Objectives: Philogen (PHG) will manufacture in its GMP facility sufficient amount of clinical-grade F16-IL2 for the execution of the clinical trial in patients with Merkel cell carcinoma. The clinical-grade samples will be shipped to the participating study centers. Philogen will act as Sponsor and will offer practical support for the execution of the trial (preparation of application in close collaboration with the clinical centers, submission to regulatory authorities, CRF preparation, site-initiation visits, monitoring services, etc.).
Expertise relevant to the proposed work: Philogen (PHG) is a privately-owned Swiss-Italian integrated biotechnology company founded in 1996 and has currently about 70 employees. The company has been a pioneer in the isolation, engineering and clinical development of lead products capable of targeting angiogenesis in vivo, and has been the first in the world to demonstrate that human monoclonal antibodies, specific for a marker of angiogenesis, can efficiently and selectively target the tumor neo-vasculature both in animal models and in cancer patients. PHG has fully equipped laboratories for biochemical, molecular biology and cell biology research. Furthermore, PHG has a 2000 m2 EMA-authorized GMP production facility, which has already manufactured seven human monoclonal antibody derivatives, which are currently applied in clinical trials in Italy, Germany, Holland and UK (www.philogen.com). This facility is fully equipped for development activity, including bioreactors for protein production using mammalian and yeast expression systems. Moreover, PHG has an inhouse clinical operations unit consisting of study managers, pharmaco-vigilance managers, clinical research associates and data management personnel to monitor the conduct of controlled phase-IIb clinical trials throughout Europe and to analyze the results.
Specific role in the project: PHG will lead WP1, the implementation and execution of a phase-II clinical trial comparing the clinical efficacy of the immunocytokine F16-IL2 plus paclitaxel to paclitaxel alone for therapy of patients with Merkel cell carcinoma. PHG will also function as the legal sponsor of this trial. Moreover PHG will be involved in WP6 and WP7, i.e. management and exploitation.