On February 12, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported Dr. Mary Simcox, vice president of translational biology and early development, will give a presentation highlighting the strategy and tactical details for testing CUE-101, the company’s lead biologic drug candidate, in a first-in-human Phase 1 trial (NCT03978689) at the Biomarkers Series UK taking place on Feb. 18-20, 2020 at the Manchester Central Convention Complex (Press release, Cue Biopharma, FEB 12, 2020, View Source [SID1234608305]). CUE-101 is designed to directly engage and activate T cells in the body to target HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), enabled by the company’s proprietary therapeutic platform Immuno-STAT (Selective Targeting and Alteration of T cells).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Presentation Details
Title: CUE-101 Phase 1 Trial in HNSCC Patients: Novel Immunotherapy Enabled by Patient Stratification & Pharmacodynamic Biomarkers
Session: Biomarker Congress Workshop, End-user Session, Designing/Applying a Biomarker Plan in Drug Development
Presenter: Mary Simcox, Ph.D., vice president of translational biology and early development
Date & Time: Feb. 18 at 4:15 p.m. GMT
"This presentation focuses on the importance of conducting early clinical immuno-oncology trials that are informed by detailed biomarker analyses, which characterize the mechanism of action and provide guidance on how the drug is used to maximize the potential for clinical benefit in cancer patients," said Ken Pienta, M.D., acting chief medical officer of Cue Biopharma. "The CUE-101 Phase 1 protocol includes implementation of multiple technologies and multiple industry and academic partners in the investigation of pharmacodynamic, response prediction, patient selection and response monitoring biomarkers. These critical biomarker data will be collected with the aim to discover correlative pharmacodynamic and response prediction markers to optimize the probability of clinical success and development of a promising and potentially new and transformative therapeutic."
About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is designed to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. 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 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 Immuno-STAT
Immuno-STAT biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.
The simultaneous engagement of co-stimulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drugs are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, stimulated and expanded outside the body (ex vivo), and reinfused in an activated state.