Clinical Trial

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Core of the Project

The core of the MERIT project will be a therapeutic phase I/II trial in patients with triple negative breast cancer conducted at 5 European clinical centers in Germany, France, Belgium, and Sweden. Patients will either receive a personalized and tumor-specific combination of selected warehouse RNAs or the selected warehouse RNAs followed by immunization with a poly-neo-epitopic RNA targeting individual tumor mutations.

MERIT clinical trial is expected to start in 2016.

The selection of target antigens for vaccination is a crucial success factor. The RNAs selected for the MERIT WAREHOUSE address the tumor expression profiles in the majority of TNBC patients. Patient-specific tumor mutations will be identified by next-generation sequencing and the majority of patients will be positive for several warehouse antigens and thus enabling us to generate a custom vaccine for each patient. In contrast to the MERIT WAREHOUSE antigens, MERIT MUTANOME targets are neo-antigens derived from mutated epitopes, which will be individually manufactured for every single patient.

Preclinical experiments have already demonstrated the proof-of-principle and the feasibility of the concept.

The MERIT study will be an international, multi-centre, open-label, interventional phase I/II trial in patients with TNBC. The vaccine will be administered on top of first line adjuvant chemotherapy. In arm one, patients will receive a personalized cocktail of selected warehouse RNAs. In arm two, patients will be administered the personalized cocktail of selected warehouse RNAs followed by immunization with a poly-neo-epitopic RNA targeting individual tumor mutations.