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

August 13, 2026: Pyxis Oncology (NASDAQ: PYXS) said updated data from micvotabart pelidotin (MICVO) are expected in two head and neck cancer studies. In the ongoing Phase 1 monotherapy study in second-line and beyond recurrent/metastatic HNSCC, an update is on track for Fall 2026 and will include patients treated at 5.4 mg/kg IV every 3 weeks at or below a dose cap, plus analyses of the dose cap’s impact on safety, tolerability, efficacy, and initial durability. Target enrollment in the Phase 1 Part 2 dose-expansion cohort was completed in Q1 2026; the study includes post-platinum/anti-PD-(L)1 patients and post-EGFRi/anti-PD-(L)1 patients, with about 20 patients per arm.

For MICVO plus pembrolizumab (KEYTRUDA) in first-line R/M HNSCC, updated Phase 1/2 dose-escalation data are expected in Q4 2026. The company said preliminary positive results for 1L/2L+ R/M HNSCC had previously been shared in December 2025.

Pyxis also highlighted financing as a corporate catalyst: a private placement completed July 2, 2026 provided about $50 million upfront gross proceeds, with up to approximately $64 million more if warrants are exercised, extending cash runway into Q2 2027 to support additional patient follow-up and data maturation.