• Cue Biopharma Inc (NASDAQ: CUE) has announced 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).

• Interim analysis highlights include:

  • Confirmed partial response (PR) in one patient and stable disease (SD) in five patients, providing early signs of potential single-agent activity of CUE-101.

  • Demonstrated evidence of both tumor-specific CD8+ T cell expansion and dose-dependent increases in NK cells in patients.

  • Observed immune cell infiltration and tumor cell necrosis in patient tumor biopsies after CUE-101 treatment.

  • Dose-proportional PK 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 was observed in patients dosed with up to 8 mg/kg of CUE-101.

• The company plans a potential selection of a recommended Phase 2 dose of CUE-101 by mid-2021 for further development as monotherapy in HPV+ R/M HNSCC.

• It also intends to report initial Phase 1 results from the combination study of CUE-101 with pembrolizumab in the second half of 2021 and initiate a Phase 2 neoadjuvant study with CUE-101 in the second half of 2021.

• Price Action: CUE is trading 30.6% higher at $14.71 during the market trading session on the last check Monday.

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