BioNTech Gets Europe Priority Medicines Designation for Investigational Therapy Candidate

By Denny Jacob

BioNTech SE said Thursday that the European Medicines Agency granted priority medicines designation to BNT211, a potential treatment for third- or later-line testicular germ cell tumors.

The product candidate, which combines two approaches in one regimen, is currently being investigated in an ongoing Phase 1/2 study evaluating the safety and preliminary efficacy in heavily pretreated patients with relapsed or refractory advanced solid tumors, the company said.

The designation is based on positive preliminary Phase 1/2 data from the ongoing study, BioNTech said. The results showed that the treatment with CLDN6 CAR-T alone or in combination with CARVac, the company's two combined products, was well tolerated and showed positive signs of anti-tumor activity in testicular cancer patients at the first evaluated dose levels, the company said.

Write to Denny Jacob at [e-mail]

(END) Dow Jones Newswires

06-23-22 1135ET