US FDA grants cinrebafusp alfa Orphan Drug Designation for the treatment of HER2-high and HER2-low expressing gastric cancers

Cinrebafusp alfa is a 4-1BB/HER2 fusion protein comprising a 4-1BB-targeting Anticalin protein and a HER2-targeting antibody. Data from a Phase 1 study demonstrated clinical benefit as single agent and a Phase II study of its use as part of combination therapy is being planned.

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Biospace Inc.