of epithelial junction proteins, indicating a compromised integrity of the oral mucosa barrier. Also, regulatory T cells were recruited to the damaged mucosa, even after avoidance of gluten. The observations suggest that an altered mucosa may have diagnostic potential for CD and may be an important target for oral immunotherapy due to its immune tolerogenic capacity. Already, this has been demonstrated in allergic patients.

The second paper, published with collaborators from Brno in the leading allergy journal Clinical & Experimental Allergy, demonstrates that Allero’s SOMIT approach via a mucoadhesive patch presenting a food allergen plus tolerogenic bacterial particles (TBPs) results in efficacious desensitization in a translational food allergy model following a short-course sublingual immunotherapy protocol.

Prolonged presentation of the allergen plus TBP patch facilitated phagocytic uptake of the antigen by submucosal antigen-presenting cells and conditioned the local cytokine milieu towards better desensitization compared to the allergen presented alone. The effect seemed to improve trafficking of allergen and TBPs to the draining lymph nodes and ultimately led to higher systemic efficacy in the treated group.

“The data underline our strategy to use oral mucosa as a target to establish immune tolerance to combat food-induced immunes disorders,” said Poul Sørensen, CSO of Allero Therapeutics. “They also suggest that our strategy to develop a non-invasive short-course allergen immunotherapy by enhanced and prolonged allergen presentation via a combination of a mucoadhesive patch with tolerogenic probiotic bacterial particles is feasible and may lead to a faster onset of the induction of immune tolerance. Thereby, it may address the current main barrier for an increased uptake among allergic patients: the long and complicated immunotherapy regime lasting three to five years.”

Poul Sørensen added that future studies are needed to explore the potential of this approach for inducing long-term disease-modifying tolerance in allergy and its relevance in other immune disorders where T regulatory cells are involved in the natural resolution of inflammation.