US 12,098,210 B2
Methods of treating cancers and enhancing efficacy of BCMAxCD3 bispecific antibodies
Jenna Goldberg, Raritan, NJ (US); Jagoda Jasielec, Spring House, PA (US); Raluca Verona, Spring House, PA (US); and Brendan Weiss, Spring House, PA (US)
Assigned to Janssen Biotech, Inc., Horsham, PA (US)
Filed by JANSSEN BIOTECH, INC., Horsham, PA (US)
Filed on Nov. 2, 2022, as Appl. No. 18/052,174.
Claims priority of provisional application 63/348,036, filed on Jun. 2, 2022.
Claims priority of provisional application 63/288,279, filed on Dec. 10, 2021.
Claims priority of provisional application 63/275,368, filed on Nov. 3, 2021.
Prior Publication US 2023/0272102 A1, Aug. 31, 2023
Int. Cl. C07K 16/28 (2006.01); A61K 31/454 (2006.01); A61K 31/573 (2006.01); A61K 39/00 (2006.01); A61K 39/395 (2006.01); A61P 35/00 (2006.01); C07K 16/30 (2006.01)
CPC C07K 16/2878 (2013.01) [A61K 31/454 (2013.01); A61K 31/573 (2013.01); A61K 39/3955 (2013.01); A61K 39/39558 (2013.01); A61P 35/00 (2018.01); C07K 16/2809 (2013.01); C07K 16/2896 (2013.01); C07K 16/30 (2013.01); A61K 2039/507 (2013.01); A61K 2039/545 (2013.01); C07K 2317/31 (2013.01)] 10 Claims
OG exemplary drawing
 
1. A method of treating multiple myeloma in a human subject in need thereof, comprising administering to the subject a BCMAxCD3 bispecific antibody and an anti-CD38 antibody in 28-day treatment cycles, wherein the method comprises:
subcutaneously administering to the subject the BCMAxCD3 bispecific antibody in step-up doses of 0.06 mg/kg and 0.3 mg/kg followed by a dose of 1.5 mg/kg once per week during treatment cycle 1, a dose of 1.5 mg/kg once per week during treatment cycle 2, and a dose of 3 mg/kg once every two weeks beginning in treatment cycle 3, and
subcutaneously administering to the subject the anti-CD38 antibody at a dose of 1800 mg once per week during treatment cycles 1 and 2, once every two weeks during treatment cycles 3-6 and once every 4 weeks beginning in treatment cycle 7,
wherein the BCMAxCD3 bispecific antibody comprises:
(1) a BCMA binding domain comprising a heavy chain variable region (VH) having heavy chain complementarity determining regions (HCDRs) HCDR1, HCDR2 and HCDR3 of the amino acid sequences of SEQ ID NO: 18, SEQ ID NO: 19, and SEQ ID NO: 20, respectively, and a light chain variable region (VL) having light chain complementarity determining regions (LCDRs) LCDR1, LCDR2 and LCDR3 of the amino acid sequences of SEQ ID NO: 21, SEQ ID NO: 22, and SEQ ID NO: 23, respectively, and
(2) a CD3 binding domain comprising a VH having HCDR1, HCDR2 and HCDR3 of the amino acid sequences of SEQ ID NO: 28, SEQ ID NO: 29, and SEQ ID NO: 30, respectively, and a VL having LCDR1, LCDR2 and LCDR3 of the amino acid sequences of SEQ ID NO: 31, SEQ ID NO: 32, and SEQ ID NO: 33, respectively,
wherein the method is effective in treating the multiple myeloma.