Cue Biopharma Provides Update on Most Advanced Clinical Stage Asset, CUE-101, Presented by Dr. Dimitrios Colevas at the DAVA 4th Hawaii Global Summit on Thoracic Malignancies
Cue Biopharma (Nasdaq: CUE) announced updated clinical data for CUE-101, its lead therapeutic candidate, in combination with KEYTRUDA庐 for treating HPV+ head and neck squamous cell carcinoma (HNSCC). The Phase 1 trial demonstrated significant efficacy improvements compared to historical data.
Key results include an overall response rate (ORR) of 50% in treatment-na茂ve patients with CPS >1, and notably, the same ORR in patients with low CPS scores (1-19). This substantially exceeds the historical 19% ORR observed with pembrolizumab monotherapy in the KEYNOTE 048 trial.
The trial showed remarkable survival metrics, with a 12-month overall survival rate of 88% and a median overall survival of 32 months. These results represent a significant reduction in death risk (HR 0.23) compared to historical data. The company is now pursuing strategic alternatives, including potential partnering opportunities.
Cue Biopharma (Nasdaq: CUE) ha annunciato dati clinici aggiornati per CUE-101, il suo principale candidato terapeutico, in combinazione con KEYTRUDA庐 per il trattamento del carcinoma squamoso della testa e del collo HPV+. Lo studio di Fase 1 ha mostrato miglioramenti significativi nell'efficacia rispetto ai dati storici.
I risultati chiave includono un tasso di risposta globale (ORR) del 50% nei pazienti non precedentemente trattati con CPS >1 e, in modo notevole, lo stesso ORR nei pazienti con punteggi CPS bassi (1-19). Questo supera ampiamente il 19% di ORR osservato con la monoterapia a base di pembrolizumab nel trial KEYNOTE 048.
Lo studio ha evidenziato metriche di sopravvivenza straordinarie, con un tasso di sopravvivenza globale a 12 mesi dell'88% e una sopravvivenza globale mediana di 32 mesi. Questi risultati rappresentano una significativa riduzione del rischio di morte (HR 0,23) rispetto ai dati storici. L'azienda sta ora valutando alternative strategiche, incluse potenziali collaborazioni.
Cue Biopharma (Nasdaq: CUE) anunci贸 datos cl铆nicos actualizados para CUE-101, su principal candidato terap茅utico, en combinaci贸n con KEYTRUDA庐 para el tratamiento del carcinoma de c茅lulas escamosas de cabeza y cuello positivo para HPV (HNSCC). El ensayo de Fase 1 mostr贸 mejoras significativas en la eficacia en comparaci贸n con datos hist贸ricos.
Los resultados clave incluyen una tasa de respuesta global (ORR) del 50% en pacientes sin tratamiento previo con CPS >1 y, notablemente, la misma ORR en pacientes con puntuaciones bajas de CPS (1-19). Esto supera ampliamente el 19% de ORR observado con la monoterapia de pembrolizumab en el ensayo KEYNOTE 048.
El estudio mostr贸 m茅tricas de supervivencia destacadas, con una tasa de supervivencia global a 12 meses del 88% y una supervivencia global mediana de 32 meses. Estos resultados representan una reducci贸n significativa del riesgo de muerte (HR 0,23) en comparaci贸n con datos hist贸ricos. La compa帽铆a est谩 explorando alternativas estrat茅gicas, incluyendo posibles oportunidades de asociaci贸n.
Cue Biopharma (雮橃姢雼�: CUE)電� HPV 鞏戩劚 霊愱步攵� 韼疙弶靹疙彫鞎�(HNSCC) 旃橂毳� 鞙勴暅 欤检殧 旃橂 頉勲炒氍检 CUE-101瓿� KEYTRUDA庐 氤戩毄 鞛勳儊 雿办澊韯� 鞐呺嵃鞚错姼毳� 氚滍憸頄堨姷雼堧嫟. 1靸� 鞁滍棙鞐愳劀 瓿缄卑 雿办澊韯� 雽�牍� 鞙犾潣氙疙暅 須姤 臧滌劆鞚� 頇曥澑霅橃棃鞀惦媹雼�.
欤检殧 瓴瓣臣搿滊姅 CPS >1鞚� 旃橂 瓴巾棙鞚� 鞐嗠姅 頇橃瀽鞐愳劀 鞝勳泊 氚橃潙毳�(ORR) 50%毳� 旮半頄堨溂氅�, CPS 鞝愳垬臧� 雮潃 頇橃瀽(1-19)鞐愳劀霃� 霃欖澕頃� ORR鞚� 氤挫榾鞀惦媹雼�. 鞚措姅 KEYNOTE 048 鞁滍棙鞐愳劀 韼笇搿るΜ欤茧 雼弲鞖旊矔鞙茧 甏�彀半悳 19% ORR鞚� 韥矊 靸來殞頃橂姅 靾橃箻鞛呺媹雼�.
鞁滍棙鞚赌 12臧滌洈 鞝勳泊 靸濎〈鞙� 88%瓿� 欷戩暀 鞝勳泊 靸濎〈旮瓣皠 32臧滌洈鞚措澕電� 霙办柎雮� 靸濎〈 歆�響滊ゼ 雮橅儉雰堨姷雼堧嫟. 鞚� 瓴瓣臣電� 瓿缄卑 雿办澊韯� 雽�牍� 靷 鞙勴棙鞚� 韥矊 欷勳澑 瓴�(HR 0.23)鞚� 鞚橂頃╇媹雼�. 須岇偓電� 順勳灛 鞝勲灥鞝� 雽�鞎�, 韽暔 韺岉姼雱堨嫮 旮绊殞毳� 氇儔 欷戩瀰雼堧嫟.
Cue Biopharma (Nasdaq : CUE) a annonc茅 des donn茅es cliniques mises 脿 jour pour CUE-101, son principal candidat th茅rapeutique, en combinaison avec KEYTRUDA庐 pour le traitement du carcinome 茅pidermo茂de de la t锚te et du cou HPV+. L'essai de phase 1 a d茅montr茅 des am茅liorations significatives de l'efficacit茅 par rapport aux donn茅es historiques.
Les r茅sultats cl茅s incluent un taux de r茅ponse globale (ORR) de 50% chez les patients non trait茅s avec un CPS >1, et de mani猫re notable, le m锚me ORR chez les patients avec des scores CPS faibles (1-19). Cela d茅passe largement le taux de 19% observ茅 avec la monoth茅rapie au pembrolizumab lors de l'essai KEYNOTE 048.
L'essai a montr茅 des indicateurs de survie remarquables, avec un taux de survie globale 脿 12 mois de 88% et une survie globale m茅diane de 32 mois. Ces r茅sultats repr茅sentent une r茅duction significative du risque de d茅c猫s (HR 0,23) par rapport aux donn茅es historiques. La soci茅t茅 explore d茅sormais des alternatives strat茅giques, y compris des opportunit茅s de partenariat potentielles.
Cue Biopharma (Nasdaq: CUE) hat aktualisierte klinische Daten f眉r CUE-101, seinen f眉hrenden Therapiekandidaten, in Kombination mit KEYTRUDA庐 zur Behandlung von HPV-positivem Kopf-Hals-Plattenepithelkarzinom (HNSCC) bekanntgegeben. Die Phase-1-Studie zeigte signifikante Verbesserungen der Wirksamkeit im Vergleich zu historischen Daten.
Wichtige Ergebnisse umfassen eine Gesamtansprechrate (ORR) von 50% bei therapienaiven Patienten mit CPS >1 und bemerkenswerterweise dieselbe ORR bei Patienten mit niedrigen CPS-Werten (1-19). Dies 眉bertrifft deutlich die historische ORR von 19%, die in der KEYNOTE 048-Studie unter Pembrolizumab-Monotherapie beobachtet wurde.
Die Studie zeigte bemerkenswerte 脺berlebenswerte mit einer 12-Monats-Gesamt眉berlebensrate von 88% und einem medianen Gesamt眉berleben von 32 Monaten. Diese Ergebnisse bedeuten eine signifikante Reduktion des Sterberisikos (HR 0,23) im Vergleich zu historischen Daten. Das Unternehmen verfolgt nun strategische Alternativen, einschlie脽lich potenzieller Partnerschaften.
- Overall response rate (ORR) of 50% significantly outperforms historical 19% ORR with pembrolizumab alone
- Strong 12-month overall survival rate of 88% with significant reduction in death risk (HR 0.23)
- Impressive median overall survival (mOS) of 32 months
- Consistent efficacy across different CPS score ranges, including low CPS scores (1-19)
- None.
Insights
CUE-101 shows impressive 50% response rate and 32-month survival in HPV+ head/neck cancer, significantly outperforming standard immunotherapy.
The Phase 1 trial results for CUE-101 in combination with pembrolizumab represent potentially significant clinical advancement for HPV+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) patients. The 50% overall response rate (ORR) substantially exceeds the historical 19% ORR observed with pembrolizumab monotherapy in the KEYNOTE-048 trial. Particularly noteworthy is the efficacy across Combined Positive Score (CPS) ranges, including in patients with low CPS scores (1-19), suggesting benefit even in patients typically less responsive to standard immunotherapy.
The 88% 12-month survival rate and hazard ratio of 0.23 indicate a substantial reduction in mortality risk compared to historical controls. The median overall survival of 32 months is particularly impressive in this difficult-to-treat patient population. For context, first-line pembrolizumab monotherapy typically achieves median survival of approximately 12-14 months in similar patients.
CUE-101's mechanism targeting and stimulating tumor-specific T cells represents a differentiated approach from conventional checkpoint inhibitors. This selective immunomodulation appears to enhance anti-tumor immunity while potentially avoiding broader immune activation that can lead to adverse events. If confirmed in larger trials, these results could position CUE-101 as a significant advance for HNSCC patients with limited effective treatment options.
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BOSTON, July 01, 2025 (GLOBE NEWSWIRE) -- 听(狈补蝉诲补辩: 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鈥檚 maturing Phase 1 trial evaluating CUE-101 in combination with KEYTRUDA庐 (pembrolizumab) for patients with recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC). Data highlights include an overall response rate (ORR) of
"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,鈥� said Matteo Levisetti, chief medical officer of Cue Biopharma. 鈥淔urthermore, 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.鈥�
About the CUE-100 Series听
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鈥檚 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 鈥渃ues鈥� 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庐).
About听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鈥檚 body. The company鈥檚 proprietary platform, Immuno-STAT鈩� (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body鈥檚 intrinsic immune system without the adverse effects of broad systemic immune modulation.
Headquartered in听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听听and follow us on听听and听.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company鈥檚 belief regarding the potential benefits and applications of its drug candidates and programs, including the CUE-100 series and that CUE-101 represents a potential breakthrough therapeutic approach for patients battling HNSCC; and the company鈥檚 business strategies, plans and prospects, including the company鈥檚 plans to pursue strategic alternatives. Forward-looking statements, which are based on certain assumptions and describe the company鈥檚 future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as 鈥渂elieve,鈥� 鈥渆xpect,鈥� 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥渃ould,鈥� 鈥渟eek,鈥� 鈥渋ntend,鈥� 鈥減lan,鈥� 鈥済oal,鈥� 鈥減roject,鈥� 鈥渆stimate,鈥� 鈥渁nticipate,鈥� 鈥渟trategy,鈥� 鈥渇uture,鈥� 鈥渓ikely,鈥� 鈥減romise鈥� or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company鈥檚 strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company鈥檚 actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company鈥檚 limited operating history, limited cash and a history of losses; the company鈥檚 ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current 鈥済oing concern鈥� determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the company鈥檚 ability to achieve profitability; potential setbacks in the company鈥檚 research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company鈥檚 ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required听U.S. Food and Drug Administration听(鈥淔DA鈥�) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company鈥檚 operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company鈥檚 reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company鈥檚 ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company鈥檚 ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company鈥檚 most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investor Contact
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Cue Biopharma, Inc.
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FAQ
What are the key clinical results for CUE-101 in treating HPV+ HNSCC?
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