Date: 2013-02-21
Type of information: Results
phase: preclinical
Announcement: results
Company: Anergis (Switzerland)
Product: AllerR
Action
mechanism: AllerR is a mix of seven Contiguous Overlapping Peptides (COPs) derived from the COP platform of Anergis.
Disease: allergy to ragweed pollen
Therapeutic area: Allergic diseases - Immunological diseases
Country:
Trial details:
Latest
news: * On February 21, 2013, Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, has reported that it will present preclinical data for its ragweed allergy vaccine at the 2013 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Antonio, TX. The results demonstrate the hypoallergenicity of AllerR and the successful recognition of the natural ragweed allergen Amb a 1 by the mouse immune system after immunization with AllerR.In the experiments, AllerR showed no detectable IgE binding in competition ELISA tests using sera from allergic patients and did not induce degranulation of humanized basophil cells, a standard test used to test the ability of a protein or peptide to elicit an allergic reaction in humans. In addition, mice sensitized to the natural allergen Amb a 1 showed no reactivity to AllerR, whereas the administration of Amb a 1 in these animals lead to anaphylactic responses. The immunogenicity of AllerR was also tested in naïve mice and showed that each COP composing AllerR elicited an antibody response and that these antibodies specifically recognized the natural Amb a 1 allergen.
“We received positive feedback from the U.S. FDA last year when we discussed the AllerR early development program and the preparation of the first clinical trial of AllerR in patients allergic to ragweed pollen,” said Vincent Charlon, CEO of Anergis. “Our goal is to start a Phase I/IIa clinical trial in 2014.”
The abstract of the poster titled “Non-Detectable IgE Binding of an Amb a 1 Derived, Contiguous Overlapping Peptide Based, SIT Product Candidate Against Ragweed Allergy” is available at:
http://download.journals.elsevierhealth.com/pdfs/journals/0091-6749/PIIS0091674912028163.pdf. It is also being published in The Journal of Allergy and Clinical Immunology - February 2013 (Vol. 131, Issue 2, Supplement, Page AB37, DOI: 10.1016/j.jaci.2012.12.815).
* On June 14, 2012, Anergis has reported that it has reached several preclinical development milestones with AllerR, a novel allergy vaccine candidate for the treatment of patients with allergies to ragweed pollen. In addition, the company received positive feedback from the FDA on its AllerR development program.
In the development of AllerR, its second allergy vaccine candidate, Anergis reached essential preclinical milestones and held its first meeting with the US FDA in preparation for the first clinical trial of AllerR in patients allergic to ragweed pollen. In preclinical experiments carried out by Anergis, binding of the AllerR peptides to IgE antibodies of allergic patients remained consistently undetectable in all conditions tested. In mice pre-sensitized to ragweed pollen, AllerR, unlike natural ragweed allergens, did not elicit an anaphylaxis-like response. And, importantly, AllerR was found to elicit antibody responses in mice, in which the antibodies recognized the natural ragweed allergens. Following collection of these data, Anergis held a pre-IND meeting with the FDA during which the regulatory path was clearly established until and including the clinical Phase I trial protocol. Last year, Anergis raised CHF 18 million from lead investors including Vinci Capital, Sunstone Capital and BioMedInvest.
