Immunology Data Further Underline the Positive Outcome of a Phase IIb Trial of Anergis' Birch Pollen Allergy Vaccine AllerT

Epalinges, Switzerland, (PresseBox) - .
- Treatment with AllerT increases allergen-specific IgG4 antibody levels by a factor of 20
- AllerT administration produces humoral immune responses similar to conventional desensitization

Anergis, a company focusing on proprietary allergy vaccines, today reported immunology data from the Phase IIb study of its lead compound AllerT. In the trial, AllerT induced a strong increase of allergen-specific IgG4, a key marker of immunological responses typically observed in successful, conventional allergy immunotherapy (AIT, previously known as allergen-specific immunotherapy, or SIT). In September 2013, Anergis had reported that the trial showed significant clinical effects of AllerT on multiple efficacy endpoints, including combined symptom and medication scores assessed daily throughout the natural birch pollen season 2013.

In the placebo-controlled, double-blind, multicenter trial, a total of 240 patients from 24 European trial centers were randomized to receive 5 pre-seasonal injections of AllerT 50 μg, AllerT 100 μg, or placebo over a period of 2 months between November 2012 and March 2013.

Allergen-specific IgG4 antibody blood levels were similar in all three groups before treatment. Four weeks after completion of treatment and prior to the birch pollen season, the IgG4 levels were markedly and similarly increased in both AllerT dose groups by a factor of about 20 compared to baseline and to placebo (all tests p < 0.0001). During the subsequent birch pollen season, the IgG4 levels remained similarly elevated in both dose groups, showing that a plateau of IgG4 had been reached. By contrast, IgG4 levels remained unchanged in the placebo group during treatment and during the pollen season.

"We are very pleased with these highly significant IgG4 results, which are very similar to the immunological effects observed in the Phase I/IIa trial," said Christophe Reymond, CSO of Anergis. "The long-term follow-up of this former trial also demonstrated the persistence of significantly elevated allergen-specific IgG4 levels up to four years after treatment."

Prof. Marek Jutel (Wroclaw Medical University, Dept. of Immunology, Poland), a member of the Trial Steering Committee, added: "The data collected in this ultra-fast desensitization with AllerT show effects similar to conventional AIT from both clinical and immunological standpoints. We are eager to see AllerT being developed further and are focusing on additional COP allergy vaccines reaching clinical development stages."

Anergis' COP (Contiguous Overlapping Peptide) technology can be applied to a broad spectrum of allergy indications. At present, Anergis is developing AllerT for the treatment of birch pollen allergy, AllerR for ragweed pollen allergies and AllerDM for dust mite allergies.

About Anergis' Contiguous Overlapping Peptides (COP) Technology

The only curative therapy of allergies available today, known as "desensitization" or "Conventional Allergy Immunotherapy" (AIT), is the process of inducing tolerance to the allergen. It requires 3-5 years of treatment and exposes patients to the risk of serious side effects - in particular immediate (<30 min) anaphylactic reactions - which can be life-threatening. With its ultra-fast desensitization, Anergis is shaping the future of allergy treatment. Anergis' vaccines are based on COPs which reproduce the complete amino acid sequence of the allergen in separate synthetic long peptides. COP allergy vaccines are pharmaceutical quality products that provide the complete allergen sequence covering all T cell epitopes, but do not cross-react with IgE, the antibody class responsible for eliciting allergic hypersensitivity. Therefore, COPs can be administered safely at high doses to induce tolerance to the allergen after a few injections only. This allows for desensitization in 2 months as opposed to 3 years. Studies of COPs targeting bee venom and birch pollen allergies in both animals and humans have demonstrated excellent safety (no immediate allergic reaction) and immunogenicity (production of specific antibodies and cytokines against the original allergen and establishment of a long-term immune memory). The Phase IIb data reported in September 2013 confirmed that COP allergy vaccines can also substantially reduce allergy symptoms under real-life conditions of natural pollen exposure.

ANERGIS SA

Anergis SA is a Swiss-based biopharmaceutical company specializing in the discovery and development of novel, proprietary allergy vaccines that target commercially attractive indications. Anergis' vaccines are based on its IP-protected Contiguous Overlapping Peptide technology. Allergies are the most prevalent and fastest growing chronic conditions in the industrialized world affecting over 500 million people.

Anergis' lead-product AllerT, a vaccine to treat birch pollen allergies, is due to enter Phase III clinical development in 2014. Two additional vaccine candidates against ragweed pollen allergies (AllerR) and house dust mite allergies (AllerDM) are in preclinical development.

Anergis has raised over CHF 22 million from Renaissance PME-Vinci Capital, Sunstone Capital, BioMedInvest and other investors, including Esperante Ventures and Initiative Capital Romandie/Defi Gestion.

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