CUE - Cue Biopharma's CUE-101 shows encouraging action in HPV+ head and neck cancer patients

Cue Biopharma (CUE) gains 8% premarket after announcing interim clinical data from its ongoing Phase 1a/1b monotherapy study of CUE-101 as second-line treatment for patients with human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC). Key interim analysis include:Confirmed partial response ((PR)) in one patient and stable disease ((SD)) in five patients, in the dose escalation phase, providing early signs of potential single-agent activity of CUE-101.Demonstrated evidence of both tumor-specific CD8+ T cell expansion as well as dose-dependent increases in NK cells in the blood of the treated patients.Observed immune cell infiltration and tumor cell necrosis in patient tumor biopsies after CUE-101 treatment, supporting CUE-101’s mechanism of action at engaging and modulating targeted T cells within the patient’s body.Dose-proportional pharmacokinetic profile and comparable drug exposure levels in patients receiving repeated dosing cycles, consistent with a lack of drug-clearing anti-drug antibodies.No maximum tolerated dose observed in patients dosed with up to 8 mg/kg

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Cue Biopharma's CUE-101 shows encouraging action in HPV+ head and neck cancer patients