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Clinical Trials

Date: 2016-04-11

Type of information: Publication of results in a medical journal

phase: preclinical

Announcement:

Company: DBV Technologies (France)

Product: Epicutaneous Immunotherapy (EPIT), oral immunotherapy (OIT) and sublingual immunotherapy (SLIT)

Action mechanism:

immunotherapy product

Disease: peanut allergy

Therapeutic area: Allergic diseases

Country:

Trial details:

To study efficacy and characterization of Tregs induced by the different therapies, mice sensitized with peanut protein extract (PPE) were randomly allocated to four groups of eight and treated for eight weeks: EPIT (100 µg), OIT (1 mg the first week, 2 mg the second week, then 5 mg the following 6 weeks), SLIT (100 µg) and a placebo group. Allergen specific responses as well as Treg phenotypes were analyzed using blood and tissue samples. To examine the transfer of protection by Tregs, mice were randomly allocated to six groups of 15 animals and treated for eight weeks: two groups treated by EPIT, two treated by SLIT and two groups treated by OIT. Following treatment, or 8 weeks after the end of treatment, one group treated with each form of immunotherapy were sacrificed for spleen cell recovery and CD4+CD25+ cell sorting. Cells were then transferred into peanut-sensitized nontreated mice (n=8 per group). Three days after the transfer, mice were orally exposed to peanuts daily for 10 days. A tissue analysis of esophagus was then conducted to assess the protection conferred by passive Tregs transfer.

Latest news:

* On April 11, 2016,  DBV Technologies announced the publication of experimental data in Cellular & Molecular Immunology characterizing the response of regulatory T cell (Tregs) to allergenspecific immunotherapy intended for the treatment of food allergies. The study characterized Tregs activity during Epicutaneous Immunotherapy (EPIT), oral immunotherapy (OIT) and sublingual immunotherapy (SLIT), and showed that all methods of treatment desensitized peanut-sensitized mice, but only EPIT-induced Tregs continued to show suppressive abilities after treatment discontinuation.  The study, “Differences in Phenotype, homing properties and suppressive activities of Regulatory T cells induced by Epicutaneous, Oral or Sublingual Immunotherapy in Mice Sensitized to Peanut”, showed that peanut desensitization with EPIT, OIT, and SLIT induce different Tregs subsets with differing homing properties, consequently inducing distinct long-term efficacy and maintenance ability in vivo. The three immunotherapy routes studied were all found to have a desensitization effect, but suppressive activities after discontinuation of treatment were only observed with EPIT, and not with OIT or SLIT. Tregs observed during OIT and SLIT showed only an effector/memory cell profile, while Tregs during EPIT showed both effector/memory and naive cell profiles. These “naive” Tregs appear to induce sustained suppression after discontinuation of treatment, suggesting the induction of a longer-lasting allergen tolerance in a mice model.


Is general: Yes