Bi- and multivalent albumin binders

HK40138721APending Publication Date: 2026-10-09ABLYNX NV +1
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Patent Information

Application Number
HK62026127095
Authority / Receiving Office
HK · HK
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-22
Filing Date
2026-08-05
Publication Date
2026-10-09
Estimated Expiration
2044-09-19

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Abstract

The present technology relates to bi- and multivalent albumin binders. In particular, the present technology relates to novel and improved human serum albumin binders, specifically to polypeptides that comprise (i) at least one immunoglobulin single variable domain (ISVD) which specifically binds to a serum albumin protein or at least one human serum albumin protein and (ii) at least one further moiety specifically binding to a serum albumin protein or at least one human serum albumin protein.
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Description

This technology relates to bivalent and multivalent albumin binders. In particular, this technology relates to novel and improved human serum albumin binders, especially peptides comprising (i) at least one immunoglobulin single variable domain (ISVD) specifically binding to serum albumin or at least one human serum albumin and (ii) at least one additional portion specifically binding to serum albumin or at least one human serum albumin. Abstract

Claims

CLAIMS1. A polypeptide comprising: at least one immunoglobulin single variable domain (ISVD) which specifically binds to a serum albumin protein; and at least one further moiety specifically binding to a serum albumin protein or at least one human serum albumin protein, wherein said (i) at least one ISVD essentially consists of 4 framework regions (FR1 to FR4, respectively) and three complementarity determining regions (CDR1 to CDR3, respectively), wherein:CDR1 comprises the amino acid sequence of SEQ ID NO: 1 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 1 or CDR1 comprises the amino acid sequence of SEQ ID NO: 22 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 22CDR2 comprises the amino acid sequence of SEQ ID NO: 2 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 2; andCDR3 comprises the amino acid sequence of SEQ ID NO: 3 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 3, and / orCDR1 comprises the amino acid sequence of SEQ ID NO: 36 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 36;CDR2 comprises the amino acid sequence of SEQ ID NO: 37 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 37; andCDR3 comprises the amino acid sequence of SEQ ID NO: 38 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 38, and / orCDR1 comprises the amino acid sequence of SEQ ID NO: 55 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 55;CDR2 comprises the amino acid sequence of SEQ ID NO: 56 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 56; andCDR3 comprises the amino acid sequence of SEQ ID NO: 57 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 57wherein the CDR sequences are determined according to AbM numbering.

2. The polypeptide according to claim 1, wherein the (i) at least one ISVD specifically binding to a serum albumin protein comprises: a CDR1 that comprises the amino acid sequence of SEQ ID NO: 1 or 22, a CDR2 that comprises the amino acid sequence of SEQ ID NO: 2; and a CDR3 that comprises the amino acid sequence of SEQ ID NO: 3; or a CDR1 that comprises the amino acid sequence of SEQ ID NO: 36, a CDR2 that comprises the amino acid sequence of SEQ ID NO: 37; and a CDR3 that comprises the amino acid sequence of SEQ ID NO: 38; or a CDR1 that comprises the amino acid sequence of SEQ ID NO: 55, a CDR2 that comprises the amino acid sequence of SEQ ID NO: 56; and a CDR3 that comprises the amino acid sequence of SEQ ID NO: 57; wherein the CDR sequences are determined according to AbM numbering.

3. The polypeptide according to any one of claims 1 to 2, wherein the (i) at least one ISVD specifically binding to a serum albumin protein has: a degree of sequence identity with any one of the sequences as defined in SEQ ID NO's: 4 to 21, 54, or 91 to 93 of at least 85%, preferably at least 90%, more preferably at least 95%, even more preferably a degree of sequence identity with any one of the sequences as defined in SEQ ID NO's: 4 to 21, 54, or 91 to 93 of 100%, in which any C- terminal extension that may be present as well as the CDRs are not taken into account for determining the degree of sequence identity; and / or no more than 7, preferably no more than 5, such as only 3, 2 or 1 amino acid differences with any one of the sequences as defined in SEQ ID NO's: 4 to 21, 54, or 91 to 93.

4. The polypeptide according to any one of claims 1 to 3, wherein the (i) at least one ISVDs comprised therein is derived from a VH, a humanized VH, a human VH, a VHH, a humanized VHH or a camelized VH (derived from a heavy-chain ISVD).

5. The polypeptide according to any one of claims 1 to 4, wherein the polypeptide comprises: at least one immunoglobulin single variable domain (ISVD) which specifically binds to a serum albumin protein as defined in any one of claims 1 to 5, and at least one human serum albumin protein.

6. The polypeptide according to any one of claims 1 to 5, wherein the polypeptide comprises: at least one immunoglobulin single variable domain (ISVD) which specifically binds to a serum albumin protein as defined in any one of claims 1 to 5, and at least one further moiety specifically binding to a serum albumin protein, wherein the (ii) at least one further moiety specifically binding to a serum albumin protein is selected from an antibody or fragment thereof, a single chain variable fragment (scFv), preferably an immunoglobulin single variable domain (ISVD), a DARP- in, an affibody, an Affitin and an albumin binding domain (ABD).

7. The polypeptide according to any one of claims 1 to 6, wherein the (ii) at least one further moiety specifically binding to a serum albumin protein is an ISVD comprising three complementarity determining regions (CDR1 to CDR3, respectively), wherein:CDR1 comprises the amino acid sequence of SEQ ID NO: 1 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 1 or CDR1 comprises the amino acid sequence of SEQ ID NO: 22 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 22;CDR2 comprises the amino acid sequence of SEQ ID NO: 2 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 2; andCDR3 comprises the amino acid sequence of SEQ ID NO: 3 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 3, and / orCDR1 comprises the amino acid sequence of SEQ ID NO: 36 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 36;CDR2 comprises the amino acid sequence of SEQ ID NO: 37 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 37; andCDR3 comprises the amino acid sequence of SEQ ID NO: 38 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 38, and / orCDR1 comprises the amino acid sequence of SEQ ID NO: 55 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 55;CDR2 comprises the amino acid sequence of SEQ ID NO: 56 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 56; andCDR3 comprises the amino acid sequence of SEQ ID NO: 57 or has 3, 2 or 1 amino acid difference(s) with SEQ ID NO: 57, wherein the CDR sequences are determined according to AbM numbering.

8. The polypeptide according to claim 7, wherein the (ii) at least one further moiety specifically binding to a serum albumin protein is an ISVD which has: a degree of sequence identity with any one of the sequences as defined in SEQ ID NO's: 4 to 21, 54, or 91 to 93 of at least 85%, preferably at least 90%, more preferably at least 95%, in which any C-terminal extension that may be present as well as the CDRs are not taken into account for determining the degree of sequence identity; and / or no more than 7, preferably no more than 5, such as only 3, 2 or 1 amino acid differences with any one of the sequences as defined in SEQ ID NO's: 4 to 21, 54, or 91 to 93, preferably wherein the ((ii) at least one further moiety specifically binding to a serum albumin protein is an ISVD which has a sequence that is chosen from SEQ ID NO's: 4 to 21, 54, or 91 to 93.

9. A fusion protein comprising the polypeptide as defined in any of claims 1 to 8, wherein the fusion protein further comprises one or more (such as one or two) other amino acid sequences, (binding) domains, binding units or other moieties or chemical entities.

10. The fusion protein according to claim 9, wherein the fusion protein comprises the polypeptide as defined in any one of claims 1 to 8 and at least one therapeutic and / or targetingmoiety, optionally wherein the therapeutic and / or targeting moiety comprises at least one ISVD specifically binding to a therapeutic target, or wherein the fusion protein further comprises one further ISVD specifically binding to (human) serum albumin.

11. A composition comprising the polypeptide as defined in any one of claims 1 to 8 and / or a fusion protein as defined in any one of claims 9 to 10, optionally wherein the composition is a pharmaceutical composition.

12. Nucleic acid or nucleic acid sequence encoding the polypeptide as defined in any one of claims 1 to 8 and / or the fusion protein as defined in any one of claims 9 to 10.

13. Vector comprising a nucleic acid or nucleic acid sequence as defined in claim 12.

14. Non-human host or host cell comprising a vector comprising a nucleic acid sequence as defined in claim 13 or expressing a nucleic acid sequence as defined in claim 12.

15. The polypeptide according to any one of claims 1 to 8, the fusion protein as defined in any one of claims 9 to 10, and / or the composition according to claim 11 for use as a medicament.