Tag: Christophe Reymond

Company News: Anergis Files Provisional U.S. Patent on AllerDM Dust Mite Allergy Treatment

– Further expansion of the company’s product pipeline and patent estate –

Anergis, a company focusing on proprietary synthetic allergy vaccines designed to provide ultra-fast desensitization, has filed for provisional patent protection of its AllerDM dust mite allergy treatment in the U.S. The company plans to extend the patent application within the next 12 months to achieve world-wide protection under the Patent Cooperation Treaty.

AllerDM is an allergy vaccine for patients with house dust mite allergy and is based on Anergis’ proprietary Contiguous Overlapping Peptide (COP) technology, which allows for ultra-fast desensitization in only two months treatment. COP allergy vaccines are pharmaceutical quality products, which have proven to be safe and well tolerated and to induce a long-term immune effect. AllerDM is currently in pre-clinical development and is expected to enter clinical stage in 2015. Further details on the product are not being disclosed at present.

House dust mites are the most frequent cause of allergy and suspected to trigger severe consecutive disorders. Asthma may be caused by house dust mite allergy in 50 to 80% of patients. It is estimated that about 60 million patients in Europe, 30 million in the U.S., 20 million in Japan and 60 million in China suffer from dust mite allergies.

AllerT, the lead product of Anergis, is currently evaluated in a double-blind, randomized, placebo-controlled Phase IIb trial in 240 patients with moderate to severe birch pollen allergy, enrolled at 24 trial centers throughout Europe. Results are expected in Q3, 2013.

Earlier this year, Anergis presented preclinical data of its ragweed allergy vaccine candidate AllerR. A Phase I/IIa trial of AllerR is expected to start in 2015.

 

Company News: Anergis Presents Preclinical Data of its Ragweed Allergy Vaccine Candidate AllerR

– AllerR induces formation of antibodies recognizing natural ragweed allergens –

Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, reported today 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.

The poster no. 136 will be presented on Saturday, February 23, 2013, at 9:45am CST in session no. 2210 “Immunotherapy I” at the Henry B. Gonzalez Convention Center, Street Level, Exhibit Hall C. 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

AllerR is a mix of seven Contiguous Overlapping Peptides (COPs) derived from the COP platform of Anergis. 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.

In the U.S., ragweed pollen allergy is the major cause of hay fever: 75% of all patients suffering from pollen allergies carry a ragweed pollen allergy. It affects about 20% of the U.S. population and is also on the rise in Europe due to the spread of ragweed (Ambrosia genus) plants accidentally introduced to Europe. The major allergenic protein has been identified as Amb a 1, a 38 kDa non-glycosylated protein composed of two subunits.

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* The poster entitled “Non-Detectable IgE Binding of an Amb a 1 Derived, Contiguous Overlapping Peptide Based, SIT Product Candidate Against Ragweed Allergy” 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)

Company News: Anergis Obtains U.S. Patent for Lead Product AllerT

Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, has been granted patent protection for its AllerT birch pollen allergy treatment in the U.S.

The patent No. 8,343,503 granted by the U.S. Patent Office broadly covers composition of matter and medical use of AllerT, the lead product of Anergis. AllerT is composed of a set of three contiguous overlapping peptides (COPs) derived from the allergen Bet v 1, which plays a key role in inducing birch pollen allergy.

AllerT is currently evaluated in a double-blind, randomized, placebo-controlled Phase IIb trial enrolling about 300 patients with moderate to severe birch pollen allergy in up to 30 trial centers throughout Europe. Results are expected in Q3, 2013. In an earlier Phase I/IIa trial, a 2-month treatment with AllerT was well tolerated by patients with moderate to severe allergy to birch pollen. In these patients, AllerT elicited long-lasting immunological responses, evidenced by significantly elevated allergen-specific IgG4 antibody levels four years after completion of the 2-month treatment with AllerT.

Company News: Long-Term Immunomodulation Induced by Anergis´ COP Allergy Vaccine AllerT Now Extends to the 4th Year After Treatment

Patients with birch pollen allergy who received an ultra-fast allergy vaccine four years ago maintain an elevated level of antibodies against the allergen, reports Swiss biopharmaceutical company Anergis.

The company, which is developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, today announced new data on the immune-regulatory effect of its AllerT vaccine.

In 2008/2009, twenty patients suffering from moderate to severe allergies to birch pollen were enrolled in a double-blind, randomized, placebo-controlled Phase I/IIa trial and received 5 subcutaneous injections over 2 months of either AllerT (N=15) or placebo (N=5). Four years later, all subjects were invited to return to the trial center. In subjects who had received AllerT, blood levels of so-called IgG4 antibodies against specific birch pollen allergens were similar to those reported after 2 years (in 2010) and still 4.5 times higher than the pre-treatment baseline level (p< 0.001). Placebo-treated patients showed no median change from baseline in allergen-specific IgG4 at any time during the trial treatment period, nor after the 2010 and 2012 birch pollen seasons.

Earlier this week, Anergis also announced the start of a large, 300-patient real-life seasonal efficacy phase IIb trial with AllerT in patients allergic to birch pollen. This trial is being conducted in multiple European countries [NCT01720251].

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