Pieris Snags Orphan Drug Status for Gastric Cancer Treatment

The FDA has granted Pieris Pharmaceuticals Orphan Drug designation for its investigational drug cinrebafusp alfa for treating human epidermal growth factor receptor (HER) 2 high- and low-expressing gastric cancer.

The designation was supported by results from a phase 1 study showing the bispecific drug, which includes a monoclonal antibody and a protein, has potential as a gastric cancer treatment.

The Boston-based company plans to launch a phase 2 trial of the drug this summer in combination with ramucirumab and paclitaxel for treating HER 2 high-expressing gastric cancer and in combination with tucatinib for treating HER 2 low-expressing gastric cancer.