BioNTech Gets EMA's Priority Medicines Status For Testicular Cancer Drug

BioNTech 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