– Arrangements started for largest field trial ever conducted with an ultra-fast treatment for tree allergy
Anergis, a company developing proprietary ultra-fast allergy immunotherapy, announced today that it has closed a CHF 5 million financing round extension with existing investors. In addition, the Company is preparing a Phase IIb clinical trial with its lead compound AllerT in patients with birch pollen allergy. The study is designed as a multicenter, double-blind, placebo-controlled, randomized trial to assess the efficacy and tolerability of two dosing regimens of AllerTIn Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis (ATIBAR). ATIBAR is expected to start in fall 2016. With a total of 450 patients, ATIBAR will be the largest field-based trial conducted so far with an ultra-fast allergy treatment for tree allergy.
Most importantly, the ATIBAR trial is designed as a confirmatory efficacy trial with the statistical power necessary to meet both European and US FDA efficacy criteria for allergy immunotherapy products. Results will be expected in the third quarter of 2017.
“Our exploratory dose ranging trial with AllerT provided us with excellent new safety, tolerability and immunogenicity data. We are now preparing the ATIBAR trial as a confirmatory efficacy trial of the 50 µg dose and to verify that 10 µg is the lowest effective dose of AllerT,” said Kim Simonsen, Chief Development Officer of Anergis.
“Thanks to the continued support of our investors, we have complemented our last financing round with a CHF 5 million extension and are now preparing AllerT for its future registration. Following a successful completion of the ATIBAR trial, we expect that only one more confirmatory efficacy Phase III trial will be required before registration,” added Vincent Charlon, Chief Executive Officer of Anergis.
– Development of broad-spectrum human antibodies for rabies post-exposure prophylaxis
– Antibodies broadly neutralize a large panel of rabies and rabies-related viruses, and are up to 1,000 times more effective than existing treatments
Humabs BioMed SA, a Swiss antibody therapeutics company, today announced the identification, isolation and characterization of two monoclonal antibodies with broad-spectrum, high potency activity against rabies viruses. As published in this week’s EMBO Molecular Medicine, the combined antibodies showed higher potency and a broader activity compared to commercially available human rabies immunoglobulins (RIGs) and to other monoclonal antibodies under clinical development. RVC20 and RVC58 may provide a very effective and affordable alternative to existing post-exposure prophylaxis of rabies infection. The results were achieved in an international collaboration with leading research institutes from Switzerland, Italy, France and the UK.
Rabies is found worldwide in different animal reservoirs and is known to be a deadly viral infection with almost 100% fatality following the onset of symptoms. There is no treatment available. However, if exposed, there is a short window before the onset of symptoms for infected humans to be treated by vaccination and co-administration of rabies immunoglobulins that are prepared from human or equine blood. This so-called post-exposure prophylaxis (PEP) must be administered as early as possible and is ineffective after the onset of symptoms. The high cost and limited availability of PEP is a huge problem in many remote areas in the poor parts of the world. Only about 1 million doses of rabies immunoglobulins are produced every year and sadly 60% of the people at high risk of developing rabies do not have access to them. Some 59,000 people are estimated to die each year, mainly in India, China and Africa, and 50% of rabies cases worldwide affect children. However, the true burden of rabies in developing countries is unknown and largely un-diagnosed. The transition from RIG to monoclonal antibody-based PEP is strongly recommended by the WHO with the aim to achieve adequate supply at affordable costs.
“Our development is in line with recommendations by the WHO to develop new, monoclonal antibody-based treatments for rabies post-exposure prophylaxis,” said Davide Corti, co-author of the paper and CSO of Humabs BioMed. “The antibody cocktail we identified and tested has high potency, targets distinct, non-overlapping antigens and broadly covers all known viruses. Moreover, the high potency of these antibodies demonstrated that only a very limited amount, as low as 3 milligrams per dose, is needed to protect humans from lethal infection.”
“The antibody cocktail has great potential,” said Paola De Benedictis, lead author of the paper and a virologist and veterinarian at the Istituto Zooprofilattico Sperimentale delle Venezie (Padua, Italy). “It may not only replace immunoglobins but it can also pave the way to a paradigm shift in rabies treatment. We noticed that in vivo even 40 days after administration of the antibodies, there was still a high neutralizing and potentially protective titer of the antibodies in the blood, so it may be possible that the prophylaxis window is widened considerably with RVC20 and RVC58.”
“Current post-exposure prophylaxis is very costly and supply is dwindling because of lack of human donors. Alternatives under development so far protect only against a limited spectrum of viruses, posing serious concerns for prophylaxis without virus characterization,” said Hervé Bourhy, co-author of the paper and Head of the WHO Collaborating Centre for Reference and Research on Rabies at Institut Pasteur (Paris, France). “The antibodies we characterized in vitro protect against a very broad spectrum of rabies viruses. Moreover, these antibodies could be formulated in ways not to require cooling, another important advantage in remote areas.”
“The isolation of these two antibodies is another validation of our approach that can lead to very potent antibodies against deadly infectious diseases,” added Filippo Riva, CEO of Humabs BioMed. “Within the past six months, we have demonstrated this in MERS, Ebola and now in Rabies. We are now seeking licensing opportunities on a worldwide basis and we are optimistic to start the development of these antibodies as soon as possible.”
Two of Humabs’ human-derived antibodies are in clinical development with the company’s partners MedImmune and Novartis.
– Company to host earnings conference call and webcast
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that it will publish its full-year 2015 financial results on April 12, 2016. In addition, the Company will host a public earnings conference call and webcast on April 12, 2016, at 03:00pm CET / 09:00am EST to present the financial results of 2015, highlight the most important events and provide an outlook for 2016.
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced its participation in several major industry conferences in the second quarter of 2016. The respective investor presentations will be made available on the company’s website.
April:
26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), April 9 – 12, 2016, in Amsterdam, The Netherlands: scientific meeting
Morgan Stanley Panel discussion and Meeting on Infectious Disease Diagnostics, April 14, 2016 in New York, NY, USA
May:
Bio€quity Europe 2016, May 10-11, 2016 in Copenhagen, Denmark: management presentation
35th Annual Conference of the Austrian Society for Hygiene, Microbiology and Prevention (ÖGHMP), May 30-June 2nd in Zell am See, Austria: scientific meeting
June:
Swiss MedLab, June 13-16, Berne, Switzerland: scientific meeting