Tag: AllerT
Company News: Anergis Reports Positive Phase IIb Data for Birch Pollen Allergy Vaccine AllerT
– AllerT 50 μg meets primary and secondary endpoints
– Vaccine improves quality of life and symptom scores
Anergis, a company focusing on proprietary allergy vaccines, reported today that a Phase IIb study of its lead compound AllerT met the primary endpoint of reducing the combined symptom and medication score with AllerT 50 μg during the birch pollen season. Moreover, the vaccine improved the quality of life and symptom scores with AllerT 50 μg and AllerT 100 μg. AllerT is a birch pollen allergy vaccine derived from the company´s proprietary Contiguous Overlapping Peptide (COP) technology platform, which is designed to provide ultra-fast allergy desensitization after only two months of treatment.
In a placebo-controlled, double-blind, randomized multicenter trial, a total of 240 patients from 24 trial centers in Switzerland, France, Poland, Latvia, Lithuania, Sweden and Denmark were divided into three groups (placebo, AllerT 50 μg and AllerT 100 μg, respectively). From November 2012 to March 2013, the patients received 5 injections over a period of 2 months as a pre-seasonal treatment.
During the subsequent 2013 birch pollen season, compared to the placebo group, the combined Rhinoconjunctivitis Symptom and Medication Score (RSMS, primary endpoint) was reduced by 30% (p=0.024, statistically significant) with AllerT 50 μg and by 19% (p=0.190, not statistically significant) with AllerT 100 μg. Both AllerT doses were associated with similar statistically significant improvements in the total score of the Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) and in the rhinoconjunctivitis symptom score throughout the birch pollen season. All other secondary endpoints showed similar efficacy trends.
AllerT was safe and well-tolerated throughout the two-month pre-seasonal treatment. Most adverse events were mild or moderate, resolved within 24 hours, and there were no reports of anaphylactic shock or grade 3 allergic reactions within 30 minutes following any of the injections.
COP vaccines can be applied to a broad variety of allergy indications. Besides AllerT for the treatment of birch pollen allergies, Anergis´ COP allergy vaccine pipeline currently includes AllerR for ragweed pollen allergies and AllerDM for dust mite allergies.
Company News: Anergis Expands Management Team
– Company Appoints Gilles Della Corte as Director of Clinical Development and Eva Castagnetti as Director of Product Development –
Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, today announced the expansion of its management team. With the appointments of Gilles Della Corte as Director of Clinical Development and Eva Castagnetti as Director of Product Development, the company has significantly strengthened its late-stage drug development expertise.
Gilles Della Corte, MD, brings to Anergis extensive expertise in global clinical development. In the past 22 years, he worked both for pharmaceutical companies, including Rhone-Poulenc Rorer, Servier, Solvay Pharma, Serono and Merck Serono, and for CROs where he held various senior positions in Research and Development. He has significant experience with all stages and aspects of clinical drug development ranging from Phase I to Phase IV. A cardiologist and pharmacologist by training, Gilles also holds diplomas in statistics and clinical trial methodology.
Eva Castagnetti, PhD, has several years of experience in both technical and business management functions in the biopharmaceutical industry with Lonza, Senn Chemicals and Rapid Pharmaceuticals. She has been responsible for the development and production of Active Pharmaceutical Ingredients (peptides) in early to late clinical phases, gaining comprehensive experience of the regulatory and quality requirements in the development of new pharmaceutical products. Eva obtained her PhD in organic chemistry in 2001 from the University of Lausanne/EPFL and spent two years as a postdoctoral fellow at the Massachusetts Institute of Technology (Cambridge/Boston) and at the ETH Zurich.
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].