On February 29, 2024 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, reported 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 (Press release, Cue Biopharma, FEB 29, 2024, View Source [SID1234640682]). The symposium is being held in Phoenix, Arizona and virtually from February 29 – March 2, 2024.
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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 Details
Poster 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: 7
Poster Session: III
Presenter: Alexander Dimitrios Colevas, M.D., professor of medicine and medical oncologist, Stanford Cancer Center, Stanford University School of Medicine
Date and Time: Friday, March 1, 2024 at 2:35 p.m. MST
About CUE-101 and the Phase 1 Trial
CUE-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).