BioNTech RNA Pharmaceuticals received a positive vote from the Paul-Ehrlich Institute and the relevant institutional review board (ethics committee) to initiate a clinical trial (IVAC MUTANOME) evaluating the safety, tolerability, and immunogenicity of vaccination with a personalized mutanome vaccine among patients with advanced melanoma.
The IVAC MUTANOME project aims to develop Individualized Cancer Immunotherapies(IVAC®) that acknowledge the heterogeneity of patients’ tumors. After determining the mutation profile (mutanome) of a patient’s tumor, patient-specific targets are identified based on immunological properties and prediction algorithms. After selection, a patient-specific, poly-neo-epitopic lead structure is designed, and GMP manufacturing of the investigational medicinal product begins. The IVAC MUTANOME trial is the first in Europe that introduces a fully personalized mutanome vaccine in malignant melanoma. The first proof-of-concept results are expected in 2015.