BioNTech, Duality: Breakthrough Therapy Designation for Antibody-Drug Conjugate 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 anti-tumor activity
• Breakthrough Therapy designation will allow for an expedited development and regulatory review of BNT323/DB-1303
• Endometrial or uterine cancer is the second most common gynecologic cancer globally with over 400,000 cases occurring each year

https://www.marketscreener.com/quote/stock/BIONTECH-SE-66771992/news/BioNTech-and-DualityBio-Receive-FDA-Breakthrough-Therapy-Designation-for-Antibody-Drug-Conjugate-Can-45617371/