BioNTech Gets Europe Priority Medicines Designation for Investigational Therapy Candidate
Source: Dow Jones News
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 denny.jacob@wsj.com
(END) Dow Jones Newswires
June 23, 2022 11:35 ET (15:35 GMT)
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