Subcutaneous Formulations Of Anti-CD38 Antibodies And Their Uses
AssigneeJanssen Biotech, Inc.
InventorsRichard Jansson, Vineet Kumar
Life of this patent
Estimating the term…
Abstract
The present invention relates to subcutaneous formulations of anti-CD38 antibodies and their uses.
Claims86
A pharmaceutical composition comprising about 1,800 mg of an anti-CD38 antibody and about 30,000 U of a hyaluronidase, wherein the anti-CD38 antibody is of an IgG1 isotype and comprises a heavy chain variable region sequence of SEQ ID NO:
- 4 and a light chain variable region sequence of SEQ ID NO:
- 5, and wherein the hyaluronidase is rHuPH20 (SEQ ID NO:
- 22).
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
A method of treating a CD38-positive multiple myeloma (MM) in a subject, comprising administering subcutaneously to the subject in need thereof a pharmaceutical composition comprising about 1,800 mg of an anti-CD38 antibody and about 30,000 U of a hyaluronidase for a time sufficient to treat the CD38-positive MM, wherein the anti-CD38 antibody is of an IgG1 isotype and comprises a heavy chain variable region sequence of SEQ ID NO:
- 4 and a light chain variable region sequence of SEQ ID NO:
- 5, and wherein the hyaluronidase is rHuPH20 (SEQ ID NO:
- 22).
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
A unit dosage form, comprising
- a) an anti-CD38 antibody of an IgG1 isotype comprising a heavy chain variable region sequence of SEQ ID NO:
- 4 and a light chain variable region sequence of SEQ ID NO:
- 5 in an amount of about 1,800 mg;
- b) a hyaluronidase in an amount of about 30,000 U;
- c) histidine at a concentration of from about 5 mM to about 15 mM;
- d) sorbitol at a concentration of from about 100 mM to about 300 mM;
- e) polysorbate-20 (PS-20) at a concentration of from about 0.01% w/v to about 0.04% w/v;
- and
- f) methionine at a concentration of from about 1 mg/mL to about 2 mg/mL, at a pH of about 5.5;
- wherein the hyaluronidase is rHuPH20 (SEQ ID NO:
- 22).
(canceled)
(canceled)
A unit dosage form, comprising
- a) an anti-CD38 antibody of an IgG1 isotype comprising a heavy chain variable region sequence of SEQ ID NO:
- 4 and a light chain variable region sequence of SEQ ID NO:
- 5 in an amount of about 1,800 mg;
- b) a hyaluronidase in an amount of about 30,000 U;
- c) histidine at a concentration of about 10 mM;
- d) sorbitol at a concentration of about 300 mM;
- e) polysorbate-20 (PS-20) at a concentration of about 0.04% w/v;
- and
- f) methionine at a concentration of about 1 mg/mL, at a pH of about 5.6;
- wherein the hyaluronidase is rHuPH20 (SEQ ID NO:
- 22).
Dependencies are inferred from the claim text.