Anergis Reaches Important Milestones with Second Product Candidate AllerR

US Regulatory path for new vaccine against ragweed pollen allergies established

EPALINGES, Switzerland I June 14, 2012 I Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, reported today 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 U.S. FDA during which the regulatory path was clearly established until and including the clinical Phase I trial protocol.

“In developing our vaccines, we need to ensure that they do not cross-react with the IgE antibodies of allergic patients, the antibody class responsible for eliciting allergic hypersensitivity,” said Dr Christophe Reymond, Chief Scientific Officer of Anergis. “For AllerR, we selected an optimal set of Contiguous Overlapping Peptides. Following our successful pre-IND meeting with the FDA on our further development plan, we are now ready to progress AllerR towards clinical Phase I.”

“Our findings with AllerR are similar to those observed with AllerT, our lead product against birch pollen allergies, which we will continue to test in a Phase II study during the next birch pollen season,” said Vincent Charlon, CEO of Anergis. “We are strongly encouraged by the highly valuable interaction with the U.S. FDA, which gave us important insights into the U.S. regulatory framework for our novel allergy vaccines. Our preclinical results and the comments by the FDA provided further confirmation of the high value of our technology that allows to design and develop novel, ultra-fast and safe vaccines against allergies.”

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About Anergis

Anergis SA is a Swiss-based biopharmaceutical company specializing in the discovery and development of novel allergy vaccines targeting the most frequent allergies. Allergies are the most prevalent and the fastest growing chronic conditions in the industrialized world with over 300 million people affected. While short-term symptomatic treatments of allergy need to be prescribed continuously, the only curative therapy of allergy, known as “desensitization” or “Specific Immunotherapy” (SIT), is a process of induction of tolerance to the allergen, that today requires 3-5 years of treatment and poses the risk of serious side effects.

Based on its proprietary Contiguous Overlapping Peptides (“COPs”) technology, which Anergis acquired in 2005 from the University of Lausanne, Switzerland (UNIL), the Federal Institute of Technology (EPFL) and the Centre Hospitalier Universitaire Vaudois (CHUV), the company is developing innovative SIT products containing so-called COPs, that reproduce the full amino acid sequence of the allergen in separate long peptides. Anergis COPs do not cross-react with IgE, the antibody class responsible for eliciting allergic hypersensitivity. Therefore, COPs can be safely administered at high doses to induce tolerance to the allergen after few injections only. 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) of Anergis products.

Anergis’ lead-product is currently in Phase II clinical development. Anergis raised CHF 18 million in March 2011 from lead investors Vinci Capital, Sunstone Capital and BioMedInvest and other investors including Esperante Ventures and Defi Gestion.

SOURCE: Anergis

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