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Cue Biopharma Reports Confirmed Partial Response (PR) in Ongoing Phase 1 Monotherapy Study of CUE-101 in Late Stage Second Line and Beyond Patients with HPV+ Recurrent/Metastatic Head and Neck Cancer
And Provides Interim Clinical Data Update Partial response data demonstrates activity of CUE-101 as monotherapy in patient with human papilloma virus positive
About this update from Cue Biopharma, Inc.
[{"type":"text","content":"And Provides Interim Clinical Data Update Partial response data demonstrates activity of CUE-101 as monotherapy in patient with human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC)The objective tumor response observed in this patient establishes initial clinical proof of concept for therapeutic modulation of the endogenous anti-tumor T-cell repertoire by the Immuno-STAT™ (Selective Targeting and Alteration of T cells) platformCompany will discuss results during its upcoming quarterly business update call on May 17, 2021 at 4:30 p.m. EDT CAMBRIDGE, Mass., May 10, 2021 (GLOBE NEWSWIRE) -- 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 within the patient’s body, announced today interim clinical data, including a confirmed partial response (PR), from its ongoing Phase 1a/1b monotherapy study of CUE-101 as second-line treatment for patients with HPV+ R/M HNSCC. To date, CUE-101 has demonstrated a favorable tolerability profile in a monotherapy dose escalation trial and continues to generate encouraging emerging data pertaining to its pharmacokinetic (PK) and pharmacodynamic (PD) profiles, as well as clinical anti-tumor activity. “We are very excited by the partial response observed in this patient, since it demonstrates single-agent activity of CUE-101, so rarely seen in mono-immunotherapy treatments,” said Ken Pienta, M.D., acting chief medical officer of Cue Biopharma. “Based on recent clinical observations, we have delivered CUE-101 to patients at tolerated doses, achieving a confirmed PR as well as stable disease (SD) in several patients while still in the dose escalation portion of the trial. This provides evidence that CUE-101 is an active agent with promising potential for HPV+ HNSCC patients. This is bolstered by the supporting pharmacodynamic data in which we have observed activation of disease-specific T cells and NK cells in the blood of our treated patients. We look forward to initiating the expansion phase of the Phase 1 trial which may provide a potential path forward for a registration-directed clinical trial for CUE-101 as a monotherapy for HPV+ R/M HNSCC.” Key interim analysis of patient data from the ongoing open-label Phas...