Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, today announced that it has completed patient enrollment in its Phase 1 clinical trial (NCT03978689) evaluating CUE-101, the company’s lead interleukin 2 (IL-2)-based biologic from the CUE-100 series, in combination with KEYTRUDA® (pembrolizumab) as first-line treatment for patients with human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC).
“Completing the enrollment of the recommended phase 2 dose patient expansion cohort is an important milestone as the data from this trial guides further development plans and associated discussions with the Food and Drug Administration (FDA),” said Daniel Passeri, chief executive officer of Cue Biopharma. “We believe the updated data will build upon the already promising clinical profile established to date, which has shown an enhancement of clinical efficacy with the CUE-101-pembrolizumab combination compared to pembrolizumab alone. With the strength of the data already observed with monotherapy in second line patients and beyond, combined with the promising combination data emerging in 1L with pembrolizumab, we plan to discuss potential registrational paths with the Food and Drug Administration (FDA) for CUE-101 both as a monotherapy and in combination with pembrolizumab, leveraging the Fast Track Designation previously granted to these programs.”
Matteo Levisetti, M.D., chief medical officer of Cue Biopharma added, “We believe the data from our CUE-101 trial represents a potential therapeutic breakthrough for HPV+ R/M HNSCC patients, bolstering our confidence in the platform to address unmet needs of patients suffering from a myriad of cancers. The maturing clinical data for CUE-101 further supports the mechanism of action which enables selective expansion of targeted tumor-specific T cells and also provides clinical validation and de-risking of our Immuno-STAT™ platform. This clinical validation is also being supported by a Phase 1 trial with our second CUE-100 series biologic, CUE-102, for Wilms’ Tumor 1-expressing tumors. Data to date has demonstrated clinical evidence of anti-tumor activity across multiple indications in patients treated in the dose escalation portion of the study, and we look forward to presenting the data at SITC.”
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’s body. 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.