News
Company News: Curetis to Present Clinical Unyvero™ Data at Major Scientific Conferences
– Lower Respiratory Tract application: initial clinical evaluation data from U.S. center will be presented at ICAAC 2013 (USA)
– New application Implant and Tissue Infections: first data will be presented at DGHM/DGI meeting (Germany)
Curetis AG today announced the upcoming presentation of new clinical data on two Unyvero™ applications at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2013) in Denver, CO (Sept. 10-13) and at the 65th Joint Annual Meeting of the German Society for Hygiene and Microbiology and the German Society for Infectious Diseases (DGHM/DGI 2013) in Rostock, Germany (Sept. 22-25).
Curetis will introduce clinical data from a U.S. pre-FDA trial phase of its Unyvero™ LRT (Lower Respiratory Tract) infection application at the ICAAC conference. The poster ‘Evaluation of a Molecular Multiplex Test For Detection of Respiratory Microorganism and Antibiotic Resistance Genes in Clinical Specimens’[1] will present data generated at Northwestern Memorial Hospital (Chicago, IL) during the initial familiarization and training phase for the FDA trial. The FDA trial is now being conducted at four sites; all clinical data are blinded until completion of this ongoing trial which is expected for 2014. The LRT application is already marketed and branded outside the U.S. as the Unyvero™ P50 pneumonia application. During ICAAC, Curetis will also showcase its Unyvero™ Solution at booth no. 822 in the exhibition hall.
Moreover, Curetis will present data of its novel Unyvero™ i60 ITI application for the diagnosis of implant and tissue infections detecting pathogens and resistance markers at the annual DGHM/DGI meeting. The poster presentation ‘A new Multiplex PCR-Panel for the Detection of Pathogens Related to Implant and Tissue Infection’[2] will introduce the panel chosen for the diagnosis of eight indication areas and present initial validation and verification data with clinical samples. Curetis will also host the industry symposium ‘Implant and Tissue Infections – A Diagnostic Challenge’ (Sept. 24, 12:15-1:15pm, Auditorium 2) featuring talks and case studies by Prof. Petra Gastmeier (Berlin, Germany), Dr. Anne Thews (Holzgerlingen, Germany), Prof. Andrej Trampuz (Berlin, Germany), and Dr. Olivier Borens (Lausanne, Switzerland). A second poster based on data independently generated at the University Hospital in Basel, Switzerland will present a ‘Comparison of the Unyvero™ Pneumonia P50 Assay with standard culture and antimicrobial susceptibility testing’.[3]
[1] Presentation D-1655a, Session: #214 – Diagnosis and Epidemiology of Respiratory Infections, Sept. 13, 8:30-10:30am, Exhibit Hall A.
[2] Presentation DVP02, Postersession I (StAG Diagnostic Microbiology and Microbiology Procedures Quality Standards), Sept. 23, 3:00pm, Auditorium 1
[3] Presentation KMP14, Postersession II (StAG Clinical Microbiology and Infectious Diseases), Sept. 24, 3:00pm, Room HS323.
Company News: Three Peer-Reviewed Papers by ISA Pharmaceuticals Introduce Strategies to Improve Immunotherapy Against Cancer
– Local Delivery of Checkpoint Control Antibodies Greatly Improve Efficacy and Safety
– Promising Potential for Combinatorial Strategies
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced the publication of three peer-reviewed papers that demonstrate the benefit of local delivery of a checkpoint control antibody targeting CTLA-4 (cytotoxic T lymphocyte antigen-4) for the successful eradication of cancer and the reduction of side effects. The papers include a review that underlines the importance of strategies for combinatorial treatments to improve further the immunotherapy of cancer. ISA Pharmaceuticals is developing cancer immunotherapies along those lines, in particular its Synthetic Long Peptide (SLP®) vaccine ISA101 for the treatment of HPV-induced diseases, such as cervical cancer and head and neck cancer, and ISA203 for the treatment of various tumors including lung cancer, head and neck cancer, breast cancer and melanoma.
In a paper just published in Clinical Cancer Research [1], a team of scientists from Leiden University Medical Center (LUMC) and ISA Pharmaceuticals report that in preclinical mouse models of cancer, the injection of a CTLA-4 blocking antibody in a slow-release formulation close to the tumor is very effective in activating a systemic anti-tumor (CD8+) T cell response. CTLA-4 is a crucial immune checkpoint protein that down-regulates the body’s immune response. The low-dose local treatment (50μg subcutaneously in a slow-release vehicle) eradicates tumors, including distant tumors, as effectively as a high-dose systemic treatment (2×200μg intraperitoneally). The method also leads to a 1000-fold decrease of antibody levels in the serum, thereby reducing adverse events and the risk of autoimmunity.
These findings are supported by an increasing number of studies demonstrating that local targets, mainly present in the microenvironment of tumors and draining lymph nodes, are key players in tumor progression. As published in a second paper by researchers from LUMC and ISA, a review in the International Journal of Cancer [2], local immunotherapies have clear advantages over systemic treatments, both in their ability to shift tumor-promoting mechanisms towards effective tumor-eradicating immunity and in terms of reducing the risks of systemic administration.
In the third publication in Seminars in Immunology [3], current cancer immunotherapy approaches are reviewed, concluding that most standalone immunotherapeutic strategies either fail to affect progressive diseases and survival significantly – or only do so in a minority of patients. The authors support combinations of synthetic vaccines that stimulate tumor-specific T cell responses and adjuvants, immune-modulating antibodies, cytokines, or chemotherapy.
[1] Fransen MF et al. (2103), Clin Cancer Res, Published Online First June 20, 2013; doi: 10.1158/1078-0432.CCR-12-0781
[2] Fransen MF et al. (2013), Int. J. Cancer, 132: 1971–1976; doi: 10.1002/ijc.27755
[3] Arens R et al., (2013), Sem Immunol, Published Online First May 21, 2013;
doi: 10.1016/j.bbr.2011.03.031
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).