Granted Patent
B2
US 12,630,609 · App. 14/128,681 · Granted May 19, 2026
Techniques for predicting, detecting and reducing a specific protein interference in assays involving immunoglobulin single variable domains
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 Neotere Ververken (Merelbeke, BE); Gerald Beste (Ghent, BE); Guy Hermans (Merelbeke, BE); Soren Steffensen (Etterbeek, BE); Alexander Szyroki (Oldenburg, DE); Tinneke Denayer (De Pinte, BE)
C07K16/00C07K16/18A61K39/39533A61K2039/505C07K16/28C07K16/2875C07K16/42C07K16/4283C07K2317/22C07K2317/31C07K2317/34C07K2317/35C07K2317/567C07K2317/569C07K2317/92C07K2317/94C07K2319/30G01N33/5306G01N33/54393G01N33/6854G01N33/6857
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Abstract
This invention provides, and in certain specific but non-limiting aspects relates to: assays that can be used to predict whether a given ISV will be subject to protein interference as described herein and/or give rise to an (aspecific) signal in such an assay (such as for example in an ADA immunoassay). Such predictive assays could for example be used to test whether a given ISV could have a tendency to give rise to such protein interference and/or such a signal; to select ISV's that are not or less prone to such protein interference or to giving such a signal; as an assay or test that can be used to test whether certain modification(s) to an ISV will (fully or partially) reduce its tendency to give rise to such interference or such a signal; and/or as an assay or test that can be used to guide modification or improvement of an ISV so as to reduce its tendency to give rise to such protein interference or signal; —methods for modifying and/or improving ISV's to as to remove or reduce their tendency to give rise to such protein interference or such a signal; —modifications that can be introduced into an ISV that remove or reduce its tendency to give rise to such protein interference or such a signal; ISV's that have been specifically selected (for example, using the assay(s) described herein) to have no or low(er)/reduced tendency to give rise to such protein interference or such a signal; modified and/or improved ISV's that have no or a low(er)/reduced tendency to give rise to such protein interference or such a signal.
Claims (22)
1 . A fusion protein comprising:
at least two heavy chain variable domains (VH or VHH), wherein
one of the at least two heavy chain variable domains (VH or VHH) is at the C-terminal end of the fusion protein,
wherein the heavy chain variable domain (VH or VHH) at the C-terminal end of the fusion protein:
does not comprise R at Kabat position 83; and
terminates in the sequence VTVSS(X) n (SEQ ID NO: 34), in which n is 1 to 5 and each X is independently chosen from the group consisting of alanine (A), glycine (G), valine (V), leucine (L) and isoleucine (I).
2 . The fusion protein according to claim 1 , in which said VH is a camelized VH or wherein said VHH is a humanized VHH.
3 . The fusion protein according to claim 1 , wherein n=1.
4 . Pharmaceutical composition that comprises a fusion protein according to claim 1 , and at least one suitable carrier, diluent or excipient.
5 . The fusion protein according to claim 1 , in which:
(a) n=1, 2 or 3 in which each X═Ala or Gly; or
(b) n=1, 2 or 3 in which each X═Ala; or
(c) n=1, 2 or 3 in which each X═Gly; or
(d) n=2 or 3 in which at least one X═Ala or Gly, with the remaining amino acid residue X being independently chosen from the group consisting of alanine (A), glycine (G), valine (V), leucine (L) and isoleucine (I); or
(e) n=2 or 3 in which all but one X═Ala or Gly, with the remaining amino acid residue X being independently chosen from the group consisting of alanine (A), glycine (G), valine (V), leucine (L) and isoleucine (I).
6 . The fusion protein according to claim 5 , in which:
(a) n=1, 2 or 3 in which each X═Ala or Gly; or
(b) n=1, 2 or 3 in which each X═Ala; or
(c) n=1, 2 or 3 in which each X═Gly.
7 . The fusion protein according to claim 6 , wherein n=1.
8 . The fusion protein according to claim 5 , in which said VH is a camelized VH or wherein said VHH is a humanized VHH.
9 . Pharmaceutical composition that comprises a fusion protein according to claim 5 , and at least one suitable carrier, diluent or excipient.
Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 10, 2022
From: ABLYNX N.V.
To: SANOFI
Reel/Frame 059883/0339 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 23, 2018
From: BAUMEISTER, JUDITH; BOUCHE, MARIE-PAULE LUCIENNE ARMANDA; BOUTTON, CARLO; BUYSE, MARIE-ANGE; SNOECK, VEERLE; STAELENS, STEPHANIE; DROMBRECHT, BRUNO; SCHOTTE, PETER; VERVERKEN, CEDRIC JOZEF NEOTERE; BESTE, GERALD; HERMANS, GUY; STEFFENSEN, SOREN; SZYROKI, ALEXANDER; DENAYER, TINNEKE
To: ABLYNX N.V.
Reel/Frame 045884/0497 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 5, 2014
From: BAUMEISTER, JUDITH; BOUCHE, MARIE-PAULE LUCIENNE ARMANDA; BOUTTON, CARLO; BUYSE, MARIE-ANGE; SNOECK, VEERLE; STAELENS, STEPHANIE
To: ABLYNX N.V.
Reel/Frame 032354/0342 →
Continuity (8)
Continuation In Part
PCTEP2012061304
· Jun 14, 2012
Continuation In Part
PCTEP2011067132
· Sep 30, 2011
Provisional Application
61541368
· Sep 30, 2011
Provisional Application
61500464
· Jun 23, 2011
Provisional Application
61500360
· Jun 23, 2011
Related Publication
20180009888A9
· Jan 11, 2018
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