Pyxis Oncology reported updated Phase 1 data for micvotabart pelidotin, or MICVO, in patients with recurrent or metastatic head and neck squamous cell carcinoma receiving second-line treatment or later. Among 33 evaluable patients treated with 5.4 mg/kg intravenously every three weeks, MICVO produced a 36% confirmed objective response rate and a 94% disease control rate. Median progression-free survival was 6.2 months, while median overall survival had not been reached and the 12-month overall survival probability was 79%. Responses were observed across subgroups regardless of prior treatment or HPV status. No new safety signals were identified among 35 safety-evaluable patients, although 54% experienced grade 3 or higher treatment-related adverse events and 14% discontinued treatment. Pyxis plans to meet the FDA (U.S. Food and Drug Administration) in the first quarter of 2027 through Project Optimus to finalize dosing, then launch a 500-patient open-label Phase 3 trial in mid-2027 against cetuximab, docetaxel or methotrexate. The company also plans to report additional MICVO and KEYTRUDA combination data in the fourth quarter of 2026. Shares were down 9.25% at $3.53 at publication, according to Benzinga Pro data.