Benzinga | Jun 10, 2021 08:01AM EDT

Cue Biopharma Announces First Patient Dosed In Part B Patient Expansion Of CUE-101 Phase 1 Monotherapy Trial In HPV+ Second Line And Beyond HNSCC

Cue Biopharma, Inc. (NASDAQ:CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient's body, announced today that it has dosed the first patient in the Part B expansion phase of its Phase 1 monotherapy clinical trial of CUE-101 at the recommended Phase 2 dose of 4mg/kg.

The Phase 1b portion of the CUE-101 monotherapy clinical trial in patients with HPV+ second line and beyond (2L+) head and neck squamous cell carcinoma (HNSCC) is expected to enroll up to 20 patients. The data supporting the patient expansion has been encouraging to date, with six patients having confirmed stable disease (SD) and one patient with a confirmed partial response of approximately 50% tumor reduction in the dose escalation Phase 1a portion of the CUE-101 monotherapy trial.

"We are very pleased to have initiated the Part B patient expansion of the CUE-101 monotherapy trial," stated Ken Pienta, M.D., acting chief medical officer of Cue Biopharma. "We believe the data supporting the selection of the cohort 6 dose at 4mg/kg to confirm a recommended Phase 2 dose gives us growing confidence that CUE-101 may provide a potential path forward for a registration-directed clinical trial as a single agent treatment for HPV+ 2L+ HNSCC."

About the CUE-101 Clinical Trial

The trial (NCT03978689) is a multi-center, first-in-human, open-label Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect and immunogenicity of CUE-101 as a monotherapy in second-line patients with confirmed HPV16-driven recurrent/metastatic HNSCC and HLA-A*02:01 serotype. Based on translational data from the Phase 1a portion of the trial, a recommended Phase 2 dose has been determined. The company has expanded the study to evaluate CUE-101 in combination with KEYTRUDA(r) (pembrolizumab) as first-line treatment in patients with HPV16-driven recurrent/metastatic HNSCC.

About the CUE-100 Series

The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.