Anti-cd19 binding agents for the treatment and prevention of immune mediated necrotizing myopathy
AssigneeViela Bio, Inc.
InventorsNishi RAMPAL, Yanping WU
Life of this patent
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Abstract
The present disclosure is related to compositions and method of treating disease (e.g., myositis) in a subject in need thereof using anti-CD19 antibodies or antigen-binding fragments thereof.
Claims48
A method of treating Immune Mediated Necrotizing Myopathy (IMNM), the method comprising administering an effective amount of an anti-CD19 antibody or antigen-binding fragment thereof to a subject in need thereof, wherein the anti-CD19 antibody or antigen-binding fragment thereof comprises Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of SEQ ID NOs:
- 2, 3, 4, 6, 7, and 8.
A method of treating Immune Mediated Necrotizing Myopathy (IMNM), the method comprising administering an effective amount of an anti-CD19 antibody or antigen-binding fragment thereof to a subject in need thereof, wherein the anti-CD19 antibody or antigen-binding fragment thereof comprises Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of SEQ ID NOs:
- 2, 3, 4, 6, 7, and 8, and wherein the subject in need thereof is pediatric.
A method of treating Immune Mediated Necrotizing Myopathy (IMNM), the method comprising administering an effective amount of an anti-CD19 antibody or antigen-binding fragment thereof to a subject in need thereof, wherein the anti-CD19 antibody or antigen-binding fragment thereof comprises Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of SEQ ID NOs:
- 2, 3, 4, 6, 7, and 8, respectively, wherein the effective amount is from about 100 mg-1000 mg.
A method of treating Immune Mediated Necrotizing Myopathy (IMNM), the method comprising administering an effective amount of an anti-CD19 antibody or antigen-binding fragment thereof to a subject in need thereof, wherein the anti-CD19 antibody or antigen-binding fragment thereof comprises Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of SEQ ID NOs:
- 2, 3, 4, 6, 7, and 8, respectively, wherein the effective amount is about 300 mg.
A method of treatment, the method comprising administering an effective amount of an anti-CD19 antibody or antigen-binding fragment thereof to a pediatric subject in need thereof, wherein the anti-CD19 antibody or antigen-binding fragment thereof comprises Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of SEQ ID NOs:
- 2, 3, 4, 6, 7, and 8, respectively.
A method of treating Immune Mediated Necrotizing Myopathy (IMNM), the method comprising administering an effective amount of inebilizumab to a subject in need thereof, wherein the effective amount is about 100 mg-1000 mg.
A method of treatment, the method comprising administering an effective amount of an anti-CD19 antibody or antigen-binding fragment thereof to a subject in need thereof, wherein the anti-CD19 antibody or antigen-binding fragment thereof comprises Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of SEQ ID NOs:
- 2, 3, 4, 6, 7, and 8, respectively, and wherein the subject is positive for autoantibodies selected from the group consisting of:
- signal recognition particle (SRP), 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR), and both SRP and HMGCR.
A method of treatment, the method comprising administering an effective amount of an anti-CD19 antibody or antigen-binding fragment thereof to a subject in need thereof, wherein the anti-CD19 antibody or antigen-binding fragment thereof comprises Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of SEQ ID NOs:
- 2, 3, 4, 6, 7, and 8, respectively, and wherein the subject is negative for autoantibodies selected from the group consisting of:
- signal recognition particle (SRP), 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR), and both SRP and HMGCR.
A method of treating Immune Mediated Necrotizing Myopathy (IMNM), the method comprising administering an effective amount of an anti-CD19 antibody or antigen-binding fragment thereof to a subject in need thereof, wherein the anti-CD19 antibody or antigen-binding fragment thereof comprises Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of SEQ ID NOs:
- 2, 3, 4, 6, 7, and 8, respectively, wherein the effective amount is about 300 mg and is administered every 6 months, and wherein two weeks prior to the first 300 mg administration every 6 months, an initial 300 mg dose is administered.
Dependencies are inferred from the claim text.