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December 21, 2023 08:00 ET | Source: BioNTech SE

BioNTech und DualityBio erhalten Breakthrough-Therapy-Status der FDA für ADC-Kandidaten BNT323/DB-1303 zur Behandlung von Gebärmutterkrebs

Breakthrough-Therapy-Status basiert auf Phase-1/2-Daten zur Sicherheit und Wirksamkeit in Patientinnen mit Human Epidermal Growth Factor Receptor 2 („HER2“) -exprimierendem, fortgeschrittenen...
December 21, 2023 08:00 ET | Source: BioNTech SE

BioNTech and DualityBio Receive FDA Breakthrough Therapy Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Endometrial Cancer

Designation is based on Phase 1/2 safety and efficacy data in patients with Human Epidermal Growth Factor Receptor 2 (“HER2”)-expressing advanced endometrial cancer with encouraging early signs of...