CUE-101 / Cue Biopharma, LG Chem - LARVOL DELTA

CUE-101with Pembrolizumab for LA-HPV+HNSCCs (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Yale University

New P2 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Cue Biopharma Reports Second Quarter 2025 Financial Results and Recent Business Highlights (GlobeNewswire) - "Poster presentation delivered by Dana-Farber Cancer Institute at the American Society of Gene & Cell Therapy Annual Meeting presented proof-of-concept data on CUE-101 and its potential to control CAR-T cell expansion and persistence in vivo."

Preclinical • Oncology

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 (GlobeNewswire) - P1 | N=85 | KEYNOTE-048 (NCT03978689) | Sponsor: Cue Biopharma | "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)."

P1 data • Head and Neck Cancer • Squamous Cell Carcinoma of Head and Neck

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 (GlobeNewswire) - P1 | N=85 | NCT03978689 | Sponsor: Cue Biopharma | "Dr. Dimitrios Colevas presented new data from the company’s maturing Phase 1 trial evaluating CUE-101 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 50% (with 1 unconfirmed PR) in patients with combined positive score (CPS) >1 and an ORR of 50% observed in patients with low CPS scores (1-19). This compares favorably to the historical ORR of 19% observed with pembrolizumab alone in the third-party KEYNOTE 048 trial. Notably, the 12-month overall survival (OS) of 88% in the Phase 1 trial represents a significant reduction in the risk of death (HR 0.23) compared to historical data from the KEYNOTE 048 study. The Kaplan-Meier (K-M) estimate for median overall survival (mOS) is currently 32 months."

P1 data • Squamous Cell Carcinoma of Head and Neck

Safety of administration of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, before curative-intent treatment in patients with HPV16+ oropharyngeal squamous cell carcinoma. (ASCO 2025) - P1, P2 | "Administration of CUE-101 (4 mg/kg IV) 14 days (Schedule A) and 14 and 7 days (Schedule B) before curative-intent treatment was safe and tolerable. Follow-up in Schedules A and B is ongoing. Schedule C is actively accruing patients."

Clinical • Anemia • Back Pain • Eosinophilia • Fatigue • Hematological Disorders • Musculoskeletal Pain • Oncology • Oropharyngeal Cancer • Pain • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IL2

Characterization of dynamic changes in tumor-infiltrating lymphocytes (TIL) after neoadjuvant administration of CUE-101, an HPV16 E7-HLA-IL2 fusion protein, to patients with HPV+ locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC). (ASCO 2025) - P2 | "Significant clonal expansion of intra-tumoral CD8 T-cells with signatures associated with tumor reactivity were observed within 2 weeks of CUE-101 administration in HPV16+ LA OPSCC. Studies in blood and of T-cell specificities are ongoing."

Clinical • IO biomarker • Metastases • Tumor-infiltrating lymphocyte • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • ENTPD1 • IL2 • PD-1 • PTPRC

Leveraging Immuno-STAT stimulation via TCR and IL-2 signaling to specifically control CAR T cell expansion and persistence in vivo (ASGCT 2025) - P1 | "IL-2 signaling through a CAR-independent circuit uniquely eradicated solid tumor models [1], but the clinical utility of non-specific cytokine CAR-T support (e.g. IL2; aldesleukin) is limited by toxicity...The first clinical-stage Immuno-STAT, CUE-101, selectively activates and expands HPV-specific CD8+ T-cells and is associated with durable anti-tumor responses in HPV+ recurrent/metastatic head and neck cancers, with the objective response rate more than doubled in combination with pembrolizumab vs historic control of pembrolizumab alone (NCT03978689, [3])... We demonstrate that Immuno-STAT treatment together with engineering co-expression of cognate exogenous TCR can specifically control the expansion and persistence of CAR-T cells. Leveraging the clinical experience with CUE-101, we anticipate future evaluation of this approach to determine whether Immuno-STAT-controlled expansion of E.T.CAR-T can enhance and control expansion/persistence of adoptive cellular..."

CAR T-Cell Therapy • IO biomarker • Preclinical • Head and Neck Cancer • Hematological Malignancies • Oncology • Solid Tumor • CD8 • IL2

Cue Biopharma Reports First Quarter 2025 Financial Results and Recent Business Highlights (GlobeNewswire) - "Upcoming Event: Novel Biologics Portfolio Virtual Event planned for May 15, 2025 at 11 AM ET: Cue Biopharma’s virtual event will feature two key opinion leaders (KOLs): Richard DiPaolo, PhD (Saint Louis University) and Andrew Cope, MD, PhD (Centre for Rheumatic Diseases, King's College London). The event will highlight new preclinical data for CUE-401...and include key updates on the CUE-100 series clinical oncology programs."

Clinical • Preclinical • Immunology • Inflammation • Oncology

KEYNOTE-A78: A Phase 1 Study in Patients with HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1 | N=85 | Active, not recruiting | Sponsor: Cue Biopharma | Trial completion date: May 2025 ➔ Jan 2026 | Trial primary completion date: Nov 2024 ➔ Jan 2026

Monotherapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CDKN2A • CTLA4

A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (SITC 2024) - P1 | "Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: Advarra Pro00037736 (Moffitt Cancer Center), IRB 52744 (Stanford University School of Medicine), HRPO# 201905108 (Washington University School of Medicine), DF/HCC IRB# 19-374 (Massachusetts General Hospital), WIRB STUDY00008948 (University of Washington, Seattle), IRB 191714 (Vanderbilt University Medical Center Vanderbilt-Ingram Cancer Center), 2019-087 Karmanos Cancer Institute, WIRB 2000026098 (Yale Cancer Center), 2019-0578 (The University of Texas MD Anderson Cancer Center), WIRB 1908869642 (University of Arizona Cancer Center), WIRB IRB00112341(Winship Cancer Institute/Emory University), IRB 20-073 (Memorial Sloan Kettering Cancer Center), IRB00255391 (Johns Hopkins University School of Medicine), IRB(IRBMED) HUM00165746 (University of Michigan Comprehensive Cancer Center), IRB0001113 (US Oncology Inc./Affiliated Oncologists,..."

Clinical • Combination therapy • Metastases • Monotherapy • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IL2

A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (SITC 2024) - P1 | "Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: Advarra Pro00037736 (Moffitt Cancer Center), IRB 52744 (Stanford University School of Medicine), HRPO# 201905108 (Washington University School of Medicine), DF/HCC IRB# 19-374 (Massachusetts General Hospital), WIRB STUDY00008948 (University of Washington, Seattle), IRB 191714 (Vanderbilt University Medical Center Vanderbilt-Ingram Cancer Center), 2019-087 Karmanos Cancer Institute, WIRB 2000026098 (Yale Cancer Center), 2019-0578 (The University of Texas MD Anderson Cancer Center), WIRB 1908869642 (University of Arizona Cancer Center), WIRB IRB00112341(Winship Cancer Institute/Emory University), IRB 20-073 (Memorial Sloan Kettering Cancer Center), IRB00255391 (Johns Hopkins University School of Medicine), IRB(IRBMED) HUM00165746 (University of Michigan Comprehensive Cancer Center), IRB0001113 (US Oncology Inc./Affiliated Oncologists,..."

Clinical • Combination therapy • Metastases • Monotherapy • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IL2

Cue Biopharma Presents Positive Updated Data from its Phase 1 Trial of CUE-101…in Head and Neck Cancer…at the SITC 39th Annual Meeting (GlobeNewswire) - P1 | N=85 | NCT03978689 | Sponsor: Cue Biopharma | "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...include: ORR of 46% and overall disease control rate (DCR) of 75% in patients with combined positive score (CPS) ≥1, compared to an ORR of 19% observed with pembrolizumab alone in the historical third-party KEYNOTE-048 trial. This includes one complete response (CR) and 10 partial responses (PR), in addition to seven durable stable diseases (DSD) of >12 weeks....Key data highlights from the CUE-101 expansion portion of the Phase 1b trial evaluating CUE-101 at the RP2D as monotherapy...include: mOS of 20.8 months, notably longer than the historical mOS of 7.5 and 8.4 months reported in historical third-party 2L R/M HNSCC trials: CheckMate 141 and KEYNOTE-040, respectively."

P1 data • Squamous Cell Carcinoma of Head and Neck

Cue Biopharma Announces Upcoming Scientific Presentations at the Society for Immunotherapy of Cancer’s (SITC) 39th Annual Meeting (GlobeNewswire) - "Cue Biopharma...announced it will deliver an oral and a poster presentation on the company’s Immuno-STAT clinical assets CUE-101 and CUE-102, representative of the CUE-100 series, at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC 2024). The conference will be held in Houston, Texas, on November 6-10, 2024."

P1 data • Squamous Cell Carcinoma of Head and Neck

Cue Biopharma to Present at The Promise of Interleukin-2 Therapy Conference (GlobeNewswire) - "Cue Biopharma, Inc...today announced that members of its management team will deliver two presentations at The Promise of Interleukin-2 Therapy Conference, taking place September 4-7, 2024 in Paris, France....Dr. Levisetti will discuss how the company’s lead oncology programs CUE-101 and CUE-102, representative of the CUE-100 series of Immuno-STAT™ biologics, enable selective targeting of the cytokine IL-2 to tumor specific T cells for enhanced efficacy and safety profiles."

Clinical data • Oncology • Solid Tumor

Cue Biopharma to Host Business Update Call and Webcast (GlobeNewswire) - "Cue Biopharma, Inc...announced today that it will host a conference call and webcast to provide a business update on Monday, August 19, 2024 at 4:30 p.m. EDT. The company will provide a business overview of its recent restructuring and near-term strategic prioritization objectives. The discussion will focus on the...enabling data from its ongoing oncology trials for CUE-101 and CUE-102 to continue to mature. Additional clinical and business updates, as well as market opportunities and anticipated near-term milestones, will also be addressed."

Clinical data • Oncology

A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab, in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC). (ASCO 2024) - P1 | "An ORR of 47% and a mPFS of 5.8 months were observed in R/M HNSCC patients treated with CUE-101 4 mg/kg + pembrolizumab as 1L therapy. A median OS of 20.8 was observed in patients treated with CUE-101 monotherapy as post-platinum/CPI therapy. CUE-101 continues to demonstrate safety, tolerability and meaningful clinical benefit in patients with HPV16+ R/M HNSCC."

Clinical • Combination therapy • Metastases • Monotherapy • P1 data • Anemia • Head and Neck Cancer • Hematological Disorders • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IL2 • PD-L1

Cue Biopharma Presents Updated Data from Phase 1 Trial of CUE-101 in Recurrent/Metastatic HPV+ Head and Neck Cancer at the 2024 ASCO Annual Meeting (GlobeNewswire) - P1b | N=85 | NCT03978689 | Sponsor: Cue Biopharma | "Key data highlights to date from the expansion portion of the trial evaluating CUE-101 at the recommended Phase 2 dose (RP2D) of 4mg/kg in combination with pembrolizumab with 24 evaluable 1L patients (data cutoff of May 1, 2024): ORR of 46% and Disease Control Rate (DCR) of 79% in patients with combined positive score (CPS) ≥1, compared to an ORR of 19% observed with pembrolizumab alone in the historical third-party KEYNOTE-048 trial. This includes one complete response (CR) and 10 partial responses (PR), in addition to eight durable stable diseases (DSD) of >12 weeks....Key data highlights from the CUE-101 expansion portion of the Phase 1b trial evaluating CUE-101 at the RP2D as monotherapy with 20 evaluable 2L+ patients (majority 3L+): mOS of 20.8 months, notably longer than the historical mOS of 7.5 and 8.4 months reported in third-party 2L R/M HNSCC trials: CheckMate 141 and KEYNOTE-040, respectively."

P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1 | N=85 | Active, not recruiting | Sponsor: Cue Biopharma | Trial completion date: Dec 2023 ➔ May 2025 | Trial primary completion date: Sep 2023 ➔ Nov 2024

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CDKN2A • CTLA4

Cue Biopharma to Present at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "The presentations will highlight the Company’s Phase 1 trials of its lead interleukin 2 (IL-2)-based biologics, CUE-101 in recurrent/metastatic head and neck cancer and CUE-102 in Wilms’ Tumor 1 positive recurrent/metastatic cancers."

P1 data • Oncology • Squamous Cell Carcinoma of Head and Neck

Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Oct 2025 ➔ Oct 2027 | Trial primary completion date: Oct 2025 ➔ Oct 2027

Metastases • Surgery • Trial completion date • Trial primary completion date • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • CDKN2A • IFNG

Cue Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results and Updated Business Highlights (GlobeNewswire) - "Concluded Type B meeting with FDA receiving guidance for potential paths for CUE-101 registrational trials in both monotherapy and combination settings."

FDA event • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Cue Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results and Updated Business Highlights (GlobeNewswire) - P1 | N=85 | NCT03978689 | Sponsor: Cue Biopharma | "Presented notable updates from the ongoing Phase 1 clinical trials of CUE-101...at the 2024 Oppenheimer Annual Healthcare Life Sciences Conference in February: CUE-101 monotherapy in 2L HPV+ R/M HNSCC demonstrated median overall survival (mOS) of 20.8 months vs. historical third-party mOS of 7.5 and 8.4 months with two different CPIs: OPDIVO (nivolumab) and pembrolizumab, respectively. CUE-101 in combination with pembrolizumab in 1L R/M HNSCC showed an overall response rate (ORR) of 46% vs. 19% with pembrolizumab alone in a third-party trial and median progression free survival (mPFS) of 8.3 months vs. 3.2 months with pembrolizumab alone in a third-party trial. CUE-101 continued to demonstrate favorable tolerability in the monotherapy and combination trials."

P1 data • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Cue Biopharma to Host Business Update Call and Webcast (GlobeNewswire) - "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 it will host a conference call and webcast to provide a business update on Monday, April 8, 2024 at 4:30 p.m. EDT...The Company will provide a corporate update highlighting measurable progress advancing its lead clinical oncology programs, CUE-101 and CUE-102..."

Clinical • Oncology

A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy in 3rd line and in combination with pembrolizumab in 1st line recurrent/metastatic (R/M) HPV16+ head and neck cancer patients. (MHNCS 2024) - "CUE-101 demonstrates safety, tolerability and meaningful anti-cancer activity. Patients treated with CUE-101 monotherapy in 3L showed a long OS. CUE-101 and pembrolizumab combination resulted in an ORR of 47% and decrease in HPV16 cfDNA in the 1L treatment of patients with HPV16+ R/M HNSCC."

Clinical • Combination therapy • Metastases • Monotherapy • P1 data • Dental Disorders • Fatigue • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Stomatitis • CD8 • IL2

Cue Biopharma’s Lead Clinical Asset, CUE-101, to be Featured at the 2024 Multi-disciplinary Head and Neck Cancers Symposium (GlobeNewswire) - P1 | N=85 | NCT03978689 | Sponsor: Cue Biopharma | "Cue Biopharma...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....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+...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..."

P1 data • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck