IP Library › Granted Patent US 12,528,874
Granted Patent B2
US 12,528,874 · App. 18/055,522 · Granted Jan 20, 2026

Methods and compositions for treating systemic lupus erythematosus (SLE) with mosunetuzumab

Inventors: Susan Lee Limb (South San Francisco, CA); Matthew Dominic Cascino (Millbrae, CA); Monique Nicoll (South San Francisco, CA); Jay Prakash Garg (Menlo Park, CA); Michael Zecong Liao (Bellevue, WA)
Assignee: Genentech, Inc.
C07K16/2887A61K31/573A61P37/06
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Quick Facts
Patent No.
US 12,528,874
App. No.
18/055,522
Granted
Jan 20, 2026
Kind
B2
Abstract

Disclosed herein are compositions and methods for the treatment of systemic lupus erythematosus using anti-CD20/anti-CD3 bispecific antibodies, such as mosunetuzumab.

Claims (30)

1 . A method of treating a patient, comprising administering to the patient an effective amount of mosunetuzumab, wherein:

(a) the patient has systemic lupus erythematosus;

(b) mosunetuzumab is administered according to a dosing regimen comprising at least a first dosing cycle of about 8 days, wherein the first dosing cycle comprises a first dose (C1D1) and a second dose (C1D2) of mosunetuzumab, wherein C1D1 is between about 1.6 mg to about 5 mg on day 1 of the cycle and the C1D2 is between about 15 mg to about 60 mg on day 8 of the cycle; and

(c) mosunetuzumab is administered subcutaneously.

2 . The method of claim 1 , wherein C1D1 is 1.6 mg or 5 mg and C1D2 is 15 mg, 45 mg, or 60 mg.

3 . The method of claim 1 , wherein at least one symptom of SLE is reduced.

4 . The method of claim 3 , wherein the at least one reduced symptom of SLE is measured using a Patient Global Impression of Severity (PGI-S), a Physician Global Assessment (PGA), a decrease in titer of antinuclear antibody (ANA), a decrease in titer of anti-double stranded DNA (dsDNA) antibody (IgG) titer, an increase in complement C3 levels, or an increase in complement C4 levels, wherein the at least one reduced symptom comprises: (a) a change in response of at least one step on the PGI-S from a previous response, wherein the change is one change of from:

(i) very severe to severe;

(ii) severe to moderate;

(iii) moderate to mild; or

(iv) mild to none; or

(b) a change in rating by a healthcare provider using the PGA, wherein the change is a decrease from a previous rating using the PGA, wherein the decrease from a previous rating using the PGA is >0.3 points from baseline.

5 . The method of claim 1 , further comprising administering to the patient a corticosteroid, cyclophosphamide, a B-cell-depleting therapy, or calcineurin inhibitor.

6 . The method of claim 5 , wherein the corticosteroid comprises hydrocortisone, cortisone acetate, prednisolone, dexamethasone, betamethasone, triamcinolone, beclometasone, methylprednisolone or prednisone; wherein the B-cell-depleting therapy comprises administering rituximab, ocrelizumab, ofatumumab, or obinutuzumab, or wherein the calcineurin inhibitor comprises ciclosporin, tacrolimus, or vocolosporin.

7 . A method of treating a patient of a population of patients, comprising administering to the patient an effective amount of mosunetuzumab, wherein:

(a) the population of patients has systemic lupus erythematosus;

(b) mosunetuzumab is administered according to a dosing regimen comprising at least a first dosing cycle of about 8 days, wherein the first dosing cycle comprises a first dose (C1D1) and a second dose (C1D2) of mosunetuzumab, wherein C1D1 is between about 1.6 mg to about 5 mg on day 1 of the cycle and the C1D2 is between about 15 mg to about 60 mg on day 8 of the cycle; and

(c) mosunetuzumab is administered subcutaneously.

8 . The method of claim 7 , wherein C1D1 is 1.6 mg or 5 mg, and C1D2 is 15 mg, 45 mg, or 60 mg.

9 . The method of claim 7 , wherein at least one symptom of SLE is reduced.

10 . The method of claim 9 , wherein the at least one reduced symptom of SLE is measured using a Patient Global Impression of Severity (PGI-S), a Physician Global Assessment (PGA), a decrease in titer of antinuclear antibody (ANA), a decrease in titer of anti-double stranded DNA (dsDNA) antibody (IgG) titer, an increase in complement C3 levels, or an increase in complement C4 levels, wherein the at least one reduced symptom comprises:

(a) a change in response of at least one step on the PGI-S from a previous response, wherein the change is one change of from:

(i) very severe to severe;

(ii) severe to moderate;

(iii) moderate to mild; or

(iv) mild to none;

or

(b) a change in rating by a healthcare provider using the PGA, wherein the change is a decrease from a previous rating using the PGA, wherein the decrease from a previous rating using the PGA is ≥0.3 points from baseline.

11 . The method of claim 7 , further comprising administering to the patient a corticosteroid, cyclophosphamide, a B-cell-depleting therapy, or calcineurin inhibitor.

12 . The method of claim 11 , wherein the corticosteroid comprises hydrocortisone, cortisone acetate, prednisolone, dexamethasone, betamethasone, triamcinolone, beclometasone, methylprednisolone or prednisone; wherein the B-cell-depleting therapy comprises administering rituximab, ocrelizumab, ofatumumab, or obinutuzumab, or wherein the calcineurin inhibitor comprises ciclosporin, tacrolimus, or vocolosporin.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 23, 2022
From: LIMB, SUSAN LEE; CASCINO, MATTHEW DOMINIC; NICOLL, MONIQUE; GARG, JAY PRAKASH; LIAO, MICHAEL ZECONG
To: GENENTECH, INC.
Reel/Frame 062217/0223 →
Continuity (3)
Provisional Application 63378353 · Oct 19, 2022
Provisional Application 63264139 · Nov 16, 2021
Related Publication 20230287133A1 · Sep 14, 2023
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