IP Library › Granted Patent US 12,202,882
Granted Patent B2
US 12,202,882 · App. 17/315,168 · Granted Jan 21, 2025

APRIL and BAFF inhibitory immunomodulatory proteins and methods of use thereof

Inventors: Stacey Dillon (Seattle, WA); Mark Rixon (Seattle, WA); Lawrence Evans (Seattle, WA); Daniel William Demonte (Seattle, WA); Joseph L. Kuijper (Seattle, WA); Stanford L. Peng (Seattle, WA)
Assignee: ALPINE IMMUNE SCIENCES, INC.
C07K14/70578A61K38/1774A61K38/1793A61K47/6425A61P37/06C07K14/7151A61K38/00A61K2039/505C07K2317/76C07K2317/92C07K2319/30C07K2319/31
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Quick Facts
Patent No.
US 12,202,882
App. No.
17/315,168
Granted
Jan 21, 2025
Kind
B2
Abstract

Provided herein are immunomodulatory proteins that exhibit neutralizing activity of BAFF and APRIL (or BAFF/APRIL heterotrimers). The immunomodulatory proteins provided herein include variant domains of Transmembrane Activator and CAML Interactor (TACI). Among provided immunodulatory proteins are TACI-Fc fusion proteins. Also provided are nucleic acid molecules encoding the immunomodulatory proteins. The immunomodulatory proteins provide therapeutic utility for a variety of immunological diseases, disorders or conditions. Also provided are compositions and methods for making and using such proteins.

Claims (27)

1. An immunomodulatory protein comprising at least one variant transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) polypeptide, wherein the at least one variant TACI polypeptide comprises one or more amino acid substitutions relative to the sequence of the extracellular domain (ECD) of a reference TACI polypeptide, wherein the one or more amino acid substitutions comprise a substitution at position 77 that is K77E and a substitution at position 78 that is F78Y, corresponding to numbering of positions set forth in SEQ ID NO:122.

2. The immunomodulatory protein of claim 1 that is a variant TACI-Fc fusion protein, the variant TACI-Fc fusion protein comprising the at least one variant TACI polypeptide, an Fc region, and a linker between one of the at least one TACI polypeptide and Fc region.

3. The immunomodulatory protein of claim 2 , wherein the TACI-Fc fusion protein is set forth in one of SEQ ID NOs:167, 168, or 201.

4. The immunomodulatory protein of claim 2 that is a homodimer comprising two identical copies of the TACI-Fc fusion protein.

5. A method of reducing an immune response in a subject comprising administering the immunomodulatory protein of claim 4 to a subject in need thereof.

6. A method of treating a disease, disorder or condition in a subject, comprising administering the immunomodulatory protein of claim 4 to a subject in need thereof.

7. The immunomodulatory protein of claim 2 , wherein the TACI-Fc fusion protein comprises the structure: (TACI)-Linker-Fc region-Linker-(TACI) or the structure: (TACI)-Linker-(TACI)-Linker-Fc region.

8. The immunomodulatory protein of claim 2 , wherein the Fc region is set forth in one of SEQ ID NOs:73 or 81.

9. The immunomodulatory protein of claim 1 , wherein the reference TACI polypeptide comprises the sequence of amino acids set forth in SEQ ID NO:122, or a portion thereof comprising one or both of a cysteine rich domain 1 (CRD1) and a CRD2 domain that binds to a proliferation-inducing ligand (APRIL), B-cell activating factor (BAFF), or a BAFF/APRIL heterotrimer.

10. The immunomodulatory protein of claim 1 , wherein:

the reference TACI polypeptide comprises the CRD1 domain and the CRD2 domain; or

the reference TACI polypeptide is a truncated wild-type TACI extracellular domain that contains the cysteine rich domain 2 (CRD2) but lacks the entirety of the cysteine rich domain 1 (CRD1).

11. The immunomodulatory protein of claim 1 , wherein the reference TACI polypeptide is a truncated wild-type TACI extracellular domain that consists of amino acid residues 68-110 set forth in SEQ ID NO: 122.

12. The immunomodulatory protein of claim 1 , wherein the one or more amino acid substitutions comprise a substitution are selected from W40R, Q59R, R60G, T61P E74V, Q75E, Q75R, G76S, Y79F, L82H, L82P, L83S, R84G, R84L, R84Q, D85E, D85V, C86Y, I87L, I87M, S88N, I92V, Q95R, P97S, K98T, Q99E, A101D, Y102D, F103S, F103V, F103Y, or a conservative amino acid substitution thereof, in addition to the substitution at positions 77 and 78.

13. The immunomodulatory protein of claim 1 , wherein the one or more amino acid substitutions comprise K77E/F78Y/Y102D, or K77E/F78Y/R84Q.

14. The immunomodulatory protein of claim 1 , wherein the variant TACI polypeptide has increased binding affinity to one or both of APRIL and BAFF compared to the reference TACI polypeptide.

15. The immunomodulatory protein of claim 1 , wherein:

the variant TACI polypeptide has at least 90% sequence identity to SEQ ID NO:122 or a specific binding fragment thereof comprising the CRD1 domain and/or CRD2 domain; or

the variant TACI polypeptide has at least 90% sequence identity to SEQ ID NO:13.

16. The immunomodulatory protein of claim 1 , wherein:

the variant TACI polypeptide comprises the sequence set forth in SEQ ID NO: 111; or

the variant TACI polypeptide comprises the sequence set forth in any one of SEQ ID NOS:26, 182, and 191.

17. The immunomodulatory protein of claim 1 , comprising a heterologous moiety that is linked to the at least one TACI polypeptide, wherein the heterologous moiety is a half-life extending moiety, a multimerization domain, a targeting moiety that binds to a molecule on the surface of a cell, or a detectable label.

18. A pharmaceutical composition, comprising the immunomodulatory protein of claim 1 and a pharmaceutically acceptable excipient.

19. A method of reducing an immune response in a subject, comprising administering the immunomodulatory protein of claim 1 to a subject in need thereof.

20. A method of treating a disease, disorder or condition in a subject, comprising administering the immunomodulatory protein of claim 1 to a subject in need thereof.

21. The immunomodulatory protein of claim 1 , wherein the reference TACI polypeptide consists essentially of the CRD2 domain.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 13, 2022
From: DILLON, STACEY; RIXON, MARK; EVANS, LAWRENCE; DEMONTE, DANIEL WILLIAM; KUIJPER, JOSEPH L.; PENG, STANFORD L.
To: ALPINE IMMUNE SCIENCES, INC.
Reel/Frame 058651/0503 →
Continuity (4)
Provisional Application 63080643 · Sep 18, 2020
Provisional Application 63034361 · Jun 3, 2020
Provisional Application 63022373 · May 8, 2020
Related Publication 20210388054A1 · Dec 16, 2021
References Cited (400)
US 5168062A · Stinski · 1992 [cited by applicant]
US 5283173A · Fields et al. · 1994 [cited by applicant]
US 5385839A · Stinski · 1995 [cited by applicant]
US 5443964A · Pickup et al. · 1995 [cited by applicant]
US 5457035A · Baum et al. · 1995 [cited by applicant]
US 5468614A · Fields et al. · 1995 [cited by applicant]
US 5500362A · Robinson et al. · 1996 [cited by applicant]
US 5624821A · Winter et al. · 1997 [cited by applicant]
US 5641870A · Rinderknecht et al. · 1997 [cited by applicant]
US 5648260A · Winter et al. · 1997 [cited by applicant]
US 5698530A · Schlom et al. · 1997 [cited by applicant]
US 5731168A · Carter et al. · 1998 [cited by applicant]
US 5821337A · Carter et al. · 1998 [cited by applicant]
US 5969102A · Bram et al. · 1999 [cited by applicant]
US 6143290A · Zhang et al. · 2000 [cited by applicant]
US 6194551B1 · Idusogie et al. · 2001 [cited by applicant]
US 6596535B1 · Carter · 2003 [cited by applicant]
US 6737056B1 · Presta · 2004 [cited by applicant]
US 6855317B2 · Koelle et al. · 2005 [cited by applicant]
US 6936257B1 · Bennett · 2005 [cited by applicant]
US 6998252B1 · Moss et al. · 2006 [cited by applicant]
US 7125717B2 · Carter · 2006 [cited by applicant]
US 7138501B2 · Ruben et al. · 2006 [cited by applicant]
US 7220840B2 · Ruben et al. · 2007 [cited by applicant]
US 7247615B2 · Schlom et al. · 2007 [cited by applicant]
US 7332581B2 · Presta · 2008 [cited by applicant]
US 7368116B2 · Schlom et al. · 2008 [cited by applicant]
US 7371826B2 · Presta · 2008 [cited by applicant]
US 7378087B2 · Jefferies et al. · 2008 [cited by applicant]
US 7501497B2 · Rixon et al. · 2009 [cited by applicant]
US 7550296B2 · Hermiston et al. · 2009 [cited by applicant]
US 7605236B2 · Ruben et al. · 2009 [cited by applicant]
US 7635767B2 · Rixon et al. · 2009 [cited by applicant]
US 7833529B1 · Gross et al. · 2010 [cited by applicant]
US 7850967B2 · Kalled et al. · 2010 [cited by applicant]
US 7862814B2 · Rixon et al. · 2011 [cited by applicant]
US 7879328B2 · Ruben et al. · 2011 [cited by applicant]
US 7951919B2 · Rixon et al. · 2011 [cited by applicant]
US 7964711B2 · Rixon et al. · 2011 [cited by applicant]
US 8101181B2 · Ruben et al. · 2012 [cited by applicant]
US 8193316B2 · Fang et al. · 2012 [cited by applicant]
US 8202698B2 · Hsu et al. · 2012 [cited by applicant]
US 8524232B2 · Rixon et al. · 2013 [cited by applicant]
US 8637021B2 · Del Rio et al. · 2014 [cited by applicant]
US 8669350B2 · Chou et al. · 2014 [cited by applicant]
US 8815238B2 · Rixon et al. · 2014 [cited by applicant]
US 8852591B2 · Ponce et al. · 2014 [cited by applicant]
US 8911726B2 · Takahashi et al. · 2014 [cited by applicant]
US 8956611B2 · Ponce et al. · 2015 [cited by applicant]
US 9168286B2 · Chevrier et al. · 2015 [cited by applicant]
US 9187548B2 · Ruben et al. · 2015 [cited by applicant]
US 9290582B2 · Yang et al. · 2016 [cited by applicant]
US 9346878B2 · Rixon et al. · 2016 [cited by applicant]
US 9545086B2 · Mackay et al. · 2017 [cited by applicant]
US 9969808B2 · Van Eenennaam et al. · 2018 [cited by applicant]
US 10183967B2 · Blum et al. · 2019 [cited by applicant]
US 10377830B2 · Van Eenennaam et al. · 2019 [cited by applicant]
US 10385123B2 · Myette et al. · 2019 [cited by applicant]
US 10562954B2 · Cai et al. · 2020 [cited by applicant]
US 10954296B2 · Myette et al. · 2021 [cited by applicant]
US 10961316B2 · Van Eenennaam et al. · 2021 [cited by applicant]
US 10968270B2 · Myette et al. · 2021 [cited by applicant]
US 11136385B2 · Myette et al. · 2021 [cited by applicant]
US 11274140B2 · Dillon et al. · 2022 [cited by applicant]
US 11698369B2 · Berenson · 2023 [cited by applicant]
US 20030059937A1 · Ruben et al. · 2003 [cited by applicant]
US 20030103986A1 · Rixon et al. · 2003 [cited by applicant]
US 20030223996A1 · Ruben et al. · 2003 [cited by applicant]
US 20040013674A1 · Ambrose et al. · 2004 [cited by applicant]
US 20050014934A1 · Hinton et al. · 2005 [cited by applicant]
US 20050163775A1 · Chan et al. · 2005 [cited by applicant]
US 20060024298A1 · Lazar et al. · 2006 [cited by applicant]
US 20060067933A1 · Gross et al. · 2006 [cited by applicant]
US 20060286093A1 · Gross et al. · 2006 [cited by applicant]
US 20070086979A1 · Chevrier et al. · 2007 [cited by applicant]
US 20080181886A1 · Kelley · 2008 [cited by applicant]
US 20090148462A1 · Chevrier et al. · 2009 [cited by applicant]
US 20090186040A1 · Busby et al. · 2009 [cited by applicant]
US 20090226440A1 · Grey · 2009 [cited by applicant]
US 20090291080A1 · Gottenberg et al. · 2009 [cited by applicant]
US 20100111953A1 · Ruben et al. · 2010 [cited by applicant]
US 20100239580A1 · Del Rio et al. · 2010 [cited by applicant]
US 20100256337A1 · Eon-Duval · 2010 [cited by applicant]
US 20100261887A1 · Del Rio et al. · 2010 [cited by applicant]
US 20100297122A1 · Del Rio et al. · 2010 [cited by applicant]
US 20110014190A1 · Migone et al. · 2011 [cited by applicant]
US 20110110950A1 · Kalled et al. · 2011 [cited by applicant]
US 20110117093A1 · Ruben et al. · 2011 [cited by applicant]
US 20110293610A1 · Ruben et al. · 2011 [cited by applicant]
US 20110311548A1 · Wasserman et al. · 2011 [cited by applicant]
US 20150322158A1 · Migone et al. · 2015 [cited by applicant]
US 20160017041A1 · Violette et al. · 2016 [cited by applicant]
US 20160311914A1 · Migone et al. · 2016 [cited by applicant]
US 20170081387A1 · Cai et al. · 2017 [cited by applicant]
US 20170145086A1 · Myette et al. · 2017 [cited by applicant]
US 20190241633A1 · Fotin-Mleczek et al. · 2019 [cited by applicant]
US 20190330326A1 · Myette et al. · 2019 [cited by applicant]
US 20200326339A1 · Berenson · 2020 [cited by applicant]
US 20210087253A1 · Fang et al. · 2021 [cited by applicant]
US 20210221900A1 · Van Eenennaam et al. · 2021 [cited by applicant]
US 20210238295A1 · Meher · 2021 [cited by applicant]
US 20220002381A1 · Fang et al. · 2022 [cited by applicant]
US 20220133633A1 · Xu et al. · 2022 [cited by applicant]
US 20220235124A1 · Myette et al. · 2022 [cited by applicant]
US 20230210948A1 · Wax et al. · 2023 [cited by applicant]
US 20230241168A1 · Dillon et al. · 2023 [cited by applicant]
US 20240002468A1 · Fang et al. · 2024 [cited by applicant]
US 20240018212A1 · Fang et al. · 2024 [cited by applicant]
CA 2446734A1 · 2002 [cited by applicant]
CA 2453995A1 · 2003 [cited by applicant]
CA 2492447A1 · 2004 [cited by applicant]
CA 2501459A1 · 2004 [cited by applicant]
CA 2585927A1 · 2006 [cited by applicant]
CA 2661872A1 · 2008 [cited by applicant]
CA 2674213A1 · 2008 [cited by applicant]
CA 2690119A1 · 2008 [cited by applicant]
CA 2701221A1 · 2009 [cited by applicant]
CA 2703545A1 · 2009 [cited by applicant]
CA 2705357C · 2009 [cited by applicant]
CA 2705435A1 · 2009 [cited by applicant]
CA 2763439A1 · 2010 [cited by applicant]
CA 2681728C · 2015 [cited by applicant]
CA 2661748C · 2016 [cited by applicant]
CA 2701329C · 2017 [cited by applicant]
CA 3019199A1 · 2017 [cited by applicant]
CA 3032120A1 · 2018 [cited by applicant]
CA 3040296A1 · 2018 [cited by applicant]
CA 3053804A1 · 2018 [cited by applicant]
CA 3053812A1 · 2018 [cited by applicant]
CA 3054068A1 · 2018 [cited by applicant]
CA 3070468A1 · 2019 [cited by applicant]
CA 3077509A1 · 2019 [cited by applicant]
CA 3078517A1 · 2019 [cited by applicant]
CA 3087149A1 · 2019 [cited by applicant]
CA 3091681A1 · 2019 [cited by applicant]
CA 3112578A1 · 2020 [cited by applicant]
CA 3117978A1 · 2020 [cited by applicant]
CN 102085368B · 2013 [cited by applicant]
EP 1746106 · 2007 [cited by applicant]
EP 2116259 · 2012 [cited by applicant]
EP 2431054 · 2012 [cited by applicant]
EP 2139517 · 2013 [cited by applicant]
EP 2161287 · 2015 [cited by applicant]
EP 3299378 · 2018 [cited by applicant]
EP 3415528 · 2018 [cited by applicant]
JP 2003533218A · 2003 [cited by applicant]
JP 2004533997A · 2004 [cited by applicant]
JP 2006517191A · 2006 [cited by applicant]
JP 2007526220A · 2007 [cited by applicant]
JP 2009504668A · 2009 [cited by applicant]
JP 2009507777A · 2009 [cited by applicant]
JP 2009537563A · 2009 [cited by applicant]
JP 2010501622 · 2010 [cited by applicant]
JP 2011523037 · 2011 [cited by applicant]
JP 2018518974A · 2018 [cited by applicant]
JP 2019521643 · 2019 [cited by applicant]
KR 20130118315A · 2013 [cited by applicant]
WO WO1993010151 · 1993 [cited by applicant]
WO WO1994029351 · 1994 [cited by applicant]
WO WO1998018921 · 1998 [cited by applicant]
WO WO1998050431 · 1998 [cited by applicant]
WO WO1999051642 · 1999 [cited by applicant]
WO WO2000067034 · 2000 [cited by applicant]
WO WO2000040716 · 2000 [cited by applicant]
WO WO2000042072 · 2000 [cited by applicant]
WO WO2001060397 · 2001 [cited by applicant]
WO WO2001081417 · 2001 [cited by applicant]
WO WO2001087979 · 2001 [cited by applicant]
WO WO2002002641 · 2002 [cited by applicant]
WO WO2002066516 · 2002 [cited by applicant]
WO WO2002094852 · 2002 [cited by applicant]
WO WO2003055979 · 2003 [cited by applicant]
WO WO2004056312 · 2004 [cited by applicant]
WO WO2004060911 · 2004 [cited by applicant]
WO WO2005005462 · 2005 [cited by applicant]
WO WO2005063816 · 2005 [cited by applicant]
WO WO2005100402 · 2005 [cited by applicant]
WO WO2006019447 · 2006 [cited by applicant]
WO WO2006029879 · 2006 [cited by applicant]
WO WO2006073941 · 2006 [cited by applicant]
WO WO2007019573 · 2007 [cited by applicant]
WO WO2007019575 · 2007 [cited by applicant]
WO WO2007134326 · 2007 [cited by applicant]
WO WO2008025747 · 2008 [cited by applicant]
WO WO2008154814 · 2008 [cited by applicant]
WO WO2008157369 · 2008 [cited by applicant]
WO WO2009062916 · 2009 [cited by applicant]
WO WO2009062926 · 2009 [cited by applicant]
WO WO2009062960 · 2009 [cited by applicant]
WO WO2009076524 · 2009 [cited by applicant]
WO WO2009132058 · 2009 [cited by applicant]
WO WO2009134633 · 2009 [cited by applicant]
WO WO2010003766 · 2010 [cited by applicant]
WO WO2010093993 · 2010 [cited by applicant]
WO WO2011109280 · 2011 [cited by applicant]
WO WO2012032112 · 2012 [cited by applicant]
WO WO2012125850 · 2012 [cited by applicant]
WO WO2012141984 · 2012 [cited by applicant]
WO WO2013041029 · 2013 [cited by applicant]
WO WO2013130683 · 2013 [cited by applicant]
WO WO2015107026 · 2015 [cited by applicant]
WO WO2016011083 · 2016 [cited by applicant]
WO WO2017011804 · 2016 [cited by applicant]
WO WO2016210293 · 2016 [cited by applicant]
WO WO2017222593 · 2016 [cited by applicant]
WO WO2017091683 · 2017 [cited by applicant]
WO WO2017106061 · 2017 [cited by applicant]
WO WO2017181152 · 2017 [cited by applicant]
WO WO2018022945 · 2018 [cited by applicant]
WO WO2018236995 · 2018 [cited by applicant]
WO WO2019074983 · 2019 [cited by applicant]
WO WO2019110209 · 2019 [cited by applicant]
WO WO2019136179 · 2019 [cited by applicant]
WO WO2019223581 · 2019 [cited by applicant]
WO WO2019241758 · 2019 [cited by applicant]
WO WO2020028572 · 2020 [cited by applicant]
WO WO2020047329 · 2020 [cited by applicant]
WO WO2020113141 · 2020 [cited by applicant]
WO WO2020214867 · 2020 [cited by applicant]
WO WO2020252421 · 2020 [cited by applicant]
WO WO2021049606 · 2021 [cited by applicant]
WO WO2021115321 · 2021 [cited by applicant]
WO WO2021128027 · 2021 [cited by applicant]
WO WO2021226553 · 2021 [cited by applicant]
WO WO2023236967 · 2023 [cited by applicant]
WO WO2024077018 · 2024 [cited by applicant]
Alperovich et al., “New immunosuppresor strategies in the treatment of murine lupus nephritis,” Lupus. (2007) 16(1): 18-24. [cited by applicant]
Andrews et al., “Spontaneous murine lupus-like syndromes. Clinical and immunopathological manifestations in several strains,” J Exp Med. (1978) 148(5): 1198-1215. [cited by applicant]
Ansell et al., “Phase I clinical study of atacicept in patients with relapsed and refractory B-cell non-Hodgkin's lymphoma,” Clin Cancer Res. (2008) 14(4): 1105-1110. [cited by applicant]
Bachmann et al., “The EVH2 Domain of the Vasodilator-stimulated Phosphoprotein Mediates Tetramerization, F-actin Binding, and Actin Bundle Formation,” J Biol Chem. (1999) 274(33):23549-23557. [cited by applicant]
Baumgartner et al., “The role of the WSXWS equivalent motif in growth hormone receptor function,” J Biol Chem. (1994) 269(46): 29094-101. [cited by applicant]
Benatuil et al., “An improved yeast transformation method for the generation of very large human antibody libraries,” Protein Eng Des Sel. (2010) 23(4): 155-159. [cited by applicant]
Benoist et al., “In vivo sequence requirements of the SV40 early promotor region,” Nature. (1981) 290(5804): 304-10. [cited by applicant]
Benson et al., “Cutting edge: the dependence of plasma cells and independence of memory B cells on BAFF and APRIL,” J Immunol. (2008) 180(6): 3655-3659. [cited by applicant]
Bilsborough et al., “TACI-Ig prevents the development of airway hyperresponsiveness in a murine model of asthma,” Clin Exp Allergy. (2008) 38(12): 1959-1968. [cited by applicant]
Brown et al., “Structure-based mutagenesis of the human immunodeficiency virus type 1 DNA attachment site: effects on integration and cDNA synthesis,” J Virol. (1999) 73(11):9011-9020. [cited by applicant]
Bruggemann et al., “Comparison of the effector functions of human immunoglobulins using a matched set of chimeric antibodies,” J Exp Med. (1987) 166(5):1351-1361. [cited by applicant]
Buchschacher et al., “Human immunodeficiency virus vectors for inducible expression of foreign genes,” J Virol. (1992) 66(5):2731-2739. [cited by applicant]
Busch et al., “Dimers, leucine zippers and DNA-binding domains,” Trends Genet. (1990) 6(2): 36-40. [cited by applicant]
Carbonatto et al., “Nonclinical safety, pharmacokinetics, and pharmacodynamics of atacicept,” Toxicol Sci. (2008) 105(1): 200-210. [cited by applicant]
Chen et al., “Pharmacokinetics, pharmacodynamics, short term efficacy and safety of RCT-18, a novel BLyS/APRIL fusion protein, in patients with rheumatoid arthritis,” Br J Clin Pharmacol. (2016) 82(1): 41-52. [cited by applicant]
Chen et al., “Pharmacokinetics, pharmacodynamics, and tolerability of single ascending doses of RCT-18 in Chinese patients with rheumatoid arthritis,” Clin Pharmacokinet. (2014) 53(11): 1033-44. [cited by applicant]
Christadoss et al., “Immunotherapy for myasthenia gravis: a murine model,” J Immunol. (1986) 136(7):2437-40. [cited by applicant]
Clynes et al., “Fc receptors are required in passive and active immunity to melanoma,” Proc Natl Acad Sci U S A. (1998) 95(2):652-656. [cited by applicant]
Cornetta et al., “No retroviremia or pathology in long-term follow-up of monkeys exposed to a murine amphotropic retrovirus,” Hum Gene Ther. (1991) Fall;2(3):215-9. [cited by applicant]
Cragg et al., “Antibody specificity controls in vivo effector mechanisms of anti-CD20 reagents,” Blood. (2004) 103(7):2738-2743. [cited by applicant]
Cragg et al., “Complement-mediated lysis by anti-CD20 mAb correlates with segregation into lipid rafts,” Blood. (2003) 101(3):1045-1052. [cited by applicant]
Daikh et al., “Long-term inhibition of murine lupus by brief simultaneous blockade of the B7/CD28 and CD40/gp39 costimulation pathways,” J Immunol. (1997) 159(7): 3104-8. [cited by applicant]
Dall'Era et al., “Reduced B lymphocyte and immunoglobulin levels after atacicept treatment in patients with systemic lupus erythematosus: results of a multicenter, phase Ib, double-blind, placebo-controlled, dose-escala… [cited by applicant]
De Wet et al., “Firefly luciferase gene: structure and expression in mammalian cells,” Mol Cell Biol. (1987) 7(2): 725-37. [cited by applicant]
Deisenhofer et al., “Crystallographic refinement and atomic models of a human Fc fragment and its complex with fragment B of protein A from [cited by applicant]
Dillon et al., “B-lymphocyte stimulator/a proliferation-inducing ligand heterotrimers are elevated in the sera of patients with autoimmune disease and are neutralized by atacicept and B-cell maturation antigen-immunoglo… [cited by applicant]
Ding et al., “Telitacicept Following Plasma Exchange in the Treatment of Subjects With Recurrent NMOSD: Study Protocol for a Single-Center, Single-Arm, Open-Label Study,” Front Neurol. (2021) 12: 596791. [cited by applicant]
Duncan et al., “The binding site for C1q on IgG,” Nature. (1988) 332(6166): 738-40. [cited by applicant]
Engelman et al., “Multiple effects of mutations in human immunodeficiency virus type 1 integrase on viral replication,” J Virol. 1995 69(5):2729-2736. [cited by applicant]
Eslami et al., “Function, occurrence and inhibition of different forms of BAFF,” Curr Opin Immunol. (2021) 71: 75-80. [cited by applicant]
Foecking et al., “Powerful and versatile enhancer-promoter unit for mammalian expression vectors,” Gene. (1986) 45(1): 101-105. [cited by applicant]
Furie et al., “A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus,” Arthritis Rheum. (2011) 63(12):… [cited by applicant]
Gazzano-Santoro et al., “A non-radioactive complement-dependent cytotoxicity assay for anti-CD20 monoclonal antibody,” J Immunol Methods. Mar. 28, 1997;202(2):163-71. [cited by applicant]
Genovese et al., “Atacicept in patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor antagonist therapy: results of a phase II, randomized, placebo-controlled, dose-finding trial,” Arthr… [cited by applicant]
Gentz et al., “Parallel association of Fos and Jun leucine zippers juxtaposes DNA binding domains,” Science. (1989) 243(4899): 1695-1699. [cited by applicant]
Gherardi et al., “Recombinant poxviruses as mucosal vaccine vectors,” J Gen Virol. (2005) 86(Pt 11):2925-2936. [cited by applicant]
Ginzler et al., “Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial,” Arthritis Res Ther. (2012) 14(1): R33. [cited by applicant]
Glabinski et al., “Murine experimental autoimmune encephalomyelitis: a model of immune-mediated inflammation and multiple sclerosis,” Methods Enzymol. (1997) 288: 182-190. [cited by applicant]
Gonzalez-Mendioroz et al., “Structural analysis of the inhibition of APRIL by TACI and BCMA through molecular dynamics simulations,” J Mol Graph Model. (2013) 39:13-22. [cited by applicant]
Gordon et al., “Post Hoc Analysis of the Phase II/III APRIL-SLE Study: Association Between Response to Atacicept and Serum Biomarkers Including BLyS and APRIL,” Arthritis Rheumatol. (2017) 69(1): 122-130. [cited by applicant]
Gorman et al., “The Rous sarcoma virus long terminal repeat is a strong promoter when introduced into a variety of eukaryotic cells by DNA-mediated transfection,” Proc Natl Acad Sci U S A. (1982) 79(22): 6777-6781. [cited by applicant]
Gross et al., “TACI-Ig neutralizes molecules critical for B cell development and autoimmune disease. impaired B cell maturation in mice lacking BLyS,” Immunity. (2001) 15(2): 289-302. [cited by applicant]
Gross et al., “TACI and BCMA are receptors for a TNF homologue implicated in B-cell autoimmune disease,” Nature. (2000) 404(6781): 995-999. [cited by applicant]
Guerra et al., “Host response to the attenuated poxvirus vector NYVAC: upregulation of apoptotic genes and NF-kappaB-responsive genes in infected Hela cells,” J Virol. (2006) 80(2): 985-98. [cited by applicant]
Hahne et al., “APRIL, a new ligand of the tumor necrosis factor family, stimulates tumor cell growth,” J Exp Med. (1998) 188(6): 1185-90. [cited by applicant]
Hamer et al., “Regulation in vivo of a cloned mammalian gene: cadmium induces the transcription of a mouse metallothionein gene in SV40 vectors,” J Mol Appl Genet. (1982) 1(4): 273-288. [cited by applicant]
Haselmayer et al., “A mouse model of systemic lupus erythematosus responds better to soluble TACI than to soluble BAFFR, correlating with depletion of plasma cells,” Eur J Immunol. (2017) 47(6): 1075-1085. [cited by applicant]
Hellstrom et al., “Antitumor effects of L6, an IgG2a antibody that reacts with most human carcinomas,” Proc Natl Acad Sci U S A. (1986) 83(18):7059-7063. [cited by applicant]
Hellstrom et al., “Strong antitumor activities of IgG3 antibodies to a human melanoma-associated ganglioside,” Proc Natl Acad Sci U S A. (1985) 82(5):1499-1502. [cited by applicant]
Hu et al., “Yaba-like disease virus: an alternative replicating poxvirus vector for cancer gene therapy,” J Virol. (2001) 75(21):10300-10308. [cited by applicant]
Huard et al., “Selective APRIL blockade delays systemic lupus erythematosus in mouse,” PLoS One. (2012) 7(2): e31837. [cited by applicant]
Hymowitz et al., “Structures of APRIL-receptor complexes: like BCMA, TACI employs only a single cysteine-rich domain for high affinity ligand binding,” J Biol Chem. (2005) 280(8): 7218-7227. [cited by applicant]
Idusogie et al., “Mapping of the C1q binding site on rituxan, a chimeric antibody with a human IgG1 Fc,” J Immunol. (2000) 164(8):4178-4184. [cited by applicant]
Isenberg et al., “Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial),” Ann Rheum Dis. (2015) 74(11… [cited by applicant]
Johann et al., “GLVR1, a receptor for gibbon ape leukemia virus, is homologous to a phosphate permease of Neurospora crassa and is expressed at high levels in the brain and thymus,” J Virol. (1992) 66(3):1635-1640. [cited by applicant]
Kabat et al., “Sequences of Proteins of Immunological Interest,” Fifth Edition, U.S. Department of Health and Human Services, NIH Publication No. 91-3242 (1991), 83 pages. [cited by applicant]
Kaegi et al., “Systematic Review of Safety and Efficacy of Atacicept in Treating Immune-Mediated Disorders,” Front Immunol. (2020) 11:433. [cited by applicant]
Kappos et al., “Atacicept in multiple sclerosis (ATAMS): a randomised, placebo-controlled, double-blind, phase 2 trial,” Lancet Neurol. (2014) 13(4): 353-63. [cited by applicant]
Kaufman et al., “Improved vectors for stable expression of foreign genes in mammalian cells by use of the untranslated leader sequence from EMC virus,” Nucleic Acids Res. (1991) 19(16): 4485-4490. [cited by applicant]
Kelkka et al., “Reactive oxygen species deficiency induces autoimmunity with type 1 interferon signature,” Antioxid Redox Signal. (2014) 21(16): 2231-2245. [cited by applicant]
Kelly et al., “APRIL/TRDL-1, a tumor necrosis factor-like ligand, stimulates cell death ” Cancer Res. (2000) 60(4): 1021-1027. [cited by applicant]
Klarquist et al., “The bm12 Inducible Model of Systemic Lupus Erythematosus (SLE) in C57BL/6 Mice,” J Vis Exp. (2015) (105): e53319. [cited by applicant]
Kimberley et al., “The design and characterization of receptor-selective APRIL variants,” J Biol Chem. (2012) 287(44): 37434-37446. [cited by applicant]
Kofler et al., “Phase 1b trial of atacicept, a recombinant protein binding BLyS and APRIL, in patients with chronic lymphocytic leukemia,” Leukemia. (2012) 26(4): 841-844. [cited by applicant]
Kolberg, “Gene-transfer virus contaminant linked to monkey's cancer,” J Nih Res. (1992) 4:43-44. [cited by applicant]
Labrijn et al., “Therapeutic IgG4 antibodies engage in Fab-arm exchange with endogenous human IgG4 in vivo,” Nat Biotechnol. Aug. 27, 2009(8):767-71. [cited by applicant]
Larsen et al., “Rational development of LEA29Y (belatacept), a high-affinity variant of CTLA4-Ig with potent immunosuppressive properties,” Am J Transplant. Mar. 2005;5(3):443-53. [cited by applicant]
Lindstrom et al., “Production and Assay of Antibodies to Acetylcholine Receptors,” Methods Enzymol. (1981) ;74 Pt C:432-60. [cited by applicant]
Linsley et al., “Human B7-1 (CD80) and B7-2 (CD86) bind with similar avidities but distinct kinetics to CD28 and CTLA-4 receptors,” Immunity. (1994) 1(9): 793-801. [cited by applicant]
Mayr et al., “Passage history, properties, and applicability of the attenuated vaccinia virus strain MVA,” Infection. (1975);3:6-14. (English translation of abstract provided). [cited by applicant]
McKnight et al., “Functional relationships between transcriptional control signals of the thymidine kinase gene of herpes simplex virus,” Cell. (1982) 31(2): 355-365. [cited by applicant]
McWilliams et al., “Mutations in the 5′ end of the human immunodeficiency virus type 1 polypurine tract affect RNase H cleavage specificity and virus titer,” J Virol. (2003) 77(20):11150-11157. [cited by applicant]
Merchant et al., “An efficient route to human bispecific IgG,” Nat Biotechnol. (1998) 16(7): 677-681. [cited by applicant]
Mercier et al., “A chimeric adenovirus vector encoding reovirus attachment protein sigma1 targets cells expressing junctional adhesion molecule 1,” Proc Natl Acad Sci U S A. (2004) 101(16): 6188-6193. [cited by applicant]
Merrill et al., “Efficacy and Safety of Atacicept in Patients With Systemic Lupus Erythematosus: Results of a Twenty-Four-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase IIb Study,” … [cited by applicant]
Merrill, J., Clinical Trials Report, “Biomarkers Relevant to Atacicept Effects in Systemic Lupus Erythrematosus Patients” Current Rheumatology Reports; 264. [cited by applicant]
Miller et al., “Construction and properties of retrovirus packaging cells based on gibbon ape leukemia virus,” J Virol. (1991) 65(5):2220-2224. [cited by applicant]
Miller et al., “Gene transfer by retrovirus vectors occurs only in cells that are actively replicating at the time of infection,” Mol Cell Biol. (1990) 10(8):4239-4242. [cited by applicant]
Miller, “Protein-protein recognition and the association of immunoglobulin constant domains,” J Mol Biol. Dec. 20, 1990;216(4):965-73. [cited by applicant]
Miyoshi et al. “Development of a self-inactivating lentivirus vector,” J Virol. (1998) 72(10):8150-8157. [cited by applicant]
Mohan et al., “Interaction between CD40 and its ligand gp39 in the development of murine lupus nephritis,” J Immunol. (1995) 154(3): 1470-1480. [cited by applicant]
Molin et al., “Two novel adenovirus vector systems permitting regulated protein expression in gene transfer experiments,” J Virol. (1998) 72(10):8358-8361. [cited by applicant]
Moore et al., “BLyS: member of the tumor necrosis factor family and B lymphocyte stimulator,” Science. (1999) 285(5425): 260-263. [cited by applicant]
Mosmann, “Rapid colorimetric assay for cellular growth and survival: application to proliferation and cytotoxicity assays,” J Immunol Methods. (1983) 65(1-2): 55-63. [cited by applicant]
Mujtaba et al., “IFN-t Suppresses Both the Autoreactive Humoral and Cellular Immune Responses and Induces Stable Remission in Mice with Chronic Experimental Allergic Encephalomyelitis,” Cell Immunol. (1998) 186(2): 94-1… [cited by applicant]
Mukhopadhyay et al., “Identification and characterization of a novel cytokine, THANK, a TNF homologue that activates apoptosis, nuclear factor-kappaB, and c-Jun NH2-terminal kinase,” J Biol Chem. (1999) 274(23): 15978-1… [cited by applicant]
Munafo et al., “Safety, pharmacokinetics and pharmacodynamics of atacicept in healthy volunteers,” Eur J Clin Pharmacol. (2007) 63(7): 647-656. [cited by applicant]
Myers et al., “Collagen-induced arthritis, an animal model of autoimmunity,” Life Sci. (1997) 61(19): 1861-1878. [cited by applicant]
Narumi et al., “Adenovirus vector-mediated perforin expression driven by a glucocorticoid-inducible promoter inhibits tumor growth in vivo,” Am J Respir Cell Mol Biol. (1998) 19(6):936-941. [cited by applicant]
Navarra et al., “Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial,” Lancet. (2011) 377(9767): 721-731. [cited by applicant]
Nestorov et al., “Pharmacokinetics and biological activity of atacicept in patients with rheumatoid arthritis,” J Clin Pharmacol. (2008) 48(4): 406-417. [cited by applicant]
Nestorov et al., “Pharmacokinetics and immunoglobulin response of subcutaneous and intravenous atacicept in patients with systemic lupus erythematosus,” J Pharm Sci. (2010) 99(1): 524-538. [cited by applicant]
Nightingale et al., “Transient gene expression by nonintegrating lentiviral vectors,” Mol Ther. (2006) 13(6):1121-1132. [cited by applicant]
Pena-Rossi et al., “An exploratory dose-escalating study investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous atacicept in patients with systemic lupus erythematosus,” Lupus. (200… [cited by applicant]
Perez-Melgosa et al., “Cutting edge: CD40 ligand is a limiting factor in the humoral response to T cell-dependent antigens,” J Immunol. (1999) 163(3): 1123-1127. [cited by applicant]
Petkova et al., “Enhanced half-life of genetically engineered human IgG1 antibodies in a humanized FcRn mouse model: potential application in humorally mediated autoimmune disease,” Int Immunol. (2006) 18(12): 1759-1769. [cited by applicant]
Pfeifer et al., “Gene therapy: promises and problems,” Annu Rev Genomics Hum Genet. (2001);2:177-211. [cited by applicant]
Philpott et al., “Use of nonintegrating lentiviral vectors for gene therapy,” Hum Gene Ther. (2007) 18(6): 483-9. [cited by applicant]
Ponce, “Preclinical support for combination therapy in the treatment of autoimmunity with atacicept,” Toxicol Pathol. (2009) 37(1): 89-99. [cited by applicant]
Powell et al., “Sequence and structural determinants required for priming of plus-strand DNA synthesis by the human immunodeficiency virus type 1 polypurine tract,” J Virol. (1996) 70(8):5288-5296. [cited by applicant]
Putterman et al., “Murine Models of Spontaneous Systemic Lupus Erythematosus,” Autoimmune Disease Models: A Guidebook, (1994) Chapter 14: 217-34. [cited by applicant]
Ramanujam et al., “Similarities and differences between selective and nonselective BAFF blockade in murine SLE,” J Clin Invest. (2006) 116(3): 724-734. [cited by applicant]
Ravetch et al., “Fc receptors,” Annu Rev Immunol. (1991) 9:457-492. [cited by applicant]
Ridgway et al., “Knobs-into-holes' engineering of antibody CH3 domains for heavy chain heterodimerization,” Protein Eng. Jul. 1996;9(7):617-21. [cited by applicant]
Rossi et al., “Atacicept in relapsed/refractory multiple myeloma or active Waldenström's macroglobulinemia: a phase I study,” Br J Cancer. 2009 101(7): 1051-1058. [cited by applicant]
Scatchard et al., “The attractions of proteins for small molecules and ions,” Ann. N.Y. Acad. Sci. (1949) 51:660. [cited by applicant]
Schenborn et al., “A new lysis buffer for luciferase, CAT and ß-galactosidase reporter gene co-transfections,” Promega Notes (1993) 41:11. [cited by applicant]
Schneider et al., “BAFF, a novel ligand of the tumor necrosis factor family, stimulates B cell growth,” J Exp Med. (1999) 189(11): 1747-1756. [cited by applicant]
Sergott et al., “ATON: results from a Phase II randomized trial of the B-cell-targeting agent atacicept in patients with optic neuritis,” J Neurol Sci. (2015) 351(1-2): 174-178. [cited by applicant]
Shaw et al., “The ability of a ternary complex to form over the serum response element correlates with serum inducibility of the human c-fos promoter,” Cell. (1989) 56(4): 563-572. [cited by applicant]
Shields et al., “High resolution mapping of the binding site on human IgG1 for Fc gamma RI, Fc gamma RII, Fc gamma RIII, and FcRn and design of IgG1 variants with improved binding to the Fc gamma R,” J Biol Chem. (2001)… [cited by applicant]
Shu et al., “TALL-1 is a novel member of the TNF family that is down-regulated by mitogens,” J Leukoc Biol. (1999) 65(5): 680-683. [cited by applicant]
Sommerfelt et al., “Receptor interference groups of 20 retroviruses plating on human cells,” Virology. (1990) 176(1): 58-69. [cited by applicant]
Tak et al., “Atacicept in patients with rheumatoid arthritis: results of a multicenter, phase Ib, double-blind, placebo-controlled, dose-escalating, single- and repeated-dose study,” Arthritis Rheum. (2008) 58(1): 61-72. [cited by applicant]
Tartaglia et al., “Highly attenuated poxvirus vectors,” AIDS Res Hum Retroviruses. (1992) 8(8):1445-1447. [cited by applicant]
Tejon et al., “A Spontaneous Mouse Model of Lupus: Physiology and Therapy,” Book Chapter Within “Lupus: New Advances and Challenges” InTechOpen.com, Apr. 23, 2019. DOI: 10.5772/intechopen.85938. [cited by applicant]
Theofilopoulos et al., “Murine Models of Systemic Lupus Erythematosus,” Adv Immunol. (1985) 37:269-390. [cited by applicant]
Urlaub et al., “Effect of gamma rays at the dihydrofolate reductase locus: deletions and inversions,” Somat Cell Mol Genet. (1986) 12(6): 555-566. [cited by applicant]
Van Vollenhoven et al., “Atacicept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase II, randomized, placebo-controlled trial,” Arthritis Rheum. (2011) 63(7): 1782-1792. [cited by applicant]
Van Vollenhoven et al., “Safety and efficacy of atacicept in combination with rituximab for reducing the signs and symptoms of rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled pilot trial,”… [cited by applicant]
Vigolo et al., “A loop region of BAFF controls B cell survival and regulates recognition by different inhibitors,” Nat Commun. (2018) 9(1): 1199. [cited by applicant]
Voulgaraki et al., “Multivalent recombinant proteins for probing functions of leucocyte surface proteins such as the CD200 receptor,” Immunology. (2005) 115(3): 337-346. [cited by applicant]
Wallace et al., “Safety and clinical activity of atacicept in the long-term extension of the Phase IIb Address II study in systemic lupus erythematosus,” Rheumatology (Oxford). (2021) keab115. [cited by applicant]
Wang et al., “Identify the key amino acid of BAFF binding with TACI,” Cell Immunol.(2013) 284(1-2): 84-90. [cited by applicant]
Wang et al., “Effect of rhTACI-Ig fusion protein on antigen-specific T cell responses from keyhole limpet haemocyanin challenged mice,” Mol Immunol. (2011) 49(1-2): 380-386. [cited by applicant]
Wang et al., “Anti-C5 monoclonal antibody therapy prevents collagen-induced arthritis and ameliorates established disease,” Proc Natl Acad Sci U S A. (1995) 92(19): 8955-8959. [cited by applicant]
Weinberg et al., “Blocking OX-40/OX-40 ligand interaction in vitro and in vivo leads to decreased T cell function and amelioration of experimental allergic encephalomyelitis,” J Immunol. (1999) 162(3): 1818-1826. [cited by applicant]
Williams et al., “Anti-tumor necrosis factor ameliorates joint disease in murine collagen-induced arthritis,” Proc Natl Acad Sci U S A. (1992) 89(20): 9784-9788. [cited by applicant]
Wilson et al., “Formation of infectious hybrid virions with gibbon ape leukemia virus and human T-cell leukemia virus retroviral envelope glycoproteins and the gag and pol proteins of Moloney murine leukemia virus,” J V… [cited by applicant]
Wilson et al., Analyzing biomolecular interactions, Science. (2002) 295(5562): 2103-2105. [cited by applicant]
Wolff et al., “Monoclonal Antibody Homodimers: Enhanced Antitumor Activity in Nude Mice,” Cancer Res. (1993) 53(11): 2560-2565. [cited by applicant]
Wooley et al., “Animal models of rheumatoid arthritis,” Curr. Opin. Rheum. (1999) 3:407-420. [cited by applicant]
Wu et al., “Experimental autoimmune myasthenia gravis in the mouse,” Curr Protoc Immunol. (2001) Chapter 15: Unit 15.8. [cited by applicant]
Wu et al., “Telitacicept (RC18) in Patients with Systemic Lupus Erythematosus (SLE): Results of a Phase 2b, Randomized, Double Blind, Placebo Controlled Study,” Oral Presentation. [cited by applicant]
Yaccoby et al., “Atacicept (TACI-Ig) inhibits growth of TACI(high) primary myeloma cells in SCID-hu mice and in coculture with osteoclasts,” Leukemia. (2008) 22(2): 406-413. [cited by applicant]
Yao et al., “Pharmacokinetics analysis based on target-mediated drug distribution for RC18, a novel BLyS/APRIL fusion protein to treat systemic lupus erythematosus and rheumatoid arthritis,” Eur J Pharm Sci. (2021) 159:… [cited by applicant]
Zapata et al., “Engineering linear F(ab')2 fragments for efficient production in [cited by applicant]
Zhao et al., “Pharmacokinetics, Pharmacodynamics, Safety, and Clinical Activity of Multiple Doses of RCT-18 in Chinese Patients With Systemic Lupus Erythematosus,” J Clin Pharmacol. (2016) 56(8): 948-959. [cited by applicant]
Zhou et al., “Synthesis of functional mRNA in mammalian cells by bacteriophage T3 RNA polymerase,” Mol Cell Biol. (1990) 10(9): 4529-4537. [cited by applicant]
Zhou et al., “Endogenous programmed death ligand-1 restrains the development and onset of Sjögren's syndrome in non-obese diabetic mice,” Scientific Reports. (2016) vol. 6; Article No. 39105. [cited by applicant]
Zufferey et al., “Self-inactivating lentivirus vector for safe and efficient in vivo gene delivery,” J Virol. (1998) 72(12):9873-9880. [cited by applicant]
U.S. Appl. No. 17/923,208, filed Nov. 3, 2022, by Dillon et al. (Copy not provided). (Copy not submitted herewith pursuant to the waiver of 37 C.F. R. § 1.98(a)(2)(iii) issued by the Office on Sep. 21, 2004). [cited by applicant]
U.S. Appl. No. 18/186,098 , filed Mar. 17, 2023, by Dillon et al. (Copy not provided). (Copy not submitted herewith pursuant to the waiver of 37 C.F. R. § 1.98(a)(2)(iii) issued by the Office on Sep. 21, 2004). [cited by applicant]
Koenen et al., “A novel bispecific antihuman CD40/CD86 fusion protein with T-cell tolerizing potential,” Transplantation (2004) 78(10):1429-1438. [cited by applicant]
Rossi et al., “Phase I study of atacicept in relapsed/refractory multiple myeloma (MM) and Waldenström's macroglobulinemia,” Clin Lymphoma Myeloma Leuk. (2011) 11(1):136-138. [cited by applicant]
Sathish et al., “Challenges and approaches for the development of safer immunomodulatory biologics,” Nature Reviews Drug Discovery (2013) 12(4):306-324. [cited by applicant]
Tangye et al., “BAFF, APRIL and human B cell disorders,” Semin Immunol. (2006) 18(5):305-17. [cited by applicant]
“Database accession No. O14836” Retrieved from Uniprot, https://www.uniprot.org/uniprot/O14836, Retrieved on Oct. 26, 2021. [cited by applicant]
“Telitacicept”, WHO Drug Information, (2018) vol. 32, No. 4; pp. 651-652. [cited by applicant]
Bossen et al., “BAFF, APRIL and their receptors: structure, function and signaling,” Semin Immunol. (2006) 18(5): 263-275. [cited by applicant]
Dillon et al. “ALPN-303, an Enhanced, Potent Dual BAFF/APRIL Antagonist Engineered by Directed Evolution for the Treatment of Systemic Lupus Erythematosus (SLE) and Other B Cell-Related Autoimmune Diseases,” Abstract OP… [cited by applicant]
Dillon et al., “B Cell Modulatory Variant TNF Receptor Domains (vTDs) Identified by Directed Evolution to Inhibit BAFF and APRIL, Alone or Combined with Variant Ig Domains (vIgD™) that Inhibit T Cell Costimulation, for … [cited by applicant]
Dillon et al. “B Cell Modulatory Variant TNF Receptor Domains (vTDs) Identified by Directed Evolution to Inhibit BAFF and APRIL, Alone or Combined with Variant Ig Domains (vIgD™) that Inhibit T Cell Costimulation, for t… [cited by applicant]
Schmidts et al., “Rational design of a trimeric APRIL-based CAR-binding domain enables efficient targeting of multiple myeloma,” Blood Adv. (2019) 3(21): 3248-3260. [cited by applicant]
Wu et al., “A Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), Telitacicept (RC18), in Systemic Lupus Erythematosus (SLE): Results of a Phase 2b Stud… [cited by applicant]
U.S. Appl. No. 18/289,746, filed Nov. 6, 2023, by Dillon et al. [cited by applicant]
Abdel-Hamid et al., “B cell activating factor gene polymorphisms in patients with risk of idiopathic thrombocytopenia purpura,” Am J Med Sci (2011) 342(1):9-14. [cited by applicant]
Anthera Pharmaceuticals INC, Form 10-K, Annual Report, Filed Mar. 5, 2018, 168 pages. [cited by applicant]
Anthera, “Anthera Announces Top LineFinal Data from the ExtensionPeriod of the Phase 2 BRIGHT-SC Study of Blisibimod inPatients with IgA Nephropathy,” Press Release Aug. 28, 2017, 7 pages. [cited by applicant]
Asashima et al., “Serum levels of BAFF are increased in bullous pemphigoid but not in pemphigus vulgaris,” Br J Dermatol. (2006) 155(2):330-6. [cited by applicant]
Baert et al., “The role of April—A proliferation inducing ligand—In autoimmune diseases and expectations from its targeting,” J Autoimmun (2018) 95:179-190. [cited by applicant]
Bag-Ozbek et al., “Emerging B-Cell Therapies in Systemic Lupus Erythematosus,” Ther Clin Risk Manag (2021) 17:39-54. [cited by applicant]
Bagchi et al., “Supportive Management of IgA Nephropathy With Renin-Angiotensin Blockade, the AIIMS Primary IgA Nephropathy Cohort (Approach) Study,” Kidney Int Rep (2021) 6(6): 1661-1668. [cited by applicant]
Banchereau et al., “Personalized Immunomonitoring Uncovers Molecular Networks that Stratify Lupus Patients,” Cell (2016) 165(6): 1548-1550. [cited by applicant]
Barrett et al., “Effect of belimumab on proteinuria and anti-phospholipase A2 receptor autoantibody in primary membranous nephropathy,” Nephrol Dial Transplant (2020) 35(4):599-606. [cited by applicant]
Blair et al., “Belimumab: A Review in Systemic Lupus Erythematosus,” Drugs (2018) 78(3):355-366. [cited by applicant]
Chen et al., “Plasma Galactose-Deficient IgA1 and C3 and CKD Progression in IgA Nephropathy,” Clin J Am Soc Nephrol (2019) 14(10): 1458-1465. [cited by applicant]
Chiche et al., “Modular transcriptional repertoire analyses of adults with systemic lupus erythematosus reveal distinct type I and type II interferon signatures,” Arthritis Rheumatol (2014) 66(6): 1583-95. [cited by applicant]
Consonni et al., “A Novel Approach to Reinstating Tolerance in Experimental Autoimmune Myasthenia Gravis Using a Targeted Fusion Protein, mCTA1-T146,” Front Immunol (2017) 8:1133, 12 pages. [cited by applicant]
Cooper et al., “Immune Thrombocytopenia,” N Engl J Med (2019) 381(10): 945-955. [cited by applicant]
Couser, “Primary Membranous Nephropathy,” Clin J Am Soc Nephrol (2017) 12(6): 983-997. [cited by applicant]
De Marchi et al., “Efficacy of belimumab for the long-term maintenance therapy of thrombocytopenia in systemic lupus erythematosus,” Clin Exp Rheumatol (2017) 35(6): 1056. [cited by applicant]
Deng et al., “Raised cerebrospinal fluid BAFF and APRIL levels in anti-N-methyl-d-aspartate receptor encephalitis: Correlation with clinical outcome,” J Neuroimmunol (2017) 305:84-91. [cited by applicant]
Desmarets et al., “Minor histocompatibility antigens on transfused leukoreduced units of red blood cells induce bone marrow transplant rejection in a mouse model,” Blood (2009) 114(11):2315-22. [cited by applicant]