IP Library › Granted Patent US 12,653,885
Granted Patent B2
US 12,653,885 · App. 17/821,558 · Granted Jun 16, 2026

Polyomavirus neutralizing antibodies

Inventors: Johanna Abend (Emeryville, CA); Vanessa Cornacchione (Basel, CH); John Michael Lindner (Basel, CH); Elisabetta Traggiai (Basel, CH)
Assignee: Novartis AG
A61K39/42A61K31/343A61K31/436A61K31/52A61K38/13A61P31/20C07K16/084C07K2317/33C07K2317/51C07K2317/515C07K2317/565C07K2317/622C07K2317/70C07K2317/76
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 12,653,885
App. No.
17/821,558
Granted
Jun 16, 2026
Kind
B2
Abstract

The present invention relates to anti-polyomavirus antibodies, antibody fragments, and their uses for the prevention and treatment of BK or JC virus infection and associated diseases.

Claims (14)

1 . An isolated antibody or antigen binding fragment thereof that binds VP1, wherein said antibody comprises:

(i) a heavy chain that comprises SEQ ID NO:294, and a light chain that comprises SEQ ID NO: 295;

(ii) a heavy chain that comprises SEQ ID NO:296, and a light chain that comprises SEQ ID NO: 297;

(iii) a heavy chain that comprises SEQ ID NO:298, and a light chain that comprises SEQ ID NO: 299;

(iv) a heavy chain that comprises SEQ ID NO:300, and a light chain that comprises SEQ ID NO: 301;

(v) a heavy chain that comprises SEQ ID NO:302, and a light chain that comprises SEQ ID NO: 303; or

(vi) a heavy chain that comprises SEQ ID NO:304, and a light chain that comprises SEQ ID NO: 305.

2 . The antibody or antigen binding fragment thereof of claim 1 , wherein the antibody or antigen binding fragment thereof is a monoclonal antibody, or a single chain antibody (scFv).

3 . The antibody or antigen binding fragment thereof of claim 1 wherein the antibody or antigen binding fragment thereof has reduced glycosylation or no glycosylation or is hypofucosylated.

4 . A pharmaceutical composition comprising the antibody or antigen binding fragment thereof of claim 1 and a pharmaceutically acceptable carrier.

5 . A pharmaceutical composition comprising a plurality of antibodies or antigen binding fragments thereof of claim 1 , wherein at least 0.05%, 0.1%, 0.5%, 1%, 2%, 3%, or 5% of the antibodies or antigen binding fragment thereof in the composition have an α2,3-linked sialic acid residue.

6 . A pharmaceutical composition comprising a plurality of antibodies or antigen binding fragments thereof of claim 1 , wherein none of the antibodies or antigen binding fragments thereof comprise a bisecting GlcNAc.

7 . A diagnostic reagent comprising the antibody or antigen binding fragment thereof of claim 1 , wherein the antibody or antigen binding fragment thereof is labeled.

8 . The diagnostic reagent of claim 7 , wherein the label is selected from the group consisting of a radiolabel, a fluorophore, a chromophore, an imaging agent, and a metal ion.

Assignments (10)
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY PREVIOUSLY RECORDED ON REEL 62108 FRAME 124. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Aug 21, 2025
From: ABEND, JOHANNA
To: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
Reel/Frame 072507/0533 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING PARTY DATA PREVIOUSLY RECORDED AT REEL: 62108 FRAME: 149. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Aug 21, 2025
From: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
To: NOVARTIS AG
Reel/Frame 072516/0012 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2022
From: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
To: NOVARTIS AG
Reel/Frame 062107/0747 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2022
From: NOVARTIS PHARMA AG
To: NOVARTIS AG
Reel/Frame 062107/0758 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2022
From: ABEND, JOHANNA
To: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
Reel/Frame 062108/0124 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2022
From: ABEND, JOHANNA
To: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
Reel/Frame 062107/0684 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2022
From: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
To: NOVARTIS AG
Reel/Frame 062108/0149 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2022
From: NOVARTIS PHARMA AG
To: NOVARTIS AG
Reel/Frame 062108/0157 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2022
From: CORNACCHIONE, VANESSA; LINDNER, JOHN MICHAEL; TRAGGIAI, ELISABETTA
To: NOVARTIS PHARMA AG
Reel/Frame 062108/0129 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2022
From: CORNACCHIONE, VANESSA; LINDNER, JOHN MICHAEL; TRAGGIAI, ELISABETTA
To: NOVARTIS PHARMA AG
Reel/Frame 062107/0732 →
Continuity (4)
Continuation 16768429
Provisional Application 62727168 · Sep 5, 2018
Provisional Application 62593566 · Dec 1, 2017
Related Publication 20230079587A1 · Mar 16, 2023
References Cited (102)
US 8470979B2 · Bondensgaard et al. · 2013 [cited by applicant]
US 9862760B2 · Abend et al. · 2018 [cited by applicant]
US 10011648B2 · Burioni et al. · 2018 [cited by applicant]
US 10435460B2 · Abend et al. · 2019 [cited by applicant]
US 10450366B2 · Abend et al. · 2019 [cited by applicant]
US 10654914B2 · Abend et al. · 2020 [cited by applicant]
US 11161894B2 · Abend et al. · 2021 [cited by applicant]
US 11433132B2 · Abend et al. · 2022 [cited by applicant]
US 11639378B2 · Abend et al. · 2023 [cited by applicant]
US 12077571B2 · Abend et al. · 2024 [cited by applicant]
US 20080107658A1 · Franks et al. · 2008 [cited by applicant]
US 20100215662A1 · Bradbury · 2010 [cited by applicant]
US 20130337438A1 · Mori et al. · 2013 [cited by applicant]
US 20140294841A1 · Scheinberg et al. · 2014 [cited by applicant]
US 20150056188A1 · Simon et al. · 2015 [cited by applicant]
US 20160052996A1 · Grimm · 2016 [cited by examiner]
US 20220363735A1 · Abend et al. · 2022 [cited by applicant]
US 20230220051A1 · Abend et al. · 2023 [cited by applicant]
US 20230399382A1 · Abend et al. · 2023 [cited by applicant]
US 20250051423A1 · Abend et al. · 2025 [cited by applicant]
CN 104520318A · 2015 [cited by applicant]
CN 104936980A · 2015 [cited by applicant]
JP 2015524389A · 2015 [cited by applicant]
JP 2016513072A · 2016 [cited by applicant]
WO WO03105894A1 · 2003 [cited by applicant]
WO WO2013142299A1 · 2013 [cited by applicant]
WO WO2013142300A2 · 2013 [cited by applicant]
WO WO2014002035A2 · 2014 [cited by applicant]
WO WO2014102399A1 · 2014 [cited by applicant]
WO WO2015095770A1 · 2015 [cited by applicant]
WO WO2015114150A1 · 2015 [cited by applicant]
WO WO2017046676A1 · 2017 [cited by applicant]
WO WO2019106578A2 · 2019 [cited by applicant]
Ambalathingal, George R. et al., “BK Polyomavirus: Clinical Aspects, Immune Regulation, and Emerging Therapies,” Clin Microbiol Rev, Feb. 22, 2017, vol. 30(2), pp. 503-528. [cited by applicant]
Caldas, Cristina et al., “Humanization of the anti-CD18 antibody 6.7: an unexpected effect of a framework residue in binding to antigen,” Molecular Immunology, vol. 39, No. 15, May 1, 2003, pp. 941-952. [cited by applicant]
Casadevall, A. et al., “Immunoglobulin isotype influences affinity and specificity,” Proceedings of the National Academy of Sciences, vol. 109, No. 31, Jul. 31, 2012, pp. 12272-12273. [cited by applicant]
Du, J. et al., “Molecular basis of recognition of human osteopontin by 23C3, a potential therapeutic antibody for treatment of rheumatoid arthritis,” Journal of Molecular Biology, Academic Press, United Kingdom, by vol.… [cited by applicant]
Geoghegan, Eileen M. E et al., “Infectious Entry and Neutralization of Pathogenic JC Polyomaviruses,” Cell Rep, Oct. 31, 2017, vol. 21,pp. 1169-1179. [cited by applicant]
Jelcic, Ivan et al., “Broadly neutralizing human monoclonal JC polyomavirus VP1-specific antibodies as candidate therapeutics for progressive multifocal leukoencephalopathy,” Sci Transl Med, 2015, vol. 7(306), 28 pages. [cited by applicant]
Kunik, Vared et al., “Structural Consensus among Antibodies Defines the Antigen Binding Site,” PLoS Computational Biology, vol. 8, No. 2, Feb. 23, 2012, pp. 1168-1179. [cited by applicant]
Chang, D., et al., “Production of the antigen and the antibody of the JC virus major capsid protein VP1”, Journal of Virological Methods, 1996, vol. 59, No. 1-2, pp. 177-187. [cited by applicant]
Henmi, C., et al., “Establishment of an immunoscreening system using recombinant VP1 protein for the isolation of a monoclonal antibody that blocks JC virus infection”, Biochemical and Biophysical Research Communication… [cited by applicant]
Wang, Dianli, JC Virus VP2 Egg White antigen antibody preparation and nuclear localization signal and nuclear import and translocation body identification, Excellent Master's Degree Thesis in China Text database (Medica… [cited by applicant]
Wang, Xinxin, “Early Kidney Transplantation,” Studies on BK virus activation in post-recipients Study, Excellent Master's Degree Thesis in China Text database (Medical and health science and technology Series), Jan. 15,… [cited by applicant]
U.S. Appl. No. 18/186,064, filed Mar. 17, 2023, 156 pages. [cited by applicant]
Abend et al. (2007). “Inhibitory Effect of Gamma Interferon on BK Virus Gene Expression and Replication” J. Virology 81 :272-279. [cited by applicant]
Altschul et al., “Gapped BLAST and PSI-BLAST: a new generation of protein database search programs,” Nucleic Acids Research (1997) 25(17):3389-3402. [cited by applicant]
Antinori et al. (2003). “Clinical epidemiology and survival of progressive multifocal leukoencephalopathy in the era of highly active antiretroviral therapy: Data from the Italian Registry Investigative Neuro AIDS (IRIN… [cited by applicant]
Astrom et al. (1958). “Progressive Multifocal Leuko-Encephalopathy a Hitherto Unrecognized Complication of Chronic Lymphatic Leukemia and Hodgkin's Disease” Brain 81(1): 93-111. [cited by applicant]
Bennett et al. (2012). “BK polyomavirus: emerging pathogen” Microbes and Infection 14(9):672-683. [cited by applicant]
Binet et al. (1999). “Polyomavirus Disease Under New Immunosuppressive Drugs: A Cause of Renal Graft Dysfunction and Graft Loss” Transplantation 67(6):918-922. [cited by applicant]
Brennan et al. (2005). “Incidence of BK with tacrolimus versus cyclosporine and impact of preemptive immunosuppression reduction” Am. J. Transplant 5(3):582-594. [cited by applicant]
Bressollette-Bodin et al. (2005). “A Prospective Longitudinal Study of BK Virus Infectionin 104 Renal Transplant Recipients” American Journal of Transplantation 5(8): 1926-1933. [cited by applicant]
Broekema et al. (2010). “A system for the analysis of BKV non-coding control regions: Application to clinical isolates from an HIV/AIDS patient” Virology 407:368-373. [cited by applicant]
Carter et al. (2003). “Lack of Serologic Evidence for Prevalent Simian Virus 40 Infection in Humans” J. Natl. Cancer Inst. 95:1522-1530. [cited by applicant]
Chatterjee et al. (2000). “Identification of Archetype and Rearranged Forms of BK Virus in Leukocytes From Healthy Individuals” Journal of Medical Virology 60:353-362. [cited by applicant]
Chen et al. (2015). “Synthetic antibodies and peptides recognizing progressive multifocal leukoencephalopathyspecific point mutations in polyomavirus JC capsid viral protein 1” mABS 7(4):681-692. [cited by applicant]
Chothia C., et al., “Canonical Structures for the Hypervariable Regions of Immunoglobulins,” Journal of Molecular Biology, Aug. 20, 1987, vol. 196, No. 4, pp. 901-917. [cited by applicant]
Chothia C., et al., “Conformations Of Immunoglobulin Hypervariable Regions,” Nature, Dec. 1989, vol. 342, pp. 877-883. [cited by applicant]
Chothia, et al., Structural repertoire of the human VH segments, Journal of Molecular Biology, Oct. 5, 1992, pp. 799-817, vol. 227, No. 3. [cited by applicant]
Derienzo et al. (2000). “Evaluation of the Half-Life of Intravenous Human Cytomegalovirus Immune Globulin in Patients Receiving Partially Mismatched Related Donor Bone Marrow Transplantation” Pharmacotherapy 20: 1175-11… [cited by applicant]
European Patent Office, International Search Report and Written Opinion for PCT/IB2016/055339, Feb. 1, 2017, 15 pages. [cited by applicant]
European Patent Office, International Search Report and Written Opinion for PCT/IB2018/059429, Jun. 4, 2019, 19 pages. [cited by applicant]
Garcia-Suarez et al. (2005). “Changes in the Natural History of Progressive Multifocal Leukoencephalopathy in HIV-negative Lymphoproliferative Disorders: Impact of Novel Therapies” Am. J Hematol 80(4):271-281. [cited by applicant]
Gardner. (1971). “New human papovavirus (B.K.) isolated from urine after renal transplantation” Lancet 297(7712):1253-1257. [cited by applicant]
Gorelik et al. (2011). “Progressive Multifocal Leukoencephalopathy (PML) Development is Associated with Mutations in JC Virus Capsid Protein VP1 that Change its Receptor Specificity” Journal of Infectious Diseases 204:2… [cited by applicant]
Goudsmit et al. (1982). “The role of BK virus in acute respiratory tract disease and the presence of BKV DNA in tonsils” Journal of Medical Virology 10:91-99. [cited by applicant]
Henikoff, et al., Trans-inactivation of the [cited by applicant]
Heritage et al. (1981). “The persistence of papovavirus BK DNA sequences in normal human renal tissue” Journal of Medical Virology 8:143-150. [cited by applicant]
Hirsch. (2002). “Polyomavirus BK nephropathy: a (re-)emerging complication in renal transplantation” Am. J. Transplant 2 (1):25-30. [cited by applicant]
Hirsch et al. (2002). “Prospective Study of Polyomavirus Type BK Replication and Nephropathy in Renal-Transplant Recipients” New England J. Medicine 347(7):488-496. [cited by applicant]
Hirsch et al. (2005). “Polyomavirus-Associated Nephropathy in Renal Transplantation: Interdisciplinary Analyses and Recommendations” Transplantation 79(1):1277-1286. [cited by applicant]
Jiang et al. (2009). “The Role of Polyomaviruses in Human Disease” Virology 384(2):266-273. [cited by applicant]
Johne et al. (2004). “Nuclear Localization of Avian Polyomavirus Structural Protein VP1 Is a Prerequisite for the Formation of Virus-Like Particles.” Journal of Virology, 78(2): 930-937. [cited by applicant]
Johne et al. (2011). “Taxonomical Developments in the Family Polyomaviridae” Arch. Virol. 156(9):1627-1634. [cited by applicant]
Johnson, et al., Kabat Database and its applications: future directions, Nucleic Acids Research, Jan. 1, 2001, pp. 205-206, vol. 29, No. 1. [cited by applicant]
Knowles et al. (2006). “Discovery and Epidemiology of the Human Polyomaviruses BK Virus (BKV) and JC Virus (JCV)” Adv. Exp. Med. Biol. 577: 19-45. [cited by applicant]
Lipshutz et al. (2004). “BK Nephropathy in Kidney Transplant Recipients Treated with a Calcineurin Inhibitor-Free Immunosuppression Regimen” American Journal of Transplantation 2004; 4: 2132-2134. [cited by applicant]
Liu. (2015). “Antibody Glycosylation and its Impact on the Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies and Fe-fusion Proteins” J. Pharm. Sci. 104(6): 1866-1884. [cited by applicant]
Mengelle et al. (2011). “JC Virus DNA in the Peripheral Blood of Renal Transplant Patients: a 1-Year Prospective Follow-up in France” J. Med. Viral. 83(1):132-136. [cited by applicant]
Neu et al. (2013). Plos Pathogens 9(10):e1003714 and e1003688. [cited by applicant]
Nickeleit et al. (1999). “Polymavirus Infection of Renal Allograft Recipients: From Latent Infection to Manifest Disease” J. Am. Seo. Neprol. 10(5):1080-1089. [cited by applicant]
O'Hara et al. (2014). “Gallic acid-based small-molecule inhibitors of JC and BK polyomaviral infection” Virus Research 189:280-285. [cited by applicant]
Padgett et al. (1971). “Cultivation of Papova-Like Virus from Human Brain with Progressive Multifocal Leucoencephalopathy” Lancet 297(7712):1257-1260. [cited by applicant]
Padgett et al. (1973). “Prevalence of Antibodies in Human Sera against JC Virus, an Isolate from a Case of Progressive Multifocal Leukoencephalopathy” Journal of Infectious Diseases 127(4):467-470. [cited by applicant]
Pastrana et al. (2012). “Neutralization Serotyping of BK Polyomavirus Infection in Kidney Transplant Recipients” PLoS Pathogens vol. 8(4)e1002650. [cited by applicant]
Purighalla et al. (1995). “BK Virus Infection in a Kidney Allograft Diagnosed by Needle Biopsy” American Journal of Kidney Diseases 26(4):671-673. [cited by applicant]
Qian et al. (2010). “Lipids and Proteins Act in Opposing Manners To Regulate Polyomavirus Infection” Journal of Virology 84(19):9840-9852. [cited by applicant]
Randhawa et al. (1999). “Human Polyoma Virus-Associated Interstital Nephritis in the Allograft Kidney” Transplantation 67:103-109. [cited by applicant]
Randhawa et al. (2006). “BK Virus Infection in Transplant Recipients: An Overview and Update” American Journal of Transplantation 6(9):2000-2005. [cited by applicant]
Randhawa et al. (2009). “Identification of Species-Specific and Cross-Reactive Epitopes in Human Polyomavirus Capsids Using Monoclonal Antibodies” Journal of General Virology 90:634-639. [cited by applicant]
Randhawa et al. (2015). “Commercially Available Immunoglobulins Contain Virus Neutralizing Antibodies Against all Major Genotypes of Polyomavirus” BK. Am J Transplant. 15(4):1014-20. [cited by applicant]
Reid et al. (2011). “Sequencing and Analysis of JC Virus DNA From Natalizumab-Treated PML Patients” J Infect Dis. 204:237-244. [cited by applicant]
Reploeg et al. (2001). “BK Virus: A Clinical Review” Clin Infect. Dis. 33(2):191-202. [cited by applicant]
Richardson. (1961). “Progressive Multifocal Leukoencephalopathy.” New England Journal of Medicine 265(17):815-823. [cited by applicant]
Rudikoff et al., “Single amino acid substitution altering antigen-binding specificity”, PNAS USA, Mar. 1982, 79(6):1979-1983. [cited by applicant]
Sabath et al. (2002). “Traffic of JC Virus from Sites of Initial Infection to the Brain: The Path to Progressive Multifocal Leukoencephalopathy” Journal Infectious Diseases 186:S180-S186. [cited by applicant]
Shinohara et al. (1993). “BK Virus Infection of the Human Urinary Tract” Journal of Medical Virology 41(4):301-305. [cited by applicant]
Wiseman et al. (2009). “Polyomavirus Nephropathy: A Current Perspective and Clinical Considerations” Am.J. Kidney Dis 54 (1):131-142. [cited by applicant]
Extended European Search Report for European Application No. 24158407.7, mailed Sep. 26, 2024, 11 pages. [cited by applicant]
Lindner J., et al., “Human Memory B Cells Harbor Diverse Cross-Neutralizing Antibodies against BK and JC Polyomaviruses,” Immunity, Mar. 1, 2019, vol. 50, No. 3, pp. 668-676. [cited by applicant]
National Institute of Health, “Immunoglobulin lambda light chain VLJ region, partial [ [cited by applicant]