Pyxis Oncology Inc. (NASDAQ:PYXS) on Wednesday shared updated data from its Phase 1 trial evaluating micvotabart pelidotin (MICVO).
The ongoing global study tested the drug as a monotherapy for patients facing second-line and beyond recurrent or metastatic head and neck squamous cell carcinoma.
Promising Efficacy And Safety Profile
The data showed rapid and deep responses in 33 evaluable patients receiving 5.4 mg/kg of MICVO intravenously every three weeks. The treatment achieved a 36% confirmed objective response rate and a 94% disease control rate.
Patients experienced a median progression-free survival of 6.2 months. Researchers have not yet reached the median overall survival, but the 12-month probability stands at 79%.
Clinical activity appeared across various subgroups, regardless of prior treatments or HPV status. Among 35 safety-evaluable individuals, researchers identified no new safety signals.
Implementing a dose cap successfully reduced the severity of adverse events in heavier patients. MICVO operates as an antibody-drug conjugate targeting the tumor extracellular matrix.
Advancing To Phase 3 And Combination Trials
The company plans to meet with the FDA in the first quarter of 2027 to finalize dose selection through Project Optimus.
Following alignment with regulators, the firm aims to launch a 500-patient, open-label Phase 3 study in mid-2027. This trial will compare MICVO against cetuximab, docetaxel, or methotrexate.
Additionally, researchers will release updated Phase 1/2 data regarding MICVO’s combination with Merck’s KEYTRUDA in the fourth quarter of 2026.
Investigators expect to share durability metrics and the recommended Phase 3 dosing for this combination by late 2027.
Analyst View
William Blair on Wednesday wrote, “…we are encouraged by the breadth of response and promising survival signals…However, we acknowledge the limitations of interpreting event-driven or landmark-based metrics, such as progression-free survival or one-year survival probability.”
Analyst Andy Hsieh further added that despite the incorporation of dose capping, micvo’s safety profile remains a key liability.
54% of the patients experienced grade 3 or higher treatment-related adverse events, which led to 14% of patients discontinuing treatment.
PYXS Price Action: Pyxis Oncology shares were down 9.25% to $3.53 at the time of publication on Wednesday, according to Benzinga Pro data.
Image via Shutterstock/ Yuganov Konstantin
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