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

BY Benzinga
— 2:42 PM ET 06/23/2022

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

More BNTX News

  • BioNTech Receives Priority Medicines (PRIME) Designation from EMA for Enhanced Regulatory Support of CAR-T Candidate BNT211 in Testicular Cancer
    GlobeNewswire - 11:00 AM ET 06/23/2022
  • BioNTech Starts Construction of First mRNA Vaccine Manufacturing Facility in Africa
    GlobeNewswire - 6:00 AM ET 06/23/2022
  • Stocks That Hit 52-Week Lows On Wednesday
    Benzinga - 12:30 PM ET 06/22/2022
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