Tag: Sunstone Capital

Company News: Anergis Closes Series B Financing Round Totaling CHF 14.5 Million

– Two U.S.-based family offices join as new investors

All Series A investors participate in the round

Anergis, a company developing proprietary ultra-fast allergy vaccines, today announced the closing of a Series B financing round totaling CHF 14.5 million (€ 12.1 million, US$ 15 million). All Series A investors participated in the round together with new private European and U.S.-based investors. The financing was jointly led by existing investors Sunstone Capital, BioMedInvest and Renaissance PME as well as new investor WJFS, Inc. Anergis has so far raised a total of CHF 44 million in private equity, which includes the latest Series B financing round.

The funds will be used to advance Anergis´ birch allergy vaccine AllerT closer to market. The company is currently preparing the Phase III clinical trial program of AllerT. Anergis has already demonstrated the rapid and long-lasting clinical efficacy of AllerT in two subsequent field-based clinical Phase II trials. The funds will also be used to advance the AllerR ragweed allergy program towards clinical testing, as well as to research and discover undisclosed new Contiguous Overlapping Peptide (COP) allergy vaccines.

Company News: Anergis Closes Financing Round Totaling CHF 8 M

– Preparation of Phase III trials with lead allergy vaccine AllerT

– Field-based, long-term efficacy milestone in patients from the AllerT Phase IIb trial coming up

Anergis, a company discovering and developing proprietary allergy vaccines, today announced the closing of a financing round totaling CHF 8 million. The financing was fully subscribed by existing investors and directors and was co-lead by Sunstone Capital, BioMedInvest and Renaissance PME/Vinci Capital.

Anergis will use the proceeds to further advance the clinical development of its lead product AllerT, a vaccine to treat birch pollen allergy, and to advance two additional vaccine candidates against house dust mite and ragweed allergies. For AllerT, the funds will specifically allow the preparation of Phase III trials and the conduct of a long-term efficacy follow-up trial of patients who participated in the recently completed field-based Phase II study. The results from this second follow-up season are expected to be available in the third quarter of 2014.

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.

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