Archive: Company News
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).
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.