Anti-tau antibodies and methods of use
Inventors
Adolfsson, Oskar • Wildsmith, Kristin Ruth • Van Der Brug, Marcel • Muhs, Andreas
Assignees
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Publication Number
US-11352419-B2
Publication Date
2022-06-07
Expiration Date
Abstract
The invention provides anti-Tau antibodies and methods of using the same.
Core Innovation
The invention relates to anti-Tau antibody compositions and methods that detect Tau and use the detected Tau for subject selection, monitoring treatment, and monitoring the progression of cognitive impairment in a subject with a tauopathy. The detection anti-Tau antibody comprises defined heavy chain and light chain antibody regions, including HVR-H1, HVR-H2, HVR-H3, HVR-L1, HVR-L2, and HVR-L3, selected from amino acid sequences provided by SEQ ID NOs. The detection step is performed on a sample from the subject using the detection anti-Tau antibody.
The disclosed antibody formats are characterized by binding multiple Tau forms including monomeric Tau, oligomeric Tau, non-phosphorylated Tau, and phosphorylated Tau (pTau). The disclosure includes targeting of epitopes within Tau, including mature human Tau amino acids 2–24, and other mapped epitope regions. The antibodies and related compositions include extensive sequence definitions for antibody variable regions using HVR-H1/H2/H3 and HVR-L1/L2/L3, with multiple alternative sequence sets.
The disclosure further connects Tau detection results to clinical decision-making and monitoring. A method of selecting a patient for treatment uses detecting Tau in a sample with the detection anti-Tau antibody, with the patient selection based on the detection result. A method of monitoring treatment uses detecting Tau in a sample from a subject undergoing treatment with a therapeutic anti-Tau antibody, including interpretation based on relative Tau change over time.
Claims Coverage
The independent claims cover three related inventive methods, each using Tau detection in a subject sample with a detection anti-Tau antibody defined by specific HVR-H and HVR-L amino acid sequences.
Patient selection by Tau detection with defined HVR detection antibody
A method of selecting a patient for treatment with a therapeutic anti-Tau antibody by detecting Tau in a sample from the subject with a detection anti-Tau antibody, wherein the detection anti-Tau antibody comprises HVR-H1, HVR-H2, HVR-H3, HVR-L1, HVR-L2, and HVR-L3 defined by specific SEQ ID NO sequence sets, including alternative combinations.
Monitoring treatment by Tau detection with defined HVR detection antibody
A method of monitoring treatment with a therapeutic anti-Tau antibody by detecting Tau in a sample from a subject undergoing treatment with a detection anti-Tau antibody, wherein the detection anti-Tau antibody comprises HVR-H1, HVR-H2, HVR-H3, HVR-L1, HVR-L2, and HVR-L3 defined by specific SEQ ID NO sequence sets, including alternative combinations.
Progression monitoring of cognitive impairment by Tau detection with defined HVR detection antibody
A method of monitoring the progression of cognitive impairment in a subject with a tauopathy by detecting Tau in a sample from the subject with a detection anti-Tau antibody, wherein the detection anti-Tau antibody comprises multiple alternative sets of HVR-H1, HVR-H2, HVR-H3, HVR-L1, HVR-L2, and HVR-L3 defined by specific SEQ ID NO sequences.
Collectively, the independent claims define Tau-based methods that rely on detection anti-Tau antibodies characterized by specified HVR-H and HVR-L sequence sets, used respectively for patient selection, monitoring treatment response, and monitoring cognitive impairment progression in tauopathy.
Stated Advantages
Patient selection for treatment using Tau detection with the specified detection anti-Tau antibody.
Monitoring treatment effectiveness using detecting Tau and relative Tau change over time.
Monitoring progression of cognitive impairment in a subject with a tauopathy using Tau detection.
Documented Applications
Patient selection for treatment with a therapeutic anti-Tau antibody by detecting Tau in a sample from the subject.
Monitoring treatment with a therapeutic anti-Tau antibody by detecting Tau in samples from a subject undergoing treatment.
Monitoring progression of cognitive impairment in a subject with a tauopathy by detecting Tau in a sample.
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