Biontech receives priority medicines (prime) designation from ema for enhanced regulatory support of car-t candidate bnt211 in testicular cancer

Mainz, germany, june 23, 2022 (globe newswire) – biontech se (nasdaq: bntx, “biontech” or “the company”) today announced that that the european medicines agency (ema) has granted priority medicines (prime) designation to biontech's fully owned product candidate bnt211 for the third- or later-line treatment of testicular germ cell tumors. bnt211 is a potential first-in-class therapeutic approach which comprises a synergistic combination of two of the company's proprietary drug products, an autologous chimeric antigen receptor (car) t cell therapy targeting the oncofetal antigen claudin-6 (cldn6) and a cldn6-encoding car-t cell amplifying rna vaccine (carvac). the product candidate is currently being investigated in an ongoing phase 1/2 study ( nct04503278 ; 2019-004323-20 ) that aims to evaluate the safety and preliminary efficacy in heavily pretreated patients with relapsed or refractory advanced solid tumors.
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