Long-Term Immunomodulation Induced by Anergis' COP Allergy Vaccine AllerT Now Extends to the 4th Year After Treatment
Published: Nov 08, 2012
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.
“These results indicate again that the immune system of patients was durably affected by the 2-months treatment with AllerT, which was administered 40-42 months earlier. This means that a long-term immunological memory appears to be present in AllerT-treated subjects,” said Christophe Reymond, Ph.D., CSO of Anergis.
“We are highly encouraged by what seems to be a very long-lasting treatment effect after such a short treatment with AllerT,” added Vincent Charlon, CEO of Anergis. “These results lend strong credibility to our hypothesis that we will be able to demonstrate a long-term disease-modifying effect on allergy symptoms after just a few injections of our COP allergy vaccines.”
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].
Anergis SA is a Swiss-based biopharmaceutical company specializing in the discovery and development of novel allergy vaccines targeting the most frequent allergies. Anergis´ vaccines are based on its proprietary Continuous Overlapping Peptides technology. Allergies are the most prevalent and the fastest growing chronic conditions in the industrialized world, with over 300 million people affected.
Anergis’ lead-product AllerT, a vaccine to treat birch pollen allergies, is in Phase II clinical development. AllerR, its second vaccine candidate for the treatment of patients with allergy to ragweed pollen, has recently reached important preclinical milestones and received positive feedback from the U.S. FDA for the subsequent clinical development program in June 2012. Anergis has raised over CHF 20 million from Vinci Capital-Renaissance PME, Sunstone Capital, BioMedInvest and other investors including Esperante Ventures and Defi Gestion.
About Anergis´ Contiguous Overlapping Peptides Technology (COPs)
The only curative therapy of allergies available today, known as “desensitization” or “Specific Immunotherapy” (SIT), is a process of induction of tolerance to the allergen requiring 3-5 years of treatment and exposing patients to the risk of serious side effects. Anergis has developed a next-generation concept of SIT: vaccines based on COPs, which reproduce the full-length amino acid sequence of the allergen in separate long peptides. 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).
Vincent Charlon, CEO
Dr. Ludger Wess, Ines Regina Buth
Tel. +49 40 88165964 or +49 30 2363 2768