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Company News: Curetis’ Unyvero System Selected for Global Phase III Antibiotics Trial

Unyvero to be used for pathogen identification and patient inclusion at several clinical sites across Europe

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that Curetis’ Unyvero System will be used in a Phase III trial of a novel formulation of the antibiotic Amikacin. Unyvero was chosen as a platform to detect pathogens and antibiotic resistances in patients to be enrolled at intensive care units at several clinical trial sites across multiple European countries. Unyvero will be used to support patient identification and help boost enrollment rates at these sites.

Amikacin is an aminoglycoside antibiotic marketed for the treatment of severe, hospital-acquired infections with multidrug-resistant Gram-negative bacteria. The trial is evaluating the efficacy of a novel drug-device combination as an adjunctive therapy for Gram-negative pneumonia in the treatment of intubated and mechanically ventilated adult patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics. The trial is recruiting approximately 650 patients at trial sites worldwide.

Under the terms of the agreement with the sponsor of the trial, Curetis will deliver Unyvero systems and CE-IVD marked P55 cartridges to the trial sites as well as install the systems and provide training and technical support at these sites. The sponsor will fully reimburse Curetis for systems, training, services and consumables. Further financial details were not disclosed.

Company News: ISA Pharmaceuticals Further Strengthens IP Position on Lead Compound ISA101

Three additional European patents and market exclusivity granted for the use of key active ingredients of ISA101

ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced it has strengthened the IP position of its lead compound ISA101. The European Patent Office has granted three patents (EP2267132, EP2112157, EP2468763) which relate to the use of HPV antigen-based peptides. ISA101, a novel immunotherapeutic consisting of synthetic long peptides (SLP®s), targets severe diseases triggered by human papillomavirus (HPV) infection.

The patents cover the application of a variety of long peptides derived from the E6 and E7 proteins of HPV, including novel epitopes or peptides with specified features, and provide exclusivity for the treatment of persistent HPV infections and resulting diseases.

ISA101 is based on ISA Pharmaceuticals´ proprietary SLP® platform and is currently in clinical Phase I/II trials in cervical cancer and anal intraepithelial neoplasia (AIN).

Company News: Lead Pharma Appoints Three Seasoned Industry Experts to its Supervisory Board

– Jan Egberts, M.D., Ir. Jan van der Hoeven and Daan van den Noort, M.D. join newly established Supervisory Board

 

Lead Pharma, a pharmaceutical company developing innovative medicines for the treatment of autoimmune diseases and cancer, today announced that it has appointed Dr. Jan Egberts, Ir. Jan van der Hoeven and Daan van den Noort to its newly established Supervisory Board.

Jan Egberts, M.D., has over 25 years of executive experience in the pharmaceutical and medical device sectors, most recently as Chief Executive Officer of Agendia Inc., a molecular diagnostics company. Prior to this, Dr. Egberts was Chief Executive Officer of OctoPlus N.V., a specialty pharmaceutical company, which was acquired by Dr. Reddy’s Laboratories Ltd. in 2013. He also served as a Senior Healthcare Advisor for 3i Group plc and as President, Chairman and Chief Executive Officer of NovaDel Pharmaceuticals Inc. In addition, he held multiple business development and general management positions at Johnson & Johnson, Merck & Co. and Mölnlycke Health Care. Dr. Egberts, who graduated from Erasmus University Medical School in the Netherlands and obtained his MBA from Stanford, also serves on the Supervisory Board of several other private and public healthcare companies.

Ir. Jan van der Hoeven brings more than 30 years of experience in the biopharmaceutical industry. In 1983, he was co-founder of the CRO NOTOX, which he also headed until it was acquired by WIL Research Laboratories in 2006. In addition, since 1988 he has advised numerous life sciences companies, e.g. as a member of the Supervisory Board. He is also an ambassador of Wageningen University (Wageningen, The Netherlands). Before founding NOTOX, he worked as a scientist at Wageningen University for six years with emphasis on the relation of food and cancer. He (co-)authored over 30 scientific publications and has been awarded the EEMS Young Scientist Award in 1985. In 2003, he received the price for entrepreneurship from Wageningen University. Ir. van der Hoeven graduated from Wageningen University.

Daan van den Noort, M.D., brings over 25 years of experience as a manager and venture capitalist in the pharmaceutical and biotechnology industry in Europe. Among others, he served as General Manager for Genentech, Asta Medica, and Ferring in The Netherlands. From 2001 to 2011, he acted as the Chief investment Officer of the Biotech Turnaround Fund. He serves on several international boards of investment companies active in the biopharmaceutical industry. Mr. van den Noort holds an MD degree from the Free University of Amsterdam.

Company News: Humabs BioMed Reports Clinical Milestone in Antibody Licensing Agreement

Humabs BioMed SA, a leading Swiss antibody therapeutics company, today announced that it has received a milestone payment from its licensing agreement with Novartis. In 2009, Humabs and Novartis entered into an exclusive licensing agreement for the use of selective human monoclonal antibodies discovered by Humabs’ proprietary Cellclone technology. A Novartis program based on this technology has entered into phase II clinical trials in the U.S. and Germany, triggering the payment.

“We are very pleased about reaching this important milestone,” said Alcide Barberis, CEO of Humabs BioMed. “This underlines the value of our platform, which is not just selecting for binders to pre-defined targets, but uses a functional, target-agnostic approach.”

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