BioNTech SE presented positive follow-up data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and efficacy of the Company's novel CAR-T cell therapy candidate, BNT211, in patients with relapsed or refractory advanced solid tumors. The results demonstrated encouraging signs of anti-tumor activity and the safety profile remained manageable for the two tested dose levels. The data were presented in the Investigational Immunotherapy Proffered Paper Session at the European Society for Medical Oncology (ESMO) Congress 2022 by Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany.

BNT211 is a novel therapeutic approach which comprises a synergistic combination of two of BioNTech's proprietary platforms. The candidate combines an autologous chimeric antigen receptor (CAR) T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) with a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). The product candidate recently received Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) for the third- or later-line treatment of testicular germ cell tumors. The designation was granted based on the encouraging initial data particularly in patients with testicular cancer which is the most common type of germ cell tumors.

BioNTech presented data from the ongoing Phase 1/2 trial (NCT04503278; 2019-004323-20) at the American Association for Cancer Research (AACR) annual meeting in April 2022 and at the annual meeting of the Association for Cancer Immunotherapy (CIMT) in May 2022.