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Company News: Agena Bioscience Launches In Vitro Diagnostic Tests for Lung and Colon Cancer in Europe

– Company achieves CE-IVD mark and enters routine molecular diagnostics market

Agena Bioscience today announced the launch of its CE-IVD marked MassARRAY® Dx products in Europe. Two targeted diagnostic panels will be sold, the MassARRAY Dx Lung Panel and the MassARRAY Dx Colon Panel, in addition to the company’s MassARRAY Dx instrumentation.

The two diagnostic panels are the first in vitro diagnostic tests marketed by Agena Bioscience in Europe, originating from its partnership with Diatech Pharmacogenetics announced in October of 2015. Diatech has gained a significant share of the cancer diagnostics market in Italy with its own MassARRAY-based tests. Additional test panels are currently in development.

With its novel MassARRAY Dx products, Agena Bioscience offers molecular pathologists a unique combination of reliability, sensitivity, ease of use, and cost-effectiveness for targeted genetic testing. The multiplexed MassARRAY assays allow the user to concurrently analyze the relevant oncogenes and thereby reduce cost and turnaround time compared to existing methods. The two test panels support personalized treatment and improved patient care through rapid analysis of clinically actionable mutations implicated in lung and colon cancer.

Pete Dansky, Chief Executive Officer of Agena Bioscience, commented: “Our entry into the European clinical diagnostics market is a pillar of Agena’s global strategy to grow its clinical business with targeted, clinically actionable tests. The MassARRAY Dx Lung and Colon Panels will provide rapid and reliable diagnostic results to help physicians select the most effective treatments for their oncology patients.”

The MassARRAY Dx Colon Panel simultaneously analyzes over 200 mutations in the four major oncogenes involved in the pathogenesis of colorectal cancer (KRAS, BRAF, NRAS, PIK3CA), using <40 ng of DNA extracted from fresh, frozen, or paraffin-embedded tissue.

The MassARRAY Dx Lung Panel simultaneously analyzes over 300 mutations in 10 genes implicated in the pathogenesis of lung cancer (EGFR, KRAS, BRAF, PIK3CA, NRAS, ALK, ERBB2, DDR2, MAP2K1, and RET), using <40ng of DNA extracted from fresh, frozen, or paraffin-embedded tissue.

The CE-IVD marked MassARRAY Dx products, consisting of the MassARRAY Dx Colon Panel, MassARRAY Dx Lung Panel, and MassARRAY Dx instrumentation (MassARRAY Dx Analyzer 4, MassARRAY Dx Nanodispenser RS 1000), are sold exclusively in Europe for diagnostic use, and are not available for sale in the United States.

Company News: Anergis Closes CHF 5 Million Financing Round Extension to Conduct Large-Scale ATIBAR Trial with Ultra-Fast Allergy Immunotherapy AllerT

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 AllerT In 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.

Company News: Humabs BioMed Leads Paradigm Shift in Rabies Treatment

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 News: Curetis to Publish its Annual Results 2015 on April 12, 2016

– 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.

The conference call will be supplemented by a presentation which can be accessed during the call at http://www.curetis.com/en/investors/financial-reports-and-conferences/financial-reports.html. The live webcast and a replay will be available at http://curetis120416-live.audio-webcast.com.

To access the call, please dial the following numbers using the passcode 93120684#

Germany: +49 69 222229043

UK: +44 20 30092452

US: +1 855 4027766

For further international dial-in numbers, please open the following link:
http://events.arkadin.com/ev/docs/International%20Access%20Numbers_%20UKFELBRI1_SU7.pdf

The full annual financial report 2015 will be available as of April 12, 2016, at http://www.curetis.com/en/investors/financial-reports-and-conferences/financial-reports.html

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