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Last Updated: March 28, 2024

Claims for Patent: 9,771,413


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Summary for Patent: 9,771,413
Title:Recombinant human antibodies for therapy and prevention of polyomavirus-related diseases
Abstract: Provided are novel human-derived antibodies specifically recognizing polyomavirus polypeptides, preferably capable of binding to polyomaviruses of the type of JC virus (JCV) and/or BK virus (BKV) as well as methods related thereto. Furthermore, assays and kits related to antibodies specific for polyomaviruses, polyomavirus VP1 and or polyomavirus VP1 Virus-Like Particles (VLPs), preferably of the type of JCV and/or BKV, are disclosed. The human-derived antibodies as well as binding fragments, derivatives and variants thereof can be used in pharmaceutical and diagnostic compositions for polyomavirus targeted immunotherapy and diagnostics.
Inventor(s): Grimm; Jan (Dubendorf, CH), Martin; Roland (Zurich, CH), Combaluzier; Benoit (Urdorf, CH), Jelcic; Ivan (Zurich, CH)
Assignee: Neurimmune Holding AG (Schlieren, CH) University of Zurich (Zurich, CH)
Application Number:14/758,615
Patent Claims:1. A complementary DNA (cDNA) molecule encoding an antibody or an antigen-binding fragment thereof, wherein the antibody or the antigen-binding fragment thereof is capable of binding to a polyomavirus or an antigen thereof, wherein the polyomavirus is a JC virus (JCV) and wherein the antibody or antigen-binding fragment thereof comprises in its variable region: (a) the complementarity determining regions (CDRs) 1, 2, and 3 of: (i) the V.sub.H variable region amino acid sequence of SEQ ID NO: 110, and (ii) the V.sub.L variable region amino acid sequence of SEQ ID NO: 112; or (b) an amino acid sequence of the V.sub.H variable region set forth in SEQ ID NO: 110 and the V.sub.L variable region set forth in SEQ ID NO: 112.

2. The cDNA molecule of claim 1, wherein the antibody or antigen-binding fragment thereof is capable of binding VP1 protein or a fragment thereof.

3. The cDNA molecule of claim 1, wherein the antibody or antigen-binding fragment thereof is capable of recognizing an epitope exposed on the surface of the virus.

4. The cDNA molecule of claim 1, wherein the antibody or antigen-binding fragment thereof does not substantially recognize serum albumin.

5. The cDNA molecule of claim 4, wherein the serum albumin is bovine serum albumin (BSA).

6. The cDNA molecule of claim 1, wherein the antibody or antigen-binding fragment thereof recognizes progressive multifocal leukoencephalopathy (PML)-associated VP1 mutants.

7. An isolated host cell comprising one or more cDNA molecule(s) of claim 1.

8. The host cell of claim 7, which is a prokaryotic or eukaryotic host cell.

9. A composition comprising the cDNA molecule of claim 1.

10. The composition of claim 9, wherein the composition: (a) is a pharmaceutical composition and further comprises a pharmaceutical acceptable carrier, or (b) is a diagnostic composition, and further comprises reagents conventionally used in immune- or nucleic acid-based diagnostic methods.

11. The composition of claim 10 further comprising an immunomodulatory agent.

12. The composition of claim 10, wherein the pharmaceutical composition is used for the prophylactic or therapeutic treatment of a disease, wherein the disease is Progressive Multifocal Leukoencephalopathy (PML), infection of granule neurons, hyperchromatic nuclei, granule cell neuronopathy, cerebral autothrophy, encephalopathy, meningitis, Polyoma-induced tumors, immune reconstitution inflammatory syndrome (IRIS), hemorrhagic cystitis, pneumonia, retinitis, colitis, vasculitis, interstitial kidney disease, infections of respiratory tract, JCV nephropathy, BKV nephropathy, meningitis, Merkel cell carcinoma, trichodysplasia spinulosa or malignant pleural mesothelioma and/or the agent is natalizumab, efalizumab, rituximab, infliximab, ocrelizumab, alemtuzumab, bentuximab, or vedotin.

13. A kit useful in the diagnosis or monitoring of the progression of Progressive Multifocal Leukoencephalopathy (PML) and/or transplant rejection following clinical bone marrow, kidney, and other solid organs transplantations, said kit comprising the cDNA molecule of claim 1.

14. The kit of claim 13 further comprising reagents and/or instructions for use.

15. One or more vector(s) comprising one or more cDNA molecule(s) of claim 1.

16. The vector(s) of claim 15, wherein the vector is an expression vector.

17. The vector(s) of claim 15, wherein the cDNA molecule is operatively linked to an expression control sequence allowing transcription of the cDNA into a translatable mRNA in prokaryotic and eukaryotic cells.

18. An isolated host cell comprising one or more vector(s) of claim 15.

19. The host cell of claim 18, which is a prokaryotic or eukaryotic host cell.

20. A polynucleotide linked to a heterologous nucleic acid, wherein the polynucleotide is selected from the group consisting of: (a) a polynucleotide encoding an immunoglobulin heavy chain or a fragment thereof comprising a VH variable region comprising CDRs 1, 2, and 3 of the VH variable region amino acid sequence of SEQ ID NO: 110 wherein the VH variable region when paired with a VL variable region comprising the amino acid sequence set forth in SEQ ID NO: 112 binds to JCV and/or an antigen thereof; (b) a polynucleotide encoding an immunoglobulin light chain or a fragment thereof comprising a VL variable region comprising CDRs 1, 2, and 3 of the VL variable region amino acid sequence of SEQ ID NO: 112 wherein the VL variable region when paired with a VH variable region comprising the amino acid sequence set forth in SEQ ID NO: 110 binds to JCV and/or an antigen thereof; (c) a polynucleotide encoding: (i) an immunoglobulin heavy chain or a fragment thereof comprising a VH variable region comprising CDRs 1, 2, and 3 of the VH variable region amino acid sequence of SEQ ID NO: 110; and (ii) an immunoglobulin light chain or a fragment thereof comprising a VL variable region comprising CDRs 1, 2, and 3 of the VL variable region amino acid sequence of SEQ ID NO: 112; (d) a polynucleotide encoding an immunoglobulin heavy chain or a fragment thereof comprising a VH variable region comprising the amino acid sequence set forth in SEQ ID NO: 110, wherein the VH variable region when paired with a VL variable region comprising the amino acid sequence set forth in SEQ ID NO: 112, binds to JCV and/or an antigen thereof; (e) a polynucleotide encoding an immunoglobulin light chain or a fragment thereof comprising a VL variable region comprising the amino acid sequence set forth in SEQ ID NO: 112, wherein the VL variable region when paired with a VH variable region comprising the amino acid sequence set forth in SEQ ID NO: 110, binds to JCV and/or an antigen thereof; and (f) a polynucleotide encoding an immunoglobulin heavy chain or a fragment thereof comprising a VH variable region comprising the amino acid sequence set forth in SEQ ID NO 110 and an immunoglobulin light chain or a fragment thereof comprising a VL variable region comprising the amino acid sequence set forth in SEQ ID NO: 112.

21. One or more vector(s) comprising one or more polynucleotide(s) of claim 20.

22. The vector(s) of claim 21, wherein the vector is an expression vector.

23. An isolated host cell comprising one or more polynucleotide(s) of claim 20.

24. An isolated host cell comprising one or more vector(s) of claim 21.

25. The host cell of claim 23, which is a prokaryotic or eukaryotic host cell.

26. The host cell of claim 24, which is a prokaryotic or eukaryotic host cell.

27. A composition comprising the polynucleotide of claim 20.

28. The composition of claim 27, wherein the composition: (a) is a pharmaceutical composition and further comprises a pharmaceutical acceptable carrier, or (b) is a diagnostic composition, and further comprises reagents conventionally used in immune- or nucleic acid-based diagnostic methods.

29. The composition of claim 28 further comprising an immunomodulatory agent.

30. The composition of claim 28, wherein the pharmaceutical composition is used for the prophylactic or therapeutic treatment of a disease, wherein the disease is Progressive Multifocal Leukoencephalopathy (PML), infection of granule neurons, hyperchromatic nuclei, granule cell neuronopathy, cerebral autothrophy, encephalopathy, meningitis, Polyoma-induced tumors, immune reconstitution inflammatory syndrome (IRIS), hemorrhagic cystitis, pneumonia, retinitis, colitis, vasculitis, interstitial kidney disease, infections of respiratory tract, JCV nephropathy, BKV nephropathy, meningitis, Merkel cell carcinoma, trichodysplasia spinulosa or malignant pleural mesothelioma and/or the agent is natalizumab, efalizumab, rituximab, infliximab, ocrelizumab, alemtuzumab, bentuximab, or vedotin.

31. A kit useful in the diagnosis or monitoring of the progression of Progressive Multifocal Leukoencephalopathy (PML) and/or transplant rejection following clinical bone marrow, kidney, and other solid organs transplantations, said kit comprising the polynucleotide of claim 20.

32. The kit of claim 31 further comprising reagents and/or instructions for use.

Details for Patent 9,771,413

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 11/26/1997 ⤷  Try a Trial 2032-12-31
Idec Pharmaceuticals Corp. RITUXAN rituximab Injection 103737 02/19/2002 ⤷  Try a Trial 2032-12-31
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 08/24/1998 ⤷  Try a Trial 2032-12-31
Genzyme Corporation CAMPATH alemtuzumab Injection 103948 05/07/2001 ⤷  Try a Trial 2032-12-31
Genzyme Corporation LEMTRADA alemtuzumab Injection 103948 11/14/2014 ⤷  Try a Trial 2032-12-31
Genzyme Corporation CAMPATH alemtuzumab Injection 103948 10/12/2004 ⤷  Try a Trial 2032-12-31
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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