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Home » Pieris Snags Orphan Drug Status for Gastric Cancer Treatment
Pieris Snags Orphan Drug Status for Gastric Cancer Treatment
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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.
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