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US 10,705,095 B2Granted
Methods and products for evaluating an immune response to a therapeutic protein
AssigneeBiogen MA Inc.
InventorsMeena Subramanyam, Lakshmi Amaravadi, Eric Wakshull, Frances Lynn, Michael Panzara, Robin McDaid Barbour, Julie Elizabeth Taylor
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Abstract
The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. Aspects of the invention relate to methods and compositions for identifying a clinically significant immune response in patients treated with therapeutic amounts of a VLA4 binding antibody (e.g., natalizumab).
Claims22
A method, comprising:
- (a) administering natalizumab to a subject having Multiple Sclerosis;
- (b) detecting in a first biological sample obtained from the subject at a first time point the presence or absence of at least a threshold level of anti-natalizumab antibody binding activity;
- and
- (c) detecting in a second biological sample obtained from the subject at a second time point the presence or absence of at least a threshold level of anti-natalizumab antibody binding activity,
- wherein the threshold level is equal to the level of anti-natalizumab antibody binding activity present in a reference sample comprising at least 500 ng/ml of anti-natalizumab antibody.
2 more elements
A method, comprising:
- (a) administering natalizumab to a subject having Multiple Sclerosis;
- (b) detecting in a first serum sample obtained from the subject at a first time point of at least 12 weeks following the administration of natalizumab, the presence or absence of at least a threshold level of anti-natalizumab antibody binding activity;
- and
- (c) detecting in a second serum sample obtained from the subject at a second time point of at least 42 days following the first time point, the presence or absence of at least a threshold level of anti-natalizumab antibody binding activity,
- wherein the threshold level is equal to the level of anti-natalizumab antibody binding activity present in a reference sample comprising at least 500 ng/ml of anti-natalizumab antibody.
2 more elements
A method, comprising:
- (a) obtaining at a first time point a first biological sample from a subject that has been administered natalizumab;
- (b) detecting in the first biological sample the presence or absence of at least a threshold level of anti-natalizumab antibody binding activity;
- (c) obtaining at a second time point a second biological sample from the subject;
- and
- (d) detecting in the second biological sample the presence or absence of at least a threshold level of anti-natalizumab antibody binding activity,
- wherein the threshold level of step (b) and step (d) is equal to the level of anti-natalizumab antibody binding activity present in a reference sample comprising at least 500 ng/ml of anti-natalizumab antibody.
3 more elements
A method, comprising:
- (a) obtaining at a first time point a first serum sample from a subject having Multiple Sclerosis that has been administered natalizumab, wherein the first time point is at least 12 weeks following administration of natalizumab;
- (b) detecting in the first serum sample the presence or absence of at least a threshold level of anti-natalizumab antibody binding activity, wherein the threshold level of step (b) is equal to the level of anti-natalizumab antibody binding activity present in a reference sample comprising at least 500 ng/ml of anti-natalizumab antibody;
- (c) obtaining at a second time point a second serum sample from the subject, wherein the second time point is at least 42 days following the first time point;
- and
- (d) detecting in the second serum sample the presence or absence of at least a threshold level of anti-natalizumab antibody binding activity, wherein the threshold level of step (d) is equal to the level of anti-natalizumab antibody binding activity present in a reference sample comprising at least 500 ng/ml of anti-natalizumab antibody.
2 more elements
Dependencies are inferred from the claim text.