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Pieris Pharmaceuticals Presents Updated Phase 1 Monotherapy Data for 4-1BB/HER2 Bispecific Cinrebafusp Alfa and Preclinical Data for 4-1BB/PD-L1 Bispecific PRS-344/S095012 at 2021 AACR Annual Meeting
Additional, ongoing confirmed durable partial response and three additional patients with stable disease as best response at the highest dose cohort of
About this update from Palvella Therapeutics, Inc.
[{"type":"text","content":"Additional, ongoing confirmed durable partial response and three additional patients with stable disease as best response at the highest dose cohort of cinrebafusp alfaDurable anti-tumor activity in heavily pre-treated patient population including \"cold\" and HER2-low expressing tumors Dose-dependent immune activation and 4-1BB modulation in both HER2-high and HER2-low expressing patientsPRS-344/S095012 preclinical data show that the drug candidate induces a dose-dependent anti-tumor response in an anti-PD-L1-resistant mouse modelBOSTON, MA / ACCESSWIRE / April 10, 2021 / Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today presented a clinical data update from the phase 1 monotherapy study of cinrebafusp alfa (PRS-343), a 4-1BB/HER2 bispecific for the treatment of HER2-expressing solid tumors, in an oral presentation at the American Association for Cancer Research (AACR) Virtual Congress 2021. The Company also presented preclinical data for PRS-344/S095012, a 4-1BB/PD-L1 bispecific the Company is developing with Servier, at a poster session at the congress.Cinrebafusp Alfa (PRS-343):Presented data demonstrated additional clinical benefit at the highest dose, including an additional, ongoing confirmed durable partial response, three additional patients with stable disease as best response, and overall durable benefit. Based on clinical benefit and pharmacodynamic correlates, cinrebafusp alfa showed a clear dose response and a 4-1BB-driven mechanism of action. Additionally, clinical benefit was observed in patients with \"cold\" tumors as well as those with HER2-low expressing tumors. Cinrebafusp alfa continues to be well-tolerated. The Company plans to initiate a phase 2 study in gastric cancer this summer that will evaluate both HER2-high and HER2-low patient settings.As of the cut-off date of February 25, 2021, 8 patients in the monotherapy trial were evaluable for a response at the highest dose cohort (cohort 13b; 18 mg/kg Q2W) out of a total of 42 response-evaluable patients enrolled in the predicted active dose cohorts (cohort 9 and higher; ≥2.5 mg/kg) in the study.In cohort 13b, one additional patient (cancer of unknown primary) achieved an ong...