Tag: AllerT

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.

Company News: Anergis Reaches Important Milestones with Second Product Candidate AllerR

– US Regulatory path for new vaccine against ragweed pollen allergies established –

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.

Company News: Anergis Appoints Jacques-François Martin as Chairman of the Board of Directors

Anergis, a clinical-stage biopharmaceutical company developing novel allergy vaccines, today announced the appointment of Jacques-François Martin, Chairman and CEO of vaccine company Mymetics, as Chairman of the Board of Directors.

Anergis develops allergy vaccines based on its proprietary technology of “Contiguous Overlapping Peptides” (“COPs”). Anergis’ lead allergy vaccine, called “AllerT”, is in clinical Phase IIb development and is designed to provide ultra-fast and safe desensitization to birch pollen allergy, a widespread condition in developed countries. Anergis’ vaccines are designed to provide long-term protection against allergies with a 2-month treatment.

Jacques-François Martin is Chairman and CEO of Mymetics Corporation. Previously, he was CEO of Chiron Vaccines (now Novartis) from 1991 to 1993 and CEO of Pasteur-Mérieux (now Sanofi-Pasteur) from 1988 to 1991. In addition, he held leadership positions with not‐for‐profit organizations dedicated to the development of vaccines for debilitating and life-threatening diseases in both developed nations and third world countries. Among others, he was the first President and CEO of The Vaccine Fund (Bill and Melinda Gates Foundation) from 2000 to January 2005 and a member of the Board of the International AIDS Vaccine Initiative (IAVI) from November 1997 to June 2003. He started his executive career as Chief Executive Officer of Rhône-Poulenc Pharma in Hamburg, Germany, in 1970. Mr. Martin is a member of the French Academy of Technologies and an officer in the French Order of Merit.

Company News: Anergis Closes CHF 18 Million Series A Financing Round to Develop its Innovative Allergy Vaccines and Expands its Board of Directors

Anergis SA announced today that it has closed a Series A financing round raising CHF 18 millions from European biotech funds and private local investors. Anergis SA is a clinical-stage biopharmaceutical company developing innovative immunotherapies against allergies. Its lead product, called “AllerT” and made of so-called Contiguous Overlapping Peptides (COPs), is designed to provide ultra-fast and safe desensitization to birch pollen allergy, a widely spread condition in developed countries.

The financing round was co-led by three major European funds with extensive biotech experience: Vinci Capital-Renaissance PME (Lausanne, Switzerland), BioMedInvest (managed by BioMedPartners AG, Basel, Switzerland) and Sunstone Capital (Copenhagen, Denmark). The syndicate was also joined by Esperante (Limhamn, Sweden), Initiative Capital Romandie (Lausanne, Switzerland) and by private investors. Up until now, Anergis has invested CHF 3 million in its innovative allergy vaccines. These funds were raised from private investors and from a grant by the Swiss Innovation Fund (CTI).

The newly joining investors also bring substantial pharmaceutical experience and know-how to Anergis: Patrick Scherrer (representing Vinci Capital-Renaissance PME), Markus Hosang (representing BioMedInvest) and Sten Verland (representing Sunstone Capital) have joined the Anergis Board of Directors. The Board will be chaired by André J. Mueller, a professional with unique executive and non-executive experience in biotech ventures, which he gained with Biogen and Actelion and as the Chairman of the Boards of Cerenis Therapeutics (Toulouse) and Addex Pharmaceuticals (Geneva).

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