Granted Patent B2

US 12,516,105 · App. 17/408,987 · Granted Jan 6, 2026

Inventors: Judith Baumeister (Mechelen, BE); Marie-Paule Lucienne Armanda Bouche (Gentbrugge, BE); Carlo Boutton (Wielsbeke, BE); Marie-Ange Buyse (Merelbeke, BE); Veerle Snoeck (Zingem, BE); Stephanie Staelens (Wevelgem, BE); Bruno Dombrecht (Heusden, BE); Peter Schotte (De Pinte, BE); Cedric Jozef Néotère Ververken (Merelbeke, BE); Gerald Beste (Ghent, BE); Guy Hermans (Merelbeke, BE); Soren Steffensen (Etterbeek, BE); Alexander Szyroki (Goldenstedt, DE); Tinneke Denayer (De Pinte, BE)

Assignees: Ablynx N.V.; Sanofi

C07K16/00C07K16/18A61K39/39533A61K2039/505C07K16/28C07K16/2875C07K16/42C07K16/4283C07K2317/22C07K2317/31C07K2317/34C07K2317/35C07K2317/567C07K2317/569C07K2317/92C07K2317/94C07K2319/30G01N33/5306G01N33/54393G01N33/6854G01N33/6857

Abstract

Claims (13)

1 . A method comprising:

(i) introducing one or more amino acid substitutions or additions in the C-terminal region of an immunoglobulin single variable domain (ISV), or a protein or a polypeptide comprising the ISV at its C-terminus, to generate a modified ISV, protein, or polypeptide, wherein the C-terminal region comprises Kabat positions 11, 13, 14, 15, 82, 82a, 82b, 83, 84, 107, 108, 109, 110, 111, 112, and 113; and

(ii) performing an immunoassay comprising the steps of: contacting the modified ISV, protein or polypeptide with a biological sample comprising antibodies or with an antibody obtained from the biological sample, wherein the biological sample is from a subject that has never received an ISV; and detecting any antibody bound to the modified ISV, protein or polypeptide.

2 . The method of claim 1 , wherein the sample is a biological fluid of a human subject.

3 . The method of claim 2 , wherein the biological fluid is a whole blood sample, a serum sample, a plasma sample, an ocular fluid sample, a bronchoalveolar fluid sample, or a cerebrospinal fluid sample.

4 . The method of claim 1 , wherein the ISV is a VHH, a humanized VHH, a VH, or a camelized VH.

5 . The method of claim 1 , wherein step (i) comprises introducing an amino acid substitution in the ISV at one or more of Kabat positions 11, 13, 14, 15, 82, 82a, 82b, 83, 84, 107, 108, 109, 110, 111, 112, and 113.

6 . The method of claim 5 , wherein the sample is a biological fluid of a human subject.

7 . The method of claim 6 , wherein the biological fluid is a whole blood sample, a serum sample, a plasma sample, an ocular fluid sample, a bronchoalveolar fluid sample, or a cerebrospinal fluid sample.

8 . The method of claim 5 , wherein the ISV is a VHH, a humanized VHH, a VH, or a camelized VH.

9 . A method comprising:

(i) introducing one or more amino acid substitutions or additions in the C-terminal region of an immunoglobulin single variable domain (ISV), or a protein or a polypeptide comprising the ISV at its C-terminus, to generate a modified ISV, protein, or polypeptide, wherein the C-terminal region comprises Kabat positions 11, 13, 14, 15, 82, 82a, 82b, 83, 84, 107, 108, 109, 110, 111, 112, and 113;

(ii) performing an immunoassay comprising the steps of: independently contacting the modified ISV, protein or polypeptide and the ISV, protein or polypeptide without the one or more amino acid substitutions with a human biological sample comprising antibodies or with an antibody obtained from the human biological sample, wherein the human biological sample is from a subject that has never received an ISV; and measuring antibody binding to the modified ISV, protein or polypeptide relative to the ISV, protein or polypeptide without the one or more amino acid substitutions.

Assignments (2)

Continuity (8)

References Cited (314)