BioNTech (NASDAQ:BNTX) received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for its product candidate BNT211 in the third- or later-line treatment of testicular germ cell tumors.
The European regulatory grant is supported by the positive preliminary data readout from ongoing phase 1/2 study demonstrating an encouraging safety profile and early signs of anti-tumor activity in testicular cancer patients that was presented at the AACR Annual Meeting in April 2022.
Prof. Özlem Türeci, Co-Founder and Chief Medical Officer, said, ”With the PRIME status and support by the EMA, we aim to expedite the further development of the BNT211 program to bring a novel therapeutic option for patients with life-threatening testicular cancer, and thus to extend the successes of CAR-T therapy also to hard-to-treat solid tumors.”
BNT211 combines two innovative approaches in one regimen, 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) to improve persistence and functionality of the adoptively transferred cells.
The EMA priority medicines status is granted to drug candidates that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options.
BioNTech shares are trading higher 6 percent at $130.57
