Pyxis Oncology announced a portfolio prioritization to focus on advancing its lead clinical program, PYX-201, a first-in-concept ADC targeting Extradomain-B Fibronectin (EDB+FN) within the tumor extracellular matrix

In November 2024, positive preliminary data from the Phase 1 dose-escalation study of PYX-201 showed a 50% ORR in patients with head and neck squamous cell carcinoma, including one CR and a 100% DCR

The Phase 1 trial also demonstrated a 26% ORR across six solid tumor types, including ovarian cancer, NSCLC, breast cancer (HR+/HER2- and triple-negative), and sarcoma, with dose-dependent responses observed

Based on the data, Pyxis Oncology plans to expand development of PYX-201 in both monotherapy and combination therapies, including a frontline HNSCC study in combination with pembrolizumab, with patient dosing set to begin in early 2025