IP Library › Granted Patent US 12,729,244
Granted Patent B2
US 12,729,244 · App. 19/364,297 · Granted Sep 8, 2026

Formulations of anti-CD38 antibodies for subcutaneous administration

Inventors: Sylvain Huille (Paris, FR); Thomas Ballet (Paris, FR); Kiran Bangari (Cambridge, MA); Ravi Chari (Cambridge, MA); Bernardo Perez-Ramirez (Cambridge, MA); Filipe Vasco (Paris, FR)
Assignee: SANOFI-AVENTIS U.S. LLC
C07K16/2896C07K2317/565C07K2317/94
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Quick Facts
Patent No.
US 12,729,244
App. No.
19/364,297
Granted
Sep 8, 2026
Kind
B2
Abstract

Provided are formulations of anti-CD38 antibodies suitable for subcutaneous administration to a subject in need thereof. The formulations include a high concentration of antibody, a viscosity lowering agent, a stabilizing agent, a buffering agent and a surfactant. In certain embodiments, the viscosity of the solution is at most 25 mPa·s, and the pH of the solution is 5.9 to 7.0. In certain embodiments, the anti-CD38 antibody is isatuximab. The formulations will find use in treating CD38 + hematological malignancies, including multiple myeloma, as well as autoimmune and inflammatory diseases, in humans.

Claims (43)

1 . A method of treating a CD38 + hematological malignancy, comprising:

administering to a subject in need thereof an effective amount of a formulation comprising 125-155 mg/mL isatuximab and excipients,

wherein the excipients consist of histidine, arginine (Arg), sucrose, and Poloxamer 188,

the formulation has a pH of 5.9-7.0 and a viscosity of at most 25 mPa·s at 20° C, and wherein the formulation is administered subcutaneously, thereby treating the CD38 + hematological malignancy.

2 . The method of claim 1 , wherein the formulation is administered by subcutaneous infusion.

3 . The method of claim 2 , wherein the subcutaneous infusion is a large-volume subcutaneous infusion.

4 . The method of claim 1 , wherein the CD38 + hematological malignancy is multiple myeloma.

5 . The method of claim 4 , wherein the multiple myeloma is relapsed multiple myeloma, refractory multiple myeloma, or both.

6 . The method of claim 1 , wherein the subject was previously treated with corticosteroids, chemotherapy, proteasome inhibitors, immunomodulatory drugs, radiotherapy, bone marrow, or stem cell transplantation.

7 . The method of claim 1 , further comprising administering to the subject one or more additional therapeutic agents selected from a corticosteroid, an immunomodulatory drug, a proteasome inhibitor, and a chemotherapy drug.

8 . The method of claim 7 , wherein the corticosteroid comprises a dexamethasone; the proteasome inhibitor comprises a bortezomib, carfilzomib, or ixazomib; the immunomodulatory drug comprises a lenalidomide, thalidomide, or pomalidomide; and the chemotherapy drug comprises a cyclophosphamide, melphalan, cytarabine, or etoposide.

9 . The method of claim 1 , wherein the histidine is at a concentration of 9 mM, the Arg is at a concentration of 90-125 mM, the sucrose is at a concentration of 2% (w/v), and the Poloxamer 188 is at a concentration of 0.4% (w/v).

10 . The method of claim 1 , wherein the formulation comprises 140 mg/mL isatuximab.

11 . A method of treating a CD38 + hematological malignancy, comprising administering to a subject in need thereof an effective amount of a formulation suitable for large volume subcutaneous administration,

the formulation comprising 125-155 mg/mL isatuximab and excipients,

wherein the excipients consist of histidine, arginine (Arg), sucrose, and Poloxamer 188, the formulation has a pH of 5.9-7.0 and a viscosity of at most 25 mPa·s at 20° C., and

wherein the large volume subcutaneous administration comprises an infusion volume of 5 mL to 30 mL, thereby treating the CD38 + hematological malignancy.

12 . The method of claim 11 , wherein the infusion volume comprises 10 mL to 15 mL.

13 . The method of claim 11 , wherein the infusion volume comprises 10 mL to 12 mL.

14 . The method of claim 11 , wherein the formulation comprises 140 mg/mL isatuximab.

15 . The method of claim 11 , wherein the CD38 + hematological maligancy comprises relapsed multiple myeloma, refractory multiple myeloma, or both.

16 . The method of claim 11 , further comprising administering to the subject one or more additional therapeutic agents selected from a corticosteroid, an immunomodulatory drug, a proteasome inhibitor, and a chemotherapy drug.

17 . The method of claim 11 , wherein the formulation has a viscosity of at most 14 mPa·s at 20° C.

18 . A method of treating a CD38 + hematological malignancy, comprising administering to a subject in need thereof an effective amount of a formulation suitable for subcutaneous administration,

the formulation comprising 125-155 mg/mL isatuximab and excipients,

wherein the excipients consist of histidine, arginine (Arg), sucrose, and Poloxamer 188, the formulation has a pH of 5.9-7.0 and a viscosity of at most 25 mPa·s at 20° C., and

wherein the formulation does not include hyaluronidase, thereby treating the CD38 + hematological malignancy.

19 . The method of claim 18 , wherein the formulation comprises 140 mg/mL isatuximab.

20 . The method of claim 18 , wherein the formulation is administered with a device selected from a syringe, a syringe driver, a pre-filled syringe, and an infusion pump.

21 . The method of claim 20 , wherein the device delivers a volume of the formulation comprising 10 mL to 12 mL.

22 . The method of claim 18 , wherein the formulation has a viscosity of at most 14 mPa·s at 20° C.

23 . The method of claim 18 , wherein the CD38 + hematological malignancy is multiple myeloma.

24 . A method of treating a CD38 + hematological malignancy, comprising administering to a subject in need thereof an effective amount of a formulation suitable for large volume subcutaneous administration,

the formulation comprising 125-155 mg/mL isatuximab and excipients,

wherein the excipients consist of histidine, arginine (Arg), sucrose, and Poloxamer 188,

wherein the formulation does not include hyaluronidase, and

wherein the large volume subcutaneous administration comprises an infusion volume of 5 mL to 30 mL, thereby treating the CD38 + hematological malignancy.

25 . The method of claim 24 , wherein the infusion volume comprises 10 mL to 12 mL.

26 . The method of claim 24 , wherein the formulation is further administered in combination with one or more additional therapeutic agents sequentially.

27 . The method of claim 24 , further comprising administering to the subject one or more additional therapeutic agents selected from a corticosteroid, an immunomodulatory drug, a proteasome inhibitor, and a chemotherapy drug.

28 . The method of claim 24 , further comprising administering to the subject dexamethasone and pomalidomide.

29 . The method of claim 24 , wherein the formulation has a viscosity of at most 14 mPa·s at 20° C.

30 . The method of claim 24 , wherein the formulation comprises 140 mg/mL isatuximab.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 2, 2026
From: BALLET, THOMAS; HUILLE, SYLVAIN; FILIPE, VASCO
To: SANOFI-AVENTIS RECHERCHE & DÉVELOPPEMENT
Reel/Frame 074823/0168 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 2, 2026
From: BANGARI, KIRAN; CHARI, RAVI; PEREZ-RAMIREZ, BERNARDO
To: GENZYME CORPORATION
Reel/Frame 074823/0256 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 2, 2026
From: SANOFI-AVENTIS RECHERCHE & DÉVELOPPEMENT
To: SANOFI-AVENTIS U.S. LLC
Reel/Frame 074823/0306 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 2, 2026
From: GENZYME CORPORATION
To: SANOFI-AVENTIS U.S. LLC
Reel/Frame 074823/0334 →
Continuity (3)
Division 17112768 · Dec 4, 2020
Provisional Application 62944082 · Dec 5, 2019
Related Publication 20260042861A1 · Feb 12, 2026
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