MICVO demonstrated rapid and deep responses, with a 36% confirmed objective response rate (cORR) and 94% disease control rate (DCR), with clinical activity observed across HPV status and prior-treatment subgroups
Substantial survival outcomes include median progression-free survival (mPFS) of 6.2 months and 12-month overall survival (OS) probability of 79%, with clinical activity observed across HPV status and prior-treatment subgroups
No new safety signals observed; tolerability profile expected & consistent with prolonged auristatin exposure; dose capping reduced frequency and severity of adverse events in high body weight patients
MICVO potentially addresses significant unmet need in 2L+ R/M HNSCC, where evolving first-line treatment landscape is expected to create a demand for novel non-EGFRi treatment options
Data support advancement of MICVO into a pivotal program in 2L+ R/M HNSCC, with initiation of Phase 3 Headliner™ trial planned for mid-2027
Company to host webcast today at 7:30 a.m. ET
BOSTON, Sept. 09, 2026 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (NASDAQ:PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today announced positive updated data as of the August 18, 2026 data cutoff date from its ongoing global Phase 1 monotherapy study evaluating micvotabart pelidotin (MICVO) in patients with second-line and beyond (2L+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).
The updated results represent a population (N=33 efficacy evaluable) dosed at 5.4 mg/kg intravenously once every three weeks with a dose equivalent to or below a dose cap. These data demonstrated rapid and deep responses, with a 36% confirmed objective response rate (cORR) and 94% disease control rate (DCR). Median progression-free survival (mPFS) was 6.2 months, and the 12-month overall survival (OS) probability was 79% while median OS (mOS) has not yet been reached. Clinical activity was observed across key patient subgroups, including HPV status and prior treatment. No new safety signals were observed (N=35 safety evaluable), and dose capping reduced the frequency and severity of adverse events in high body weight patients.
MICVO, the company’s lead program, is a first-in-concept antibody-drug conjugate (ADC) targeting extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix. MICVO’s differentiated, non-EGFR targeting mechanism of action positions it to potentially serve a significant patient population and address unmet need in 2L+ R/M HNSCC as the first-line treatment landscape continues to evolve.