Targeted Personalized Therapeutic Cancer Vaccines - Clinical trial phase IIa

The purpose of the project is to carry out a phase IIa clinical trial of individualized therapeutic cancer vaccines that activate the immune system to attack unique mutations in a given patient's cancer cell. The phase IIa of the study will explore efficacy of individualized VB10.NEO immunotherapy. We are currently running a phase I clinical trial to explore our proprietary vaccine platform, VB10.NEO, for advanced therapy. The VB10.NEO vaccine platform makes use of a DNA plasmid vaccine adapted for administration of an individualized cancer vaccine in solid tumors, including locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial cancer or squamous cell carcinoma of the head and neck. The phase I clinical trial will enroll up to 40 patients at three international renowned clinical sites based in Germany (National Center for Tumour Diseases in Heidelberg, Department of Oncology and Hematology Clinic Nordwest, Frankfurt am Main, Tumour Immunology and Translational Immunotherapy, University Hospital Klinikum Rechts der Isar, Munich). In the phase IIa, we will choose one or more of the five cancer indications for separate cohort(s) with up to 17 patients in each. The application for an SMEI-2 grant will be for the first of such cohorts. Given current status of enrollment in the phase I study, the most likely first expansion cohort will be for patients with clear renal cell carcinoma. The expansion cohort will enroll up to 17 patients to whom we will manufacture and administer an individualized cancer vaccine holding cancer mutation specific for each patient’s tumor. The patients will be vaccinated according to the same dosing schedule as in the Phase I trial and monitored for safety, immunogenicity signal and clinical efficacy. The phase IIa trial will be conducted in collaboration with the same clinical sites as in the Phase I.