Christine Hawner, BioNtech, Mainz, Germany

Every tumor has an exclusive pattern of tumor antigens which are based on acquired mutations. Even within the same type of cancer, only a small percentage of mutations is shared, most of them are absolutely unique for each and every patient. At BioNTech, we use next generation sequencing of patient samples and proprietary analytical algorithms to define these tumor-specific antigen signatures. Using these signatures or “mutanomes” we generate treatments tailored to target each individual tumor. We have developed an mRNA-based cancer-immunotherapy platform that utilizes this tumor-specific information to develop personalized treatments for each patient.

The goal is to activate each patient’s immune system to recognize, target and fight their individual cancer.

In cooperation with Genentech, we have started a phase I clinical study in which we use our Personalized Cancer Vaccine (PCV) as single agent or in combination with Atezolizumab. We need to produce the PCV for up to 572 patients which required automation of our processes. The process starts with the reception and processing of patient blood and tumor samples to prepare the samples for downstream sequencing. In our Biosampling department, we built a semi-automated platform that allows the reception, processing, storage and hand out of tissue, blood and PBMC samples for a large number of patients as part of a manufacturing process and in order to serve our immune monitoring program.