Partial hold on BioNTech, MediLink cancer drug lifted by FDA
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Contributor since / Followers
Contributor since / Followers
3 months ago
Sean Gallup
- The U.S. FDA has lifted a partial clinical hold on a phase 1 trial of an antibody drug conjugate candidate under development by BioNTech (NASDAQ:BNTX) and MediLink Therapeutics (Suzhou).
- The hold was placed in June over concerns about drug safety at higher doses. A decline in neutrophil count (neutropenia) and an increasing rate of mucositis events were observed.
- MediLink, which is the study sponsor, has lowered dose levels for participants that enrolled at higher dose levels.
- The candidate, BNT326/YL202, is under investigation for solid tumors.