IZB Martinsried/Munich
its Phase 2b COMPONENT study with the immune modulator vidofludimus in patients with rheumatoid arthritis (RA) in November 2011. The compound showed a substantial reduction of objective inflammatory parameters in RA patients and, combined with its safety profile, confirmed its high potential for treating various autoimmune diseases including inflammatory bowel disease (IBD).
4SC expects to be able to announce top-line results from the Phase 2 SHELTER study with resminostat in patients with hepatocellular carcinoma (HCC) early next year. Based on the final data from these two studies, the company will then discuss plans with medicinal agencies for a ‘pivotal’ programme, ie a development programme for resminostat aimed at achieving regulatory approval. Besides HL and HCC, resminostat will be further investigated in a third indication, colon cancer. Initial results from the ongoing Phase 1/2 SHORE study are expected in 2012. Progress is also being made in the company’s other clinical development programmes in oncology. Patient recruitment for the Phase 1 AEGIS study of the compound 4SC-205 in patients with solid tumours or lymphomas is expected to be completed as planned in 2011. Results will be available for publication early next year.
www.4sc.de
EUROCALIN Consortium grant to develop anemia therapeutic The EUROCALIN Consortium, comprising ten companies and universities in Europe, has initiated a collaboration focused on attaining and completing initial clinical development of a novel Anticalin therapeutic. The project will be funded to a large extent by the European Commission Seventh Framework Programme. Anticalins are novel, next- generation therapeutic proteins designed to bind and antagonise a wide spectrum of ligands.
Under the grant, the Consortium will develop, manufacture and clinically test an Anticalin specific for hepcidin, a small peptide in human blood that is a key
regulator of iron homeostasis and an important target for the treatment of multiple types of anemia.
EUROCALIN stands for ‘EUROpean Consortium for AntiCALINS as next- generation high-affinity protein therapeutics’. The objective of the EUROCALIN Consortium is to advance a drug candidate, to date in preclinical development at Pieris AG, an IZB company, through to completion of a Phase 1a/b clinical trial. With the total funding allotment of €6 million, the grant is designed to fund the majority of the continuing development of the anti-hepcidin Anticalin programme over the next four years using the expertise of both academic and commercial organisations throughout Europe.
The Consortium consists of Pieris AG (Germany), as project coordinator; the technical University of Munich (Germany); the Medical University of Innsbruck (Austria); Radboud University Nijmegen Medical Centre (Netherlands); Covance Laboratories Ltd (UK); Antitope Ltd (UK); FUJIFILM Diosynth Biotechnologies LtdUK Limited (UK); Coriolis Pharma Research GmbH (Germany); FGK Clinical Research GmbH (Germany); and ConsulTech GmbH (Germany).
www.eurocalin-ffp7.eu Pieris recently presented the results of its first clinical evaluation of its most advanced Anticalin, PRS-050, an anti-VEGF targeted protein therapeutic, at the 2011 AACR-NCI- EORTC International Conference held in San Francisco, California, USA. The dose escalation trial investigated the recommended Phase 2 dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PRS-050 administered to patients with advanced solid tumours. PRS-050 was well-tolerated, with no maximum tolerated dose reached, while demonstrating biological activity and a complete lack of immunogenicity, supporting further evaluation in a Phase 2 clinical trial. The Phase 1 clinical trial of PRS-050 was conducted in 26 patients with advanced solid tumours as an open-label, dose- escalating evaluation of the compound’s safety, tolerability and PK/PD profile. The
Meet Dr Peter Hanns Zobel of IZB
Since 1996, Dr Peter Hanns Zobel has been Managing Director of the Innovation and Startup Centers for Biotechnology (IZB) in Martinsried and Freising-Weihenstephan near Munich, Germany, where he has supported the start-up of about 100 companies. Currently, 54 tenants employing about 600 people work in 25,000 sq m of office and lab space at IZB.
4 Life Science CLUSTERS Supplement
Dr Zobel gained his doctorate in economics/strategic management from Ludwig-Maximilians University and then joined Fraunhofer Management GmbH where he held positions of increasing responsibility related to location development, finance and technology centres. He is member of the curatorship of the Max Planck Institutes and chairman of the Daycare Center bioKids.
protein drug exhibited a half-life of six days, there was no immunogenicity (no anti-drug antibodies) observed across all cohorts and multiple dose-dependent PD effects were obtained. The compound began the clinical trial at three different sites in Germany during the first half of 2010. www.pieris-
ag.com
German Government grant for LEUKOCARE orthopedic implants coatings
The German Ministry of Economics has granted non-refundable subsidies to LEUKOCARE for the development of functional coatings for orthopedic implants. The company is developing the coatings in collaboration with the University of Düsseldorf. Based on LEUKOCARE’s proprietary Stabilizing and Protecting Solutions technologies (SPS), antibacterial biomolecules are coupled to the surface of osteosynthesis implants in order to prevent biofilm formation.
www.leukocare.com
SuppreMol starts SM101 dosing in SMILE study SuppreMol GmbH, a privately-held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases and allergies, has started dosing within the international SMILE study (SM101 in lupus erythematosus). The Phase 2a, double-blind clinical trial of SM101, the compaany’s lead compound, involves patients suffering from systemic lupus erythematosus (SLE). The first patient was treated in Australia in October. Additional study centres in Belgium, Germany, France, the UK, Italy, the Netherlands, Poland, Spain and the Czech Republic will commence patient treatment in coming weeks. Over the course of one month, the study participants will receive placebo or two different doses of SM101 weekly.
SM101 is a soluble version of the Fc gamma receptor IIb, which binds to autoantibody/autoantigen complexes and thereby blocks the triggering of Fc receptors on the surface of immune cells. SM101 has been studied in the context of a clinical phase 1b/2a trial for the indication of primary immune thrombocytopenia (ITP) since 2010.
The product is designated for this indication as an ‘orphan drug’ in the EU and in the USA.
www.suppremol.com
Further information Email:
gl@izb-online.de Web:
www.izb-online.de
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44