Pieris Pharmaceuticals announced that the first patient has been dosed in the phase 2 study of cinrebafusp alfa (PRS-343), a 4-1BB/HER2 Anticalin-based bispecific for the treatment of HER2-expressing gastric cancer. The two-arm study is evaluating cinrebafusp alfa in combination with ramucirumab and paclitaxel in patients with HER2-high gastric cancer and in combination with tucatinib in patients with HER2-low gastric cancer. Data for the HER2-low arm are expected later this year, with data from the HER2-high arm to follow in 2023.
Pieris presented phase 1 data from a monotherapy trial in November of 2021 showing clinical benefit at active dose levels, including confirmed complete response and several confirmed partial responses. Dose dependent immune activation was seen in both HER2-high and HER2-low patients and durable anti-tumor activity was observed in this heavily pre-treated population, including “cold” tumors.
The two-arm, multicenter, open-label phase 2 study plans to enroll 80 patients who will receive a loading dose of 18 mg/kg in week one and three, followed by maintenance doses of 8 mg/kg (Q2W) for both arms in the study. The Company is targeting an Overall Re...
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