IP Library › Granted Patent US 12,344,678
Granted Patent B2
US 12,344,678 · App. 18/980,920 · Granted Jul 1, 2025

FcRn/HSA binding molecules and methods of use

Inventors: Vladimir Bobkov (Ghent, BE); Karen Silence (Ghent, BE); Jolien Van Santbergen (Ghent, BE); René Bigirimana (Ghent, BE); Judith Baumeister (Ghent, BE); Johannes de Haard (Ghent, BE); Christophe Blanchetot (Ghent, BE)
Assignee: argenx BV
C07K16/4258C07K16/18A61K2039/505C07K2317/569C07K2317/92C07K2317/94
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,344,678
App. No.
18/980,920
Granted
Jul 1, 2025
Kind
B2
Abstract

Provided herein are binding molecules comprising a human neonatal Fc receptor (FcRn) binding molecule and at least one antigen-binding domain linked to the FcRn binding molecule. Polynucleotides, vectors, host cells, and methods of production are also provided herein. Methods of treating an antibody-mediated disorder with an FcRn/antigen-binding molecule are further provided.

Claims (21)

1. A heterodimeric protein comprising a first polypeptide and a second polypeptide, wherein:

a) the first polypeptide comprises a first Fc domain comprising the amino acid sequence of SEQ ID NO: 5 and a VHH comprising the CDR1, CDR2, and CDR3 amino acid sequences of the VHH amino acid sequence set forth in SEQ ID NO: 44, and

b) the second polypeptide comprises a second Fc domain comprising the amino acid sequence of SEQ ID NO: 8.

2. The heterodimeric protein of claim 1 , wherein the CDR1, CDR2, and CDR3 amino acid sequences are set forth in SEQ ID NO: 14, SEQ ID NO: 11, and SEQ ID NO: 12, respectively.

3. The heterodimeric protein of claim 1 , wherein the VHH comprises the amino acid sequence of SEQ ID NO: 44.

4. The heterodimeric protein of claim 1 , wherein the VHH consists of the amino acid sequence of SEQ ID NO: 44.

5. The heterodimeric protein of claim 4 , further comprising one or more additional amino acids at the C-terminal end of the VHH, wherein the one or more additional amino acids are selected from the group consisting of:

a) A;

b) AG;

c) GG;

d) PP; and

e) AA.

6. The heterodimeric protein of claim 1 , wherein the VHH is fused to the C-terminus of the first Fc domain via a peptide linker.

7. The heterodimeric protein of claim 6 , wherein the peptide linker is a GS linker that is 20 or 30 amino acids in length.

8. The heterodimeric protein of claim 1 , wherein the first Fc domain consists of the amino acid sequence of SEQ ID NO: 5.

9. The heterodimeric protein of claim 1 , wherein the second Fc domain consists of the amino acid sequence of SEQ ID NO: 8.

10. A heterodimeric protein comprising a first polypeptide comprising the amino acid sequence of SEQ ID NO: 180 and a second polypeptide comprising the amino acid sequence of SEQ ID NO: 8.

11. The heterodimeric protein of claim 10 , wherein the first polypeptide consists of the amino acid sequence of SEQ ID NO: 180 and the second polypeptide consists of the amino acid sequence of SEQ ID NO: 8.

12. The heterodimeric protein of claim 11 , wherein the heterodimer protein consists of the first polypeptide and the second polypeptide.

13. A composition comprising the heterodimeric protein of claim 1 and at least one pharmaceutically acceptable carrier.

14. A composition comprising the heterodimeric protein of claim 10 and at least one pharmaceutically acceptable carrier.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 18, 2024
From: BOBKOV, VLADIMIR; SILENCE, KAREN; VAN SANTBERGEN, JOLIEN; BIGIRIMANA, RENÉ; BAUMEISTER, JUDITH; DE HAARD, JOHANNES; BLANCHETOT, CHRISTOPHE
To: ARGENX BV
Reel/Frame 069622/0703 →
Continuity (3)
Continuation PCTEP2023066180 · Jun 15, 2023
Provisional Application 63352589 · Jun 15, 2022
Related Publication 20250122310A1 · Apr 17, 2025
References Cited (400)
US 5326856A · Coughlin et al. · 1994 [cited by applicant]
US 5624821A · Winter et al. · 1997 [cited by applicant]
US 5648260A · Winter et al. · 1997 [cited by applicant]
US 5677425A · Bodmer et al. · 1997 [cited by applicant]
US 5869046A · Presta et al. · 1999 [cited by applicant]
US 5885573A · Bluestone et al. · 1999 [cited by applicant]
US 6121022A · Presta et al. · 2000 [cited by applicant]
US 6165745A · Ward et al. · 2000 [cited by applicant]
US 6194551B1 · Idusogie et al. · 2001 [cited by applicant]
US 6277375B1 · Ward · 2001 [cited by applicant]
US 6528624B1 · Idusogie et al. · 2003 [cited by applicant]
US 6737056B1 · Presta · 2004 [cited by applicant]
US 6821505B2 · Ward · 2004 [cited by applicant]
US 6992234B2 · Roopenian · 2006 [cited by applicant]
US 7083784B2 · Dall'Acqua et al. · 2006 [cited by applicant]
US 7183387B1 · Presta · 2007 [cited by applicant]
US 7670600B2 · Dall'Acqua et al. · 2010 [cited by applicant]
US 7704497B2 · Dall'Acqua et al. · 2010 [cited by applicant]
US 8012476B2 · Dall'Acqua et al. · 2011 [cited by applicant]
US 8021856B2 · Umana et al. · 2011 [cited by applicant]
US 8067232B2 · Kanda et al. · 2011 [cited by applicant]
US 8101186B2 · Mezo et al. · 2012 [cited by applicant]
US 8163881B2 · Ober · 2012 [cited by applicant]
US 8195661B2 · Kalavade · 2012 [cited by applicant]
US 8216805B2 · Carter et al. · 2012 [cited by applicant]
US 8273351B2 · TenHoor et al. · 2012 [cited by applicant]
US 8323962B2 · Dall'Acqua et al. · 2012 [cited by applicant]
US 8475792B2 · Dall'Acqua et al. · 2013 [cited by applicant]
US 8680237B2 · Strome et al. · 2014 [cited by applicant]
US 8795661B2 · Dall'Acqua et al. · 2014 [cited by applicant]
US 8815246B2 · TenHoor et al. · 2014 [cited by applicant]
US 8834871B2 · Ober · 2014 [cited by applicant]
US 9260520B2 · TenHoor et al. · 2016 [cited by applicant]
US 9573992B2 · Dombrecht · 2017 [cited by examiner]
US 10316073B2 · Ulrichts et al. · 2019 [cited by applicant]
US 11505585B2 · Ulrichts et al. · 2022 [cited by applicant]
US 11591388B2 · Borgions et al. · 2023 [cited by applicant]
US 12202900B2 · de Haard et al. · 2025 [cited by applicant]
US 12240875B2 · de Haard et al. · 2025 [cited by applicant]
US 20040002587A1 · Watkins et al. · 2004 [cited by applicant]
US 20040010124A1 · Johnson et al. · 2004 [cited by applicant]
US 20040047862A1 · Lazarus et al. · 2004 [cited by applicant]
US 20040265321A1 · Johnson et al. · 2004 [cited by applicant]
US 20050053598A1 · Burke et al. · 2005 [cited by applicant]
US 20060210557A1 · Luisi et al. · 2006 [cited by applicant]
US 20070092507A1 · Balthasar et al. · 2007 [cited by applicant]
US 20090252729A1 · Farrington et al. · 2009 [cited by applicant]
US 20110066111A1 · Teschner et al. · 2011 [cited by applicant]
US 20110081345A1 · Moore et al. · 2011 [cited by applicant]
US 20110243966A1 · Farrington et al. · 2011 [cited by applicant]
US 20130142802A1 · Chang et al. · 2013 [cited by applicant]
US 20130156765A1 · Block et al. · 2013 [cited by applicant]
US 20140302028A1 · Zha · 2014 [cited by applicant]
US 20160252497A1 · Ling · 2016 [cited by applicant]
US 20160264669A1 · Ulrichts et al. · 2016 [cited by applicant]
US 20170260238A1 · Abrahmsen et al. · 2017 [cited by applicant]
US 20190194277A1 · de Haard et al. · 2019 [cited by applicant]
US 20200024344A1 · de Haard et al. · 2020 [cited by applicant]
US 20210236596A1 · Verheesen et al. · 2021 [cited by applicant]
US 20220275035A1 · Ulrichts et al. · 2022 [cited by applicant]
US 20220298241A1 · Blumberg et al. · 2022 [cited by applicant]
US 20230357382A1 · Borgions et al. · 2023 [cited by applicant]
US 20240325528A1 · Van Bragt et al. · 2024 [cited by applicant]
US 20240369467A1 · Verheesen et al. · 2024 [cited by applicant]
US 20250051453A1 · Verheesen et al. · 2025 [cited by applicant]
US 20250084171A1 · van der Woning et al. · 2025 [cited by applicant]
US 20250101111A1 · Brinkhaus et al. · 2025 [cited by applicant]
EP 0227110A2 · 1987 [cited by applicant]
WO WO1994029351A2 · 1994 [cited by applicant]
WO WO1996022024A1 · 1996 [cited by applicant]
WO WO1997034631A1 · 1997 [cited by applicant]
WO 1998023289A1 · 1998 [cited by applicant]
WO WO1999004813A1 · 1999 [cited by applicant]
WO WO1999058572A1 · 1999 [cited by applicant]
WO WO2000042072A2 · 2000 [cited by applicant]
WO WO2001058957A2 · 2001 [cited by applicant]
WO WO2002043658A2 · 2002 [cited by applicant]
WO WO2002060919A2 · 2002 [cited by applicant]
WO WO2004016750A2 · 2004 [cited by applicant]
WO WO2004029207A2 · 2004 [cited by applicant]
WO WO2004035752A2 · 2004 [cited by applicant]
WO WO2004063343A2 · 2004 [cited by applicant]
WO WO2004063351A2 · 2004 [cited by applicant]
WO WO2004099249A2 · 2004 [cited by applicant]
WO WO2005040217A2 · 2005 [cited by applicant]
WO 2006028936A2 · 2006 [cited by applicant]
WO 2006122787A1 · 2006 [cited by applicant]
WO WO2006118772A2 · 2006 [cited by applicant]
WO WO2006130834A2 · 2006 [cited by applicant]
WO WO2007098420A2 · 2007 [cited by applicant]
WO WO2009100105A2 · 2009 [cited by applicant]
WO WO2009131702A2 · 2009 [cited by applicant]
WO WO2010014909A1 · 2010 [cited by applicant]
WO WO2010106180A2 · 2010 [cited by applicant]
WO WO2010111254A1 · 2010 [cited by applicant]
WO WO2011044368A1 · 2011 [cited by applicant]
WO WO2011080209A2 · 2011 [cited by applicant]
WO WO2012160448A2 · 2012 [cited by applicant]
WO 2012175400A1 · 2012 [cited by applicant]
WO WO2012167039A1 · 2012 [cited by applicant]
WO WO2013063186A2 · 2013 [cited by applicant]
WO WO2013074598A1 · 2013 [cited by applicant]
WO WO2013100702A1 · 2013 [cited by applicant]
WO WO2013166604A1 · 2013 [cited by applicant]
WO WO2013192504A1 · 2013 [cited by applicant]
WO WO2014008391A1 · 2014 [cited by applicant]
WO WO2014019727A1 · 2014 [cited by applicant]
WO WO2014140366A1 · 2014 [cited by applicant]
WO WO2014204280A1 · 2014 [cited by applicant]
WO WO2015071330A1 · 2015 [cited by applicant]
WO WO2015073721A1 · 2015 [cited by applicant]
WO WO2015081073A2 · 2015 [cited by applicant]
WO WO2015100299A1 · 2015 [cited by applicant]
WO WO2016042083A1 · 2016 [cited by applicant]
WO WO2016123521A2 · 2016 [cited by applicant]
WO WO2016142782A1 · 2016 [cited by applicant]
WO WO2016180765A1 · 2016 [cited by applicant]
WO WO2016183352A1 · 2016 [cited by applicant]
WO WO2017012959A1 · 2017 [cited by applicant]
WO WO2017121330A1 · 2017 [cited by applicant]
WO WO2017189959A1 · 2017 [cited by applicant]
WO WO2018023136A1 · 2018 [cited by applicant]
WO WO2018083122A1 · 2018 [cited by applicant]
WO 2018187057A1 · 2018 [cited by applicant]
WO WO2019110823A1 · 2019 [cited by applicant]
WO WO2019118791A1 · 2019 [cited by applicant]
WO WO2019234713A2 · 2019 [cited by applicant]
WO WO2020078905A1 · 2020 [cited by applicant]
WO WO2020097099A1 · 2020 [cited by applicant]
WO 2020208177A1 · 2020 [cited by applicant]
WO WO2020227515A1 · 2020 [cited by applicant]
WO WO2020236695A1 · 2020 [cited by applicant]
WO WO2020245420A1 · 2020 [cited by applicant]
WO WO2021022249A1 · 2021 [cited by applicant]
WO WO2020245420A9 · 2021 [cited by applicant]
WO WO2021140202A1 · 2021 [cited by applicant]
WO WO2021216756A2 · 2021 [cited by applicant]
WO WO2022098955A1 · 2022 [cited by applicant]
WO WO2023012515A2 · 2023 [cited by applicant]
WO WO2023135321A1 · 2023 [cited by applicant]
WO WO2023156614A1 · 2023 [cited by applicant]
WO WO2023209036A1 · 2023 [cited by applicant]
WO WO2023242361A1 · 2023 [cited by applicant]
WO WO2023242362A1 · 2023 [cited by applicant]
WO WO2023242371A1 · 2023 [cited by applicant]
WO WO2023242372A1 · 2023 [cited by applicant]
WO 2024052358A1 · 2024 [cited by applicant]
WO WO2024100453A1 · 2024 [cited by applicant]
WO WO2024100455A1 · 2024 [cited by applicant]
WO WO2024105445A2 · 2024 [cited by applicant]
WO WO2024147074A1 · 2024 [cited by applicant]
WO WO2024150073A1 · 2024 [cited by applicant]
WO WO2024189430A1 · 2024 [cited by applicant]
WO 2025017368A1 · 2025 [cited by applicant]
Vincke, Cecile, et al. “General strategy to humanize a camelid single-domain antibody and identification of a universal humanized nanobody scaffold.” Journal of Biological Chemistry 284.5 (2009): 3273-3284. (Year: 2009). [cited by examiner]
Kipriyanov, Sergey M., and Favrice Le Gall. “Generation and production of engineered antibodies.” Molecular biotechnology 26.1 (2004): 39-60. (Year: 2004). [cited by examiner]
Ghahroudi, M et al. “Selection and identification of single domain antibody fragments from camel heavy-chain antibodies.” FEBS letters vol. 414,3 (1997): 521-6. doi:10.1016/s0014-5793(97)01062-4 (Year: 1997). [cited by examiner]
“Vyvgart™ (efgartigimod alfa-fcab) injection, for intravenous Use”, Initial U.S. Approval, Dec. 2021, 14 pages. [cited by applicant]
Alexion Pharmaceuticals Inc., “A Phase 1b/2, Multicenter, Open-Label, Safety, and Dose-Finding Study of SYNT001 in Subjects with Pemphigus (Vulgaris or Foliaceus)”, Retrieved from: https://cdn.clinicaltrials.gov/large-d… [cited by applicant]
Briani et al., “Therapeutic Monoclonal Antibody Therapies in Chronic Autoimmune Demyelinating Neuropathies”, Neurotherapeutics, 2022, 19(3):874-884. [cited by applicant]
Brinkhaus et al., “Glycine 236 in the Lower Hinge Region of Human IgG1 Differentiates FcgammaR from Complement Effector Function”, The Journal of Immunology, Dec. 15, 2020, 205(12):3456-3467. [cited by applicant]
Miyamoto et al., “Pemphigus “Is Rituximab effective?””, MB Derma, 2012, 190:91-93 (English Translation and Official Copy). [cited by applicant]
Nelke et al., “Neonatal Fc Receptor-Targeted Therapies in Neurology”, Neurotherapeutics, 2022, 19(3):729-740. [cited by applicant]
Simpson et al., “The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermat… [cited by applicant]
Smith et al., “Mouse model recapitulating human FcGamma receptor structural and functional diversity”, PNAS, Apr. 17, 2012, 109(16):6181-6186. [cited by applicant]
Svaina et al., “Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Current Therapies and Future Approaches”, Current Pharmaceutical Design, 2022, 28(11):854-862. [cited by applicant]
Syntimmune, Inc., “Syntimmune Announces Positive Preliminary Results from Clinical Proof-of-Concept Trial of SYNT001 in Pemphigus Vulgaris and Foliaceus”, Retrieved from: https://www.businesswire.com/news/home/201805170… [cited by applicant]
International Search Report and Written Opinion received for PCT Application No. PCT/IB2024/000374, mailed on Nov. 12, 2024, 16 pages. [cited by applicant]
“Assignment submission for U.S. Appl. No. 61/920,547 confirming change of legal form of arGEN-X B.V. to arGEN-X N.V. on May 28, 2014”, Document D30 submitted with Notice of Opposition for European Patent No. 3087095 (U.… [cited by applicant]
“Appeal from the United States District Court for the District of Delaware”, [cited by applicant]
“Auxiliary Request 1—Annotated Version” for European Patent No. 3087095 (Application No. 14827372.5), dated Oct. 28, 2020, 5 pages. [cited by applicant]
“Auxiliary Request 1—Clean Version” for European Patent No. 3087095 (Application No. 14827372.5), dated Oct. 28, 2020, 5 pages. [cited by applicant]
“Auxiliary Request 2—Annotated Version” for European Patent No. 3087095 (Application No. 14827372.5), dated Oct. 28, 2020, 5 pages. [cited by applicant]
“Auxiliary Request 2—Clean Version” for European Patent No. 3087095 (Application No. 14827372.5), dated Oct. 28, 2020, 4 pages. [cited by applicant]
“Declaration of Pieter Spuijbroek”, Document D42 submitted with Reply to Notice of Opposition for European Patent No. 3087095 (Application No. 14827372.5), dated Oct. 28, 2020, 5 pages. [cited by applicant]
“Guidance for Industry Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers”, FDA, Jul. 2005, 30 pages. [cited by applicant]
“Main Request—Annotated Version” for European Patent No. 3087095 (Application No. 14827372.5), dated Oct. 28, 2020, 5 pages. [cited by applicant]
“Main Request—Clean Version” for European Patent No. 3087095 (Application No. 14827372.5), dated Oct. 28, 2020, 5 pages. [cited by applicant]
“Sequence Alignment of SEQ ID No. 22 from D6 vs SEQ ID Nos. 1, 2, and 3 from opposed patent”, Document D32 submitted with Notice of Opposition for European Patent No. 3087095 (Application No. 14827372.5), dated May 7, 2… [cited by applicant]
“Sequence Alignment of SEQ ID Nos. 1, 2 and 3 from opposed patent vs corresponding portion of Uniprot ID: P01857”, Document D24 submitted with Notice of Opposition for European Patent No. 3087095 (Application No. 148273… [cited by applicant]
“Swiss Webster Mice”, Taconic—Models for Life, Aug. 23, 2018, pp. 1-7. [cited by applicant]
“UniProtKB—P01857 (IGHG1_HUMAN)”, Document D43 submitted with Reply to Notice of Opposition for European Patent No. 3087095 (Application No. 14827372.5), dated Oct. 28, 2020, 6 pages. [cited by applicant]
Abdiche et al., “The neonatal Fc receptor (FcRn) binds independently to both sites of the IgG homodimer with identical affinity”, mAbs, 2015, 7(2):331-343. [cited by applicant]
Akilesh et al., “The MHC class I-like Fc receptor promotes humorally mediated autoimmune disease”, The Journal of Clinical Investigation, May 2004, 113(9):1328-1333. [cited by applicant]
Alegre et al., “A Non-Activating “Humanized” Anti-CD3 Monoclonal Antibody Retains Immunosuppressive Properties In Vivo”, Transplantation, Jun. 1994, 57(11):1537-1543. [cited by applicant]
Alipour-Faz et al., “A comparison between IVIG and plasma exchange as preparations before thymectomy in myasthenia gravis patients”, Acta Neurol Belg, 2016, 117(1):245-249. [cited by applicant]
Allen et al., “Efgartigimod in Chronic Inflammatory Demyelinating Polyneuropathy: Adhere Phase 2 Trial Design”, Muscle and Nerve, Oct. 1, 2020, 62(Suppl. 1):abstract, 1 page. [cited by applicant]
Andersen et al., “Structure-based mutagenesis reveals the albumin-binding site of the neonatal Fc receptor”, Nature Communications, 2012, 3(610), pp. 1-9. [cited by applicant]
Anonymous, “A Randomized, Double-Blinded, Placebo-Controlled Trial of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus)”, Jul. 16, 2021, Retrieved from: https://rctportal.niph.go.jp/en/detail… [cited by applicant]
Anonymous, “argenx announces initial results from Phase 1 multiple ascending dose (MAD) study of ARGX-113 in healthy volunteers—Argenx”, Jun. 29, 2016, 3 pages. [cited by applicant]
Anthony et al., “Recapitulation of IVIG Anti-Inflammatory Activity with a Recombinant IgG Fc”, Science, Apr. 18, 2008, 320(5874):373-376. [cited by applicant]
Antohe et al., “Expression of Functionally active FcRn and the Differentiated Bidirectional Transport of IgG in Human Placental Endothelial Cells”, Human Immunol., 2001, 62(2):93-105. [cited by applicant]
Arduin et al., “Highly reduced binding to high and low affinity mouse Fc gamma receptors by L234A/L235A and N297A Fc mutations engineered into mouse IgG2a”, Molecular Immunology, 2015, 63(2):456-463. [cited by applicant]
Argen-X N.V., “arGEN-X advances ARGX-113 into preclinical development for autoimmune disorders”, Press Release, arGEN-X, Apr. 24, 2014, 3 pages. [cited by applicant]
Argen-X N.V., “arGEN-X Announces Positive Preclinical Results for ARGX-113”, Press Release. EURONEXT, Aug. 19, 2014, 3 pages. [cited by applicant]
Argen-X N.V., “Prospectus for Public Offering of arGEN-X N.V.”, Jun. 20, 2014, 253 pages. [cited by applicant]
Argen-X, “An Emerging Antibody Force: Company Presentation”, Presentation Slides, Oct. 2013, 15 pages. [cited by applicant]
Argen-X, “ARGX-113”, Retrieved from: http://www.argen-x.com/en-GB/contenl/argx-113/22, 2017, 4 pages. [cited by applicant]
Argen-X, “ARGX-113: Development Opportunity in Autoimmunity”, Presentation Slides, Oct. 2013, 17 pages. [cited by applicant]
Armour et al., “Recombinant human IgG molecules lacking Fc gamma receptor I binding and monocyte triggering activities”, Eur. J. Immunol., 1999, 29(8):2613-2624. [cited by applicant]
Azevedo, “argenx Doses First Subject in Study Evaluating Subcutaneous ARGX-113 for Autoimmune Diseases”, Myasthenia Gravis News, Oct. 31, 2017, 2 pages. [cited by applicant]
Balighi et al., “Comparing early and late treatments with rituximab in pemphigus vulgaris: which one is better?”, Archives of Dermatological Research, 2019, 311(1):63-69. [cited by applicant]
Ballow, “Mechanisms of Action of Intravenous Immunoglobulin Therapy and Potential Use in Autoimmune Connective Tissue Diseases”, Cancer, 1991, 68(6):1430-1436. [cited by applicant]
Barth et al., “Comparison of IVIg and PLEX in patients with myasthenia gravis”, Neurology, Jun. 7, 2011, 76(23):2017-2023. [cited by applicant]
Basta et al., “High-dose intravenous immunoglobulin exerts its beneficial effect in patients with dermatomyositis by blocking endomysial deposition of activated complement fragments”, The Journal of Clinical Investigati… [cited by applicant]
Bitonti et al., “Pulmonary delivery of an erythropoietin Fc fusion protein in non-human primates through an immunoglobulin transport pathway”, PNAS, Jun. 29, 2004, 101(26):9763-9768. [cited by applicant]
Blanchette et al., “Intensive plasma exchange therapy in ten patients with idiopathic thrombocytopenia purpura”, Transfusion, 1984, 24(5):388-394. [cited by applicant]
Blumberg et al., “Antibodies in the breakdown lane”, Nature Biotechnology, Oct. 2005, 23(10):1232-1234. [cited by applicant]
Blumberg et al., “Blocking FcRn in humans reduces circulating IgG levels and inhibits IgG immune complex-mediated immune responses”, Sci. Adv., Dec. 18, 2019, 5(12):eaax9586, 12 pages. [cited by applicant]
Brinkhaus et al., “The Fab region of IgG impairs the internalization pathway of FcRn upon Fc management”, Nature Communications, 2022, 13(1):6073, pp. 1-14. [cited by applicant]
Broome et al., “Abstract PB0830: Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients with Primary Immune Thrombocytopenia: Advance SC, a Global Phase 3 Clinical Trial in Progress”, Res Pract Thromb H… [cited by applicant]
Broome et al., “Efficacy and safety of the neonatal Fc receptor inhibitor efgartigimod in adults with primary immune thrombocytopenia (Advance IV): a multicentre, randomised, placebo-controlled, phase 3 trial”, Lancet, … [cited by applicant]
Bruhns et al., “Colony-Stimulating Factor-1-Dependent Macrophages are Responsible for IVIG Protection in Antibody-Induced Autoimmune Disease”, Immunity, Apr. 2003, 18(4):573-581. [cited by applicant]
Brych et al., “Characterization of Antibody Aggregation: Role of Buried, Unpaired Cysteines in Particle Formation”, Journal of Pharmaceutical Sciences, Feb. 2010, 99(2):764-781. [cited by applicant]
Burmeister et al., “Crystal structure at 2.2 Å resolution of the MHC-related neonatal Fc receptor”, Nature, Nov. 24, 1994, 372(6504):336-343. [cited by applicant]
Burns, “History of outcome measures for myasthenia gravis”, Muscle & Nerve, Jul. 2010, 42(1):5-13. [cited by applicant]
Burns, “Of Mice and Children: Lessons From a Kawasaki Mouse Model”, Circulation, 2012, 125:1480-1481. [cited by applicant]
Bussel et al., “A randomized, double-blind study of romiplostim to determine its safety and efficacy in children with immune thrombocytopenia”, Blood, Jul. 7, 2011, 118(1):28-36. [cited by applicant]
Bussel et al., “Eltrombopag for the Treatment of Chronic Idiopathic Thrombocytopeni Purpura”, The New England Journal of Medicine, Nov. 29, 2007, 357(22):2237-2247. [cited by applicant]
Bussel et al., “Long-Term use of the Thrombopoietin-Mimetic Romiplostim in Children With Severe Chronic Immune Thrombocytopenia (ITP): Romiplostim in Pediatric ITP”, Pediatric Blood Cancer, 2015, 62(2):208-213. [cited by applicant]
Bystryn et al., “IVIg selectively and rapidly decreases circulating pathogenic autoantibodies in pemphigus vulgaris”, Autoimmunity, Nov. 2006, 39(7):601-607. [cited by applicant]
Carter, “Potent antibody therapeutics by design”, Nature Reviews, Immunology, May 2006, 6(5):343-357. [cited by applicant]
Challa et al., “Autoantibody depletion ameliorates disease in murine experimental autoimmune encephalomyelitis”, mAbs, Sep./Oct. 2013, 5(5):655-659. [cited by applicant]
Challa et al., “Neonatal Fc receptor expression in macrophages is indispensable for IgG homeostasis”, MABS., 2019, 11(5):848-860. [cited by applicant]
Chaudhury et al., “The Major Histocompatibility Complex-related Fc Receptor for IgG (FcRn) Binds Albumin and Prolongs Its Lifespan”, The Journal of Experimental Medicine, Feb. 3, 2003, 197(3):315-322. [cited by applicant]
Cipriani et al., “MET as a target for treatment of chest tumours”, Lung Cancer, Feb. 2009, 63(2):169-179. [cited by applicant]
Clarkson et al., “Treatment of Refractory Immune Thrombocytopeniaurpura with an Anti-Fc gamma-Receptor Antibody”, The New England Journal of Medicine, May 8, 1986, 314(9):1236-1239. [cited by applicant]
ClinicalTrials.gov, “A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)”, ClinicalTrials.gov Identifier: NCT04968912, Jul. 20, 2021, 9 pages. [cited by applicant]
ClinicalTrials.gov, “A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)”, ClinicalTrials.gov Identifier: NCT05810948, Oct. 2, 2023, 17 pages. [cited by applicant]
ClinicalTrials.gov, “A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus) (Address+)”, ClinicalTrials.gov Identifier:… [cited by applicant]
ClinicalTrials.gov, “A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with ITP”, ClinicalTrials.gov Identifier: NCT03102593, Apr. 6, 2017, 7 pages. [cited by applicant]
ClinicalTrials.gov, “A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients with Pemphigus”, ClinicalTrials.gov Identifier: NCT03334058, Nov. 7, 2017, 8 pages. [cited by applicant]
ClinicalTrials.gov, “Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS (POTS)”, ClinicalTrials.gov Identifier: NCT05633407, Nov. 29, 2022, 13 pages. [cited by applicant]
ClinicalTrials.gov, “Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis (Adaptsc+)”, ClinicalTrials.gov Identifier: NCT048… [cited by applicant]
ClinicalTrials.gov, “History of Changes for Study: NCT05267600—A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (Ballad)”, Apr. 14, 2022, 7 pages. [cited by applicant]
ClinicalTrials.gov, “History of Changes for Study: NCT05810961—A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Primary Membranous Nephropathy (ZL-1103-014)”, Oct. 2, 2023, 11 pages. [cited by applicant]
Coetzee et al., “The Effect of Monoclonal Anti-human-platelet Antibodies on Platelet Kinetics in a Baboon Model: IgG Subclass Dependency”, Thromb Haemost, 2000, 83(1):148-156. [cited by applicant]
Crow et al., “The Mechanisms of Action of Intravenous Immunoglobulin and Polyclonal Anti-D Immunoglobulin in the Amelioration of Immune Thrombocytopeni Purpura: What Do We Really Know?”, Transfusion Medicine Reviews, Ap… [cited by applicant]
Crow et al., “The neonatal Fc receptor (FcRn) is not required for IVIg or anti-CD44 monoclonal antibody-mediated amelioration of murine immune thrombocytopenia”, Blood, Dec. 8, 2011, 118(24):6403-6406. [cited by applicant]
Dalakas et al., “A controlled trial of high-dose intravenous immune globulin infusions as treatment for dermatomyositis”, N Engl J Med., Dec. 30, 1993, 329(27):1993-2000. [cited by applicant]
Dalakas et al., “High-dose intravenous immune globulin for stiff-person syndrome”, The New England Journal of Medicine, Dec. 27, 2001, 345(26):1870-1876. [cited by applicant]
Dalakas, “Update on Intravenous Immunoglobulin in Neurology: Modulating Neuro-autoimmunity, Evolving Factors on Efficacy and Dosing and Challenges on Stopping Chronic IVIg Therapy”, Neurotherapeutics, 2021, 18(4):2397-2… [cited by applicant]
Dall'Acqua et al., “Increasing the Affinity of a Human IgG1 for the Neonatal Fc Receptor: Biological Consequences”, The Journal of Immunology, 2002, 169:5171-5180. [cited by applicant]
Dall'Acqua et al., “Properties of Human IgG1s Engineered for Enhanced Binding to the Neonatal Fc receptor (FcRn)”, Journal of Biological Chemistry, Aug. 18, 2006, 281(33):23514-23524. [cited by applicant]
Darabi et al., “Current usage of intravenous immune globulin and the rationale behind it: the Massachusetts General Hospital data and a review of the literature”, Transfusion, May 2006, 46(5):741-753. [cited by applicant]
Daugherty et al., “Formulation and delivery issues for monoclonal antibody therapeutics”, Advanced Drug Delivery Reviews, 2006, 58(5-6):686-706. [cited by applicant]
De Haard et al., “Advancing ARGX-113 and ARGX-110 to Clinical Proof of Concept”, Dec. 4, 2016, pp. 1-57. [cited by applicant]
Debré et al., “Infusion of Fc gamma fragments for treatment of children with acute immune thrombocytopenia purpura”, The Lancet, Oct. 16, 1993, 342(8877):945-949. [cited by applicant]
Deisenhofer, “Crystallographic Refinement and Atomic Models of a Human Fc Fragment and Its Complex with Fragment B of Protein A from [cited by applicant]
Deng et al., “Pharmacokinetic/Pharmacodynamic Modeling of IVIG Effects in a Murine Model of Immune Thrombocytopenia”, Journal of Pharmaceutical Sciences, Jun. 2007, 96(6):1625-1637. [cited by applicant]
Dick Jr., et al., “C-Terminal Lysine Variants in Fully Human Monoclonal Antibodies: Investigation of Test Methods and Possible Causes”, Biotechnology and Bioengineering, Aug. 15, 2008, 100(6):1132-1143. [cited by applicant]
Dickinson et al., “Bidirectional FcRn-dependent IgG transport in a polarized human intestinal epithelial cell line”, The Journal of Clinical Investigation, Oct. 1999, 104(7):903-911. [cited by applicant]
Dimitrov, “Engineered CH2 domains (nanoantibodies)”, mAbs, Jan./Feb. 2009, 1(1):26-28. [cited by applicant]
Duncan et al., “Localization of the binding site for the human high-affinity Fc receptor on IgG”, Nature, Apr. 7, 1988, 332(6164):563-564. [cited by applicant]
Dylewski et al., “Exploiting the neonatal crystallizable fragment receptor to treat kidney disease”, Kidney International, 2024, 105(1):54-64. [cited by applicant]
Eddleston et al., “Blockade of the Neonatal Fc Receptor (FcRn) Represents an Effective Mechanism for the Removal of Pathogenic Autoantibodies in Primary Immune Thrombocytopenia”, Blood, Dec. 7, 2017, 130(Suppl. 1):230, … [cited by applicant]
Edelman et al., “The covalent structure of an entire gamma G immunoglobulin molecule”, Proc. N. A. S., Mar. 21, 1969, 63(1):78-85. [cited by applicant]
El-Salem et al., “Treatment of MuSK-Associated Myasthenia Gravis”, Curr Treat Options Neurol, Feb. 8, 2014, 16(4):283, 17 pages. [cited by applicant]
Evoli et al., “Diagnosis and therapy of myasthenia gravis with antibodies to muscle-specific kinase”, Autoimmunity Reviews, 2013, 12(9):931-935. [cited by applicant]
Eymard, “Antibodies in myasthenia gravis”, Rev. Neurol., 2009, 165(2):137-143. [cited by applicant]
Federico et al., “Multifocal motor neuropathy improved by IVIg: Randomized, double-blind, placebo-controlled study”, Neurology, 2000, 55(9):1256-1262. [cited by applicant]
Firan et al., “The MHC class I-related receptor, FcRn, plays an essential role in the maternofetal transfer of gamma-globulin in humans”, International Immunology, 2001, 13(8):993-1002. [cited by applicant]
Flaherty et al., “Nonclinical Evaluation of GMA161—An Antihuman CD16 (Fc gamma RIII) Monoclonal Antibody for Treatment of Autoimmune Disorders in CD16 Transgenic Mice”, Toxicological Sciences, 2012, 125(1):299-309. [cited by applicant]
Furusho et al., “High-dose intravenous gammaglobulin for Kawasaki disease”, Lancet, Nov. 10, 1984, 2:1055-1058. [cited by applicant]
Gan et al., “Analyses of the recycling receptor, FcRn, in live cells reveal novel pathways for lysosomal delivery”, Traffic, May 2009, 10(5):600-614. [cited by applicant]
Garcia et al., “Kinetics and thermodynamics of T cell receptor-autoantigen interactions in murine experimental autoimmune encephalomyelitis”, PNAS, Jun. 5, 2001, 98(12):6818-6823. [cited by applicant]
Genbank Accession No. NM_000569, “ [cited by applicant]
Ghanima et al., “Pharmacokinetic / Pharmacodynamic (PK/PD) Simulations Guide Selection of the Dose for Administration of Efgartigimod Subcutaneously in a Phase 3 Clinical Trial in Patients with Primary Immune Thrombocyt… [cited by applicant]
Ghetie et al., “Abnormally short serum half-lives of IgG in beta 2-microglobulin-deficient mice”, Eur. J. Immunol., 1996, 26(3):690-696. [cited by applicant]
Ghetie et al., “FcRn: the MHC class I-related receptor that is more than an IgG transporter”, Immunology Today, 1997, 18(12):592-598. [cited by applicant]
Ghetie et al., “Increasing the serum persistence of an IgG fragment by random mutagenesis”, Nature Biotechnology, Jul. 1997, 15(7):637-640. [cited by applicant]
Ghetie et al., “Multiple Roles for the Major Histocompatibility Complex class I-Related Receptor FcRn”, Annu. Rev. Immunol., 2000, 18(1):739-766. [cited by applicant]
Ghetie et al., “Transcytosis and catabolismof antibody”, Immunologic Research, 2002, 25(2):97-113. [cited by applicant]
Gilhus et al., “Myasthenia Gravis: A Review of Available Treatment Approaches”, Autoimmune Diseases, 2011, Article ID 847393, 7 pages. [cited by applicant]
Goebeler et al., “Treatment of pemphigus vulgaris and foliaceus with efgartigimod, a neonatal Fc receptor inhibitor: a phase II multicentre, open-label feasibility trial”, British Journal of Dermatology, 2022, 186(3):42… [cited by applicant]
Goh et al., “Impact of host cell line choice on glycan profile”, Critical Reviews in Biotechnology, 2018, 38(6):851-867. [cited by applicant]
Gomez-Guerrero et al., “Administration of IgG Fc Fragments Prevents Glomerular Injury in Experimental Immune Complex Nephritis”, The Journal of Immunology, 2000, 164(4):2092-2101. [cited by applicant]
Grau, “IgG core a-fucosylation and its impact on Fc gamma RIIIa binding”, Pharma Research and Early Development, Sep. 21, 2011, pp. 1-20. [cited by applicant]
Grevys et al., “Fc Engineering of Human IgG1 for Altered Binding to the Neonatal Fc Receptor Affects Fc Effector Functions”, The Journal of Immunology, 2015, 194(11):5497-5508. [cited by applicant]
Guptill et al., “Effect of FcRn antagonism on protective antibodies and to vaccines in IgG-mediated autoimmune diseases pemphigus and generalised myasthenia gravis”, Autoimmunity, 2022, 55(8):620-631. [cited by applicant]
Guptill et al., “Effect of therapeutic plasma exchange on immunoglobulins in myasthenia gravis”, Autoimmunity, Aug. 11, 2016, 49(7):472-479. [cited by applicant]
Ha et al., “Immunoglobulin Fc Heterodimer Platform Technology: From Design to Applications in Therapeutic Antibodies and Proteins”, Frontiers in Immunology, Oct. 6, 2016, 7(394), pp. 1-16. [cited by applicant]
Haller, “Converting Intravenous Dosing to Subcutaneous Dosing with Recombinant human Hyaluronidase”, Pharmaceutical Technology, Advanstar Communications Inc., Oct. 2, 2007, 31(10), pp. 1-5. [cited by applicant]
Hansen et al., “Intravenous Immunoglobulin Mediates an Increase in Anti-Platelet Antibody Clearance via the FcRn Receptor”, Thromb Haemost., 2002, 88:898-899. [cited by applicant]
Hanson, “The role of the Immunoglobulin G1 Fc N-glycan in Fc gamma RIIIa affinity”, Graduate Thesis and Dissertations, Paper 14135, 2014, 69 pages. [cited by applicant]
Heo, “Efgartigimod: First Approval”, Drugs, Feb. 18, 2022, 82(3):341-348 [cited by applicant]
Hettmann et al., “Development of the clinical candidate PBD-C06, a humanized pGlu3-ABeta-specific antibody against Alzheimer's disease with reduced complement activation”, Scientific Reports, 2020, 10(3294), pp. 1-13. [cited by applicant]
Hinton et al., “Engineered human IgG Antibodies with Longer Serum Half-Lives in Primates”, The Journal of Biological Chemistry, Feb. 20, 2004, 279(8):6213-6216. [cited by applicant]
Hoffman, “Subcutaneous Efgartigimod Shows Noninferiority to IV Formulation in Generalized Myasthenia Gravis”, NeurologyLive, Retrieved from: https://web.archive.org/web/20220326043901/https://www.neurologylive.com/view/… [cited by applicant]
Howard et al., “A double-blind placebo-controlled study to evaluate safety and efficacy of FcRn antagonist ARGX-113 (efgartigimod) in generalized myasthenia gravis”, 70th Annual Meeting of the American Academy of Neurol… [cited by applicant]
Howard et al., “Randomized phase 2 study of FcRn antagonist efgartigimod in generalized myasthenia gravis”, Neurology, Jun. 4, 2019, 92(23), pp. 1-8. [cited by applicant]
Howard Jr. et al., “A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Eculizumab in Patients with Refractory Generalized Myasthenia Gravis”, Muscle & Nerve, Jul. 2013, 48(1):76-84. [cited by applicant]
Howard Jr. et al., “Poster 133: Response to Coronavirus 2019 Vaccination in Patients Receiving Efgartigimod”, Aanem, Sep. 21-24, 2022, 1 page. [cited by applicant]
Howard Jr. et al., “Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (Adapt): a multicentre, randomised, placebo-controlled, phase 3 trial”, Lancet Neurology, Jul. 2021, … [cited by applicant]
Huang et al., “The central residues of a T cell receptor sequence motif are key determinants of autoantigen recognition in murine experimental autoimmune encephalomyelitis”, Eur. J. Immunol., 2005, 35(1):299-304. [cited by applicant]
Hubbard et al., “Poster—97: Design of a Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-blind Study to Assess the Efficacy and Safety of Nipocalimab, an FcRn Antagonist, in Adults with Primary Sjogrens Synd… [cited by applicant]
Hutchins et al., “Improved biodistribution, tumor targeting, and reduced immunogenicity in mice with a gamma4 variant of Campath-1 H”, Proc. Natl. Acad. Sci., Dec. 1995, 92:11980-11984. [cited by applicant]
Idusogie et al., “Engineered Antibodies with Increased Activity to Recruit Complement”, The Journal of Immunology, 2001, 166(4):2571-2575. [cited by applicant]
Idusogie et al., “Mapping of the C1q binding site on rituxan, a chimeric antibody with a human IgG1 Fc”, The Journal of Immunology, 2000, 164(8):4178-4184. [cited by applicant]
Imbach et al., “High-dose intravenous gammaglobulin for idiopathic thrombocytopeni purpura in childhood”, The Lancet, Jun. 6, 1981, 317(8232):1228-1231. [cited by applicant]
Imbach et al., “Intravenous immunoglobulin versus oral corticosteroids in acute immune thrombocytopenia purpura in childhood”, The Lancet, Aug. 31, 1985, 326(8453):464-468. [cited by applicant]
Imbach et al., “Intravenous immunoglobulins induce potentially synergistic immunomodulations in autoimmune disorders”, Vox Sanguinis, 2009, pp. 1-10. [cited by applicant]
Imbach, “Treatment of immune thrombocytopenia with intravenous immunoglobulin and insights for other diseases: A historical review”, Swiss Medical Weekly, May 31, 2012, pp. 1-10. [cited by applicant]
Ishii-Watabe et al., “Molecular Design of Therapeutics Monoclonal Antibodies”, Journal of Pharmaceutical Science and Technology, Japan, 2014, 74(1):4-11 (English Abstract Submitted). [cited by applicant]
Israel et al., “Increased clearance of IgG in mice that lack Beta 2-microglobulin: possible protective role of FcRn”, Immunology, 1996, 89(4):573-578. [cited by applicant]
Jacob et al., “Presence and Pathogenic Relevance of Antibodies to Clustered Acetylcholine Receptor in Ocular and Generalized Myasthenia Gravis”, Arch Neurol., Aug. 2012, 69(8):994-1001. [cited by applicant]
Jain et al., “Fully recombinant IgG2a Fc multimers (stradomers) effectively treat collagen-induced arthritis and prevent idiopathic thrombocytopenia purpura in mice”, Arthritis Research & Therapy, 2012, 14:R192, pp. 1-1… [cited by applicant]
Janeway et al., “The interaction of the antibody molecule with specific antigen”, Immunobiology: The Immune System in Health and Disease. 5th edition., 2001, 5 pages. [cited by applicant]
Jaretzki III et al., “Myasthenia Gravis: Recommendations for Clinical Research Standards”, Ann Thorac Surg., 2000, 70(1):327-334. [cited by applicant]
Jaretzki III et al., “Myasthenia gravis: recommendations for clinical research standards”, Neurology, 2000, 55(1):16-23. [cited by applicant]
Jefferis et al., “Human immunoglobulin allotypes: Possible implications for immunogenicity”, MAbs, Jul./Aug. 2009, 1(4):332-338. [cited by applicant]
Jefferis et al., “Interaction sites on human IgG-Fc for Fc gamma R: current models”, Immunology Letters, 2002, 82:57-65. [cited by applicant]
Jefferis et al., “Modulation of Fc gamma R and human complement activation by IgG3-core oligosaccharide interactions”, Immunology Letters, 1996, 54(2-3):101-104. [cited by applicant]
Jefferis et al., “Recognition sites on human IgG for Fc gamma receptors: the role of glycosylation”, Immunology Letters, 1995, 44(2-3):111-117. [cited by applicant]
Joshi et al., “An Update on Disease Modifying Antirheumatic Drugs”, Inflammation & Allergy—Drug Targets, 2014, 13(4):249-261. [cited by applicant]
Julien et al., “Abstract No. L10—Efgartigimod Prevents Necrosis and Allows for Muscle Fiber Regeneration in a Humanized Mouse Model of Immune-mediated Necrotizing Myopathy (IMNM)”, Meeting—ACR Convergence, Oct. 18, 2022… [cited by applicant]
Junghans et al., “The protection receptor for IgG catabolismis the beta2-microglobulin-containing neonatal intestinal transport receptor”, Proc. Natl. Acad. Sci., May 1996, 93(11):5512-5516. [cited by applicant]
Junghans, “Finally! The Brambell receptor (FcRB): Mediator of Transmission of Immunity and Protection from Catabolismfor IgG”, Immunologic Research, 1997, 16(1):29-57. [cited by applicant]
Kabat et al., “Sequences of Proteins of Immunological Interest”, 5th Edition, U.S. Department of Health and Human Services, 1991, (Title Page and Table of Contents), 11 pages. [cited by applicant]
Kabat et al., “Unusual Distributions of Amino Acids in Complementarity-determining (Hypervariable) Segments of Heavy and Light Chains of Immunoglobulins and Their Possible Roles in Specificity of Antibody-combining Site… [cited by applicant]
Kanda et al., “Comparison of biological activity among nonfucosylated therapeutic IgG1 antibodies with three different N-linked Fc oligosaccharides: the high-mannose, hybrid, and complex types”, Glycobiology, Sep. 29, 2… [cited by applicant]
Kaneko et al., “Anti-Inflammatory Activity of Immunoglobulin G Resulting from Fc Sialylation”, Science, Aug. 4, 2006, 313(5787):670-673. [cited by applicant]
Kang et al., “Rapid Formulation Development for Monoclonal Antibodies”, BioProcess International, Retrieved from: https://bioprocessintl.com/manufacturing/formulation/rapid-formulation-development-for-monoclonal-antibod… [cited by applicant]
Kasperkiewicz et al., “Pemphigus”, Nature Reviews Disease Primers, 2017, 3(Article No. 17026), pp. 1-40. [cited by applicant]
Kasprick et al., “Treatment with anti-neonatal Fc receptor (FcRn) antibody ameliorates experimental epidermolysis bullosa acquisita in mice”, Br J Pharmacol., 2020, 177(10):2381-2392. [cited by applicant]
Khan et al., “Clinical Practice Updates in the Management of Immune Thrombocytopenia”, P&T, Dec. 2017, 42(12):756-763. [cited by applicant]
Kiessling et al., “The FcRn inhibitor rozanolixizumab reduces human serum IgG concentration: A randomized phase 1 study”, Sci. Transl. Med., Nov. 1, 2017, 9(414), pp. 1-12. [cited by applicant]
Kiessling et al., “Safety, Pharmacokinetics and Pharmacodynamics of the FCRN Inhibitor UCB7665: A Phase I Study”, Journal of the Peripheral Nervous System, 2017, 22(3):226-414, 1 page. [cited by applicant]
Kim et al., “Localization of the site of the murine IgG1 molecule that is involved in binding to the murine intestinal Fc receptor”, Eur. J. Immunol., 1994, 24(10):2429-2434. [cited by applicant]
Kim et al., “Mapping the site on human IgG for binding of the MHC class I-related receptor, FcRn”, Eur. J. Immunol., 1999, 29:2819-2825. [cited by applicant]
Knoebl et al., “Pb2305-Efgartigimod: Clinical Development of a Novel FcRn Antagonist in the Treatment of Autoimmune Diseases”, Hemasphere, 2022, 6:2175-2176. [cited by applicant]
Kobayashi et al., “FcRn-mediated transcytosis of immunoglobulin G in human renal proximal tubular epithelial cells”, Am J Physiol Renal Physiol., 2002, 282:F358-F365. [cited by applicant]
Law et al., “High-Dose Intravenous Immune Globulin and The Response to Splenectomy in Patients with Idiopathic Thrombocytopeniaurpura”, The New England Journal of Medicine, May 22, 1997, 336(21):1494-1498. [cited by applicant]
Li et al., “Complete FcRn dependence for intravenous Ig therapy in autoimmune skin blistering diseases”, The Journal of Clinical Investigation, Dec. 2005, 115(12):3440-3450. [cited by applicant]
Li et al., “Myasthenia gravis: Newer therapies offer sustained improvement”, Cleveland Clinic Journal of Medicine, Nov. 2013, 80(11):711-721. [cited by applicant]
Liu et al., “Amelioration of Experimental Autoimmune Myasthenia Gravis in Rats by Neonatal FcR Blockade”, The Journal of Immunology, 2007, 178(8):5390-5398. [cited by applicant]
Liu et al., “Comparing the Autoantibody Levels and Clinical Efficacy of Double Filtration Plasmapheresis, Immunoadsorption, and Intravenous Immunoglobulin for the Treatment of Late-onset Myasthenia Gravis”, Therapeutic … [cited by applicant]
Lobner et al., “Engineered IgG1-Fc—one fragment to bind them all”, Immunological Reviews, 2016, 270(1):113-131. [cited by applicant]
Low et al., “Inhibitors of the FcRn:IgG Protein-Protein Interaction”, The AAPS Journal, Sep. 2009, 11(3):432-434. [cited by applicant]
Lund et al., “Human Fc gamma RI and Fc gamma RII interact with distinct but overlapping sites on human IgG”, J Immunol., Oct. 15, 1991, 147(8):2657-2662. [cited by applicant]
Lund et al., “Multiple binding sites on the CH2 Domain of IgG for Mouse Fc Gamma RII”, Molecular Immunology, 1992, 29(1):53-59. [cited by applicant]
Lund et al., “Multiple interactions of IgG with its core oligosaccharide can modulate recognition by complement and human Fc gamma receptor I and influence the synthesis of its oligosaccharide chains”, The Journal of Im… [cited by applicant]
Lund et al., “Oligosaccharide-protein interactions in IgG can modulate recognition by Fc gamma receptors”, The FASEB Journal, Aug. 2016, 9(1):115-119. [cited by applicant]
Lutterbach et al., “Lung Cancer Cell Lines Harboring MET Gene Amplification are Dependent on Met for Growth and Survival”, Cancer Research, Mar. 1, 2007, 67(5):2081-2088. [cited by applicant]
MacCallum et al., “Antibody-antigen Interactions: Contact Analysis and Binding Site Topography”, J. Mol. Biol., 1996, 262(5):732-745. [cited by applicant]
Maho-Vaillant et al., “FcRn Antagonism Leads to a Decrease of Desmoglein-Specific B Cells: Secondary Analysis of a Phase 2 Study of Efgartigimod in Pemphigus Vulgaris and Pemphigus Foliaceus”, Frontiers in Immunology, M… [cited by applicant]
Martin et al., “Crystal Structure at 2.8 A of an FcRn/Heterodimeric Fc Complex: Mechanism of pH-Dependent Binding”, Molecular Cell, Apr. 2001, 7(4):867-877. [cited by applicant]
Massachusetts General Hospital, “Suppremol's Sm101 Shows a Sustained Clinical Activity and a Favorable Safety Profile in Primary Immune Thrombocytopenia (ITP) Patients”, Press Release. Evaluate Ltd., Dec. 10, 2012, 1 pa… [cited by applicant]
McCarthy et al., “Bidirectional transcytosis of IgG by the rat neonatal Fc receptor expressed in a rat kidney cell line: a system to study protein transport across epithelia”, Journal of Cell Science, 2000, 113(Pt 7):12… [cited by applicant]
Medesan et al., “Comparative studies of rat IgG to further delineate the Fc:FcRn interaction site”, European Journal of Immunology, 1998, 28(7):2092-2100. [cited by applicant]
Medesan et al., “Delineation of the Amino Acid Residues Involved in Transcytosis and Catabolismof Mouse IgG1”, The Journal of Immunology, 1997, 158(5):2211-2217. [cited by applicant]
Mendell et al., “Randomized controlled trial of IVIg in untreated chronic inflammatory demyelinating polyradiculoneuropathy”, Neurology, Feb. 2001, 56(4):445-449. [cited by applicant]
Meriggioli et al., “Autoimmune myasthenia gravis: emerging clinical and biological heterogeneity”, Lancet Neurol., May 2009, 8(5):475-490. [cited by applicant]
Mezo et al., “Reduction of IgG in nonhuman primates by a peptide antagonist of the neonatal Fc receptor FcRn”, PNAS, Feb. 19, 2008, 105(7):2337-2342. [cited by applicant]
Mi et al., “Targeting the neonatal Fc receptor for antigen delivery using engineered Fc fragments”, The Journal of Immunology, Dec. 1, 2008, 181(11):7550-7561. [cited by applicant]
Miyagawa, “Idiopathic Thrombocytopenia Purpura”, Mebio., 2017, 34(6):102-107. [cited by applicant]
Mohamed et al., “Massive intravascular haemolysis after high dose intravenous immunoglobulin therapy”, British Journal of Haematology, Jan. 7, 2013, 160(5):570, 1 page. [cited by applicant]
Monnet et al., “Combined glyco- and protein-Fc engineering simultaneously enhance cytotoxicity and half-life of a therapeutic antibody”, mAbs, Mar./Apr. 2014, 6(2):422-436. [cited by applicant]
Montoyo et al., “Conditional deletion of the MHC class I-related receptor FcRn reveals the sites of IgG homeostasis in mice”, PNAS, Feb. 24, 2009, 106(8):2788-2793. [cited by applicant]
Morea et al., “Antibody Modeling: Implications for Engineering and Design”, Methods, 2000, 20(3):267-279. [cited by applicant]
Newburger et al., “Diagnosis, Treatment, and Long-Term Management of Kawasaki Disease: A Statement for Health Professionals From the Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovas… [cited by applicant]
Newland et al., “High-Dose Intravenous IgG in Adults with Autoimmune Thrombocytopenia”, The Lancet, Jan. 15, 1983, 321(8316):84-87. [cited by applicant]
Newland et al., “Phase 2 study of efgartigimod, a novel FcRn antagonist, in adult patients with primary immune thrombocytopenia”, Am J Hematol., 2020, 95(2):178-187. [cited by applicant]
Nieswandt et al., “Acute Systemic Reaction and Lung Alterations Induced by an Antiplatelet Integrin gpIIb/IIIa Antibody in Mice”, Blood, Jul. 15, 1999, 94(2):684-693. [cited by applicant]
Niknami et al., “Beneficial effect of a multimerized immunoglobulin Fc in an animal model of inflammatory neuropathy (experimental autoimmune neuritis)”, Journal of the Peripheral Nervous System, 2013, 18(2):141-152. [cited by applicant]
Ober et al., “Exocytosis of IgG as mediated by the receptor, FcRn: An analysis at the single-molecule level”, PNAS, Jul. 27, 2004, 101(30):11076-11081. [cited by applicant]
Ober et al., “Visualizing the Site and Dynamics of IgG Salvage by the MHC class I-Related Receptor, FcRn”, The Journal of Immunology, 2004, 172:2021-2029. [cited by applicant]
Olaru et al., “Neonatal Fc Receptor Promotes Immune Complex-Mediated Glomerular Disease”, J Am Soc Nephrol, 2014, 25(5):918-925. [cited by applicant]
Oshima et al., “Characterization of murine CD70 by molecular cloning and mAb”, International Immunology, 1998, 10(4):517-526. [cited by applicant]
Patel et al., “FcRn blockade by Fc engineering ameliorates arthritis in a murine model”, J Immunol., Jul. 15, 2011, 187(2):1015-1022. [cited by applicant]
Patel et al., “Neonatal Fc receptor blockade by Fc engineering ameliorates arthritis in a murine model”, The Journal of Immunology, 2011, 187(2):1015-1022. [cited by applicant]
Patel et al., “Neonatal Fc receptor in human immunity: Function and role in therapeutic intervention”, J Allergy Clin Immunol., Sep. 2020, 146(3):467-478. [cited by applicant]
Peene et al., “AB0520: Treatment of Primary Sjogren's Syndrome by Inhibiting FcRn: A Phase 2 Randomized, Placebo Controlled, Double-Blind, Proof of Concept Study with Efgartigimod”, Scientific Abstracts, May 30, 2023, 1… [cited by applicant]
Peter et al., “Targeting FcRn for immunomodulation: Benefits, risks, and practical considerations”, J. Allergy Clin. Immunol., Sep. 2020, 146(3):479-491. [cited by applicant]
Pevzner et al., “Anti-LRP4 autoantibodies in AChR-and MuSK-antibody-negative myasthenia gravis”, J. Neurol., 2012, 259(3):427-435. [cited by applicant]
Polanco et al., “Spontaneous Remission of Nephrotic Syndrome in Idiopathic Membranous Nephropathy”, J Am Soc Nephrol., 2010, 21(4):697-704. [cited by applicant]
Popov et al., “The Stoichiometry and Affinity of the Interaction of Murine Fc Fragments with the MHC Class I-Related receptor, FcRn”, Molecular Immunology, 1996, 33(6):521-530. [cited by applicant]
Prabhat et al., “Elucidation of intracellular recycling pathways leading to exocytosis of the Fc receptor, FcRn, by using multifocal plane microscopy”, PNAS, Apr. 3, 2007, 104(14):5889-5894. [cited by applicant]
Press Release “argenx Announces Approval of Vyvgart (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia”, Mar. 26, 2024, 4 pages. [cited by applicant]
Press Release “argenx Reports Topline Results from Address Study of Efgartigimod SC in Pemphigus”, Dec. 20, 2023, 5 pages. [cited by applicant]
Press Release “argenx Reports Topline Results from Advance-SC Study of Vyvgart Hytrulo in Primary Immune Thrombocytopenia”, Nov. 28, 2023, 4 pages. [cited by applicant]
Press Release, “argenx Advances Clinical Development of Efgartigimod in Primary Sjogren's Disease”, Mar. 27, 2024, 3 pages. [cited by applicant]
Press Release, “argenx Advances Clinical Development of Efgartigimod SC in Idiopathic Inflammatory Myopathies”, Nov. 20, 2024, 3 pages. [cited by applicant]
Press Release, “argenx and Zai Lab Announce Approval of Efgartigimod Alfa Injection (Subcutaneous Injection) for Generalized Myasthenia Gravis in China”, Jul. 16, 2024, 4 pages. [cited by applicant]
Press Release, “argenx and Zai Lab Announce Approval of Vyvgart Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy in China”, Nov. 11, 2024, 4 pages. [cited by applicant]
Press Release, “argenx Announces Approval of Vyvdura (efgartigimod alfa and hyaluronidase-qvfc) in Japan for Adults with Chronic Inflammatory Demyelinating Polyneuropathy”, Dec. 27, 2024, 4 pages. [cited by applicant]
Press Release, “argenx Announces FDA Approval of Vyvgart Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy”, Jun. 21, 2024, 5 pages. [cited by applicant]
Press Release, “argenx Announces Publication in The Lancet Neurology of Pivotal Adhere Study Data in Chronic Inflammatory Demyelinating Polyneuropathy”, Sep. 19, 2024, 5 pages. [cited by applicant]
Press Release, “argenx Data Highlight Evidence that Vyvgart and Vyvgart Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune Disease”, Apr. 16, 2024, 6 pages. [cited by applicant]
Press Release, “argenx Highlights 2025 Strategic Priorities”, Jan. 13, 2025, 7 pages. [cited by applicant]
Press Release, “argenx Highlights Breadth of Autoimmune Pipeline with New Multifocal Motor Neuropathy Data at 2024 Peripheral Nerve Society Annual Meeting”, Jun. 25, 2024, 5 pages. [cited by applicant]
Press Release, “argenx Highlights Data Showing Patient Impact Across Multiple Immunology Programs at 2024 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting and Myasthenia Gravis Foundatio… [cited by applicant]
Press Release, “argenx Reports First Quarter 2024 Financial Results and Provides Business Update”, May 9, 2024, 7 pages. [cited by applicant]
Press Release, “argenx Reports Half Year 2024 Financial Results and Provides Second Quarter Business Update”, Jul. 25, 2024, 7 pages. [cited by applicant]
Press Release, “argenx Reports Third Quarter 2024 Financial Results and Provides Business Update”, Oct. 31, 2024, 8 pages. [cited by applicant]
Press Release, “argenx to unveil its ‘Vision 2030: Taking Breakthrough Science to 50,000 Patients’ during its Upcoming R&D Day on Jul. 16, 2024”, Jun. 17, 2024, 4 pages. [cited by applicant]
Presta et al., “Engineering therapeutic antibodies for improved function”, Biochemical Society Transactions, 2002, 30(4):487-490. [cited by applicant]
Putnam et al., “Proteins In Multiple Myeloma: VIII. Biosynthesis of Abnormal Proteins”, J. Biol. Chem., 1958, 231(2):671-684. [cited by applicant]
Pyzik et al., “The Neonatal Fc Receptor (FcRn): A Misnomer?”, Frontiers in Immunology, Jul. 10, 2019, 10(Article 1540), pp. 1-24. [cited by applicant]
Raghavan et al., “Analysis of the pH Dependence of the Neonatal Fc Receptor/Immunoglobulin G Interaction Using Antibody and Receptor Variants”, Biochemistry, 1995, 34(45):14649-14657. [cited by applicant]
Cited By (3)
US 12,565,538 US 12,637,505 US 12,673,988