Anti-Tau antibodies and methods of use
Inventors
Adolfsson, Oskar • Ayalon, Gai • Hotzel, Isidro • Di Cara, Danielle Marie
Assignees
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Publication Number
US-11555065-B2
Publication Date
2023-01-17
Expiration Date
Abstract
The invention provides anti-Tau antibodies and methods of using the same.
Core Innovation
The invention relates to an isolated antibody that binds human Tau. The antibody is defined by specific HVR-H1, HVR-H2, HVR-H3, HVR-L1, HVR-L2, and HVR-L3 amino acid sequences, with each HVR comprising the amino acid sequence of a corresponding SEQ ID NO. The described HVR set establishes binding to human Tau through defined variable-region sequence content.
The invention further specifies additional sequence-identity and variant-defining constraints for the heavy chain variable region and light chain variable region relative to particular SEQ ID NOs. The scope includes antibody class constraints such as IgG1 and IgG4 and the introduction of named point mutations into the antibody design. This defines a family of anti-human-Tau antibodies based on particular HVR sequences, identity requirements, and mutation sets.
The invention expands beyond a binding antibody by defining affinity and Tau-species coverage. It includes binding to monomeric Tau, phosphorylated Tau, non-phosphorylated Tau, and oligomeric Tau with a KD threshold. The invention also encompasses an immunoconjugate formed by combining the antibody with a second therapeutic agent.
Claims Coverage
The provided claim set centers on an isolated antibody that binds human Tau and specifies the main inventive structure as six HVR regions provided by particular SEQ ID NO sequences, with dependent claims refining sequence identity thresholds, immunoglobulin class, specific point mutations, binding-affinity thresholds to multiple Tau forms, and an immunoconjugate.
Isolated antibody binding human Tau with defined HVR sequences
An isolated antibody that binds human Tau, wherein the antibody comprises HVR-H1 comprising the amino acid sequence of SEQ ID NO: 112; HVR-H2 comprising the amino acid sequence of SEQ ID NO: 113; HVR-H3 comprising the amino acid sequence of SEQ ID NO: 114; HVR-L1 comprising the amino acid sequence of SEQ ID NO: 115; HVR-L2 comprising the amino acid sequence of SEQ ID NO: 116; and HVR-L3 comprising the amino acid sequence of SEQ ID NO: 117.
Defined HVR/HVL sequence identity relative to SEQ ID NOs 110 and 111
An isolated antibody whose heavy chain variable region and/or light chain variable region contain sequences at least 95% identical to SEQ ID NO: 110 and SEQ ID NO: 111, respectively.
IgG1 or IgG4 antibody class
An isolated antibody specified to be either an IgG1 or an IgG4 antibody.
Specific point mutations in the antibody
An isolated antibody that contains the M252Y, S254T, and T256E mutations.
Binding affinity threshold to multiple Tau forms
An isolated antibody that binds monomeric Tau, phosphorylated Tau, non-phosphorylated Tau, and oligomeric Tau with a KD of less than 100 nM.
Immunoconjugate formed with a second therapeutic agent
An immunoconjugate formed by combining the antibody of the claim with a second therapeutic agent.
The claims are directed to an isolated human Tau-binding antibody defined by specified HVR amino acid sequences, with refinements that include VH/VL sequence-identity thresholds, IgG1 or IgG4 selection, named point mutations, binding to multiple Tau species with a KD threshold, and formation of an immunoconjugate with a second therapeutic agent.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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