IP Library › Granted Patent US 12698337
Granted Patent B2
US 12698337 · App. 18/329,562 · Granted Aug 4, 2026

Subcutaneous formulations of anti-CD38 antibodies and their uses

Inventors: Richard Jansson (Spring House, PA); Vineet Kumar (Spring House, PA)
Assignee: JANSSEN BIOTECH, INC.
C07K16/2896A61K9/0019A61K38/47A61K39/3955A61K45/06A61K47/02A61K47/12A61K47/20A61K47/22A61K47/26A61P35/00A61K2039/505A61K2039/54A61K2039/545A61K2039/55C07K2317/94
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Quick Facts
Patent No.
US 12698337
App. No.
18/329,562
Granted
Aug 4, 2026
Kind
B2
Abstract

The present invention relates to subcutaneous formulations of anti-CD38 antibodies and their uses.

Claims (90)

1 . A pharmaceutical composition, comprising:

a) about 1,800 mg of an anti-CD38 antibody, wherein the anti-CD38 antibody is of IgG1 isotype and comprises:

i) a heavy chain variable region (VH) of SEQ ID NO: 4; and

ii) a light chain variable region (VL) of SEQ ID NO: 5; and

b) rHuPH20 recombinant hyaluronidase,

wherein the pharmaceutical composition has a hyaluronidase enzymatic activity of about 30,000 U.

2 . The pharmaceutical composition of claim 1 , further comprising a pharmaceutically acceptable carrier.

3 . The pharmaceutical composition of claim 1 , further comprising from about 5 mM to about 10 mM histidine.

4 . The pharmaceutical composition of claim 1 , further comprising about 8 mM histidine.

5 . The pharmaceutical composition of claim 1 , further comprising from about 0.1 mg/mL to about 2.5 mg/mL methionine.

6 . The pharmaceutical composition of claim 1 , further comprising methionine at a concentration of about 1 mg/mL.

7 . The pharmaceutical composition of claim 1 , further comprising from about 100 mM to about 300 mM sorbitol.

8 . The pharmaceutical composition of claim 1 , further comprising about 270 mM sorbitol.

9 . The pharmaceutical composition of claim 1 , further comprising from about 0.01% w/v to about 0.1% w/v polysorbate-20 (PS-20).

10 . The pharmaceutical composition of claim 1 , further comprising from about 0.01% w/v to about 0.04% w/v PS-20.

11 . The pharmaceutical composition of claim 1 , further comprising about 0.04% w/v PS-20.

12 . The pharmaceutical composition of claim 1 , further comprising:

a) from about 5 mM to about 10 mM histidine;

b) from about 0.1 mg/mL to about 2.5 mg/mL methionine;

c) from about 100 mM to about 300 mM sorbitol; and

d) from about 0.01% w/v to about 0.1% w/v PS-20.

13 . The pharmaceutical composition of claim 1 , further comprising:

a) from about 5 mM to about 10 mM histidine;

b) from about 0.1 mg/mL to about 2.5 mg/mL methionine;

c) from about 100 mM to about 300 mM sorbitol; and

d) from about 0.01% w/v to about 0.04% w/v PS-20.

14 . The pharmaceutical composition of claim 1 , further comprising:

a) about 8 mM histidine;

b) about 1 mg/mL methionine;

c) about 270 mM sorbitol; and

d) about 0.04% w/v PS-20.

15 . A pharmaceutical composition, comprising:

a) about 1,800 mg of an anti-CD38 antibody, wherein the anti-CD38 antibody is of IgG1 isotype and comprises:

i) a heavy chain of SEQ ID NO: 12; and

ii) a light chain of SEQ ID NO: 13; and

b) rHuPH20 recombinant hyaluronidase,

wherein the pharmaceutical composition has a hyaluronidase enzymatic activity of about 30,000 U.

16 . The pharmaceutical composition of claim 15 , further comprising a pharmaceutically acceptable carrier.

17 . The pharmaceutical composition of claim 15 , further comprising:

a) from about 5 mM to about 10 mM histidine;

b) from about 0.1 mg/mL to about 2.5 mg/mL methionine;

c) from about 100 mM to about 300 mM sorbitol; and

d) from about 0.01% w/v to about 0.1% w/v PS-20.

18 . The pharmaceutical composition of claim 15 , further comprising:

a) from about 5 mM to about 10 mM histidine;

b) from about 0.1 mg/mL to about 2.5 mg/mL methionine;

c) from about 100 mM to about 300 mM sorbitol; and

d) from about 0.01% w/v to about 0.04% w/v PS-20.

19 . The pharmaceutical composition of claim 15 , further comprising:

a) about 8 mM histidine;

b) about 1 mg/mL methionine;

c) about 270 mM sorbitol; and

d) about 0.04% w/v PS-20.

20 . The pharmaceutical composition of claim 15 , further comprising a buffer.

21 . The pharmaceutical composition of claim 20 , further comprising from about 100 mM to about 300 mM of a saccharide.

22 . The pharmaceutical composition of claim 21 , wherein the saccharide is sorbitol.

23 . The pharmaceutical composition of claim 22 , further comprising about 0.04% w/v polysorbate-20.

24 . The pharmaceutical composition of claim 23 , further comprising from about 0.1 mg/mL to about 2.5 mg/mL methionine.

25 . The pharmaceutical composition of claim 24 , wherein the pharmaceutical composition is at pH 5.3 to 5.8.

26 . The pharmaceutical composition of claim 25 , wherein the pharmaceutical composition is at pH about 5.5.

27 . The pharmaceutical composition of claim 21 , wherein the saccharide is trehalose.

28 . The pharmaceutical composition of claim 27 , further comprising about 0.04% w/v polysorbate-20.

29 . The pharmaceutical composition of claim 28 , further comprising from about 0.1 mg/mL to about 2.5 mg/mL methionine.

30 . The pharmaceutical composition of claim 29 , wherein the pharmaceutical composition is at pH 5.3 to 5.8.

31 . The pharmaceutical composition of claim 30 , wherein the pharmaceutical composition is at pH about 5.5.

32 . The pharmaceutical composition of claim 15 , further comprising from about 5 mM to about 50 mM of histidine.

33 . The pharmaceutical composition of claim 32 , further comprising from about 100 mM to about 300 mM of a saccharide.

34 . The pharmaceutical composition of claim 33 , wherein the saccharide is sorbitol.

35 . The pharmaceutical composition of claim 34 , further comprising about 0.04% w/v polysorbate-20.

36 . The pharmaceutical composition of claim 35 , further comprising from about 0.1 mg/mL to about 2.5 mg/mL methionine.

37 . The pharmaceutical composition of claim 36 , wherein the pharmaceutical composition is at pH 5.3 to 5.8.

38 . The pharmaceutical composition of claim 37 , wherein the pharmaceutical composition is at pH about 5.5.

39 . The pharmaceutical composition of claim 33 , wherein the saccharide is trehalose.

40 . The pharmaceutical composition of claim 39 , further comprising about 0.04% w/v polysorbate-20.

41 . The pharmaceutical composition of claim 40 , further comprising from about 0.1 mg/mL to about 2.5 mg/mL methionine.

42 . The pharmaceutical composition of claim 41 , wherein the pharmaceutical composition is at pH 5.3 to 5.8.

43 . The pharmaceutical composition of claim 42 , wherein the pharmaceutical composition is at pH about 5.5.

44 . The pharmaceutical composition of claim 15 , wherein the anti-CD38 antibody is at a concentration of:

a) from about 10 mg/mL to about 180 mg/mL;

b) from about 20 mg/mL to about 160 mg/mL;

c) from about 20 mg/mL to about 140 mg/mL;

d) from about 20 mg/mL to about 120 mg/ml;

e) from about 40 mg/mL to about 120 mg/mL;

f) from about 60 mg/mL to about 120 mg/mL;

g) from about 80 mg/mL to about 120 mg/mL; or

h) from about 100 mg/mL to about 120 mg/mL.

45 . The pharmaceutical composition of claim 15 , wherein the anti-CD38 antibody is at a concentration of from about 100 mg/mL to about 120 mg/mL.

46 . The pharmaceutical composition of claim 15 , wherein the anti-CD38 antibody is at a concentration of about 20 mg/mL.

47 . The pharmaceutical composition of claim 15 , wherein the anti-CD38 antibody is at a concentration of about 100 mg/mL.

48 . The pharmaceutical composition of claim 15 , wherein the anti-CD38 antibody is at a concentration of about 120 mg/mL.