Heavy chain antibodies binding to CD22
Inventors
Force Aldred, Shelley • van Schooten, Wim • OGANA, HEATHER ANNE N. • DAVISON, LAURA MARIE • Harris, Katherine • RANGASWAMY, UDAYA • Trinklein, Nathan D.
Assignees
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Publication Number
US-11873336-B2
Publication Date
2024-01-16
Expiration Date
Abstract
Anti-CD22 heavy chain antibodies (e.g., UniAbs™) are disclosed, along with methods of making such antibodies, compositions, including pharmaceutical compositions, comprising such antibodies, and their use to treat B cell disorders that are characterized by the expression of CD22.
Core Innovation
The invention relates to human anti-CD22 heavy chain-only antibodies that bind CD22. The antibodies are described as heavy chain-only antibodies (UniAbs™/HCAbs, including UniDabs™ and UniRat™-derived formats) comprising a heavy chain variable region with CDR1, CDR2, and CDR3 sequences defined by specified sequence options and amino-acid position formulas.
The antibodies include a human VH framework and are described with an absence of CH1 in the constant region (ΔCH1). The disclosure further describes constant-region formats that may include a Fc region, including optional human IgG subclasses (including IgG4), and variants of the Fc region.
The disclosure describes that the antibodies can be used in multi-specific or bispecific formats, including anti-CD22×anti-CD3 for CAR-T use and redirected T-cell activity. The therapeutic context is described as treatment of CD22+ B-cell disorders, including diffuse large B-cell lymphoma (DLBCL) and other B-cell malignancies, and it further references use in disorders described as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and multiple sclerosis (MS).
Claims Coverage
The independent claim set covers a heavy chain-only antibody binding to CD22 defined by explicit CDR1 sequence selections and explicit CDR2/CDR3 amino-acid position formulas. The scope is then narrowed and expanded through dependent claim features, including human VH framework context, absence of CH1, optional human IgG4 Fc, multi-specific/bispecific formats, and an administration-based treatment use for CD22-expressing B-cell disorders.
CD22 heavy chain-only antibody variable-region CDR constraints
A heavy chain-only antibody binding to CD22 comprising a heavy chain variable region with a CDR1 sequence of any one of SEQ ID NOs: 2-10; a CDR2 sequence matching the formula X7 X8 Y X9 G X10 X11 with position restrictions for X7, X8, X9, X10, and X11; and a CDR3 sequence matching the formula X12 R X13 D S S X14 W R S with position restrictions for X12, X13, and X14.
Human VH framework for the CDRs
A heavy chain-only antibody in which the CDR1, CDR2, and CDR3 sequences are present in a human VH framework.
Constant region without CH1 (ΔCH1)
A heavy chain-only antibody whose heavy chain constant region sequence does not include a CH1 sequence.
Human IgG4 Fc region
A heavy chain-only antibody that further includes a human IgG4 Fc region.
Bispecific heavy chain-only antibody
A bispecific heavy chain-only antibody as defined in the dependent structure recited in the claim set.
Treatment of a CD22-expressing B-cell disorder by administration
A method for treating a CD22-expressing B-cell disorder by administering the heavy chain-only antibody described in the claim set to a subject with the disorder.
Overall, the claim coverage centers on CD22-binding heavy chain-only antibodies defined by strict CDR1 selections and CDR2/CDR3 positional formulas, with further refinements specifying a human VH framework, a constant region lacking CH1 (ΔCH1), optional inclusion of a human IgG4 Fc region, and multi-specific/bispecific formats. The claim set also includes a treatment method by administering the antibody to a subject with a CD22-expressing B-cell disorder.
Stated Advantages
Documented Applications
Therapeutic treatment of CD22-expressing B-cell disorders, including CD22+ B-cell malignancies described as diffuse large B-cell lymphoma (DLBCL) and other non-Hodgkin's lymphoma (NHL) contexts.
Multi-specific/bispecific use described for anti-CD22×anti-CD3, including redirected T-cell activity and CAR-T use against CD22+ lymphoma cell lines.
Use contexts referenced in the disclosure as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and multiple sclerosis (MS) [as disorders described in the document].
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