Anti-MUC1-C antibodies and CAR-T structures
Inventors
Harris, Katherine • Avanzino, Brian • Trinklein, Nathan • CHANG, Karen • Allen, Nicole
Assignees
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Publication Number
US-12735503-B2
Publication Date
2026-09-15
Expiration Date
Abstract
Anti-MUC1-C antibodies (e.g., UniAbs™) and CAR-T structures are disclosed, along with methods of making such antibodies and CAR-T structures, compositions, including pharmaceutical compositions, comprising such antibodies and CAR-T structures, and their use to treat disorders that are characterized by the expression of MUC1-C.
Core Innovation
The invention provides isolated antibodies that bind to MUC1-C. The antibodies comprise heavy-chain variable regions defined by specified CDR1, CDR2, and CDR3 sequences (SEQ ID NOs: 1-6), with framework embodiments including a human VH framework and heavy-chain constant regions lacking CH1, with optional identity/substitution constraints as described.
The invention also provides CAR-T and VCAR structures in which an extracellular antigen-binding domain binds to MUC1-C. In the CAR-T context, the CAR includes a heavy-chain variable region containing CDR1/CDR2/CDR3 sequences selected from the specified sets (SEQ ID NOs: 1-3 or SEQ ID NOs: 4-6), and the document further describes bispecific/multispecific constructs including anti-MUC1-C combined with CD3-binding arms, including TCA formats and representative CD3-binding CDR sequences (SEQ ID NOs: 9-20).
The patent describes a treatment scope for disorders/cancers characterized by MUC1-C expression, including solid carcinomas and hematologic malignancies. It further includes composition, formulation, and kit concepts using defined antibody/effector/CAR terminology, including Fc-silencing options such as IgG4 knob/hole as described in the document.
Claims Coverage
The independent claims are directed to an isolated antibody binding to MUC1-C and a CAR-T cell with a CAR that binds to MUC1-C. The main inventive features include specified heavy-chain CDR1/CDR2/CDR3 combinations for the heavy chain variable region, and for the CAR-T, an extracellular antigen-binding domain within the CAR that uses the same CDR-defined heavy chain variable region.
MUC1-C binding isolated antibody defined by heavy-chain CDR1/CDR2/CDR3 sets
An isolated antibody that binds to MUC1-C, comprising a heavy chain variable region comprising either a CDR1 sequence of SEQ ID NO: 1, a CDR2 sequence of SEQ ID NO: 2, and a CDR3 sequence of SEQ ID NO: 3; or a CDR1 sequence of SEQ ID NO: 4, a CDR2 sequence of SEQ ID NO: 5, and a CDR3 sequence of SEQ ID NO: 6.
MUC1-C binding CAR-T extracellular antigen-binding domain defined by heavy-chain CDR1/CDR2/CDR3 sets
A CAR-T cell comprising a CAR comprising an extracellular antigen-binding domain that binds to MUC1-C, comprising a heavy chain variable region comprising either a CDR1 sequence of SEQ ID NO: 1, a CDR2 sequence of SEQ ID NO: 2, and a CDR3 sequence of SEQ ID NO: 3; or a CDR1 sequence of SEQ ID NO: 4, a CDR2 sequence of SEQ ID NO: 5, and a CDR3 sequence of SEQ ID NO: 6.
Across the independent claims, the central coverage is the use of heavy-chain variable region CDR1/CDR2/CDR3 sequence sets (SEQ ID NOs: 1-3 or 4-6) to define MUC1-C binding, applied to an isolated antibody and to a CAR-T extracellular antigen-binding domain.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treatment of disorders/cancers characterized by MUC1-C expression, including solid carcinomas and hematologic malignancies.
CAR-T evaluation for MUC1-C+ tumor control in murine xenograft tumor models, with associated T-cell expansion and persistence for described CAR-T clones.
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