- Selective activation and growth of Wilms’ Tumor 1 (WT1)-specific cytotoxic CD8+ T cells in preclinical fashions helps the potential for medical exercise treating WT1-expressing cancers
- Additional development of CUE-102 enhances pipeline improvement and demonstrates modularity of the Immuno-STAT™ platform for addressing a myriad of most cancers antigens
CAMBRIDGE, Mass., Jan. 05, 2022 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical firm engineering a novel class of injectable biologics to selectively have interaction and modulate focused T cells straight inside the affected person’s physique, together with LG Chem Life Sciences, introduced right this moment {that a} key milestone within the collection of a medical product candidate has been reached of their collaboration for CUE-102, an Immuno-STAT™ biologic, collectively developed to selectively goal WT1-expressing cancers. The milestone represents vital progress for the CUE-102 program and an necessary achievement in producing promising preclinical exercise and knowledge to be shared with the FDA as a part of an investigational New Drug (IND) submitting that’s deliberate for the primary quarter of 2022. Underneath the phrases of the collaboration settlement, Cue Biopharma will obtain a $3 million milestone cost from LG Chem Life Sciences, the life sciences division of LG Chem Ltd.
“We’re extremely inspired with the progress made in our collaboration with LG Chem, our associate and collaborator for CUE-101 and CUE-102 in sure Asia nations, and happy to be advancing CUE-102 for a deliberate IND submission this 12 months,” mentioned Daniel Passeri, chief government officer of Cue Biopharma. “This milestone displays ongoing progress for CUE-102, our second program from the IL-2 primarily based CUE-100 sequence, and we consider offers a big alternative to deal with a excessive unmet want in a variety of stable tumors and hematologic WT1-positive malignancies. The CUE-102 preclinical knowledge continues to assist and bolster the flexibility and modularity of our CUE-100 sequence biologics and the Immuno-STAT platform, and we sit up for executing on our objective to advance this drug candidate into the clinic for sufferers in want.”
Dr. Jeewoong Son, president of LG Chem Life Sciences added, “This vital milestone for CUE-102 underscores the spirit of the partnership and collaboration for advancing our shared imaginative and prescient with Cue Biopharma. We’re more than happy and inspired by the medical knowledge reported from the CUE-101 program and consider these knowledge assist the potential for CUE-102 to offer a big therapeutic development for sufferers with WT1-expressing cancers.”
Cue Biopharma offered preclinical knowledge on CUE-102 and interim medical knowledge on CUE-101, its lead oncology asset, on the Society for Immunotherapy of Most cancers’s (SITC) thirty sixth Annual Assembly in November 2021.
About Immuno-STAT
The corporate’s Immuno-STAT™ (Selective Concentrating on and Alteration of T cells) platform biologics are designed for focused modulation of disease-associated T cells within the areas of immuno-oncology and autoimmune illness. Every of our biologic medicine is designed utilizing our proprietary scaffold comprising: 1) a peptide-major histocompatibility advanced (pMHC) to offer selectivity by way of interplay with the T cell receptor (TCR), and a pair of) a novel co-stimulatory signaling molecule to modulate the exercise of the goal T cells.
The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the indicators delivered by antigen presenting cells (APCs) to T cells throughout a pure immune response. This design allows Immuno-STAT biologics to interact with the T cell inhabitants of curiosity, leading to selective T cell modulation. As a result of our drug candidates are delivered straight within the affected person’s physique (in vivo), they’re essentially completely different from different T cell therapeutic approaches that require the sufferers’ T cells to be extracted, modified exterior the physique (ex vivo) and reinfused.
In regards to the CUE-100 Sequence
The CUE-100 sequence consists of Fc-fusion biologics that incorporate peptide-major histocompatibility advanced (pMHC) molecules together with rationally engineered interleukin 2 (IL-2) molecules. These singular biologics are anticipated to selectively goal, activate and broaden a sturdy repertoire of tumor-specific T cells straight within the affected person’s physique. The binding affinity of IL-2 for its receptor has been intentionally attenuated to realize preferential selective activation of tumor-specific effector T cells whereas lowering potential for results on regulatory T cells (Tregs) or broad systemic activation, probably mitigating the dose-limiting toxicities related to present IL-2-based therapies.
About CUE-102
Leveraging the Immuno-STAT™ (Selective Concentrating on and Alteration of T cells) platform of focused interleukin 2 (IL-2) therapies and the continuing improvement of CUE-101, CUE-102 is being developed as a novel therapeutic fusion protein to selectively activate tumor antigen-specific T cells to deal with Wilms’ Tumor 1 (WT1)-expressing cancers. CUE-102 consists of two human leukocyte antigen (HLA) molecules presenting a WT1 peptide, 4 affinity-attenuated IL-2 molecules, and an effector attenuated human immunoglobulin G (IgG1) Fc area.
About LG Chem Life Sciences
LG Chem Life Sciences is a enterprise division inside LG Chem, engaged within the improvement, manufacturing, in addition to commercializing pharmaceutical merchandise globally. LG Chem Life Sciences seeks to broaden and make world presence by specializing in key core therapeutic areas of Immunology, Oncology, and Metabolic Ailments (particularly, diabetes and associated metabolic ailments). To attain such, its technique is to actively pursue world collaboration encompassing from asset-centric to strategic funding and collaboration. LG Chem Life Sciences Innovation Middle: innovation.lgchem.com
About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical firm, is engineering a novel class of injectable biologics to selectively have interaction and modulate focused T cells straight inside the affected person’s physique to rework the remedy of most cancers, infectious illness and autoimmune illness. The corporate’s proprietary Immuno-STAT™ (Selective Concentrating on and Alteration of T cells) platform, is designed to harness the physique’s intrinsic immune system with out the necessity for ex vivo manipulation.
Headquartered in Cambridge, Massachusetts, the corporate is led by an skilled administration group and unbiased Board of Administrators with deep experience in immunology and immuno-oncology in addition to the design and medical improvement of protein biologics.
For extra info, go to https://www.cuebiopharma.com and observe us on Twitter at https://twitter.com/CueBiopharma.
Ahead-Wanting Statements
This press launch comprises forward-looking statements inside the that means of Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Trade Act of 1934, as amended, which can be meant to be coated by the secure harbor created by these sections. Such forward-looking statements embrace, however are usually not restricted to, these relating to: the corporate’s plans to submit an IND for CUE-102; the corporate’s perception that the Immuno-STAT platform stimulates focused immune modulation by way of the selective engagement of disease-relevant T cells; and the corporate’s enterprise methods, plans and prospects. Ahead-looking statements, that are primarily based on sure assumptions and describe the corporate’s future plans, methods and expectations, can usually be recognized by means of forward-looking phrases similar to “consider,” “count on,” “might,” “will,” “ought to,” “would,” “might,” “search,” “intend,” “plan,” “objective,” “mission,” “estimate,” “anticipate,” “technique,” “future,” “probably” or different comparable phrases, though not all forward-looking statements comprise these figuring out phrases. All statements aside from statements of historic information included on this press launch relating to the corporate’s methods, prospects, monetary situation, operations, prices, plans and goals are forward-looking statements. Essential elements that would trigger the corporate’s precise outcomes and monetary situation to vary materially from these indicated within the forward-looking statements embrace, amongst others, the corporate’s restricted working historical past, restricted money and a historical past of losses; the corporate’s means to realize profitability; potential setbacks within the firm’s analysis and improvement efforts together with unfavourable or inconclusive outcomes from its preclinical research, its means to safe required U.S. Meals and Drug Administration (“FDA”) or different governmental approvals for its product candidates and the breadth of any authorized indication; hostile results brought on by public well being pandemics, together with COVID-19, together with potential results on the corporate’s trials; unfavourable or inconclusive outcomes from the corporate’s medical trials or preclinical research or critical and surprising drug-related unwanted effects or different issues of safety skilled by members in medical trials; delays and modifications in regulatory necessities, coverage and pointers together with potential delays in submitting required regulatory purposes to the FDA; the corporate’s reliance on licensors, collaborators, contract analysis organizations, suppliers and different enterprise companions; the corporate’s means to acquire sufficient financing to fund its enterprise operations sooner or later; operations and medical the corporate’s means to keep up and implement vital patent and different mental property safety; aggressive elements; common financial and market situations and the opposite dangers and uncertainties described within the Threat Elements and in Administration’s Dialogue and Evaluation of Monetary Situation and Outcomes of Operations sections of the corporate’s most not too long ago filed Annual Report on Kind 10-Okay and any subsequently filed Quarterly Report(s) on Kind 10-Q. Any forward-looking assertion made by the corporate on this press launch relies solely on info presently obtainable to the corporate and speaks solely as of the date on which it’s made. The corporate undertakes no obligation to publicly replace any forward-looking assertion, whether or not written or oral, which may be made sometimes, whether or not because of new info, future developments or in any other case.
Investor Contact
George B. Zavoico, Ph.D.
VP, Investor Relations & Company Growth
Cue Biopharma, Inc.
[email protected]
Media Contact
Darren Opland, Ph.D.
LifeSci Communications
[email protected]
