Methods for determining responsiveness to an anti-CD47 agent
AssigneeThe Board of Trustees of the Leland Stanford Junior University
InventorsKipp Andrew Weiskopf, Irving L. Weissman
Life of this patent
Estimating the term…
Abstract
Methods and kits are provided for determining whether an individual is responsive to an anti-CD47 agent and for determining whether an individual is maintaining responsiveness to an anti-CD47 agent by assaying biological samples for the level of at least one biomarker in a biological sample.
Claims20
A method of determining whether an individual is responsive to an anti-Cluster-of-Differentiation-47 (CD47) agent, the method comprising:
- administering the anti-CD47 agent, wherein the anti-CD47 agent is a CD47 blocking antibody, an anti-Signal-Regulatory-Protein-α (SIRPα) antibody, a SIRPα polypeptide that binds to human CD47 and blocks the interaction between CD47 and SIRPα, or a soluble CD47 polypeptide, to the individual after isolating a pre-treatment biological sample, and before isolating a post-treatment biological sample of the same type of biological sample, wherein the biological sample is selected from a blood sample, a serum sample, a plasma sample, a bone marrow sample, a biopsy sample, a fine needle aspirate, a lymph node aspirate, a cystic aspirate, a paracentesis sample, a thoracentesis sample;
- assaying the pre-treatment and post-treatment biological samples to determine the level of a positive biomarker Macrophage Inflammatory Protein-1 alpha/Chemokine (C-C) motif ligand 3 (MIP-1α/CCL3);
- and
- determining that the individual is responsive to the anti-CD47 agent when the level of the positive biomarker in the post-treatment biological sample is about 1.5-fold or more greater than the level of the positive biomarker in the pre-treatment biological sample, or determining that the individual is not responsive to the anti-CD47 agent when the level of the positive biomarker in the post-treatment biological sample is less than about 1.5-fold greater than the level of the positive biomarker in the pre-treatment biological sample.
A method of determining whether an individual is maintaining responsiveness to an anti-CD47 agent wherein the anti-CD47 agent is a CD47 blocking antibody, an anti-SIRPα antibody, a SIRPα polypeptide that binds to human CD47 and blocks the interaction between CD47 and SIRPα, or a soluble CD47 polypeptide, the method comprising:
- assaying a pre-treatment biological sample, a first post-treatment biological sample, and a second post-treatment biological sample of the same type from an individual treated with a first anti-CD47 agent, to determine the level of positive biomarker Macrophage Inflammatory Protein-1 alpha (MIP-1α) (MIP-1α), wherein the biological sample is selected from a blood sample, a serum sample, a plasma sample, a bone marrow sample, a biopsy sample, a fine needle aspirate, a lymph node aspirate, a cystic aspirate, a paracentesis sample, a thoracentesis sample;
- and
- determining that the individual is maintaining responsiveness to the anti-CD47 agent when the level of the positive biomarker in each of the first and second post-treatment biological samples is about 1.5-fold or more greater than the level of the positive biomarker in the pre-treatment biological sample, or determining that the individual is not maintaining responsiveness to the anti-CD47 agent when the level of the positive biomarker in each of the first and second post-treatment biological samples is less than about 1.5-fold greater than the level of the positive biomarker in the pre-treatment biological sample.
Dependencies are inferred from the claim text.