Pyxis Oncology to present updated Phase 1 data for micvotabart pelidotin
- Pyxis Oncology to present Phase 1 monotherapy data for micvotabart pelidotin on September 9, 2026
- Analysis focuses on patients treated at 5.4 mg/kg dose cap in recurrent/metastatic HNSCC
- MICVO retains FDA Fast Track Designation for second-line and beyond treatment settings
- Event features clinical expert Alan L. Ho from Memorial Sloan Kettering Cancer Center

*this image is generated using AI for illustrative purposes only.
Pyxis Oncology, Inc. (NASDAQ: PYXS) announced it will host a live webcast on September 9, 2026, at 7:30 am Eastern Time to present updated clinical data from its ongoing Phase 1 monotherapy study. The study evaluates micvotabart pelidotin (MICVO) in patients with second-line and beyond (2L+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Clinical Presentation Details
The presentation will cover the scientific rationale for MICVO, a novel antibody-drug conjugate (ADC), and its implications within the evolving treatment landscape for R/M HNSCC. Key data points include detailed analyses of patients treated at 5.4 mg/kg intravenously once every three weeks, specifically those receiving a dose equivalent to or below a dose cap.
Updated efficacy and safety results from the expansion trial will be disclosed, alongside next steps in clinical development. The event features Alan L. Ho, M.D., Ph.D., Chief of Head and Neck Oncology Service at Memorial Sloan Kettering Cancer Center, along with Pyxis Oncology management.
Regulatory and Development Context
MICVO holds Fast Track Designation from the U.S. Food and Drug Administration for treating adult patients with R/M HNSCC whose disease progressed following platinum-based chemotherapy and anti-PD-(L)1 therapy. The drug targets extradomain-B of fibronectin (EDB+FN), a structural component of the tumor extracellular matrix selectively overexpressed in solid tumors.
| Study Parameter | Detail |
|---|---|
| Drug Candidate | Micvotabart pelidotin (MICVO) |
| Indication | 2L+ Recurrent/Metastatic HNSCC |
| Dose Analyzed | 5.4 mg/kg IV every three weeks |
| Regulatory Status | FDA Fast Track Designation |
Pyxis Oncology is also evaluating MICVO in combination with Merck’s KEYTRUDA (pembrolizumab) in a Phase 1/2 study for R/M HNSCC and other solid tumors. An archived webcast will be available on the company’s investor relations website following the live event.
How might the efficacy and safety profile of MICVO at the 5.4 mg/kg dose influence Pyxis Oncology's strategy for initiating a pivotal Phase 3 trial?
What are the potential implications for Pyxis Oncology's valuation if the combination study with Merck’s KEYTRUDA shows synergistic effects in head and neck cancer?
Given the FDA Fast Track designation, what specific clinical endpoints must MICVO meet to accelerate its regulatory approval timeline for R/M HNSCC?































