POLYOMAVIRUS NEUTRALIZING ANTIBODIES
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Accused Products
Abstract
The present disclosure is directed to anti-VP1 antibodies, antibody fragments, and their uses for the reducing the likelihood or treatment of polyoma virus infection.
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Citations
45 Claims
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1-6. -6. (canceled)
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7. An antibody, wherein said antibody or antigen binding fragment specifically binds to a VP1 epitope.
- View Dependent Claims (8, 10, 11, 12, 13, 14, 15, 16, 17, 25, 26, 27, 28, 29, 30, 31, 32, 33, 42, 43, 44)
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8. The antibody of claim 7, wherein said antibody or antigen binding fragment thereof comprises:
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(i) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
126, (b) a HCDR2 of SEQ ID NO;
127, (c) a HCDR3 of SEQ ID NO;
128; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
136, (e) a LCDR2 of SEQ ID NO;
137, and (f) a LCDR3 of SEQ ID NO;
138;(ii) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
146, (b) a HCDR2 of SEQ ID NO;
147, (c) a HCDR3 of SEQ ID NO;
148; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
156, (e) a LCDR2 of SEQ ID NO;
157, and (f) a LCDR3 of SEQ ID NO;
158;(iii) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
166, (b) a HCDR2 of SEQ ID NO;
167, (c) a HCDR3 of SEQ ID NO;
168; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
176, (e) a LCDR2 of SEQ ID NO;
177, and (f) a LCDR3 of SEQ ID NO;
178;(iv) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
226, (b) a HCDR2 of SEQ ID NO;
227, (c) a HCDR3 of SEQ ID NO;
228; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
236, (e) a LCDR2 of SEQ ID NO;
237, and (f) a LCDR3 of SEQ ID NO;
238;(v) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
246, (b) a HCDR2 of SEQ ID NO;
247, (c) a HCDR3 of SEQ ID NO;
248; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
256, (e) a LCDR2 of SEQ ID NO;
257, and (f) a LCDR3 of SEQ ID NO;
258;(vi) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
266, (b) a HCDR2 of SEQ ID NO;
267, (c) a HCDR3 of SEQ ID NO;
268; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
276, (e) a LCDR2 of SEQ ID NO;
277, and (f) a LCDR3 of SEQ ID NO;
278;(vii) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
286, (b) a HCDR2 of SEQ ID NO;
287, (c) a HCDR3 of SEQ ID NO;
288; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
296, (e) a LCDR2 of SEQ ID NO;
297, and (f) a LCDR3 of SEQ ID NO;
298;(viii) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
306, (b) a HCDR2 of SEQ ID NO;
307, (c) a HCDR3 of SEQ ID NO;
308; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
314, (e) a LCDR2 of SEQ ID NO;
315, and (f) a LCDR3 of SEQ ID NO;
316;(ix) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
322, (b) a HCDR2 of SEQ ID NO;
323, (c) a HCDR3 of SEQ ID NO;
324; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
332, (e) a LCDR2 of SEQ ID NO;
333, and (f) a LCDR3 of SEQ ID NO;
334;(x) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
342, (b) a HCDR2 of SEQ ID NO;
343, (c) a HCDR3 of SEQ ID NO;
344; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
349, (e) a LCDR2 of SEQ ID NO;
350, and (f) a LCDR3 of SEQ ID NO;
351;(xi) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
356, (b) a HCDR2 of SEQ ID NO;
357, (c) a HCDR3 of SEQ ID NO;
358; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
363, (e) a LCDR2 of SEQ ID NO;
364, and (f) a LCDR3 of SEQ ID NO;
365;(xii) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
370, (b) a HCDR2 of SEQ ID NO;
371, (c) a HCDR3 of SEQ ID NO;
372; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
377, (e) a LCDR2 of SEQ ID NO;
378, and (f) a LCDR3 of SEQ ID NO;
379;(xiii) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
384, (b) a HCDR2 of SEQ ID NO;
385, (c) a HCDR3 of SEQ ID NO;
386; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
391, (e) a LCDR2 of SEQ ID NO;
392, and (f) a LCDR3 of SEQ ID NO;
393;(xiv) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
398, (b) a HCDR2 of SEQ ID NO;
399, (c) a HCDR3 of SEQ ID NO;
400; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
405, (e) a LCDR2 of SEQ ID NO;
406, and (f) a LCDR3 of SEQ ID NO;
407;(xv) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
412, (b) a HCDR2 of SEQ ID NO;
413, (c) a HCDR3 of SEQ ID NO;
414; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
419, (e) a LCDR2 of SEQ ID NO;
420, and (f) a LCDR3 of SEQ ID NO;
421;(xvi) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
426, (b) a HCDR2 of SEQ ID NO;
427, (c) a HCDR3 of SEQ ID NO;
428; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
433, (e) a LCDR2 of SEQ ID NO;
434, and (f) a LCDR3 of SEQ ID NO;
435;(xvii) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
440, (b) a HCDR2 of SEQ ID NO;
441, (c) a HCDR3 of SEQ ID NO;
442; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
447, (e) a LCDR2 of SEQ ID NO;
448, and (f) a LCDR3 of SEQ ID NO;
449;(xviii) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
454, (b) a HCDR2 of SEQ ID NO;
455, (c) a HCDR3 of SEQ ID NO;
456; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
461, (e) a LCDR2 of SEQ ID NO;
462, and (f) a LCDR3 of SEQ ID NO;
463;(xix) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
468, (b) a HCDR2 of SEQ ID NO;
469, (c) a HCDR3 of SEQ ID NO;
470; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
475, (e) a LCDR2 of SEQ ID NO;
476, and (f) a LCDR3 of SEQ ID NO;
477;(xx) a heavy chain variable region that comprises;
(a) a HCDR1 of SEQ ID NO;
482, (b) a HCDR2 of SEQ ID NO;
483, (c) a HCDR3 of SEQ ID NO;
484; and
a light chain variable region that comprises;
(d) a LCDR1 of SEQ ID NO;
489, (e) a LCDR2 of SEQ ID NO;
490, and (f) a LCDR3 of SEQ ID NO;
491.
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10. The antibody of claim 8 wherein one or two amino acids within a CDR have been modified, deleted or substituted.
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11. The antibody of claim 8, wherein the antibody contains the modifications in Table 3.
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12. The antibody of claim 8 that retains at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identity over either the variable heavy chain region or the variable light chain region.
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13. The antibody of claim 8 wherein the antibody is a monoclonal antibody, a chimeric antibody, a humanized antibody, a human engineered antibody, a human antibody, a single chain antibody (scFv) or an antibody fragment.
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14. The antibody of claim 7 wherein said antibody or antigen binding fragment thereof comprises:
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(i) a heavy chain variable region (vH) that comprises SEQ ID NO;
132, and a light chain variable region (vL) that comprises SEQ ID NO;
142;(ii) a heavy chain variable region (vH) that comprises SEQ ID NO;
152, and a light chain variable region (vL) that comprises SEQ ID NO;
162;(iii) a heavy chain variable region (vH) that comprises SEQ ID NO;
172, and a light chain variable region (vL) that comprises SEQ ID NO;
182;(iv) a heavy chain variable region (vH) that comprises SEQ ID NO;
232, and a light chain variable region (vL) that comprises SEQ ID NO;
242;(v) a heavy chain variable region (vH) that comprises SEQ ID NO;
252, and a light chain variable region (vL) that comprises SEQ ID NO;
262;(vi) a heavy chain variable region (vH) that comprises SEQ ID NO;
272, and a light chain variable region (vL) that comprises SEQ ID NO;
282;(vii) a heavy chain variable region (vH) that comprises SEQ ID NO;
292, and a light chain variable region (vL) that comprises SEQ ID NO;
302;(viii) a heavy chain variable region (vH) that comprises SEQ ID NO;
312, and a light chain variable region (vL) that comprises SEQ ID NO;
320;(ix) a heavy chain variable region (vH) that comprises SEQ ID NO;
328, and a light chain variable region (vL) that comprises SEQ ID NO;
338;(x) a heavy chain variable region (vH) that comprises SEQ ID NO;
348, and a light chain variable region (vL) that comprises SEQ ID NO;
355;(xi) a heavy chain variable region (vH) that comprises SEQ ID NO;
362, and a light chain variable region (vL) that comprises SEQ ID NO;
369;(xii) a heavy chain variable region (vH) that comprises SEQ ID NO;
376, and a light chain variable region (vL) that comprises SEQ ID NO;
383;(xiii) a heavy chain variable region (vH) that comprises SEQ ID NO;
390, and a light chain variable region (vL) that comprises SEQ ID NO;
397;(xiv) a heavy chain variable region (vH) that comprises SEQ ID NO;
404, and a light chain variable region (vL) that comprises SEQ ID NO;
411;(xv) a heavy chain variable region (vH) that comprises SEQ ID NO;
418, and a light chain variable region (vL) that comprises SEQ ID NO;
425;(xvi) a heavy chain variable region (vH) that comprises SEQ ID NO;
432, and a light chain variable region (vL) that comprises SEQ ID NO;
439;(xvii) a heavy chain variable region (vH) that comprises SEQ ID NO;
446, and a light chain variable region (vL) that comprises SEQ ID NO;
453;(xviii) a heavy chain variable region (vH) that comprises SEQ ID NO;
460, and a light chain variable region (vL) that comprises SEQ ID NO;
467;(xix) a heavy chain variable region (vH) that comprises SEQ ID NO;
474, and a light chain variable region (vL) that comprises SEQ ID NO;
481;
or(xx) a heavy chain variable region (vH) that comprises SEQ ID NO;
488, and a light chain variable region (vL) that comprises SEQ ID NO;
495.
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15. The antibody or fragment thereof, of claim 14 that retains at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identity over either the variable light or variable heavy region.
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16. The antibody of claim 14, wherein one, two, three, four or five, but less than 10 amino acids within the variable light or variable heavy region have been modified, deleted or substituted.
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17. The antibody of claim 14 wherein the antibody is a monoclonal antibody, a chimeric antibody, a humanized antibody, a human engineered antibody, a human antibody, a single chain antibody (scFv) or an antibody fragment.
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25. A method of neutralizing a BK virus or JC virus infection comprising administering via injection or infusion to a patient in need an effective amount of the antibody or the pharmaceutical composition of claim 7 or claim 14.
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26. The method of claim 25, wherein the patient in need is diagnosed with BK viruria or BK viremia.
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27. A method of treating or reducing the likelihood of a BK virus or JC virus associated disorder, comprising administering via injection or infusion to a patient in need an effective amount of the antibody or the pharmaceutical composition of claim 7 or claim 14, and wherein the disorder is:
- nephropathy, BKVAN, hemorrhagic cystitis (HC), Progressive Multifocal Leukoencephalopathy (PML), granule cell neuronopathy (GCN), interstitial kidney disease, ureteral stenosis, vasculitis, colitis, retinitis, meningitis, and immune reconstitution inflammatory syndrome (IRIS).
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28. The method of claim 25 or 27, wherein the antibody or composition is reconstituted prior to injection or infusion.
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29. The method of claim 25 or 27, wherein the antibody or the pharmaceutical composition is administered in combination with another therapeutic agent.
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30. The method of claim 29, wherein the therapeutic agent is an immunosuppressive agent.
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31. The method of claim 30, wherein the immune suppressive agent is:
- a monophosphate dehydrogenase inhibitor, a purine synthesis inhibitor, a calcineurin inhibitor or an mTOR inhibitor.
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32. The method of claim 31, wherein the immunosuppressive agent is mycophenolate mofetil (MMF), mycophenolate sodium, azathioprine, tacrolimus, sirolimus or cyclosporine.
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33. The method of claim 29, wherein the therapeutic agent is an additional anti-VP1 antibody.
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42. A nucleic acid that encodes the antibody or antigen binding fragment of claim 7.
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43. A vector comprising the nucleic acid of claim 42.
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44. A host cell comprising the vector of claim 43.
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8. The antibody of claim 7, wherein said antibody or antigen binding fragment thereof comprises:
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9. (canceled)
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34-41. -41. (canceled)
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45. A process for producing an antibody or antigen binding fragment comprising cultivating the host cell and recovering the antibody from the culture.
Specification
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Current AssigneeNovartis Ag
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Original AssigneeAdam Lloyd Feire, Fangmin Xu, Lichun WANG, Mark Knapp, Qilong Wu, Steven Kovacs, Yongqiang Wang
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InventorsABEND, Johanna, DRAGIC, Zorica, FEIRE, Adam Lloyd, KNAPP, Mark, KOVACS, Steven, TRAGGIAI, Elisabetta, WANG, Lichun, WANG, Yongqiang, WU, Danqing, WU, Qilong, XU, Fangmin
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Granted Patent
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Time in Patent OfficeDays
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Field of Search
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US Class Current
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CPC Class CodesA61K 39/42 viralA61K 45/06 Mixtures of active ingredie...A61K 9/19 lyophilised , i.e. freeze-d...A61P 1/00 Drugs for disorders of the ...A61P 13/02 of urine or of the urinary ...A61P 13/10 of the bladderA61P 13/12 of the kidneysA61P 25/00 Drugs for disorders of the ...A61P 29/00 Non-central analgesic, anti...A61P 31/20 for DNA virusesA61P 37/02 ImmunomodulatorsA61P 37/06 Immunosuppressants, e.g. dr...A61P 43/00 Drugs for specific purposes...A61P 9/00 Drugs for disorders of the ...A61P 9/10 for treating ischaemic or a...C07K 16/084 Papovaviridae, e.g. papillo...C07K 2317/20 characterized by taxonomic ...C07K 2317/21 from primates, e.g. manC07K 2317/24 containing regions, domains...C07K 2317/33 Crossreactivity, e.g. for s...C07K 2317/34 : Identification of a linear ...C07K 2317/41 : Glycosylation, sialylation,...C07K 2317/56 : variable (Fv) region, i.e. ...C07K 2317/565 : Complementarity determining...C07K 2317/622 : Single chain antibody (scFv)C07K 2317/76 : Antagonist effect on antige...C07K 2317/92 : Affinity (KD), association ...Y02A 50/30 : Against vector-borne diseas...