Cue Biopharma Inc. and Merck are evaluating the combination of Cue Biopharma’s investigational product candidate CUE-101, a first-in-class biologic, with Merck’s Keytruda in patients with advanced head and neck cancer.
Cue Biopharma is a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body.
Under the terms of the agreement, Cue Biopharma will conduct a phase I study, KEYNOTE-A78, evaluating CUE-101 in combination with Kekytruda in first-line HPV+ advanced head and neck cancer.
KEYNOTE-A78 will be conducted alongside the ongoing phase I monotherapy study of CUE-101 post first-line treatment. The early monotherapy PK data from the first two dosing cohorts demonstrates dose-related drug exposure consistent with preclinical modeling. Subsequent to the respective dose escalations, expansion cohorts evaluating CUE-101 as a monotherapy and in combination with Keytruda will be conducted at optimized dosing regimens.
“Through the monotherapy and combination studies, we believe we will be able to demonstrate the mechanistic advantages of our approach and platform for modulating disease-relevant T cells directly in the patient’s body to safely enhance efficacy over current standards of care,” Daniel Passeri, chief executive officer of Cue Biopharma, said in a statement.
“Based on a novel mechanism of action designed to induce and expand tumor-specific T cells in the patient’s body, we believe CUE-101 may lead to enhanced anti-tumor activity in combination with KEYTRUDA,” Ken Pienta, acting chief medical officer of Cue Biopharma, said in a statement.
CUE-101 is a fusion protein comprised of a human leukocyte antigen complex, an HPV16 E7 peptide epitope, reduced affinity human interleukin-2 molecules, and an effector attenuated human immunoglobulin G (IgG1) Fc domain. In preclinical studies, CUE-101 has demonstrated selective induction and expansion of HPV16 E7-specific cytotoxic T cells with both in vitro and in vivo evidence supporting its potential for clinical efficacy both as a monotherapy and in combination with anti-PD1 checkpoint blockade.
