Benzinga | May 10, 2021 01:14PM EDT

Cue Biopharma's Stock Shoots Up After CUE-101 Shows Promise In Early-Stage Head & Neck Cancer Study

* 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.