DBV Raises $25.5M in Series C for Clinical-Stage Food Allergy Desensitization Technology

French biotech firm DBV Technologies raised $25.5 million in a Series C financing round led by new investors InnoBioFund and Lundbeckfond Ventures. Shire and Alto Invest also joined the round, together with existing investors Sofinnova Partners and Alk Abello.

DBV is focused on the development of products for the diagnosis and treatment of food allergies. Its approach is to elicit an immune response by delivering allergens to antigen-presenting cells at the skin epidermis. This approach hinges on the firm’s noninvasive Viaskin® delivery system, which uses electrostatic forces to present and deliver active compounds to the epidermis of the skin without breaking the basement membrane. DBV claims that because presented compounds such as allergens do not cross the blood-skin barrier, the risk of anaphylactic shock in allergic patients is dramatically reduced.

The firm is exploiting the technology to develop epicutaneous immunotherapy (EPIT) for patients with severe IgE-mediated peanut or milk allergies. The Viaskin EPIT approach involves maintaining an allergen on the skin of an allergic subject for repeated and prolonged periods, in order to achieve clinical desensitization/tolerization. This approach is an alternative to established subcutaneous allergen-specific immunotherapy or sublingual allergen-specific immunotherapy techniques, DBV claims.

In July 2010 the firm was granted IND clearance by FDA to start clinical investigation of its Viaskin Peanut EPIT product in both adults and children. The Phase Ib studies are ongoing at various clinical centers across the U.S. In September Viaskin Peanut was selected for further evaluation in a Phase II study led by the U.S. Consortium of Food Allergy Research. This Phase II study will be funded by a renewed five-year grant from the U.S National Institutes of Health and is expected to begin in mid-2011.

DBV has separately conducted a double-blind placebo-controlled pilot trial with its Viaskin Milk EPIT product on a small number of children with severe cow’s milk protein allergy (CMPA). The firm says that although the French trial involved only a limited number of patients, it suggested the EPIT approach was safe and could constitute a therapeutic option in children with severe IgE-mediated CMPA.

DBV cites Food Allergy and Anaphylaxis Network statistics suggesting that there are some 12 million food-allergic people in the U.S., and the incidence of peanut allergy in children has doubled over the last five years.