IP Library Granted Patent US 12,466,890
Granted Patent B1
US 12,466,890 · App. 19/005,529 · Granted Nov 11, 2025

TL1A binding proteins and methods of use

Inventors: Eric Franklin Zhu (Cambridge, MA); Hussam Hisham Shaheen (Auburn, NH); Daniel Rios (Boston, MA)
Assignee: Paragon Therapeutics, Inc.
C07K16/2875A61K2039/505C07K2317/76C07K2317/92C07K2317/94
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Quick Facts
Patent No.
US 12,466,890
App. No.
19/005,529
Granted
Nov 11, 2025
Kind
B1
Abstract

Provided herein are TL1A binding proteins (e.g., antibodies that bind TL1A) and methods of use.

Claims (41)

1 . A TL1A binding protein, comprising:

a heavy chain variable region (VH) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 5, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 15, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 25; and

a light chain variable region (VL) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 35, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 45, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 55; or

a heavy chain variable region (VH) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 6, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 16, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 26; and

a light chain variable region (VL) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 36, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 46, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 56; or

a heavy chain variable region (VH) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 7, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 17, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 27; and

a light chain variable region (VL) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 37, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 47, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 57; or

a heavy chain variable region (VH) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 8, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 18, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 28; and

a light chain variable region (VL) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 38, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 48, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 58; or

a heavy chain variable region (VH) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 9, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 19, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 29; and

a light chain variable region (VL) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 39, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 49, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 59; or

a heavy chain variable region (VH) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 10, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 20, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 30; and

a light chain variable region (VL) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 40, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 50, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 60.

2 . The TL1A binding protein of claim 1 , wherein

the VH comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 185 and the VL comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 195,

the VH comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 186 and the VL comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 196,

the VH comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 187 and the VL comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 197,

the VH comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 188 and the VL comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 198,

the VH comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 189 and the VL comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 199, or

wherein the VH comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 190 and the VL comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 200.

3 . The TL1A binding protein of claim 1 , wherein the TL1A binding protein is an antibody having IgG1, IgG2 or IgG4 immunoglobulin Fc domain.

4 . The TL1A binding protein of claim 3 , wherein the Fc domain is a modified Fc that extends half-life of the TL1A binding protein as compared to a TL1A binding protein that does not comprise the modified Fc domain.

5 . The TL1A binding protein of claim 3 , wherein the Fc domain is an IgG1 Fc domain and comprises amino acid modifications L234A/L235A (LALA) and/or M252Y, S254T, and T256E (YTE) according to Kabat numbering.

6 . An injectable liquid composition comprising the TL1A binding protein of claim 1 and a pharmaceutically acceptable carrier.

7 . A TL1A binding protein, comprising:

a heavy chain variable region (VH) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 9, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 19, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 29; and

a light chain variable region (VL) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 39, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 49, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 59.

8 . A TL1A binding protein, comprising:

a heavy chain variable region (VH) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 10, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 20, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 30; and

a light chain variable region (VL) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 40, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 50, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 60.

9 . The TL1A binding protein of claim 8 , wherein the VH comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 190 and the VL comprises a sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 200.

10 . The TL1A binding protein of claim 8 , wherein the VH comprises the amino acid sequence of SEQ ID NO: 190 and the VL comprises the amino acid sequence of SEQ ID NO: 200.

11 . A TL1A binding protein, comprising:

a heavy chain variable region (VH) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 5, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 15, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 25; and

a light chain variable region (VL) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 35, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 45, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 55; or

a heavy chain variable region (VH) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 6, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 16, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 26; and

a light chain variable region (VL) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 36, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 46, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 56; or

a heavy chain variable region (VH) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 7, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 17, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 27; and

a light chain variable region (VL) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 37, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 47, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 57; or

a heavy chain variable region (VH) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 8, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 18, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 28; and

a light chain variable region (VL) comprising (i) a CDR1 having an amino acid sequence according to SEQ ID NO: 38, (ii) a CDR2 having an amino acid sequence according to SEQ ID NO: 48, and (iii) a CDR3 having an amino acid sequence according to SEQ ID NO: 58.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 7, 2025
From: ZHU, ERIC FRANKLIN; SHAHEEN, HUSSAM HISHAM; RIOS, DANIEL
To: PARAGON THERAPEUTICS, INC.
Reel/Frame 070143/0816 →
Continuity (9)
Continuation PCTUS2024041774 · Aug 9, 2024
Provisional Application 63559060 · Feb 28, 2024
Provisional Application 63559071 · Feb 28, 2024
Provisional Application 63554916 · Feb 16, 2024
Provisional Application 63554897 · Feb 16, 2024
Provisional Application 63604104 · Nov 29, 2023
Provisional Application 63599923 · Nov 16, 2023
Provisional Application 63592535 · Oct 23, 2023
Provisional Application 63519056 · Aug 11, 2023
References Cited (230)
US 6737056B1 · Presta · 2004 [cited by applicant]
US 7597886B2 · Yu et al. · 2009 [cited by applicant]
US 7612181B2 · Wu et al. · 2009 [cited by applicant]
US 7820798B2 · Yu et al. · 2010 [cited by applicant]
US 8105589B2 · Yu et al. · 2012 [cited by applicant]
US 8258268B2 · Wu et al. · 2012 [cited by applicant]
US 8263743B2 · Smith et al. · 2012 [cited by applicant]
US 8642741B2 · Classon et al. · 2014 [cited by applicant]
US 8728482B2 · Smith et al. · 2014 [cited by applicant]
US 9068003B2 · Siegel et al. · 2015 [cited by applicant]
US 9290576B2 · Attinger et al. · 2016 [cited by applicant]
US 9416185B2 · Smith et al. · 2016 [cited by applicant]
US 9556277B2 · Classon et al. · 2017 [cited by applicant]
US 9683998B2 · Arch et al. · 2017 [cited by applicant]
US 9737612B2 · Anderson et al. · 2017 [cited by applicant]
US 9896511B2 · Siegel et al. · 2018 [cited by applicant]
US 10138296B2 · Poulton et al. · 2018 [cited by applicant]
US 10149462B2 · Lee et al. · 2018 [cited by applicant]
US 10221251B2 · Humphreys et al. · 2019 [cited by applicant]
US 10308703B2 · Aharoni et al. · 2019 [cited by applicant]
US 10316083B2 · Michelsen et al. · 2019 [cited by applicant]
US 10322174B2 · Bilsborough et al. · 2019 [cited by applicant]
US 10590201B2 · Siegel et al. · 2020 [cited by applicant]
US 10626180B2 · McGovern et al. · 2020 [cited by applicant]
US 10633449B2 · Shih et al. · 2020 [cited by applicant]
US 10683338B2 · Gieffers et al. · 2020 [cited by applicant]
US 10689439B2 · Watkins et al. · 2020 [cited by applicant]
US 10822422B2 · Poulton et al. · 2020 [cited by applicant]
US 10829566B2 · Rapecki · 2020 [cited by applicant]
US 10968279B2 · Pashine et al. · 2021 [cited by applicant]
US 11059911B2 · Humphreys et al. · 2021 [cited by applicant]
US 11104745B2 · Hsu et al. · 2021 [cited by applicant]
US 11136386B2 · Kruidenier et al. · 2021 [cited by applicant]
US 11186872B2 · Gonsky et al. · 2021 [cited by applicant]
US 11220549B2 · Poulton et al. · 2022 [cited by applicant]
US 11292848B2 · Watkins et al. · 2022 [cited by applicant]
US 11312768B2 · Michelson et al. · 2022 [cited by applicant]
US 11434296B2 · Shih et al. · 2022 [cited by applicant]
US 11440954B2 · Watkins et al. · 2022 [cited by applicant]
US 11474112B2 · Arch et al. · 2022 [cited by applicant]
US 11767364B2 · Pashine · 2023 [cited by examiner]
US 11820793B2 · Igawa et al. · 2023 [cited by applicant]
US 11999789B2 · Watkins et al. · 2024 [cited by applicant]
US 20020111325A1 · Li et al. · 2002 [cited by applicant]
US 20030129189A1 · Yu et al. · 2003 [cited by applicant]
US 20030198640A1 · Yu et al. · 2003 [cited by applicant]
US 20040038349A1 · Hilbert et al. · 2004 [cited by applicant]
US 20050163747A1 · Hilbert et al. · 2005 [cited by applicant]
US 20050214305A1 · Li et al. · 2005 [cited by applicant]
US 20070010658A1 · Holtet et al. · 2007 [cited by applicant]
US 20070128184A1 · Podack et al. · 2007 [cited by applicant]
US 20080003221A1 · Podack · 2008 [cited by applicant]
US 20090269345A1 · Fan et al. · 2009 [cited by applicant]
US 20090317388A1 · Burkly et al. · 2009 [cited by applicant]
US 20110110852A1 · Miller et al. · 2011 [cited by applicant]
US 20110129458A1 · Dolk et al. · 2011 [cited by applicant]
US 20110195048A1 · Podack · 2011 [cited by applicant]
US 20110217310A1 · Siegel et al. · 2011 [cited by applicant]
US 20120195900A1 · Ghayur et al. · 2012 [cited by applicant]
US 20120201746A1 · Liu et al. · 2012 [cited by applicant]
US 20120328559A1 · Podack et al. · 2012 [cited by applicant]
US 20130004416A1 · Wu et al. · 2013 [cited by applicant]
US 20140255302A1 · Poulton et al. · 2014 [cited by applicant]
US 20150004167A1 · Wu et al. · 2015 [cited by applicant]
US 20150056182A1 · Igawa et al. · 2015 [cited by applicant]
US 20160096885A1 · Shih et al. · 2016 [cited by applicant]
US 20160208329A1 · Targan et al. · 2016 [cited by applicant]
US 20170096491A1 · Classon et al. · 2017 [cited by applicant]
US 20170166967A1 · Rotter et al. · 2017 [cited by applicant]
US 20170190781A1 · Mills et al. · 2017 [cited by applicant]
US 20170218091A1 · Ambrosi · 2017 [cited by applicant]
US 20180052175A1 · Arch et al. · 2018 [cited by applicant]
US 20180086840A1 · Attinger et al. · 2018 [cited by applicant]
US 20180156781A1 · Shih et al. · 2018 [cited by applicant]
US 20180230543A1 · McGovern · 2018 [cited by applicant]
US 20180256747A1 · Hawthorne et al. · 2018 [cited by applicant]
US 20180319889A1 · Croft et al. · 2018 [cited by applicant]
US 20190106486A1 · Poulton et al. · 2019 [cited by applicant]
US 20190135928A1 · Pashine · 2019 [cited by examiner]
US 20190211400A1 · Rotter et al. · 2019 [cited by applicant]
US 20190247498A1 · Bilsborough et al. · 2019 [cited by applicant]
US 20200079863A1 · Attinger et al. · 2020 [cited by applicant]
US 20200181258A1 · Leger et al. · 2020 [cited by applicant]
US 20200362025A1 · Kruidenier et al. · 2020 [cited by applicant]
US 20200392227A1 · Wang · 2020 [cited by applicant]
US 20210070871A1 · Watkins et al. · 2021 [cited by applicant]
US 20210079473A1 · McGovern et al. · 2021 [cited by applicant]
US 20210093718A1 · Bilsborough et al. · 2021 [cited by applicant]
US 20210122816A1 · Lee et al. · 2021 [cited by applicant]
US 20210122828A1 · Watkins et al. · 2021 [cited by applicant]
US 20210238684A1 · Bilsborough et al. · 2021 [cited by applicant]
US 20210301015A1 · Tseng · 2021 [cited by applicant]
US 20210347904A1 · Poulton et al. · 2021 [cited by applicant]
US 20210371931A1 · McGovern · 2021 [cited by applicant]
US 20210395824A1 · Gonsky et al. · 2021 [cited by applicant]
US 20220002411A1 · Chen et al. · 2022 [cited by applicant]
US 20220152085A1 · Dong et al. · 2022 [cited by applicant]
US 20220185902A1 · Poulton et al. · 2022 [cited by applicant]
US 20220213226A1 · Hsu et al. · 2022 [cited by applicant]
US 20220259320A1 · Watkins et al. · 2022 [cited by applicant]
US 20220290241A1 · McGovern et al. · 2022 [cited by applicant]
US 20220306735A1 · Dekosky et al. · 2022 [cited by applicant]
US 20220340642A1 · Kanai et al. · 2022 [cited by applicant]
US 20220363745A1 · Michelsen et al. · 2022 [cited by applicant]
US 20220390463A1 · Arch et al. · 2022 [cited by applicant]
US 20230018729A1 · Kruidenier et al. · 2023 [cited by applicant]
US 20230020356A1 · Gonsky et al. · 2023 [cited by applicant]
US 20230060770A1 · Wang et al. · 2023 [cited by applicant]
US 20230091596A1 · Shih et al. · 2023 [cited by applicant]
US 20230157264A1 · Lee et al. · 2023 [cited by applicant]
US 20230159649A1 · Croft et al. · 2023 [cited by applicant]
US 20230192835A1 · Watkins et al. · 2023 [cited by applicant]
US 20230235070A1 · Baniecki et al. · 2023 [cited by applicant]
US 20230272061A1 · Kruidenier et al. · 2023 [cited by applicant]
US 20230272098A1 · Kruidenier et al. · 2023 [cited by applicant]
US 20230287499A1 · Gonsky et al. · 2023 [cited by applicant]
US 20230304095A1 · McGovern et al. · 2023 [cited by applicant]
US 20230366028A1 · McGovern et al. · 2023 [cited by applicant]
US 20230381308A1 · Bilsborough et al. · 2023 [cited by applicant]
US 20240034799A1 · Gonsky et al. · 2024 [cited by applicant]
US 20240059799A1 · Apgar et al. · 2024 [cited by applicant]
US 20240141053A1 · Poulton et al. · 2024 [cited by applicant]
US 20240209103A1 · Potdar et al. · 2024 [cited by applicant]
US 20240254238A1 · Rohlff · 2024 [cited by applicant]
US 20240269319A1 · Hawthorne et al. · 2024 [cited by applicant]
US 20240309104A1 · Luo et al. · 2024 [cited by applicant]
US 20240327532A1 · Watkins et al. · 2024 [cited by applicant]
US 20240336691A1 · Luo et al. · 2024 [cited by applicant]
US 20240368263A1 · Watkins et al. · 2024 [cited by applicant]
EP 1042343B1 · 2008 [cited by applicant]
EP 1487854B1 · 2010 [cited by applicant]
EP 1558640B1 · 2011 [cited by applicant]
EP 2546268A1 · 2013 [cited by applicant]
EP 1667730B1 · 2013 [cited by applicant]
EP 2353615B1 · 2014 [cited by applicant]
EP 2638069B1 · 2018 [cited by applicant]
EP 2941302B1 · 2018 [cited by applicant]
EP 2978440B1 · 2019 [cited by applicant]
EP 3350223B1 · 2020 [cited by applicant]
EP 3402494B1 · 2021 [cited by applicant]
EP 3613766B1 · 2023 [cited by applicant]
EP 3639841B1 · 2023 [cited by applicant]
EP 3774897B1 · 2023 [cited by applicant]
EP 3458466B1 · 2024 [cited by applicant]
WO 2014028776A1 · 2014 [cited by applicant]
WO 2018154584A1 · 2018 [cited by applicant]
WO 2019209995A2 · 2019 [cited by applicant]
WO 2021247770A1 · 2021 [cited by applicant]
WO 2022103961A1 · 2022 [cited by applicant]
WO 2022140283A1 · 2022 [cited by applicant]
WO 2022119842A1 · 2022 [cited by applicant]
WO 2022178158A1 · 2022 [cited by applicant]
WO 2022178159A1 · 2022 [cited by applicant]
WO 2022232253A1 · 2022 [cited by applicant]
WO 2023009545A1 · 2023 [cited by applicant]
WO 2023046047A1 · 2023 [cited by applicant]
WO 2023047375A9 · 2023 [cited by applicant]
WO 2023102051A1 · 2023 [cited by applicant]
WO 2023102071A1 · 2023 [cited by applicant]
WO 2023133538A1 · 2023 [cited by applicant]
WO 2023141611A2 · 2023 [cited by applicant]
WO 2023220663A1 · 2023 [cited by applicant]
WO 2024026386A1 · 2024 [cited by applicant]
WO 2024026395A1 · 2024 [cited by applicant]
WO 2024067451A1 · 2024 [cited by applicant]
WO 2024078479A1 · 2024 [cited by applicant]
WO 2024112618A2 · 2024 [cited by applicant]
WO 2024118630A2 · 2024 [cited by applicant]
WO 2024137353A1 · 2024 [cited by applicant]
WO 2024148218A2 · 2024 [cited by applicant]
WO 2024148222A1 · 2024 [cited by applicant]
WO 2024173838A2 · 2024 [cited by applicant]
WO 2024173861A2 · 2024 [cited by applicant]
WO 2024173865A2 · 2024 [cited by applicant]
WO 2024173877A1 · 2024 [cited by applicant]
WO 2024186859A2 · 2024 [cited by applicant]
Edwards et al., J. Mol. Biol. (2003) 334, 103-118. [cited by examiner]
Iwahashi et al., Moleculer Immunology, 36: 1079-1091, 1999. [cited by examiner]
Aiba et al., “The Role of TL1A and DR3 in Autoimmune and Inflammatory Diseases”, Mediators of Inflammation, vol. 2013, Article ID 258164, 9 pages. [cited by applicant]
Aliprantis et al., “A Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of a Respiratory Syncytial Virus Neutralizing Monoclonal Antibody MK-1654 in Heal… [cited by applicant]
Bamias et al., “Differential Expression of the TL1A/DcR3 System of TNF/TNFR-Like Proteins in Large vs. Small Intestinal Crohn's Disease”, Digestive and Liver Disease, vol. 44, pp. 30-36, 2012. [cited by applicant]
Bamias et al., “Expression, Localization, and Functional Activity of TL1A, a Novel Th1-Polarizing Cytokine in Inflammatory Bowel Disease”, The Journal of Immunology, vol. 171, No. 9, pp. 4868-4874, Nov. 1, 2003. [cited by applicant]
Bamias et al., “High Intestinal and Systemic Levels of Decoy Receptor 3 (DcR3) and its Ligand TL1A in Active Ulcerative Colitis”, Clinical Immunology, vol. 137, Issue 2, Nov. 2010, pp. 242-249. [cited by applicant]
Cavallini et al., “The TNF-Family Cytokine TL1A Inhibits Proliferation of Human Activated B Cells”, PLOS One, vol. 8, Iss. 4, e60136, pp. 1-11, Apr. 2013. [cited by applicant]
Collins et al., “CCL3 and MMP-9 are Induced by TL1A During Death Receptor 3 (TNFRSF25)-Dependent Osteoclast Function and Systemic Bone Loss”, Bone, vol. 97, pp. 94-104, Apr. 1, 2017. [cited by applicant]
Dall'Acqua et al., “Properties of Human IgG1s Engineered for Enhanced Binding to the Neonatal Fc Receptor (FcRn)”, The Journal of Biological Chemistry, vol. 281, No. 33, pp. 23514-23524, Aug. 18, 2006. [cited by applicant]
Danese et al., “Anti-TL1A Antibody PF-06480605 Safety and Efficacy for Ulcerative Colitis: A Phase 2a Single-Arm Study”, Clinical Gastroenterology and Hepatology, vol. 19, No. 11, pp. 2324-2332, Nov. 2021. [cited by applicant]
Endo et al., “TL1A (TNFSF15) Genotype Affects the Long-Term Therapeutic Outcomes of Anti-TNFα Antibodies for Crohn's Disease Patients”, JGH Open, vol. 4, No. 6, pp. 1108-1113, 2020. [cited by applicant]
Feagan et al., “The Anti-TL1A Antibody PRA023 Demonstrated Proof-of-Concept in Crohn's Disease: Phase 2a APOLLO-CD Study Results” Abstract, The American Journal of Gastroenterology, vol. 118, Supplement, pp. S875-S876, … [cited by applicant]
Haraya et al., “Translational Approach for Predicting Human Pharmacokinetics of Engineered Therapeutic Monoclonal Antibodies with Increased FcRn-Binding Mutations”, BioDrugs, vol. 37, No. 1, pp. 99-108, Jan. 2023. [cited by applicant]
Hassan-Zahraee et al., “Antitumor Necrosis Factor-like Ligand 1A Therapy Targets Tissue Inflammation and Fibrosis Pathways and Reduces Gut Pathobionts in Ulcerative Colitis”, Inflammatory Bowel Diseases, vol. 28, No. 3,… [cited by applicant]
Jackson et al., “Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype”, N. Engl. Journal of Medicine, 2024. [cited by applicant]
Jacob et al., “Direct Signaling of TL1A-DR3 on Fibroblasts Induces Intestinal Fibrosis in Vivo”, Nature, vol. 10, 18189, pp. 1-13, 2020. [cited by applicant]
Jacob et al., “Inflammation Independent TL1A-Mediated Intestinal Fibrosis is Dependent on the Gut Microbiome”, Mucosal. Immunol., vol. 11, No. 5, pp. 1466-1476, Sep. 2018. [cited by applicant]
Kamada et al., “TL1A Produced by Lamina Propria Macrophages Induces Th1 and Th17 Immune Responses in Cooperation with IL-23 in Patients with Crohn's Disease”, Inflammatory Bowel Diseases, vol. 16, Iss. 4, pp. 568-575, A… [cited by applicant]
Kokkotis et al., “TL1A as a Therapeutic Target in Inflammatory Bowel Disease”, Expert Review of Clinical Immunology, vol. 18, No. 6, pp. 551-555, Jun. 3, 2022. [cited by applicant]
Li et al., “TL1A Blocking Ameliorates Intestinal Fibrosis in the T Cell Transfer Model of Chronic Colitis in Mice”, Pathology—Research and Practice, vol. 214, Issue 2, pp. 217-227, Feb. 2018. [cited by applicant]
Ma et al., TL1A Increased IL-6 Production on Fibroblast-Like Synoviocytes by Preferentially Activating TNF Receptor 2 in Rheumatoid Arthritis, Cytokine, vol. 83, pp. 92-98, 2016. [cited by applicant]
Meylan et al., The TNF-Family Cytokine TL1A Drives IL-13-Dependent Small Intestinal Inflammation, Nature, vol. 4, No. 2, pp. 172-185, Mar. 2011. [cited by applicant]
Meylan et al., The TNF-Family Cytokine TL1A Promotes Allergic Immunopathology Through Group 2 Innate Lymphoid Cells, Nature, vol. 7, No. 4, pp. 958-968, Jul. 2014. [cited by applicant]
Michelsen et al., “IBD-Associated TL1A Gene (TNFSF15) Haplotypes Determine Increased Expression of TL1A Protein”, PLoS One, vol. 4, Iss. 3, e4719 (1-11), Mar. 2009. [cited by applicant]
Nowak et al., “A Phase 1 Randomized Dose-Escalation Study of a Human Monoclonal Antibody to IL-6 in CKD”, Kidney360, vol. 2, pp. 224-235, Feb. 2021. [cited by applicant]
Orito et al., “A Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Respiratory Syncytial Virus Neutralizing Monoclonal Antibody MK-1654 in Healthy Japanese Adults”, Clin. Transl. Sci., vol. 15,… [cited by applicant]
Pappu et al., “TL1A-DR3 Interaction Regulates Th17 Cell Function and Th17-Mediated Autoimmune Disease”, J. Exp. Med., vol. 205, No. 5, pp. 1049-1062, May 12, 2008. [cited by applicant]
Ramdani et al., “Monoclonal Antibody Engineering and Design to Modulate FcRn Activities: A Comprehensive Review”, Int. J. Mol. Sci., vol. 23, No. 17, 9604, pp. 1-12, Aug. 2022. [cited by applicant]
Raphael et al., “TEV-48574, an Anti-TL1A Antibody I Development for Use in IBD, is Safe and Well Tolerated Following 16 Weeks of Subcutaneous Treatment in Adults with Severe Uncontrolled T2-Low/Non T2 Asthma”, Clinical:… [cited by applicant]
Reinisch et al., “Phase 2 Basket Design Study Evaluating the Efficacy and Safety of an Anti-TL1A Antibody (TEV-48574) in Moderate to Severe Ulcerative Colitis or Crohn's Disease (Relieve UCCD)”, Clinical: Therapy and Ob… [cited by applicant]
Richard et al., “Reduced Monocyte and Macrophage TNFSF15/TL1A Expression is Associated with Susceptibility to Inflammatory Bowel Disease”, PLoS Genetics, vol. 14, No. 9, e1007458, pp. 1-24, Sep. 10, 2018. [cited by applicant]
Sands et al., “Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis”, N. Engl. Journal of Medicine, vol. 391, No. 12, pp. 1119-1129, Sep. 26, 2024. [cited by applicant]
Shih et al., “Inhibition of a Novel Fibrogenic Factor Tl1a Reverses Established Colonic Fibrosis”, Mucosal Immunol., vol. 7, No. 6, pp. 1492-1503, Nov. 2014. [cited by applicant]
Siakavellas et al., “Tumor Necrosis Factor-Like Cytokine TL1A and Its Receptors DR3 and DcR3: Important New Factors in Mucosal Homeostasis and Inflammation”, Inflamm. Bowel Dis., vol. 21, No. 10, pp. 2441-2452, Oct. 201… [cited by applicant]
Singh et al., “A Phase 1 Study of the Long-Acting Anti-IL-5 Monoclonal Antibody GSK3511294 in Patients with Asthma”, Br. J. Clin. Pharmacol., vol. 88, No. 2, pp. 702-712, Feb. 2022. [cited by applicant]
Solitano et al., “TL1A Inhibition for Inflammatory Bowel Disease Treatment: From Inflammation to Fibrosis”, Med, vol. 5, pp. 386-400, May 10, 2024. [cited by applicant]
Song et al., “TL1A Promotes Fibrogenesis in Colonic Fibroblasts via the TGF-β1/Smad3 Signaling Pathway*”, Current Medical Science, vol. 44, No. 3, pp. 519-528, 2024. [cited by applicant]
Takedatsu et al., “TL1A (TNFSF15) Regulates the Development of Chronic Colitis by Modulating Both T-Helper 1 and T-Helper 17 Activation”, Gastroenterology, vol. 135, Issue 2, pp. 552-567.e2, Aug. 2008. [cited by applicant]
Tougaard et al., “Biologics Beyond TNF-a Inhibitors and the Effect of Targeting the Homologues TL1A-DR3 Pathway in Chronic Inflammatory Disorders”, Immunopharmacology and Immunotoxicology, vol. 38, No. 1, pp. 29-38, 201… [cited by applicant]
Valatas et al., “TL1A (TNFSF15) and DR3 (TNFRSF25): A Co-Stimulatory System of Cytokines With Diverse Functions in Gut Mucosal Immunity”, Frontiers in Immunology, vol. 10, Article 583, pp. 1-14, Mar. 2019. [cited by applicant]
Wenxiu et al., “Effect and Mechanism of TL1A Expression on Epithelial-Mesenchymal Transition during Chronic Colitis-Related Intestinal Fibrosis”, Mediators of Inflammation, vol. 2021, No. 1, Article 5927064, pp. 1-21, 2… [cited by applicant]
Xu et al., “PCSK9 Inhibitor Recaticimab for Hypercholesterolemia on Stable Statin Dose: a Randomized, Double-Blind, Placebo Controlled Phase 1b/2 Study”, BMC Medicine, vol. 20, No. 1, pp. 1-13, Jan. 2022. [cited by applicant]
Xu et al., “Role of TL1A in Inflammatory Autoimmune Diseases: A Comprehensive Review”, Frontiers in Immunology, vol. 13, Art. 891328, pp. 1-10, Jul. 2022. [cited by applicant]
Zhan et al., “Biochemical and Structural Characterization of the Human TL1A Ectodomain”, Biochemistry, vol. 48, No. 32, pp. 7636-7645, 2009. [cited by applicant]
Zhu et al., “Development and Characterization of SPY002, a Novel Extended Half-Life Monoclonal Antibody Drug Candidate Targeting TL1A for the Treatment of IBD”, Clinical: Therapy and Observation, https://academic.oup.co… [cited by applicant]
Zhu et al., “Development and Characterization of SPY002, a Novel Extended Half-Life Monoclonal Antibody Drug Candidate Targeting TL1A for the Treatment of IBD”, Spyre ECCO Poster P911. [cited by applicant]
Chiu et al., “Antibody Structure and Function: The Basis for Engineering Therapeutics”, Antibodies, vol. 8, Article 55, pp. 1-80, 2019. [cited by applicant]
Clarke et al., “An anti-TL1A antibody for the treatment of asthma and inflammatory bowel disease”, MAbs, vol. 10, No. 4, pp. 664-677, May 19, 2018. [cited by applicant]
Goel et al., “Plasticity within the Antigen-Combining Site May Manifest as Molecular Mimicry in the Humoral Immune Response”, The Journal of Immunology, vol. 173, pp. 7358-7367, 2004. [cited by applicant]
Janeway et al., “Structure of the Antibody Molecule and Immunoglobulin Genes”, Immunobiology, The Immune System in Health and Disease, Third Edition, Part II, Chapter 3, pp. 1-11, Garland Publishing Inc., 1997. [cited by applicant]
Kanyavuz et al., “Breaking the Law: Unconventional Strategies for Antibody Diversification”, Nature Reviews, Immunology, vol. 19, pp. 355-368, Jun. 2019. [cited by applicant]
Lloyd et al., “Modelling the human immune response: performance of a 10″ human antibody repertoire against a broad panel of therapeutically relevant antigens”, Protein Engineering, Design & Selection, vol. 22, No. 3, pp… [cited by applicant]
Sela-Culang et al., “The Structural Basis of Antibody-Antigen Recognition”, Frontiers in Immunology, vol. 4, Article 302, pp. 1-13, Oct. 2013. [cited by applicant]