Cue Biopharma Inc【CUE】株式ニュース

Cue Biopharma Reports New Complete Response and Confirmed 50% Overall Response Rate in Ongoing Phase 1 Trial of CUE-101 and Pembrolizumab in Recurrent/Metastatic HPV+ Head and Neck Cancer

July 16, 2025

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 a clinical update on its most advanced asset, CUE-101, representative of the CUE-100 series.

“We are excited to report an additional CR in a patient that had recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) treated with CUE-101 in combination with pembrolizumab (KEYTRUDA®),” said Matteo Levisetti, chief medical officer at Cue Biopharma. “This patient had durable stable disease for close to two years and more recently demonstrated significant tumor reductions and now a complete response. Notably, the patient had multiple sites of disease, including the lungs that cleared prior to the complete response observed in the target lesion. We believe the kinetics of tumor reduction and disease eradication in this patient is due to the repeated stimulation and expansion of tumor-specific T cells given the mechanism of action of CUE-101. It also serves as a clear example of the differences in timing of the clinical activity often observed with immunotherapy compared to traditional cytotoxic therapies and supports the prolonged mOS observed in this trial.”

Key data highlights from the expansion portion of the trial evaluating CUE-101 at the recommended Phase 2 dose (RP2D) of 4mg/kg in combination with pembrolizumab in 1L patients (data cutoff of July 14, 2025) include:

• ORR of 50% (2 CR and 10 partial responses (PR) in patients with CPS =1, compared to an ORR of 19% observed with pembrolizumab alone in the historical third-party KEYNOTE-048 trial).
• Survival metrics have continued to mature favorably: 12-month overall survival (OS) of 88% compared to 57% with pembrolizumab alone in the historical KEYNOTE-048 trial, representing a reduction in the risk of death (HR 0.23) compared to historical data.
• mOS of 32 months compared to 12.3 months in the historical KEYNOTE-048 trial.
• ORR of 50% in patients, including 50% with low PD-L1 expression CPS (1-19).

Dan Passeri, chief executive officer at Cue Biopharma, added, "The culmination of maturing data further support our conviction that CUE-101, representative of our approach with the CUE-100 series, demonstrates a potential breakthrough therapeutic approach for establishing a new standard of care. With this maturing data, we are further emboldened in our conviction that our Immuno-STAT® platform represents transformative potential for selectively modulating the patient’s immune system.”

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.

Headquartered in Boston, Massachusetts, we are led by an experienced management team 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 X and LinkedIn.

https://ih.advfn.com/stock-market/NASDAQ/cue-biopharma-CUE/stock-news/96440730/cue-biopharma-reports-new-complete-response-and-co

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According to the 3 analysts' twelve-month price targets for Cue Biopharma, the average price target is $3.00. The highest price target for CUE is $4.00, while the lowest price target for CUE is $2.00. The average price target represents a forecasted upside of 255.87% from the current price of $0.84.

https://www.marketbeat.com/stocks/NASDAQ/CUE/forecast/

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Based on short-term price targets offered by three analysts, the average price target for Cue Biopharma, Inc. comes to $4.00. The forecasts range from a low of $2.00 to a high of $6.00. The average price target represents an increase of 471.43% from the last closing price of $0.70.

https://www.zacks.com/stock/research/CUE/price-target-stock-forecast

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