Pyxis Oncology Completes Phase 1 MICVO Enrollment, Reports 46% Monotherapy ORR and 71% Combo ORR
Pyxis Oncology completed enrollment of ~40 patients in its Phase 1 MICVO trial for recurrent/metastatic HNSCC and expects mid-2026 safety and efficacy data on modified dosing. The company reported 46% ORR and 92% DCR in monotherapy, 71% ORR with 100% DCR in combination, extending cash runway to Q4 2026.
1. Business Update and Leadership
Pyxis Oncology named Thomas Civik as Interim Chief Executive Officer and reported financial results for the quarter and full year ended December 31, 2025. The company expects its existing cash to fund operations into the fourth quarter of 2026.
2. Phase 1 Monotherapy Enrollment
The company completed enrollment of approximately 40 patients in its Phase 1 monotherapy dose expansion study of micvotabart pelidotin (MICVO) in second-line and later recurrent/metastatic head and neck squamous cell carcinoma during the first quarter of 2026. Enrollment included two arms targeting post–platinum and post–EGFRi or anti-PD(L)-1 experienced patients.
3. Efficacy Results and Dosing Modifications
Preliminary monotherapy data showed a 46% confirmed objective response rate and 92% disease control rate in 13 evaluable patients, with no grade 4 or 5 treatment-related adverse events. The company implemented a modified weight-based dosing approach with dose caps and adjusted ideal body weight to optimize drug exposure and is on track to report detailed safety and efficacy analyses by mid-2026.
4. Combination Study and Future Milestones
In combination with pembrolizumab, MICVO achieved a 71% ORR and 100% DCR in seven patients with no grade 3 or higher adverse events of interest. Pyxis Oncology plans to share updated combination data in the second half of 2026 and has received FDA feedback on the design of a pivotal monotherapy study in this indication.