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Sunday, December 16, 2018

DBV Data Backs Through-Skin Immunotolerance at Skin Disease Summit


First-of-its-kind study evaluated immune profile of healthy human skin in different body sites
Findings support application of epicutaneous immunotherapy (EPIT) to inter-scapular region of peanut-allergic patients for greater allergen exposure
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that an oral abstract evaluating differences in the immune profile of healthy human skin across different body areas was presented by Dr. Ester Del Duca, Icahn School of Medicine at Mount Sinai, at the 3rd Inflammatory Skin Disease Summit (ISDS) in Vienna, Austria, December 12-15, 2018.
The study results have important implications for treating immunological disorders, such as food allergies, with epicutaneous immunotherapy (EPIT). For food allergies, EPIT is designed to target specific skin immune cells in order to desensitize patients to allergens. In the study presented, of the four body sites studied, the upper back region showed the highest up-regulation of Th2/Th17 pathway genes and regulatory T cells, which are important targets for preventing allergic reactions. The findings support the use of the Company’s investigational Viaskin Peanut treatment for peanut allergy at the inter-scapular region of the upper back due to the local immune profile of the skin.
We are proud to support leading research that helps characterize the significant potential of the skin as the largest immune organ and contributes to our growing understanding of how to best treat food allergies and other immunological diseases,” said Dr. Hugh Sampson,Chief Scientific Officer of DBV Technologies and Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai.The data presented at ISDS 2018 suggest that the specific immune environment of the skin on the back has the greatest potential to induce immunotolerance in patients with food allergies compared with other areas of the body explored in this study.  Such data help ensure that novel treatments are optimized in the real-world and further support the therapeutic benefit that children with peanut allergy may receive from treatment with Viaskin Peanut, which is applied directly to the upper back.”
In an oral presentation entitled, Major Differences in Expression of Inflammatory Products in Skin from Different Body Sites of Healthy Individuals” (#A67), Dr. Ester Del Duca, from the laboratory of Dr. Emma Guttman at Icahn School of Medicine at Mount Sinai, New York, NY, presented findings showing significant differences in the distribution of cell types and immune profile of the skin across different body areas from healthy individuals. Out of the four locations studied – inner upper arm, upper back, outer upper thigh and lower abdomen – the upper back region showed the highest up-regulation of Th2/Th17 pathway genes and regulatory T cells, important targets for preventing an allergic reaction. The back also had the highest number of dendritic cells and Langerhans cells, as well as the lowest expression of negative immune regulators, which together can support better immune recognition of antigens when treated with EPIT.
In October 2018, DBV Technologies submitted a Biologics License Application to the U.S. Food and Drug Administration for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years of age. Viaskin Peanut is the Company’s lead product candidate, which is based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that delivers biologically active compounds to the immune system through the skin. Viaskin Peanut previously received Breakthrough and Fast Track Designation from the FDA. The submission was supported by a global development in children four to 11 years of age, in which treatment with Viaskin Peanut 250 µg was observed to demonstrate a significant desensitization to peanut as compared to placebo.

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