Cue Biopharma’s Lead Clinical Asset, CUE-101, to be Featured at the 2024 Multi-disciplinary Head and Neck Cancers Symposium

Rhea-AI Summary

Cue Biopharma, Inc. (Nasdaq: CUE) announces the presentation of CUE-101 at the 2024 Multi-disciplinary Head and Neck Cancers Symposium. The data highlights include an overall response rate of 47% in first-line patients and a median overall survival of 20.8 months in second-line patients.

Oncology Doctor

The reported overall response rate (ORR) of 47% in first line (1L) patients treated with CUE-101 and pembrolizumab is a significant finding, considering the historical ORR of 19% from the KEYNOTE-48 trial. This suggests a potential improvement in treatment outcomes for patients with HPV+ head and neck squamous cell carcinoma (HNSCC). It is important to note, however, that these results are preliminary and should be interpreted with caution until peer-reviewed data is available.

Furthermore, the median overall survival (mOS) of 20.8 months for second line (2L) and beyond patients treated with CUE-101 monotherapy, compared to a mOS of approximately eight months from the KEYNOTE-40 trial, indicates a substantial increase in survival time. This could represent a significant advancement in the second line treatment landscape for HNSCC, which has historically had limited options.

The tolerability of the side effect profile is also an encouraging aspect of this treatment combination. A favorable safety profile is crucial for patient compliance and quality of life, especially in a disease as debilitating as HNSCC.

Medical Research Analyst

The data on CUE-101, particularly in combination with pembrolizumab, demonstrates a potentially synergistic effect that could redefine standard care protocols for HPV+ HNSCC. The mechanism of action involving selective modulation of disease-specific T cells is an area of high interest, as it aligns with the broader trend towards personalized medicine in oncology.

From a research perspective, the progression to later-phase trials will be pivotal in validating these results. The biopharmaceutical industry will closely monitor subsequent data releases, as they will influence the drug's commercial viability and competitive positioning within the oncology market.

Market Research Analyst

The promising results from Cue Biopharma's ongoing Phase 1 trial could have a notable impact on the company's market valuation and investor sentiment. An ORR that significantly exceeds historical benchmarks may lead to increased investor confidence in the drug's potential for FDA approval and market penetration.

It is also essential to consider the size of the potential market. HPV+ HNSCC is a relatively prevalent cancer and the introduction of a more effective treatment option could lead to substantial revenue for Cue Biopharma. However, market dynamics, such as pricing, reimbursement challenges and competition from other pharmaceutical companies, will ultimately determine the financial success of CUE-101.

BOSTON, Feb. 29, 2024 (GLOBE NEWSWIRE) -- 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 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^®).

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 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 Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com

Media Contact
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com

What is the ticker symbol for Cue Biopharma, Inc. mentioned in the press release?

The ticker symbol for Cue Biopharma, Inc. is CUE.

Where will the presentation of CUE-101 take place?

The presentation of CUE-101 will take place at the 2024 Multi-disciplinary Head and Neck Cancers Symposium in Phoenix, Arizona, and virtually.

What are the data highlights mentioned in the press release for CUE-101?

The data highlights include an overall response rate of 47% in first-line patients and a median overall survival of 20.8 months in second-line patients.

Who will be presenting the data on CUE-101 at the symposium?

Dr. Alexander Dimitrios Colevas, a principal investigator at Stanford University, will be presenting the data on CUE-101 at the symposium.

What is the date and time of the presentation of CUE-101?

The presentation of CUE-101 is scheduled for Friday, March 1, 2024, at 2:35 p.m. MST.