Tag: BioMedInvest

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: Curetis AG Successfully Increases Series A Round to EUR 24.5 Million

Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced an extension of its Series A financing, bringing the total size of the round to € 24.5 million. CD-Venture joined the funding as a new investor, while all of Curetis’ existing VC investors participated in the round. Several private investors also continued to co-invest.

Following the appointment of Oliver Schacht, PhD, as the new CEO of Curetis last month, this financing transaction is the first step towards funding next year’s commercial launch and roll-out of the Unyvero product platform together with the first CE marked IVD test cartridge for pneumonia and antibiotic resistances in Europe. The additional funds will allow Curetis to pursue a more aggressive strategy towards initiating a US clinical trial in H2-2011 with a goal of filing for FDA approval in 2012. This Series A financing positions Curetis as a solidly funded molecular diagnostics company with near-term commercial-stage products and its unique platform solution addressing a clear unmet medical need in the rapid diagnosis of infectious diseases and antibiotic resistance.

Curetis’ CEO Oliver Schacht will present an update on the company at the upcoming BioEquity 2011 in Paris. The presentation is scheduled for May 23, 2011, at 5:00 pm CET, Room Pont de Sully.

Further details can be found here.

 

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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