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Cue Biopharma Reports Confirmed Partial Response 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 recurrent/metastatic head and neck squamous cell carcinoma

05/10/2021 08:01

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) platform
  • Company 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 Phase 1a/1b study include:

  • Confirmed PR in one patient and SD in five patients, all confirmed by RECIST criteria, in the dose escalation phase of the study to date, 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 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 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 (MTD) observed in patients dosed with up to 8 mg/kg of CUE-101.
     

Dan Passeri, chief executive officer of Cue Biopharma added, "Receiving early confirmation of clinical activity of CUE-101 as a monotherapy in this challenging patient population is an important validation of the potential of the CUE-101 program for oncology, as well as for our follow-on programs such as CUE-102, from the IL2-based CUE-100 series. This confirmed PR provides valuable proof of concept of the Immuno-STAT™ platform to activate and expand disease specific T cells and NK cells as a method to treat other cancers. We anticipate a number of important milestones throughout this year with the potential of further data to inform CUE-101's clinical application. These milestones include, the potential selection of a recommended Phase 2 dose of CUE-101 by mid-2021 for further development as a single-agent treatment for HPV+ 2L+ head and neck squamous cell carcinoma; our plans to report initial Phase 1 results from the combination study of CUE-101 with pembrolizumab in the second half of 2021; and our plans to initiate a Phase 2 neoadjuvant study to evaluate the effects of CUE-101 on the tumor microenvironment, which is also expected to start in the second half of 2021."