Early-Stage Proprietary Model Suggests that Serum Biomarkers may help Monitor Treatment Progression with Viaskin Peanut
Additionally, Another DBV Data Presentation is Chosen as “Best of Poster Discussion Session” by EAACI Congress DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage specialty biopharmaceutical company, presented data on immune biomarkers collected from patients treated with Viaskin Peanut at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2016 in Vienna, Austria. Preliminary results showed that patient response throughout the course of treatment could be modeled using a proprietary statistical algorithm based on peanut-specific biomarkers.
Luis Salmun, MD, Vice President, Medical Affairs, DBV Technologies, presented the results of an early-stage model on Monday, June 13 at 4:35pm CEST, in a late-breaking session entitled “Prediction of Peanut-Challenge Outcome with Biomarkers: Monitoring Viaskin Peanut Treatment Progression with Biomarkers.” The study highlighted a model supported by Viaskin Peanut clinical data, which combines different serological biomarkers into a potential tool that could help physicians monitor patients during treatment course. Data for this study was collected from the company’s Phase IIb clinical trial, VIPES and its open-label follow-up study, OLFUS-VIPES.
“As we continue to develop this model, our goal is that it may eventually become a valuable resource for allergists, patients and caretakers to monitor ongoing treatment with Viaskin Peanut. This study provides us with proprietary algorithms of peanut-specific biomarkers that may enable physicians assess desensitization with a practical tool that can be easily implemented in routine clinical practice” said Dr. Salmun. “This proprietary research continues to reinforce our commitment to integrating innovative science with our patient-driven approach to product development. As we collect new data from additional trials with our Viaskin Peanut, we will continue to refine the robustness of these models.”
Study Details
Data presented evaluated biomarkers from children who underwent three double-blind, placebo-controlled food challenges (DBPCFC) during VIPES and OLFUS-VIPES: at baseline, year-1 and year-2 of treatment with Viaskin Peanut. Concentrations of serum biomarkers (including peanut-specific IgE [p-sIgE], peanut-specific IgG4 [p-sIgG4] and Ara h 2 p-sIgE [a2-sIgE]) and other variables were collected before each challenge. In this study, the DBPCFC outcome was modeled as a binary endpoint defined by three reactive threshold doses of 300 mg, 1000 mg and 2000 mg.
Very short signatures of two to four variables measured predictability of response to the OFC for all three models. The ratios p-sIgG4/a2-sIgE and p-sIgG4/p-sIgE were always among the top-ranked variables.
Based on these results, the researchers concluded that modeling the response to an oral food challenge based on a subset of serum biomarkers is feasible, and the model may eventually be employed to monitor treatment progression with Viaskin Peanut.
“Best of Poster Discussion Session” Award Details
“Epicutaneous immunotherapy but not oral immunotherapy prevents eosinophilic infiltration in the esophagus in a model of milk sensitized mice,” presented by Lucie Mondoulet, PhD, DBV Technologies, on Monday, June 13 at 10:45am - 12:15pm CEST, received the honor of “best of” in the Poster Discussion Sessions category. Dr. Mondoulet’s preclinical study evaluated the prevention of oral milk-induced esophageal eosinophilic inflammation by milk EPIT, compared to oral immunotherapy (OIT). Researchers concluded that EPIT, not OIT, is effective in preventing esophageal milk-induced eosinophilic infiltration in a model of milk-sensitized mice.
According to EAACI, the two session chairs selected the best abstract presentation in each session, and selection was based on scientific content/methodology, novelty and originality of research, as well as the ability of the presenter to present the abstract in a concise and clear manner and answer questions.
About DBV Technologies
DBV Technologies developed Viaskin®, a proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT®, DBV’s method of delivering biologically active compounds to the immune system through intact skin. With this new class of self-administered and non-invasive product candidates, the company is dedicated to safely transforming the care of food allergic patients, for whom there are no approved treatments. DBV’s food allergies programs include ongoing clinical trials of Viaskin Peanut and Viaskin Milk, and preclinical development of Viaskin Egg. DBV is also pursuing a human proof concept clinical study of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and exploring potential applications of its platform in vaccines and other immune diseases.
DBV Technologies has global headquarters in Montrouge, France and New York, NY. Company shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and traded on the Nasdaq Global Select Market in the form of American Depositary Shares (each representing one-half of one ordinary share) (Ticker: DBVT). For more information on DBV Technologies, please visit our website: www.dbv-technologies.com
