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  • ||||||||||  CUE-101 / Cue Biopharma, LG Chem
    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 (Grand Ballroom AB - George R. Brown Convention Center) -  Oct 4, 2024 - Abstract #SITC2024SITC_1805;    
    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, LLC), WCG IRB00000533 (Gabrail Cancer Center), IRB000001113 (George Washington University Cancer Center).
  • ||||||||||  CUE-102 / Cue Biopharma, LG Chem
    A phase 1 trial of CUE-102, a novel WT1-pHLA-IL2-Fc T cell engager in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers (Grand Ballroom AB - George R. Brown Convention Center) -  Oct 4, 2024 - Abstract #SITC2024SITC_1772;    
    P1
    Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: WCG1340057 (Carolina BioOncology, Gabrail Cancer Center, University of Wisconsin Carbone Cancer Center, Samuel Oschin Cancer Center/Cedars-Sinai Medical Center, Winship Cancer Institute/Emory University, Northwest Medical Specialties/Tacoma Medical Oncology), Advarra MCC# 22112 (Moffitt Cancer Center), BRANY 22-06-326-01 (Albert Einstein Cancer Center), IRB00349569 (Johns Hopkins University School of Medicine), 2022-0761 (The University of Texas MD Anderson Cancer Center), UHIRB STUDY20221273 (UH Cleveland Medical center, Seidman Cancer Center).
  • ||||||||||  CUE-101 / Cue Biopharma, LG Chem
    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 (George R. Brown Convention Center - Level 3 - Grand Ballroom C) -  Oct 4, 2024 - Abstract #SITC2024SITC_1478;    
    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, LLC), WCG IRB00000533 (Gabrail Cancer Center), IRB000001113 (George Washington University Cancer Center).
  • ||||||||||  CUE-102 / Cue Biopharma, LG Chem
    A phase 1 trial of CUE-102, a novel WT1-pHLA-IL2-Fc T cell engager in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers (Exhibit Halls AB - George R. Brown Convention Center) -  Oct 4, 2024 - Abstract #SITC2024SITC_1022;    
    P1
    Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: WCG1340057 (Carolina BioOncology, Gabrail Cancer Center, University of Wisconsin Carbone Cancer Center, Samuel Oschin Cancer Center/Cedars-Sinai Medical Center, Winship Cancer Institute/Emory University, Northwest Medical Specialties/Tacoma Medical Oncology), Advarra MCC# 22112 (Moffitt Cancer Center), BRANY 22-06-326-01 (Albert Einstein Cancer Center), IRB00349569 (Johns Hopkins University School of Medicine), 2022-0761 (The University of Texas MD Anderson Cancer Center), UHIRB STUDY20221273 (UH Cleveland Medical center, Seidman Cancer Center).
  • ||||||||||  CUE-102 / Cue Biopharma, LG Chem
    Enrollment closed, Monotherapy, Metastases:  CUE-102-01: A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers (clinicaltrials.gov) -  Jul 9, 2024   
    P1,  N=52, Active, not recruiting, 
    IRB reference numbers: WCG1340057 (Carolina BioOncology, Gabrail Cancer Center, University of Wisconsin Carbone Cancer Center, Samuel Oschin Cancer Center/Cedars-Sinai Medical Center, Winship Cancer Institute/Emory University, Northwest Medical Specialties/Tacoma Medical Oncology), Advarra MCC# 22112 (Moffitt Cancer Center), BRANY 22-06-326-01 (Albert Einstein Cancer Center), IRB00349569 (Johns Hopkins University School of Medicine), 2022-0761 (The University of Texas MD Anderson Cancer Center), UHIRB STUDY20221273 (UH Cleveland Medical center, Seidman Cancer Center). Recruiting --> Active, not recruiting
  • ||||||||||  CUE-101 / Cue Biopharma, LG Chem
    Enrollment closed, Trial primary completion date, Combination therapy, Monotherapy, Metastases:  KEYNOTE-A78: A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) -  Sep 21, 2023   
    P1,  N=85, Active, not recruiting, 
    Patients treated with CUE-101 monotherapy in 3L showed a long OS and CUE-101 and pembrolizumab combination resulted in an ORR of 44% with a corresponding decrease in HPV16 cfDNA in the 1L treatment of patients with HPV16+ R/M HNSCC. Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2023 --> Sep 2023
  • ||||||||||  CUE-401 / Cue Biopharma, Ono Pharma
    Inducing/expanding Tregs (Exhibit Hall; Poster Board No. P902) -  Apr 11, 2023 - Abstract #IMMUNOLOGY2023IMMUNOLOGY_690;    
    Finally, CUE-401 induced iTregs were effective at suppressing organ specific autoimmunity. These studies identify a new injectable therapeutic, and new approach to induce and expand Tregs
  • ||||||||||  CUE-102 / Cue Biopharma, LG Chem
    CUE-102 selectively activates and expands WT1-specific T cells for the treatment of patients with WT1+ malignancies (Hall C) -  Oct 6, 2022 - Abstract #SITC2022SITC_1627;    
    P1
    These results, together with its similarity to CUE-101, support its anticipated tolerability profile and potential for clinical efficacy in an ongoing Phase 1 clinical trial ( NCT05360680 ). Ethics Approval Studies using animals were conducted in accordance with guidelines established by the Smart Labs Institutional Animal Care and Use Committee under protocol 21SL09-0007.
  • ||||||||||  CUE-101 / Cue Biopharma, LG Chem
    Targeting engineered interleukin-2 (IL-2) to antigen specific T cells via novel biologic platforms (Poster Hall) -  Oct 1, 2021 - Abstract #SITC2021SITC_580;    
    Emerging clinical data from our lead candidate CUE-101, which targets HPV-specific T cells in 2L+ R/M HNSCCC, provides PoC for the approach and builds confidence for broad applications in numerous cancers...Conclusions The IST, NST, and RDI-STAT platforms provide novel opportunities for selective targeting of IL-2 to tumor-relevant T cells while avoiding global immune activation and cytokine release. The scalability and versatility of NSTs highlight the potential to target multiple TAA T cell responses, while RDI-STATs highlight a novel means to harness antiviral immunity against cancer, especially in cases where the tumor may escape immune detection due to loss of HLA.
  • ||||||||||  CUE-401 / Cue Biopharma
    [VIRTUAL] CUE-401: A novel IL-2/TGF-beta fusion protein for the induction of CD4+ FOXP3+ regulatory T cells () -  May 24, 2021 - Abstract #FOCIS2021FOCIS_563;    
    In conclusion, we have engineered a novel, bispecific biologic capable of potently inducing Tregs in vitro and in vivo in settings where TCR-stimulation is provided in the context of the developing or existing autoimmune milieu. Bias toward iTreg induction rather than manipulation of the limited number and repertoire of existing nTregs may provide significant opportunities for the treatment of patients with various autoimmune diseases as well as treatment of GVHD.
  • ||||||||||  CUE-101 / Cue Biopharma
    Journal:  CUE-101, a Novel HPV16 E7-pHLA-IL-2-Fc Fusion Protein, Enhances Tumor Antigen Specific T Cell Activation for the Treatment of HPV16-Driven Malignancies. (Pubmed Central) -  Jan 28, 2021   
    P1
    Bias toward iTreg induction rather than manipulation of the limited number and repertoire of existing nTregs may provide significant opportunities for the treatment of patients with various autoimmune diseases as well as treatment of GVHD. Consistent with its design, CUE-101 demonstrates selective expansion of an HPV16 E7-specific population of cytotoxic CD8T cells, a favorable safety profile, and in vitro and in vivo evidence supporting its potential for clinical efficacy in an ongoing Phase 1 trial (NCT03978689).