Archive: Company News
Company News: ISA Pharmaceuticals Establishes Advisory Board
– Renowned Specialists to Support Development of ISA’s Advancing Pipeline –
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced the establishment of an advisory board of seasoned executives and scientists. Five world-renowned specialists will bring strong clinical, regulatory, scientific and business expertise to assist ISA in developing and implementing its corporate and R&D strategy.
The members of ISA’s advisory board are:
Alex Eggermont, M.D., Ph.D., is General Director of the Institut de Cancérologie Gustave Roussy (IGR, Villejuif) and a Professor of Surgical Oncology at Rotterdam’s Erasmus University (Netherlands). Prof. Eggermont specializes in preclinical and clinical / translational oncology, and is a specialist in immunotherapy research and the treatment of melanomas and sarcomas.
Ulrich Granzer, Ph.D., is a pharmacist and founder of Granzer Regulatory Consulting & Services. In addition, he is a founding member and President of the Board of the German Association of Regulatory Affairs (DGRA). He has long-standing experience in all regulatory aspects of the pharmaceutical industry from his time at Glaxo (now GSK), BASF, Pharma / Knoll, and Bayer. At Bayer, as Vice President of Global Regulatory Affairs he was responsible for all regulatory aspects of the development and submission of projects worldwide. Dr. Granzer’s expertise in regulatory affairs extends to both U.S. (FDA) and European (EMA) regulatory authorities.
Drew M. Pardoll, M.D., Ph.D., is a cancer immunologist and an Abeloff Professor of Oncology, Medicine, Pathology and Molecular Biology and Genetics at the Johns Hopkins University School of Medicine. He is also Director of Cancer Immunology at the Sidney Kimmel Comprehensive Cancer Center. Dr. Pardoll specializes in cancer immunology and cancer immunotherapy and has contributed to the development of many immunotherapies.
Sjoerd H. van der Burg, Ph.D., is a Professor in Experimental Cancer Immunology and Therapy at the Department of Clinical Oncology of the Leiden University Medical Center. He has extensive experience in tumor immunology and the immunotherapy of cancer, in particular the development of therapeutic vaccine strategies and the adoptive transfer of ex-vivo expanded T cells. He is specialized in the immunomonitoring of human T cell responses and is the current Chair of the Association for Cancer Immunotherapy Immunoguiding Program (CIP).
Mark Krul, Ph.D., is a co-founder of ISA Pharmaceuticals and a co-founder and Managing Partner at Aglaia BioMedical Ventures, a Dutch venture firm focusing on oncology. He is a molecular biologist and immunologist with over 20 years of experience in anti-cancer drug development, among others as a Research Manager at the European Cancer Center and as Head of the Department of Molecular Virology at the National Institute of Public Health and Environmental Protection in the Netherlands. Mark Krul has a strong track record in founding, managing and financing early-stage oncology companies. Mark Krul will chair ISA’s advisory board.
Company News: Curetis Presents New Clinical Validation Data on its Unyvero™ P50 Pneumonia / LRT Application
– Clinical studies from U.S. and Switzerland confirm previous performance data
– Findings presented at DGHM/DGI 2013 and ICAAC 2013
Curetis AG today announced the presentation of additional clinical validation data on its Unyvero™ P50 / LRT application at two international conferences. The cartridge is designed to detect 16 respiratory bacteria and one fungus responsible for about 80% of severe non-viral pneumonia cases. In addition, it is able to simultaneously identify 22 antibiotic resistance markers.
At this year’s 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2013) in Denver, CO, researchers from the Northwestern Memorial Hospital (Chicago, IL) and Curetis presented data generated during the initial familiarization and training phase for the FDA trial of the Unyvero™ LRT application, an investigational device. It is based on the panel of the P50 cartridge, which is already marketed outside the U.S. In the small cohort using native clinical samples, the Unyvero™ LRT application achieved an overall sensitivity of 89% and an overall specificity of 98% for pathogen identification. Moreover, it detected 6 additional pathogens not discovered by routine microbiological culture. The resistance markers showed an overall sensitivity of 87% at an overall specificity of 97%. The authors conclude that “this data indicates that the system can significantly contribute to patient management by providing rapid pathogen identification and antimicrobial resistance profiling.”
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, clinicians from the University Hospital Basel, Switzerland, presented data comparing the Unyvero™ P50 cartridge with standard microbiological culture, including anti-microbial susceptibility testing. While in 104 cases microbiology culture detected 96 pathogens evaluable by the Unyvero™ P50 cartridge, P50 detected 73 pathogens (76%). However, Unyvero™ P50 detected 68 microorganisms that were not listed in the culture report. Of these, 46% were S. pneumoniae and 10% were H. influenzae – pathogens difficult to culture or part of the oral flora for which clinical significance is not yet determined. The discrepancies are still under investigation. Phenotypic antimicrobial susceptibility or resistance was predicted correctly in 82% of cases by Unyvero™ P50. While standard culture and anti-microbial susceptibility testing took 2 to 4 days, the Unyvero™ results were obtained in less than 4.5 hours. The Basel microbiology team concluded that the “Unyvero™ Pneumonia P50 assay is able to provide fast and clinically useful results on the most prevalent pathogens causing pneumonia and their antibiotic resistance genes.”
A previous study testing more than 1,000 samples in Europe showed an overall sensitivity of 81% and an overall specificity of 96%.
Company News: Merus Secures €31 Million in Series B Round Extension
– Investment brings Series B to a total of €47.6 million
– Johnson & Johnson Development Corporation joins as new investor; receives board seat
Merus B.V., a biopharmaceutical company focusing on innovative human antibody therapeutics, today announced a €31 million (US$42 million) extension to its Series B financing round, bringing the total round to €47.6 million (US$65 million). Johnson & Johnson Development Corporation (JJDC) joined as a new investor along with existing investors Novartis Venture Fund, Pfizer Venture Investments, Bay City Capital, LSP (Life Sciences Partners), and Aglaia Oncology Fund. A representative of JJDC will join Merus’ Board of Directors. Merus will use the new funds to broaden its portfolio of pre-clinical programs for the treatment of cancer patients and to bring its lead programs into phase I clinical testing.
The investment of JJDC in Merus B.V. was announced at the launch of the Johnson & Johnson Innovation Centre in London today.
Earlier this year, Merus presented encouraging research and preclinical data of MCLA-117, a product candidate to treat acute myeloid leukemia, a disease with very poor long-term prognosis. MCLA-117 is based on Merus’ proprietary Biclonics™ ENGAGE platform and is currently in development.
Company News: ISA Pharmaceuticals Presents Novel Data at the European Cancer Congress 2013 – Strong Synergies Between Cancer Vaccine ISA101 and Chemotherapy
– Chemotherapy improves immune response to therapeutic vaccine against Human Papilloma Virus type 16 (HPV16) –
ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced that it had presented novel data on its lead compound ISA101 at this year´s European Cancer Congress (ECCO-ESMO-ESTRO) in Amsterdam, The Netherlands.
In a preclinical mouse model of cancer, chemotherapy with cisplatin increased the therapeutic response to subsequent vaccination with an HPV16 synthetic long peptide (SLP®). While cisplatin or HPV-SLP® treatment alone increased survival, long-term survival was only achieved by combining chemotherapy with the vaccine.
These findings are further supported by a Phase I toxicity / immunogenicity study in 18 women with advanced or recurrent cervical cancer eligible for chemotherapy. Concurrent with standard chemotherapy (including carboplatin and paclitaxel), 12 patients received ISA101, a therapeutic cancer vaccine consisting of 13 synthetic long peptides from the E6 and E7 oncoproteins of HPV16. The control group (n=6) did not receive vaccination. The study demonstrates that chemotherapy doe s not cause lymphodepletion or suppression of cellular immune responses in patients. Patients showed shifts in leukocyte composition associated with increased dendritic cell function and improved memory T cell responses to common recall antigens. Patients treated with chemotherapy and ISA101 exhibited robust and sustained HPV16-specific proliferative T cell responses.