Cue Biopharma Provides Update on Most Advanced Clinical Stage Asset, CUE-101

BOSTON, Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, today provided an update on its most advanced clinical stage asset, CUE-101, representative of the CUE-100 series.

Dr. Dimitrios Colevas presented new data from the company’s maturing Phase 1 trial evaluating CUE-101 in combination with KEYTRUDA^® (pembrolizumab) for patients with recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC). Data highlights include an overall response rate (ORR) of 50% (with 1 unconfirmed PR) in patients with combined positive score (CPS) >1 and an ORR of 50% observed in patients with low CPS scores (1-19). This compares favorably to the historical ORR of 19% observed with pembrolizumab alone in the third-party KEYNOTE 048 trial. Notably, the 12-month overall survival (OS) of 88% in the Phase 1 trial represents a significant reduction in the risk of death (HR 0.23) compared to historical data from the KEYNOTE 048 study. The Kaplan-Meier (K-M) estimate for median overall survival (mOS) is currently 32 months.

“We believe the clinical activity and enhanced survival observed in this trial to date is due to the repeated stimulation and expansion of tumor-specific T cells given the mechanism of action of CUE-101,” said Matteo Levisetti, chief medical officer of Cue Biopharma. “Furthermore, we believe the culmination of data positions us well for pursuing strategic alternatives, including prospective partnering options. These maturing data support our conviction that CUE-101 represents a potential breakthrough therapeutic approach for patients battling 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 interleukin 2 (IL-2) molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells. 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.

About CUE-101 and the Phase 1 trial
CUE-101 is Cue Biopharma’s most advanced clinical stage drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting two signals or “cues” to T cells. Signal #1 incorporates the HPV E7 protein, harbored by HPV-induced cancer cells, to provide selectivity through interaction with the HPV-specific T cell receptor. Signal #2 consists of an engineered IL-2 variant to stimulate the activity of T cells. CUE-101 is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study, for the treatment of HPV16+ driven recurrent/metastatic head and neck squamous cell carcinoma in second line (2L) and beyond patients as a monotherapy, and as a first line (1L) therapy in combination with pembrolizumab (KEYTRUDA^®).

About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation.

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