micvotabart pelidotin (PYX-201-101) - (MICVO)

November 5, 2026: Pyxis Oncology (NASDAQ: PYXS) reported updated development plans and prior Phase 1 data for micvotabart pelidotin (MICVO) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). For MICVO monotherapy in second-line-and-beyond R/M HNSCC, the company said it has aligned with FDA and EMA on the design of the global pivotal Phase 3 Headliner trial, planned to start in mid-2027. The randomized, open-label study will enroll about 500 patients who progressed after platinum chemotherapy and anti-PD-1 therapy, comparing MICVO vs investigator’s choice of cetuximab, docetaxel, or methotrexate; co-primary endpoints are objective response rate and overall survival. FDA feedback on dose selection after the End-of-Phase 2 meeting is expected in 1Q 2027, and updated overall survival data from the ongoing monotherapy study are expected in 1H 2027.

The company reiterated September 9, 2026 Phase 1 monotherapy data at 5.4 mg/kg IV Q3W with dose cap (N=33 efficacy-evaluable): confirmed ORR 36% (12/33), disease control rate 94% (31/33), median PFS 6.2 months (95% CI 4.8–8.8), and 12-month OS probability 79% (95% CI 58.1, 90.3); median OS was not reached. No new safety signals were observed in 35 safety-evaluable patients.

MICVO monotherapy data will be presented in a late-breaking oral presentation at the EORTC-NCI-AACR Symposium on November 19, 2026. A December 2026 corporate update will include combination data for MICVO plus pembrolizumab in first-line R/M HNSCC, with at least 20 patients at 3.6 mg/kg and 4.4 mg/kg; additional durability data are expected in 2H 2027.