On March 2, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported it will give an oral presentation at the Festival of Biologics World Immunotherapy Congress which is being held at the Marriott Marquis in San Diego, California March 9-11, 2022 (Press release, Cue Biopharma, MAR 2, 2022, View Source [SID1234609400]).
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At the conference, Cue Biopharma’s senior vice president of clinical development, Dr. Matteo Levisetti, will present an updated overview of Cue Biopharma’s Immuno-STAT (Selective Targeting and Alteration of T cells) platform, designed to enable selective engagement and activation of tumor-specific T cells. Dr. Levisetti will also highlight recent data from the ongoing clinical trial of CUE-101, the Company’s lead clinical candidate representative of the interleukin 2 (IL-2)-based CUE-100 series, in patients with human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC). Data demonstrates favorable tolerability throughout a range of doses and anti-tumor activity as a monotherapy in late stage (HPV+ R/M HNSCC) patients. The data provides support for proof of concept and de-risking of CUE-101 as well as subsequent programs and platform applications across the IL-2 based CUE-100 series. Additionally, Dr. Levisetti will discuss Cue Biopharma’s platform expansion via Neo-STAT and bispecific RDI-STAT, which allows for targeting multiple tumor antigens and for harnessing the protective anti-viral T cell repertoire to destroy tumors, respectively.
Presentation Details
Title: Targeting IL-2 to tumor-specific T cells via novel biologic platforms
Presenter: Dr. Matteo Levisetti, senior vice president, clinical development
Date & Time: Thursday, March 10, 2022 at 2:20 p.m. PST or 5:20 p.m. EST
"We are very pleased to have Dr. Levisetti present an updated overview of the IL-2 based CUE-100 series at the 2022 Festival of Biologics, with a particular emphasis on the promising clinical data that provides clear differentiation for our strategy focused on selective activity of IL-2 on tumor-specific T cells," said Dr. Anish Suri, president and chief scientific officer of Cue Biopharma. "IL-2 has been a validated therapeutic target with significant hurdles pertaining to lack of specificity, systemic immune activation and serious toxicities. We believe the preliminary anti-tumor activity and positive tolerability profile of CUE-101 is highly encouraging and supportive of its mechanistic advantages and superior differentiation from all other IL-2 variants in development. CUE-101 has demonstrated an impressive tolerability profile as a monotherapy and has achieved targeted engagement of tumor specific T cells without reaching a maximum tolerated dose (MTD). With its unique mechanism of action, we believe CUE-101 has the potential to change the treatment landscape and improve the lives of patients with head and neck cancer as well as a broad range of other indications."
About the Festival of Biologics
The Festival of Biologics brings together pharma & biotech, academics and research institutes, together with their partners across the value chain. Across antibodies, immunotherapy and biosimilars participants share research, create new partnerships, and tackle the clinical trials, manufacturing and commercial challenges involved in bringing new therapies to market.
About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-major histocompatibility complex (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 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 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 Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) 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-major histocompatibility 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-regulatory 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 selective T cell modulation. Because our drug candidates 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, modified outside the body (ex vivo), and reinfused.