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Company News: Curetis Initiates Prospective Multicenter Unyvero™ Study in Europe

– Study to demonstrate added value of Unyvero™ P50 pneumonia application in clinical routine –

Curetis AG today announced the start of an additional prospective, multicenter clinical trial of its marketed Unyvero™ P50 Pneumonia Application to demonstrate its clinical and health economic value.

The CE performance evaluation completed last year already demonstrated 81% sensitivity at 99% specificity for detecting pneumonia-causing pathogens. Following the market launch in April 2012, Curetis in 2013 presented data from more than 1,000 patient samples showing overall sensitivity of its pathogen panel of 80.6% at a specificity of 96% (ECCMID European Conference of Clinical Microbiology and Infectious Diseases, Berlin).[1]

The new multicenter study aims to establish real-world data on the health economic impact of fast, patient-near molecular testing and subsequent therapy adjustments (if necessary). It will be conducted in five leading European centers and will involve several hundred critically ill patients with pneumonia requiring mechanical ventilation. The study is designed to first evaluate the current pneumonia treatment and clinical outcome situation  by detailed chart reviews comparing patients having received initial adequate, respectively inadequate treatment. Data will be used to fine tune endpoints for the interventional, randomized second part of the study, which aims to investigate the potential clinical and economic benefit of the Unyvero™ system. Parameters analyzed will be, e.g. type of antibiotic regimen and costs, length of stay in the ICU, etc.

Participating clinicians are world-renowned intensive care, pulmonology and microbiology specialists: Prof. Manfred Quintel (University of Goettingen), Prof. Tobias Welte (MHH University Clinic Hanover), Prof.s Philippe Eggimann and Gilbert Greub (CHUV University Hospital of Lausanne), Prof. Mathias Pletz (Jena University) and Prof. Antoni Torres (University Hospital Clinic Barcelona).

Preliminary results of the study are expected by the end of this year.

 


[1] Abstract Nr. 2360: M. Klein et al., First clinical validation of a rapid molecular test (Unyvero™ P50 Pneumonia Application) detecting microorganisms and antibiotic resistances in patients suspected with severe pneumonia.

Company News: ISA Pharmaceuticals Strengthens Management Team

–      Company hires Jan Fagerberg as Chief Medical Officer and Jens Hennecke as Chief Business Officer

–      Ronald Loggers becomes Acting Chief Executive Officer and Gerard Platenburg Chief Operating Officer

ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced that it has appointed Dr. Jan Fagerberg, M.D., Ph.D., as Chief Medical Officer and Dr. Jens Hennecke, Ph.D., as Chief Business Officer and Advisor. Furthermore, Ronald Loggers, M.Sc., MBA, will step down from the Board of Directors and assume the role of Acting Chief Executive Officer, while Gerard Platenburg will become Chief Operating Officer.

Dr. Jan Fagerberg (51) is a board-certified clinical oncologist with more than 20 years of experience in clinical research and the development of oncology drugs. He joins ISA from Amgen where he was Vice President Global Development and Managing Director of Amgen Research (Munich) GmbH. During his career, Dr. Fagerberg has held senior executive positions at Amgen, Micromet, TopoTarget, and F. Hoffmann-La Roche. His responsibilities have included the global clinical development of blinatumomab (AMG 103), belinostat (PXD101), capecitabine (Xeloda), and clinical development programs of bevacizumab (Avastin) outside the U.S.. Dr. Fagerberg has extensive international regulatory experience, and was successful in obtaining 11 FDA and EMA approvals for Xeloda and Avastin. At Micromet, he also initiated the clinical development of several compounds in collaboration with global pharma companies. Jan Fagerberg received his M.D. (1988) and Ph.D. (1995) for work in clinically applied passive and active immunotherapy in cancer from the Karolinska Institute in Stockholm (Sweden).

Dr. Jens Hennecke (45) has a strong track record in business development, corporate development and licensing. He brings extensive experience in the negotiation and closing of corporate alliances. Prior to joining ISA and building his own business development advisory franchise, he was Senior Vice President Business Development at Micromet, Inc., where he managed the company’s business and corporate development, intellectual property and information technology departments. He also played a key role in establishing partnerships with major pharma companies, and in Micromet’s acquisition by Amgen in 2012. Prior to joining Micromet in 2001, Dr. Hennecke was a post-doctoral researcher at Harvard University. He holds a B.Sc. in biology from the University of Göttingen, Germany, and a Ph.D. from the ETH Zurich, Switzerland.

Before becoming Acting Chief Executive Officer, Ronald Loggers (45) had been on the Supervisory Board of ISA since 2009. He is currently also Managing Director at Multifund B.V., a family-owned investment company. Prior to that, he worked seven years for HAL Investments B.V., five years for McKinsey & Company and one year for Fokker Aircraft B.V. He brings extensive managerial, investment and financing experience. Ronald obtained an MBA from INSEAD (France) and an M.Sc. in Chemical Engineering from Delft University of Technology (The Netherlands).

Gerard Platenburg (48) joined ISA Pharmaceuticals in an executive role in 2009 and helped to mature ISA’s organization into its current form. He has over 20 years of experience as an executive in the biotech industry. He gained experience in several innovative biotech companies, amongst others Pharming and Prosensa, which he co-founded and grew into a clinical-stage company. Gerard holds a degree as a chemist/molecular biologist from the University of Leiden, The Netherlands.

The management team will consist of Ronald Loggers (Acting Chief Executive Officer), Gerard Platenburg (Chief Operating Officer), Prof. Kees Melief (Chief Scientific Officer), Jan Fagerberg (Chief Medical Officer) and Jens Hennecke (Chief Business Officer).

Company News: vasopharm Closes Series F Financing Round

– Company receives additional €5 million for preparation of Phase III study –

vasopharm GmbH, a privately held biopharmaceutical company focusing on novel therapeutics for the treatment of cerebro- and cardiovascular diseases, today announced the successful completion of a Series F financing round totalling €5 million (~ US$6.5 million). The round was led by existing investors HeidelbergCapital Private Equity and Entrepreneurs Fund (EF Investments S.à.r.l.). Bayern Kapital, another existing investor, also participated in the Series F round. The consortium was joined by new investors Hanseatic Asset Management LBG and Dr Andrew Clark, Chairman of the Board of vasopharm. The new consortium also acquired the shares of one of the founding investors seeking to exit.

The proceeds of this round will be used primarily for the preparation of a Phase III clinical study of the company’s lead compound VAS203, an allosteric nitric oxide synthase inhibitor under development for the treatment of traumatic brain injury (TBI). The compound has met all clinical endpoints for safety and demonstrated strong evidence of clinical benefit in the Phase IIa European NOSTRA trial completed in 2012. Detailed results of the trial will be published soon in a peer-reviewed journal.

Company News: Merus Presents Preclinical Data on its Novel Bispecific Antibody MCLA-117 at EHA 2013

– Clinical Candidate Designed for the Treatment of Acute Myeloid Leukemia (AML) –

Merus B.V., a biopharmaceutical company focusing on innovative human antibody therapeutics, has presented preclinical data on its antibody MCLA-117 at the Annual 18th Congress of the EHA 2013 (European Hematology Association) in Stockholm. The compound is being developed for the treatment of acute myeloid leukemia (AML), a disease with very poor long-term prognosis.

MCLA-117 activates the patient’s own immune system by simultaneously binding to the CLEC12A molecule expressed by AML tumor cells and the CD3 molecule expressed by T cells. CLEC12A is a myeloid differentiation antigen that is expressed on 90-95% of de novo and relapsed AML cases and is selectively expressed on leukemic stem cells.

Co-incubation of patients´ resting T cells and AML tumor cells via MCLA-117 resulted in efficient tumor cell lysis, i.e. the potent killing of cancerous AML cells. By introducing mutations in the heavy chain constant region CH2 domain, Merus was able to develop an antibody that in peripheral blood mononuclear cell (PBMC) assays prevented the release of non-specific, pro-inflammatory cytokines, while retaining its full capacity to induce T cell-mediated elimination of AML tumor cells.

The MCLA-117 antibody is based on Merus’ proprietary Biclonics™ ENGAGE platform. Human bispecific antibodies from this platform can be manufactured and administered like conventional, full-length IgG molecules, thereby providing for high yield, good stability and a long serum half-life.

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