Pyxis Oncology Announces Favorable Preliminary Phase 1 Data for PYX-201 and Collaboration with Merck

PYXS
October 07, 2025

Pyxis Oncology, Inc. today announced positive preliminary data from its ongoing Phase 1 clinical dose escalation study evaluating PYX-201 in multiple solid tumors. PYX-201 achieved a confirmed 50% objective response rate (ORR) by RECIST 1.1, including one complete response, and a 100% disease control rate in six heavily pretreated head and neck squamous cell carcinoma (HNSCC) patients. Across all six solid tumor types of interest (n=31), PYX-201 demonstrated an overall 26% ORR with dose-dependent responses observed.

The company also announced a new Clinical Trial Collaboration Agreement with Merck to evaluate PYX-201 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). This combination study is expected to begin dosing patients in the first quarter of 2025 across indications including HNSCC, HR+/HER2- breast, TNBC, and sarcoma.

PYX-201 was generally well-tolerated with a favorable safety profile, showing a low incidence of dose discontinuation, interruptions, or delays due to treatment-related adverse events. Monotherapy expansion trials in HNSCC are also planned to begin dosing in the first quarter of 2025, with multiple data updates anticipated in 2025.

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