US 12,466,886 B2
Method of treatment using a bispecific antibody binding bcma and CD3
Qiang Li, Shanghai (CN); Shixiang Jia, Shanghai (CN); Lili Zhao, Linyi (CN); Guimin Zhang, Linyi (CN); Zhong Liu, Linyi (CN); Xinlu Ma, Shanghai (CN); Yuan Yan, Shanghai (CN); Zhenyu Li, Linyi (CN); Xingxia Hu, Linyi (CN); Yuhua Zhang, Shanghai (CN); and Bin Li, Linyi (CN)
Assigned to SHANDONG NEW TIME PHARMACEUTICAL CO., LTD., Linyi (CN)
Filed by Shandong New Time Pharmaceutical Co., Ltd., Shandong (CN)
Filed on May 22, 2024, as Appl. No. 18/671,707.
Application 18/671,707 is a continuation of application No. 17/290,401, granted, now 12,030,939, previously published as PCT/CN2019/108057, filed on Sep. 26, 2019.
Claims priority of application No. 201811294887.4 (CN), filed on Nov. 1, 2018.
Prior Publication US 2024/0301063 A1, Sep. 12, 2024
Int. Cl. A61K 39/395 (2006.01); A61P 35/00 (2006.01); C07K 16/28 (2006.01); C07K 16/46 (2006.01); C12N 15/62 (2006.01); C12N 15/85 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/2809 (2013.01) [A61K 39/3955 (2013.01); A61P 35/00 (2018.01); C07K 16/2803 (2013.01); C07K 16/2878 (2013.01); C07K 16/468 (2013.01); C12N 15/62 (2013.01); C12N 15/85 (2013.01); A61K 2039/505 (2013.01); C07K 2317/24 (2013.01); C07K 2317/31 (2013.01); C07K 2317/33 (2013.01); C07K 2317/35 (2013.01); C07K 2317/52 (2013.01); C07K 2317/524 (2013.01); C07K 2317/526 (2013.01); C07K 2317/53 (2013.01); C07K 2317/565 (2013.01); C07K 2317/622 (2013.01); C07K 2317/73 (2013.01)] 1 Claim
OG exemplary drawing
 
1. A method of treating or improving a plasma cell disorder, a B cell disorder associated with a B cell maturation antigen (BCMA) expression, or an autoimmune disease, comprising a step of administering to a subject in need thereof with an effective amount of a bispecific antibody,
wherein the plasma cell disorder is selected from a group consists of multiple myeloma, plasmacytoma, plasma cell leukemia, macroglobulinaemia, amyloidosis, Waldenstrom's macroglobulinaemia, solitary bone plasmacytoma, extramedullary plasmacytoma, osteosclerotic myeloma, a heavy chain disease, monoclonal gammopathy of undetermined significance and smoldering multiple myeloma;
wherein the bispecific antibody is composed of two identical polypeptide chains bonded covalently to form a tetravalent homodimer, wherein each of the polypeptide chains has an amino acid sequence as set forth in SEQ ID NO: 20, wherein each of the polypeptide chains consists of an anti-BCMA (B cell maturation antigen) scFv, a linker peptide L2, an anti-CD3 scFv, and an Fc fragment in order, wherein VH (heavy chain variable region) and VL (light chain variable region) within the anti-BCMA scFv and the anti-CD3 scFv are connected by a linker sequence respectively, and wherein the amino acid sequence of the linker sequence is amino acids 3-17 of SEQ ID NO: 10, wherein the amino acid sequences of the VH and the VL of the anti-BCMA scFv are SEQ ID NO: 7 and SEQ ID NO: 8, respectively, wherein the amino acid sequences of the VH and the VL of the anti-CD3 scFv are SEQ ID NO: 17 and SEQ ID NO: 18, respectively, wherein the linker peptide L2 consists of a flexible peptide and a rigid peptide, wherein the amino acid sequence of the flexible peptide is SEQ ID NO: 29, and wherein the amino acid sequence of the rigid peptide is SEQ ID NO: 24.