BioNTech investigates cancer vaccine BNT122 in Phase II trial

As part of the 2016 pact with Swiss Roche AG’s US subsidiary Genentech to develop mRNA vaccines against up to 20 patient-specific neoantigens, Mainz-based BioNTech SE has surprisingly continued Phase II testing of its colon cancer candidate BNT122 (RO7198457). Used as an immune booster for Roche’s checkpoint inhibitor Tecentriq, the individualised mRNA-based cancer vaccines had shown a response in only 8% of the 108 advanced colorectal cancer patients enrolled in a Phase Ib trial; the monotherapy worked in only half of them, although 77% of patient sera had shown neoantigen-specifical T-cell responses in the lab test.

But after evaluating the results, the companies are starting an open Phase II trial with about 200 differently selected patients. These patients have already received chemotherapy after removal of the tumour and have a high probability of relapse after two to three years because characteristic circular DNA markers can be detected in their blood. The non-blinded Phase II trial is investigating the efficacy of BNT122 monotherapy compared to standard wait-and-see therapy in this patient group. The primary endpoint of the study is disease-free survival (DFS). Secondary objectives include relapse-free survival (RFS), overall survival (OS) and safety of therapy.