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Cue Biopharma
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21 Erie Street Cambridge, MA 02139
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617-949-2680

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CUE-101 is a novel fusion protein that incorporates HLA-A*0201 allele (the MHC portion) bound to an epitope from the HPV 16 E7 protein, which is investigated in combination with pembrolizumab for the treatment head and neck squamous.


Lead Product(s): CUE-101,Pembrolizumab

Therapeutic Area: Oncology Product Name: CUE-101

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 26, 2023

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Under the terms of the agreement, Cue Biopharma will be responsible for the research and development of CUE-401, a bispecific protein designed to induce and expand regulatory T cells (Tregs) for the treatment of autoimmune and inflammatory diseases.


Lead Product(s): CUE-401

Therapeutic Area: Immunology Product Name: CUE-401

Highest Development Status: PreclinicalProduct Type: Large molecule

Partner/Sponsor/Collaborator: Ono Pharmaceutical

Deal Size: $220.0 million Upfront Cash: Undisclosed

Deal Type: Collaboration February 22, 2023

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CUE-101 is a novel fusion protein that incorporates HLA-A*0201 allele (the MHC portion) bound to an epitope from the HPV 16 E7 protein (E711-20) and is designed to activate and expand tumor-specific T cells that target Human Papilloma Virus 16 (HPV16)-driven malignancies.


Lead Product(s): CUE-101

Therapeutic Area: Oncology Product Name: CUE-101

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 01, 2023

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Net proceeds from the PIPE financing are expected to be used to advance the clinical development of CUE-101, Cue Biopharma’s lead interleukin 2 (IL-2)-based Immuno-STAT™ biologic.


Lead Product(s): CUE-101

Therapeutic Area: Oncology Product Name: CUE-101

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Piper Sandler & Co.

Deal Size: $30.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement November 14, 2022

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CUE-101 is a novel fusion protein designed to activate and expand a population of tumor specific T cells to eradicate human papilloma virus (HPV)-driven malignancies. HPV causes multiple tumor types including cervical, head and neck squamous cell carcinoma and anal cancers.


Lead Product(s): CUE-101,Pembrolizumab

Therapeutic Area: Oncology Product Name: CUE-101

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 05, 2022

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CUE-101 is designed to activate and expand HPV16 tumor-specific T cells by presenting two signals or “cues” to T cells. Signal #1 incorporates HPV E7 protein, harbored by HPV-induced cancer cells, to provide selectivity through interaction with HPV-specific T cell receptor.


Lead Product(s): CUE-101,Pembrolizumab

Therapeutic Area: Oncology Product Name: CUE-101

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 04, 2022

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CUE-401, a novel bispecific molecule designed for differentiation and expansion of induced regulatory T cells (iTregs),or the treatment of patients with autoimmune and graft-versus-host disease.


Lead Product(s): CUE-401

Therapeutic Area: Immunology Product Name: CUE-401

Highest Development Status: PreclinicalProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 07, 2022

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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.


Lead Product(s): CUE-102

Therapeutic Area: Oncology Product Name: CUE-102

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 22, 2022

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The CUE-101 consists of Fc-fusion biologics that incorporate peptide-MHC molecules along with rationally engineered IL-2 molecules. The singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells.


Lead Product(s): CUE-101,Pembrolizumab

Therapeutic Area: Oncology Product Name: CUE-101

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 26, 2022

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Details:

CUE-102 consists of two HLA molecules presenting a WT1 peptide, four affinity-attenuated IL-2 molecules, and an effector attenuated human immunoglobulin G Fc domain.


Lead Product(s): CUE-102

Therapeutic Area: Oncology Product Name: CUE-102

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2022

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