Heterodimeric antibodies and antigen-binding fragment thereof
AssigneeChimagen Biosciences, Ltd.
InventorsZhenhao ZHOU, Jie ZHANG
Life of this patent
Estimating the term…
Abstract
Provided are novel polypeptide complexes that are useful for enhancing correct light chain pairing in a bispecific or multi-specific molecule. Further provided are nucleic acids comprising nucleotide sequences encoding the polypeptide complexes, vectors comprising the nucleic acids, host cells comprising the nucleic acids or the vectors, pharmaceutical compositions comprising the polypeptide complexes, as well as use of the polypeptide complexes for treating or preventing from diseases, conditions, or symptoms.
Claims62
A polypeptide complex comprising a first target-binding domain comprising a first target-binding moiety operably linked to a first constant moiety, wherein the first constant moiety comprises a first heavy chain constant region 1 (CH1) associated with a first light chain constant region (CL), wherein:
- a) the first CH1 region comprises a first amino acid residue at EU position n1, and the first CL region comprises a second amino acid residue at EU position n2, wherein n1:n2 position pair is selected from the group consisting of 128:118 and 173:160, and wherein the first amino acid residue and the second amino acid residue form a covalent bond;
- and
- b) the first CH1 region further comprises a third amino acid residue at EU position n3, and the first CL region further comprises a fourth amino acid residue at EU position n4, wherein n3:n4 position pair is selected from the group consisting of 183:176, 141:116, 126:121, and 218:122;
- wherein the third amino acid residue and the fourth amino acid residue form a non-covalent bond.
The polypeptide complex of any of the preceding claims, wherein covalent bond is a disulfide bond.
The polypeptide complex of any of preceding claims, wherein:
- (a) the third amino acid residue at EU position n3 is a positive-charged amino acid residue, and the fourth amino acid residue at EU position n4 is a negative-charged amino acid residue;
- or
- (b) the third amino acid residue at EU position n3 is a negative-charged amino acid residue, and the fourth amino acid residue at EU position n4 is a positive-charged amino acid residue.
The polypeptide complex of any one of the preceding claims, wherein at least one, two, three, or four of the first amino acid residue at EU position n1, the second amino acid residue at EU position n2, the third amino acid residue at EU position n3, and fourth amino acid residue at EU position n4 are introduced by substitution.
The polypeptide complex of any of the preceding claims, wherein the first target-binding domain comprises a first combination of substitutions at (n1+n2):(n3+n4) positions, and/or the second target-binding domain comprises a second combination of substitutions at (n5′+n6′):(n7′+n8′) positions, and wherein the first combination of substitutions and/or the second combination of substitutions are selected from the group consisting of:
- (L128C+S183K):(F118C+S176D), (L128C+S183K):(F118C+S176E), (L128C+S183R):(F118C+S176D), (L128C+S183R):(F118C+S176E), (L128C+S183H):(F118C+S176D), (L128C+S183H):(F118C+S176E), (L128C+S183D):(F118C+S176K), (L128C+S183D):(F118C+S176R), (L128C+S183D):(F118C+S176H), (L128C+S183E):(F118C+S176K), (L128C+S183E):(F118C+S176R), (L128C+S183E):(F118C+S176H), (V173C+A141K):(Q160C (or E160C)+F116D), (V173C+A141K):(Q160C (or E160C)+F116E), (V173C+A141R):(Q160C (or E160C)+F116D), (V173C+A141R):(Q160C (or E160C)+F116E), (V173C+A141H):(Q160C (or E160C)+F116D), (V173C+A141H):(Q160C (or E160C)+F116E), (V173C+A141D):(Q160C (or E160C)+F116K), (V173C+A141D):(Q160C (or E160C)+F116R), (V173C+A141D):(Q160C (or E160C)+F116H), (V173C+A141E):(Q160C (or E160C)+F116K), (V173C+A141E):(Q160C (or E160C)+F116R), (V173C+A141E):(Q160C (or E160C)+F116H), (V173C+S183K):(Q160C (or E160C)+S176D), (V173C+S183K):(Q160C (or E160C)+S176E), (V173C+S183R):(Q160C (or E160C)+S176D), (V173C+S183R):(Q160C (or E160C)+S176E), (V173C+S183H):(Q160C (or E160C)+S176D), (V173C+S183H):(Q160C (or E160C)+S176E), (V173C+S183D):(Q160C (or E160C)+S176K), (V173C+S183D):(Q160C (or E160C)+S176R), (V173C+S183D):(Q160C (or E160C)+S176H), (V173C+S183E):(Q160C (or E160C)+S176K), (V173C+S183E):(Q160C (or E160C)+S176R), (V173C+S183E):(Q160C (or E160C)+S176H), (L128C+F126K):(F118C+S121D), (L128C+F126K):(F118C+S121E), (L128C+F126R):(F118C+S121D), (L128C+F126R):(F118C+S121E), (L128C+F126H):(F118C+S121D), (L128C+F126H):(F118C+S121E), (L128C+F126D):(F118C+S121K), (L128C+F126D):(F118C+S121R), (L128C+F126D):(F118C+S121H), (L128C+F126E):(F118C+S121K), (L128C+F126E):(F118C+S121R), (L128C+F126E):(F118C+S121H), (V173C+F126K):(Q160C (or E160C)+S121D), (V173C+F126K):(Q160C (or E160C)+S121E), (V173C+F126R):(Q160C (or E160C)+S121D), (V173C+F126R):(Q160C (or E160C)+S121E), (V173C+F126H):(Q160C (or E160C)+S121D), (V173C+F126H):(Q160C (or E160C)+S121E), (V173C+F126D):(Q160C (or E160C)+S121K), (V173C+F126D):(Q160C (or E160C)+S121R), (V173C+F126D):(Q160C (or E160C)+S121H), (V173C+F126E):(Q160C (or E160C)+S121K), (V173C+F126E):(Q160C (or E160C)+S121R), (V173C+F126E):(Q160C (or E160C)+S121H), (L128C+K218D):(F118C+D122K), (L128C+K218D):(F118C+D122H), (L128C+K218D):(F118C+D122R), (L128C+K218E):(F118C+D122K), (L128C+K218E):(F118C+D122H), (L128C+K218E):(F118C+D122R), (V173C+K218D):(Q160C (or E160C)+D122K), (V173C+K218D):(Q160C (or E160C)+D122H), (V173C+K218D):(Q160C (or E160C)+D122R), (V173C+K218E):(Q160C (or E160C)+D122K), (V173C+K218E):(Q160C (or E160C)+D122H), and (V173C+K218E):(Q160C (or E160C)+D122R),
- provided that, when both the first combination of substitutions and the second combination of substitutions are selected, the n5′:n6′ position pair is different from the n1:n2 position pair, and the n7′:n8′ position pair is different from the n3:n4 position pair.
The polypeptide complex of any of the preceding claims, wherein the first target-binding moiety comprises a first polypeptide fragment operably linked to the first CL region, and/or the second target-binding moiety comprises a second polypeptide fragment operably linked to the second CL region, wherein the first polypeptide fragment has a different amino acid sequence from the second polypeptide fragment, or either the first polypeptide fragment or the second polypeptide fragment is absent from the polypeptide complex.
The polypeptide complex of any of the preceding claims, further comprising an Fc region operably linked to the first target-binding domain and the second target-binding domain.
Dependencies are inferred from the claim text.