	US 12,281,177 B2
	Heterodimer molecule based on CH3 domain, and preparation method and use thereof
Ting Xu, Jiangsu (CN)
Assigned to JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD., Jiangsu (CN); and SUZHOU ALPHAMAB CO., LTD., Jiangsu (CN)
Filed by JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD., Jiangsu (CN); and SUZHOU ALPHAMAB CO., LTD., Jiangsu (CN)
Filed on Oct. 7, 2021, as Appl. No. 17/496,240.
Application 17/496,240 is a continuation of application No. 16/062,405, granted, now 11,168,149, previously published as PCT/CN2016/110252, filed on Dec. 16, 2016.
Claims priority of application No. 201510938995.0 (CN), filed on Dec. 16, 2015.
Prior Publication US 2022/0017643 A1, Jan. 20, 2022
Int. Cl. C07K 16/46 (2006.01); A61K 39/395 (2006.01); C07K 16/00 (2006.01); C07K 19/00 (2006.01); C12N 15/11 (2006.01); C12N 15/62 (2006.01); C12P 21/00 (2006.01)

CPC C07K 16/468 (2013.01) [A61K 39/395 (2013.01); C07K 16/00 (2013.01); C07K 16/46 (2013.01); C07K 19/00 (2013.01); C12N 15/11 (2013.01); C12N 15/62 (2013.01); C12P 21/00 (2013.01); C07K 2317/31 (2013.01); C07K 2317/524 (2013.01); C07K 2317/526 (2013.01); C07K 2317/94 (2013.01); C07K 2319/74 (2013.01)]

3 Claims

1. A bispecific antibody comprising heterodimeric CH3 domains, comprising a first polypeptide chain and a second polypeptide chain, wherein said first polypeptide chain comprises a first CH3 domain of an antibody heavy chain constant region, said second polypeptide chain comprises a second CH3 domain of an antibody heavy chain constant region, and comparing to a corresponding wild-type CH3 domain of a human antibody heavy chain constant region, said first CH3 domain and said second CH3 domain comprise amino acid mutations and said amino acid mutations consist of substitution mutations selected from the following groups:

1) said first CH3 domain: T366W+F405K, said second CH3 domain: T366S+L368A+Y407V+K409A;

2) said first CH3 domain: T366W+F405K+D399S, said second CH3 domain: T366S+L368A+Y407V+K409A+K392D;

3) said first CH3 domain: T366W+F405K, said second CH3 domain: T366S+L368G+Y407A+K409A;

4) said first CH3 domain: T366W+F405K+Y349D, said second CH3 domain: T366S+L368A+Y407V+K409A+E357A; and,

5) said first CH3 domain: T366W+F405K+Y349D+S354D, said second CH3 domain: T366S+L368A+Y407V+K409A+E357A;

wherein said amino acid is numbered according to the EU index of the KABAT numbering of the antibody Fc region, and wherein said wild-type CH3 domain of the human antibody heavy chain constant region is a CH3 domain of a human IgG1 heavy chain constant region.