Csf-1r antibodies for the treatment of chronic graft versus host disease
AssigneeSyndax Pharmaceuticals, Inc.
InventorsPeter ORDENTLICH, Michael MEYERS, Briggs W. MORRISON
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Abstract
The present invention relates to methods of treating sclerotic conditions and more specifically to methods of treating chronic graft versus host disease with specific dosages of an anti-CSF-1R antibody, specifically axatilimab.
Claims26
A method for the treatment of chronic graft versus host disease (cGVHD), wherein the method comprises comprising administering to a patient an anti-CSF-1R antibody or anti-CSF-1 antibody or antigen binding fragment thereof to a patient in need thereof.
The method of any one of the preceding claims, wherein the anti-CSF-1R antibody or antigen binding fragment thereof comprises:
- a heavy chain, wherein the heavy chain comprises the sequence given in SEQ ID NO:23;
- and
- a light chain, wherein the light chain comprises the sequence given in SEQ ID NO:15.
The method of any one of the preceding claims, wherein the anti-CSF-1R antibody or anti-CSF-1 antibody or antigen binding fragment thereof, or the inhibitor of CSF-1R activity is administered between once every three weeks and four times every week.
The method of any one of the preceding claims, wherein the anti-CSF-1R antibody or anti-CSF-1 antibody or antigen binding fragment thereof, or the inhibitor of CSF-1R activity is administered between once every two weeks.
The method of any one of the preceding claims, wherein the anti-CSF-1R antibody or anti-CSF-1 antibody or antigen binding fragment thereof, or the inhibitor of CSF-1R activity is administered at a dosage of between about 0.3 mg/kg and 3 mg/kg.
The method of any one of the preceding claims, wherein the anti-CSF-1R antibody or anti-CSF-1 antibody or antigen binding fragment thereof, or the inhibitor of CSF-1R activity is administered at a dosage of about 0.3 mg/kg.
The method of any one of the preceding claims, wherein the anti-CSF-1R antibody or anti-CSF-1 antibody or antigen binding fragment thereof, or the inhibitor of CSF-1R activity is administered at a dosage of about 1 mg/kg.
The method of any one of the preceding claims, wherein the anti-CSF-1R antibody or anti-CSF-1 antibody or antigen binding fragment thereof, or the inhibitor of CSF-1R activity is administered at a dosage of about 0.3 mg/kg every two weeks.
The method of any one of the preceding claims, wherein the anti-CSF-1R antibody or anti-CSF-1 antibody or antigen binding fragment thereof, or the inhibitor of CSF-1R activity is administered at a dosage of about 3 mg/kg every four weeks.
The method of any one of the preceding claims, wherein the chronic graft versus host disease is selected from skin chronic graft versus host disease, eyes chronic graft versus host disease, mouth chronic graft versus host disease, esophagus chronic graft versus host disease, upper GI chronic graft versus host disease, lower GI chronic graft versus host disease, liver chronic graft versus host disease, lungs chronic graft versus host disease, joints and fascia chronic graft versus host disease, or global chronic graft versus host disease
The method of any one of the preceding claims, wherein the chronic graft versus host disease is selected from one or more of skin chronic graft versus host disease, eyes chronic graft versus host disease, lungs chronic graft versus host disease, joints and fascia chronic graft versus host disease, mouth chronic graft versus host disease, lower GI chronic graft versus host disease, and esophagus chronic graft versus host disease.
The method of any one of the preceding claims, wherein the patient has progressed on one or more prior therapies.
The method of any one of the preceding claims, wherein the patient has progressed on at least two prior therapies.
The method of any one of the preceding claims, wherein the patient progressed from a previous ibrutinib treatment.
The method of any one of the preceding claims, wherein the patient has progressed on at least two prior therapies, wherein one of the prior therapies was ibrutinib.
The method of any one of the preceding claims, wherein the level of monocytes is not fully depleted between doses of the CSF-1R inhibitor.
The method of any one of the preceding claims, wherein the level of monocytes are fully depleted between doses of the CSF-1R inhibitor.
The method of any one of the preceding claims, wherein the CSF-1R inhibitor or anti-CSF-1R antibody is axatilimab.
The method of any preceding claim, wherein the cGVHD is sclerodermatous.
The method of any preceding claim, wherein the cGVHD is sclerodermatous with ulceration.
The method of any preceding claim, wherein the terminal C-terminal lysine of the axatilimab antibody heavy chain is absent.
The method of any preceding claim, wherein the method further comprises administering a second therapeutic agent.
The method of any preceding claim, wherein the method further comprises administering a second therapeutic agent, wherein the second therapeutic agent is a corticosteroid.
The method of any preceding claim, wherein the method further comprises administering a second therapeutic agent, wherein the second therapeutic agent is prednisone.
Dependencies are inferred from the claim text.