On January 5, 2022 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 directly within the patient’s body, along with LG Chem Life Sciences, reported that a key milestone in the selection of a clinical product candidate has been reached in their collaboration for CUE-102, an Immuno-STAT biologic, jointly developed to selectively target WT1-expressing cancers (Press release, Cue Biopharma, JAN 5, 2022, View Source [SID1234608263]). The milestone represents significant progress for the CUE-102 program and an important achievement in generating promising preclinical activity and data to be shared with the FDA as part of an investigational New Drug (IND) filing that is planned for the first quarter of 2022. Under the terms of the collaboration agreement, Cue Biopharma will receive a $3 million milestone payment from LG Chem Life Sciences, the life sciences division of LG Chem Ltd.

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"We are highly encouraged with the progress made in our collaboration with LG Chem, our partner and collaborator for CUE-101 and CUE-102 in certain Asia countries, and pleased to be advancing CUE-102 for a planned IND submission this year," said Daniel Passeri, chief executive officer of Cue Biopharma. "This milestone reflects ongoing progress for CUE-102, our second program from the IL-2 based CUE-100 series, and we believe provides a significant opportunity to address a high unmet need in a wide range of solid tumors and hematologic WT1-positive malignancies. The CUE-102 preclinical data continues to support and bolster the versatility and modularity of our CUE-100 series biologics and the Immuno-STAT platform, and we look forward to executing on our goal to advance this drug candidate into the clinic for patients in need."

Dr. Jeewoong Son, president of LG Chem Life Sciences added, "This significant milestone for CUE-102 underscores the spirit of the partnership and collaboration for advancing our shared vision with Cue Biopharma. We are very pleased and encouraged by the clinical data reported from the CUE-101 program and believe these data support the potential for CUE-102 to provide a significant therapeutic advancement for patients with WT1-expressing cancers."

Cue Biopharma presented preclinical data on CUE-102 and interim clinical data on CUE-101, its lead oncology asset, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting in November 2021.

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) platform 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.

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. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. 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 CUE-102
Leveraging the Immuno-STAT (Selective Targeting and Alteration of T cells) platform of targeted interleukin 2 (IL-2) therapies and the ongoing development of CUE-101, CUE-102 is being developed as a novel therapeutic fusion protein to selectively activate tumor antigen-specific T cells to treat Wilms’ Tumor 1 (WT1)-expressing cancers. CUE-102 consists of two human leukocyte antigen (HLA) molecules presenting a WT1 peptide, four affinity-attenuated IL-2 molecules, and an effector attenuated human immunoglobulin G (IgG1) Fc domain.