CUE Cue Biopharma Inc

Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, announced today that the company’s lead clinical asset, CUE-101, will be featured in a presentation at the 2024 Multi-disciplinary Head and Neck Cancers Symposium given by Alexander Dimitrios Colevas, M.D., a principal investigator at Stanford University participating in the CUE-101 clinical trial. The symposium is being held in Phoenix, Arizona and virtually from February 29 – March 2, 2024.

Dr. Colevas will discuss previously presented data from the company’s ongoing Phase 1 trial evaluating CUE-101, as a monotherapy and 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 47% in first line (1L) patients treated with CUE-101 and pembrolizumab, compared to the historical ORR of 19% reported in the KEYNOTE-48 trial. In second line (2L) and beyond patients treated with CUE-101 monotherapy, the reported median overall survival (mOS) was 20.8 months, compared to a mOS of approximately eight months reported in the KEYNOTE-40 trial.  

“Preliminary data of CUE-101 in combination with immunotherapy has been really promising with a much higher response rate than we would expect from immunotherapy alone, and a very tolerable side effect profile”, stated Dr. Colevas.

Presentation DetailsPoster Title: A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy in 3L and in combination with pembrolizumab in 1L recurrent/metastatic (R/M) HPV16+ head and neck cancer patients.Poster Number: 7Poster Session: III Presenter: Alexander Dimitrios Colevas, M.D., professor of medicine and medical oncologist, Stanford Cancer Center, Stanford University School of MedicineDate and Time: Friday, March 1, 2024 at 2:35 p.m. MST

About CUE-101 and the Phase 1 TrialCUE-101 is Cue Biopharma’s lead clinical 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 BiopharmaCue 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 through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation.

Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.

For more information please visit www.cuebiopharma.com and follow us on Twitter and LinkedIn.

Investor Contact Marie Campinell Senior Director, Corporate CommunicationsCue Biopharma, Inc.mcampinell@cuebio.com

Media ContactJonathan PappasLifeSci Communicationsjpappas@lifescicomms.com