Archive: Company News
Company News: Anergis Receives Swiss Life Sciences Prize
– Prestigious annual award under the patronage of the Swiss Biotech Association and BioValley Basel
– Sponsored by BB Biotech Ventures, Novartis Venture Fund and Venture Incubator
Anergis, a company focusing on proprietary allergy vaccines, today announced it has been awarded the Swiss Life Sciences Prize 2013. The prize, which has been granted for the tenth time in 2013, is under the patronage of the Swiss Biotech Association and BioValley Basel. Sponsors of the Swiss Life Sciences Prize are BB Biotech Ventures, Novartis Venture Fund and Venture Incubator. Jury members are Dr. Philippe Dro (CEO, GlycoVaxyn AG), Dr. Reinhard Glück (Former President, Swiss Biotech Association), Dr. Franz Saladin (Director, Chamber of Commerce of Basel), Dr. Dieter Scholer (Member, University Council, University of Basel), Dr. Matthias Staehelin (Head Life Sciences, VISCHER) and Jürg Zürcher (EMEIA Biotechnology Leader, Ernst & Young).
Company News: Curetis and Mediphos to Sponsor Expert Discussion on the Future of Infectious Diseases Testing
– Satellite symposium will be held during the 8th European Meeting on Molecular Diagnostics (EMMD)
– Presentation of Curetis´ Unyvero™ system by distribution partner Mediphos
Curetis AG today announced it will host the satellite symposium “Molecular microbiology – the future of infectious diseases testing?” together with its Dutch distribution partner Mediphos Medical Supplies during the upcoming 8th European Meeting on Molecular Diagnostics (EMMD). The EMDD will be held from October 2 – 4, 2013, in Scheveningen, The Netherlands.
The symposium, which is scheduled for Oct. 2 from 8:30-10am (Adama Zijlstra Rooms 1 & 2), will be chaired by Prof. Paul Savelkoul (Maastricht University, The Netherlands) and Dr. Anne Thews (Curetis, Germany). Following an overview on the expectations for the future of molecular biology by Prof. Savekoul, three lectures will discuss challenges and applications: Dr. Eric Claas (LUMC Leiden, the Netherlands) is to talk about “Benefits and challenges of molecular testing in infectious diseases”. Dr. Jan Weile (Heart and Diabetes Center Bad Oeynhausen, Germany) will present “First clinical experience with the Unyvero™ P50 Pneumonia Application” and Dr. Anne Thews (Medical Director, Curetis AG) is going to discuss “Implant and tissue infections – a need for multiplexed testing?”. The subsequent panel discussion will focus on the question whether fast molecular infectious disease testing will improve patient outcome.
In addition, Mediphos Medical Supplies, the exclusive distribution partner of Curetis for The Netherlands, will present Curetis´ Unyvero™ System during the EMMD.
Company News: ISA Pharmaceuticals Initiates Phase I/II Clinical Trial of ISA101 in Patients with Anal Intraepithelial Neoplasia (AIN)
Therapeutic vaccine against Human Papilloma Virus type 16 (HPV16) tested in HIV-positive male patients
ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed, fully synthetic therapeutic vaccines against cancer and persistent viral infections, today announced the initiation of a Phase I/II clinical study of its lead candidate ISA101 in HIV-positive men suffering from anal intraepithelial neoplasia (AIN). The study is supported by ZonMw, the Dutch Organisation for Health Research and Development, and is being conducted in The Netherlands.
ISA101 is a synthetic long peptide (SLP®) vaccine for the treatment of diseases induced by human papilloma virus type 16 (HPV16), such as cervical cancer, ano-genital premalignant and malignant lesions, and head and neck cancer.
The open-label, dose-response study will be conducted in 30 HIV-positive male patients suffering from HPV16-positive high-grade AIN, who failed previous treatment. In the first dose escalation part of the trial, patients will be vaccinated with ISA101 in three dosing cohorts three times at three-week intervals, either with or without administration of peg-interferon-α on the day of vaccination. An additional group of 15 patients will be treated with the optimal ISA101 schedule. Primary clinical endpoints will be toxicity and safety as well as regression of lesions at 3, 6 and 12 months. Secondary endpoints are regression of lesions at 18 months and HPV16-specific immunity in the blood.
AIN is caused by infection with high-risk papilloma viruses (HPV) and known as a cancer precursor lesion that can lead to the development of anal cancer. AIN of any grade has been reported to be present in 63–81% of HIV-positive men, and high-grade disease (AIN 2 or 3) in 25–52%. The majority (approximately 60%) of high-grade AIN is caused by HPV16. Incidence of anal cancer has increased significantly since 1997 in both men and women, and especially in HIV-positive men. This is assumed to be a result of the significantly prolonged life span of HIV-positive patients. Therefore, early diagnosis and treatment of AIN is important to prevent malignancy. At present, there is no systemic treatment.
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.