Pyxis Oncology, Inc. announced significant progress in its clinical program for PYX-201, its lead antibody-drug conjugate. The company has initiated a Phase 1/2 combination trial (PYX-201-102) evaluating PYX-201 with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) and other advanced solid tumors. This combination study is actively recruiting and on track to initiate patient dosing in Q1 2025.
In parallel, the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 PYX-201-101 study have begun enrolling patients. These expansion cohorts are focused on R/M HNSCC patients across sites in the US, EU, and other countries.
PYX-201 is designed to deliver its AUR-0101 payload within the tumor microenvironment, potentially inducing immunogenic cell death and enhancing responses when combined with pembrolizumab. These trials represent a critical step in advancing PYX-201 as a potential treatment for cancers with limited options.
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