IP Library Granted Patent US 12,703,755
Granted Patent B2
US 12,703,755 · App. 17/764,308 · Granted Aug 11, 2026

Antibody targeting BCMA, bispecific antibody, and use thereof

Inventors: Lei Shi (Suzhou, CN); Xuekun Zhang (Suzhou, CN); Yun He (Suzhou, CN); Jianxun Zhao (Suzhou, CN); Wei Zhou (Suzhou, CN); Fei Chen (Suzhou, CN); Xiangyang Tan (Suzhou, CN); Yiping Rong (Suzhou, CN)
Assignee: HARBOUR BIOMED (SUZHOU) CO., LTD.
C07K16/2878A61K47/6849A61P35/00C07K16/2809A61K2039/505C07K2317/21C07K2317/24C07K2317/31C07K2317/53C07K2317/565C07K2317/732C07K2317/734C07K2317/76C07K2317/92
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Quick Facts
Patent No.
US 12,703,755
App. No.
17/764,308
Filed
Mar 28, 2022
Granted
Aug 11, 2026
Kind
B2
Art Unit
1642
USPC
424/136.1
Abstract

Provided are an antibody targeting BCMA, a bispecific antibody targeting BCMA and CD3, and applications thereof. The antibody targeting BCMA comprises two heavy chain variable regions, the heavy chain variable regions comprising HCDR1, HCDR2, and HCDR3 as shown in the amino acid sequences of SEQ ID NO: 22, SEQ ID NO: 33 and SEQ ID NO: 42, or HCDR1, HCDR2, and HCDR3 as shown in the amino acid sequences of SEQ ID NO: 26, SEQ ID NO: 37 and SEQ ID NO: 41. The antibody effectively targets human BCMA and binds to cynomolgus BCMA; the bispecific antibody effectively targets both human BCMA and human CD3, and can bind to cynomolgus BCMA and cynomolgus CD3.

Claims (13)

1 . A monoclonal antibody or antigen-binding fragments thereof targeting BCMA comprising a heavy chain variable region, wherein the heavy chain variable region comprises HCDR1, HCDR2 and HCDR3 comprising the amino acid sequences of SEQ ID NO: 26, SEQ ID NO: 37 and SEQ ID NO: 41, respectively.

2 . The monoclonal antibody or antigen-binding fragments thereof targeting BCMA of claim 1 , wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 60.

3 . An isolated nucleic acid encoding the monoclonal antibody or antigen-binding fragments thereof targeting BCMA of claim 1 .

4 . An isolated expression vector comprising the isolated nucleic acid of claim 3 .

5 . An isolated host cell comprising the isolated expression vector of claim 4 .

6 . An antibody drug conjugate comprising the monoclonal antibody or antigen-binding fragments thereof targeting BCMA of claim 1 , and a cytotoxic agent.

7 . A pharmaceutical composition comprising the monoclonal antibody or antigen-binding fragments thereof targeting BCMA of claim 1 , and a pharmaceutically acceptable carrier.

8 . A method for treating cancer in a subject in need thereof, comprising: administering an effective amount of the monoclonal antibody or antigen-binding fragments thereof targeting BCMA of claim 1 to the subject.

9 . A method for treating cancer in a subject in need thereof, comprising: administering an effective amount of the antibody drug conjugate of claim 6 to the subject.

10 . The monoclonal antibody or antigen-binding fragment thereof targeting BCMA of claim 2 , wherein the antibody targeting BCMA further comprises an Fc fragment.

11 . The monoclonal antibody targeting BCMA of claim 10 , wherein the Fc fragment is an Fc fragment of hIgG1, hIgG2, hIgG3 or hIgG4 or a mutant thereof, the mutant of the human heavy chain constant region being selected from the group consisting of: (1) L234A/L235A mutation; (2) knob mutation T366W and hole mutations T366S, L368A and Y407V; (3) knob mutation S354C and hole mutation Y349C.

12 . The monoclonal antibody or antigen-binding fragment thereof targeting BCMA of claim 2 , the heavy chain of the antibody targeting BCMA has an amino acid sequence of SEQ ID NO: 7.

13 . The isolated host cell of claim 5 , wherein the isolated host cell is a prokaryotic cell or a eukaryotic cell.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 22, 2024
From: NONA BIOSCIENCES (SUZHOU) CO., LTD.
To: HARBOUR BIOMED (SHANGHAI) CO., LTD.
Reel/Frame 067489/0370 →
CHANGE OF NAME Recorded Feb 2, 2023
From: HARBOUR BIOMED (SUZHOU) CO., LTD.
To: NONA BIOSCIENCES (SUZHOU) CO., LTD.
Reel/Frame 062634/0427 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 28, 2022
From: SHI, LEI; ZHANG, XUEKUN; HE, YUN; ZHAO, JIANXUN; ZHOU, WEI; CHEN, FEI; TAN, XIANGYANG; RONG, YIPING
To: HARBOUR BIOMED (SUZHOU) CO., LTD.
Reel/Frame 059416/0368 →
Priority Claims (1)
CN 201910941311.0 · Sep 30, 2019 · national
Continuity (1)
Related Publication 20220340673A1 · Oct 27, 2022
References Cited (47)
US 8846042B2 · Zhou · 2014 [cited by applicant]
US 9556264B2 · Shiraiwa et al. · 2017 [cited by applicant]
US 10562972B2 · Brentjens et al. · 2020 [cited by applicant]
US 10815304B2 · Qu et al. · 2020 [cited by applicant]
US 20070148164A1 · Farrington · 2007 [cited by examiner]
US 20200048348A1 · Trinklein et al. · 2020 [cited by applicant]
CN 103842383A · 2014 [cited by applicant]
CN 107206076A · 2017 [cited by applicant]
CN 104136610B · 2018 [cited by applicant]
CN 109485734A · 2019 [cited by applicant]
CN 109694413A · 2019 [cited by applicant]
CN 109843325A · 2019 [cited by applicant]
CN 109942708A · 2019 [cited by examiner]
WO WO2002085945A3 · 2003 [cited by applicant]
WO WO2009073533A2 · 2009 [cited by examiner]
WO WO2009080251A1 · 2009 [cited by applicant]
WO WO2009080252A1 · 2009 [cited by applicant]
WO WO2017084495A1 · 2017 [cited by applicant]
WO 2017125897A1 · 2017 [cited by applicant]
WO WO2018052503A1 · 2018 [cited by applicant]
WO WO2018119215A1 · 2018 [cited by applicant]
WO 2018140845A2 · 2018 [cited by applicant]
Rudikoff et al. Proceedings of the National Academy of Sciences USA, vol. 79, p. 1979-1983, 1982 (Year: 1982). [cited by examiner]
Kappell et al., Current Opinions in Biotechnology, vol. 3, p. 548-553, 1992 (Year: 1992). [cited by examiner]
Paul, Fundamental Immunology, 3rd Edition, 1993, pp. 292-295 (Year: 1993). [cited by examiner]
Houdebine et al., Journal of Biotechnology, vol. 34, p. 269-287, 1994 (Year: 1994). [cited by examiner]
Bendig M. M. Methods: A Companion to Methods in Enzymology, 1995; 8:83-93 (Year: 1995). [cited by examiner]
Wall et al., Theriogenology, vol. 45, p. 57-68, 1996 (Year: 1996). [cited by examiner]
Evans et al. Q. J. Med 1999: 92: 299-307 (Year: 1999). [cited by examiner]
Cuzick et al. The Lancet, vol. 361, p. 296-300, 2003 (Year: 2003). [cited by examiner]
Komenaka et al., Clinics in Dermatology, 2004, vol. 22, p. 251-265 (Year: 2004). [cited by examiner]
Schiffman et al., The New England Journal of Medicine, Vo. 353, No. 20, p. 2101-2104, 2005 (Year: 2005). [cited by examiner]
Houdebine. Comparative Immunology, Microbiology, and Infectious Diseases, vol. 32, p. 107-121, 2009 (Year: 2009). [cited by examiner]
Hernandez-Ledesma Peptides, vol. 30, p. 426-430, 2009 (Year: 2009). [cited by examiner]
Cohen et al. First in human study with GSK2857916, an antibody drug conjugated to microtubule-disrupting agent directed against B-cell maturation antigen (BCMA) in patients with relapsed/refractory multiple myeloma (MM)… [cited by examiner]
Sedykh et al. “Bispecific antibodies: design, therapy, perspectives.” Drug design, development and therapy (2018): 195-208. (Year: 2018). [cited by examiner]
Jan. 7, 2021 International Search Report issued in International Patent Application No. PCT/CN2020/118780. [cited by applicant]
Jan. 7, 2021 Written Opinion of the International Searching Authority issued in International Patent Application No. PCT/CN2020/118780. [cited by applicant]
Nov. 25, 2021 Taiwan Office Action issued in Patent Application No. 109133807. [cited by applicant]
Seckinger,A, et al. “Target Expression, Generation, Preclinical Activity, and Pharmacokinetics of the BCMA-T Cell Bispecific Antibody EM801 for Multiple Myeloma Treatment”, Cancer Cell, vol. 31, Mar. 13, 2017 (Mar. 13, … [cited by applicant]
Ahamadi-Fesharaki, R. et al. “Single-Chain Variable Fragment-Based Bispecific Antibodies: Hitting Two Targets with One Sophisticated Arrow”, Molecular Therapy: Oncolytics, vol. 14, Mar. 23, 2019 (Mar. 23, 2019), pp. 38-… [cited by applicant]
Trinklein ND, Pham D, Schellenberger U, et al. Efficient tumor killing and minimal cytokine release with novel T-cell agonist bispecific antibodies. MAbs. 2019;11(4):639-652. [cited by applicant]
Buelow B, Pham D, Clarke S, et al. Development of a fully human T cell engaging bispecific antibody for the treatment of multiple myeloma[J]. 2017. [cited by applicant]
Jun. 2, 2023 Search Report issued in Chinese Patent Application No. 202080068742.1. [cited by applicant]
Jun. 2, 2023 First Office Action issued in Chinese Patent Application No. 202080068742.1. [cited by applicant]
Hipp et al. Leukemia 31, 1743-1751; 2017 (Year: 2017). [cited by applicant]
Byers, T. CA Cancer Journal for Clinicians, vol. 49, No. 6, Nov./Dec. 1999 (Year: 1999). [cited by applicant]