Tag: birch pollen
Company News: Anergis Appoints Dr. Dino Dina to its Board of Directors
– Company appoints seasoned US vaccine and biotech executive –
Anergis, a company focusing on proprietary allergy vaccines, today announced the appointment of Dino Dina, MD, to its Board of Directors. Dr. Dina brings extensive expertise in the research and development of vaccines for allergy, cancer and infectious diseases as well as in building successful US biopharmaceutical companies.
From 1998 to 2013, Dr. Dina served as Chief Executive Officer of Dynavax Technologies Corporation and has been a member of Dynavax´ Board of Directors since 1997. During his tenure, he secured extensive financing through corporate alliances (UCB, Sanofi, AstraZeneca, GSK, Merck), private financings, an initial public offering (2004), and a series of public equity financings. Prior to joining Dynavax, Dr. Dina held a series of positions with increasing responsibility at Chiron Corporation, where he ultimately served as President of Chiron Vaccines. Under Dr. Dina’s direction, Chiron Vaccines received the first-ever approval of an adjuvanted influenza vaccine in Italy, successfully completed development of the first genetically engineered pertussis vaccine, and conducted clinical trials for vaccines to prevent HIV, herpes simplex type II, cytomegalovirus, and hepatitis B infections.
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].
Company News: Anergis Starts European Phase IIb Clinical Trial with AllerT in Patients with Moderate to Severe Allergy to Birch Pollen
– First patient treated with novel allergy vaccine –
Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, reported today that it has treated the first patient in a large, well-controlled Phase IIb clinical trial in individuals with birch pollen allergy. The trial is designed to evaluate the efficacy and tolerability of a 5-injection / 2- months treatment with Anergis´ lead allergy vaccine, AllerT.
The multicentre, double-blind, placebo-controlled, randomized trial called AN004T was designed in collaboration with an International Steering Committee of experts with comprehensive experience in the design and conduct of allergen-specific immunotherapy trials(1). The trial will enroll about 300 patients with moderate to severe birch pollen allergy from up to 30 trial centers throughout Europe. Trial centers are located in Denmark, France, Latvia, Lithuania, Poland, Sweden and Switzerland. AN004T will evaluate the efficacy and safety of two doses of AllerT in comparison with placebo. The first patient was randomized and treated on November 3rd, 2012, in Vilnius, Lithuania.
As recommended by the European Guideline on the Clinical Development of Products for Specific Immunotherapy for the Treatment of Allergic Diseases (CHMP/EWP/18504/2006), the efficacy of AllerT will be assessed using a combined symptom and medication score as primary endpoint of the trial (combined Rhinoconjunctivitis Symptom and Medication Score RSMS). RSMS assessment is based on allergy symptom and medication data reported through electronic diaries by the trial subjects during the 2013 birch pollen season. Secondary and exploratory endpoints will include other clinical parameters related to symptoms and/or medications taken for allergy, as well as quality of life and immunological marker assessments.