Archive: Company News

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

Company News: Curetis Announces Participation in Several Investor and Industry Conferences in Q2-2016

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

Company News: Humabs BioMed Reports Regulatory Milestone in MedImmune Partnership

– MedImmune Receives U.S. Fast Track Designation for MEDI8852 Antibody Developed Under a Collaboration with Humabs for the Treatment of Influenza A

Humabs BioMed SA, a leading Swiss antibody therapeutics company, today announced that a novel antibody developed using its proprietary Cellclone technology has received Fast Track designation from the US Food and Drug Administration (FDA). The investigational human monoclonal antibody MEDI8852 is being clinically developed by MedImmune, the global biologics research and development arm of AstraZeneca, for the treatment of patients hospitalized with Type A strain influenza.

The antibody with broad influenza-neutralizing properties is a human IgG1 kappa monoclonal antibody administered via infusion. The precursor to MEDI8852 was isolated from human memory B cells by Humabs BioMed and further optimized for enhanced neutralization activity at MedImmune. MEDI8852 binds to a region within the stalk of the hemagglutinin protein that is highly conserved amongst all influenza A subtypes. MEDI8852 is being developed as a treatment for patients hospitalized with seasonal influenza caused by Type A strains in conjunction with local standard of care. It is anticipated that it could also be used in the pandemic setting.

MEDI8852 is currently being evaluated in a Phase Ib/IIa clinical trial to investigate the safety and efficacy of a single intravenous dose in combination with oseltamivir, and as a monotherapy in adult patients with confirmed acute, uncomplicated influenza caused by Type A strains. A recently completed Phase I study in healthy adult subjects demonstrated that MEDI8852 had an acceptable safety and pharmacokinetics profile, which supports continued development in patients with influenza.

The FDA’s Fast Track program is designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.

“We are very pleased that our partner MedImmune received Fast Track designation for the antibody we jointly identified only five years ago,” said Filippo Riva, CEO of Humabs BioMed. “This is a validation of our technology and also of our strategy to rapidly discover and develop human-derived antibodies in life-threatening infectious diseases.”

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