IP Library › Granted Patent US 50,753
Granted Patent E1
US 50,753 · App. 17/934,479 · Granted Jan 20, 2026

Recombinant adenoviruses and use thereof

Inventors: Dan H. Barouch (Newton, MA); Herbert Virgin, IV (St. Louis, MO); Peter Abbink (Winthrop, MA)
Assignee: Beth Israel Deaconess Medical Center, Inc.
C12N7/00A61K39/00A61K39/12
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Quick Facts
Patent No.
US 50,753
App. No.
17/934,479
Granted
Jan 20, 2026
Kind
E1
Abstract

The present invention relates to recombinant adenoviruses and vectors thereof. In particular, the adenoviruses are novel simian adenoviruses having a low seroprevalence and high immunogenicity relative to other adenoviruses and vectors thereof. The invention also provides methods for production of the adenoviruses and for the treatment of diseases by administering the adenoviral vector(s) to a subject (e.g., a human).

Claims (89)

1 . A recombinant adenovirus comprising a nucleotide sequence having at least 90% sequence identity over the entire sequence of any one of SEQ ID NOs: 10 and 12, or a complementary sequence to a nucleotide sequence having at least 90% sequence identity over the entire sequence of any one of SEQ ID NOs: 10 and 12;

wherein said recombinant adenovirus comprises a deletion in or of an E1 region, an E3 region, and/or an E4 region, said deletion rendering said recombinant adenovirus a replication-defective virus.

2 . The recombinant adenovirus of claim 1 , wherein said nucleotide sequence further comprises all or a portion of any one of SEQ ID NOs: 4, 6, 7, 9, 13, 15, 16, and 18, or a complementary sequence to all or a portion of any one of SEQ ID NOs: 4, 6, 7, 9, 13, 15, 16, and 18.

3 . The recombinant adenovirus of claim 1 , further comprising a nucleotide sequence having at least 90% sequence identity to the sequence of any one of SEQ ID NOs: 1 and 3 or a complementary sequence to a nucleotide sequence having at least 90% sequence identity over the entire sequence of any one of SEQ ID NOs: 1 and 3.

4 . The recombinant adenovirus of claim 2 , wherein said nucleotide sequence comprises the nucleotide sequence of any one of SEQ ID NOs: 34-39 and 46-51.

5 . The recombinant adenovirus of claim 1 , further comprising a heterologous nucleotide sequence encoding an antigenic or therapeutic gene product of interest, or fragment thereof, wherein said antigenic gene product, or fragment thereof, comprises a bacterial, viral, parasitic, or fungal protein, or fragment thereof.

6 . The recombinant adenovirus of claim 5 , wherein:

(i) said bacterial protein, or fragment thereof, is from Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium africanum, Mycobacterium microti, Mycobacterium leprae, Pseudomonas aeruginosa, Salmonella typhimurium, Escherichia coli, Klebsiella pneumoniae, Streptococcus pneumoniae, Staphylococcus aureus, Francisella tularensis, Brucella, Burkholderia mallei, Yersinia pestis, Corynebacterium diphtheria, Neisseria meningitidis, Bordetella pertussis, Clostridium tetani, or Bacillus anthracis;

(ii) said parasitic protein, or fragment thereof, is from Toxoplasma gondii, Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae, Trypanosoma spp., or Legionella spp; or

(iii) said fungal protein, or fragment thereof, is from Aspergillus, Blastomyces dermatitidis, Candida, Coccidioides immitis, Cryptococcus neoformans, Histoplasma capsulatum var. capsulatum, Paracoccidioides brasiliensis, Sporothrix schenckii, Zygomycetes spp., Absidia corymbifera, Rhizomucor pusillus, or Rhizopus arrhizus.

7 . The recombinant adenovirus of claim 5 , wherein said viral protein, or fragment thereof, is from a viral family selected from the group consisting of Retroviridae, Flaviviridae, Arenaviridae, Bunyaviridae, Filoviridae, Togaviridae, Poxviridae, Herpesviridae, Orthomyxoviridae, Coronaviridae, Rhabdoviridae, Paramyxoviridae, Picornaviridae, Hepadnaviridae, Papillomaviridae, Parvoviridae, Astroviridae, Polyomaviridae, Calciviridae, and Reoviridae, or

said viral protein, or fragment thereof, is from human immunodeficiency virus (HIV), human papillomavirus (HPV), hepatitis A virus (Hep A), hepatitis B virus (HBV), hepatitis C virus (HCV), Variola major, Variola minor, monkeypox virus, measles virus, rubella virus, mumps virus, varicella zoster virus (VZV), poliovirus, rabies virus, Japanese encephalitis virus, herpes simplex virus (HSV), cytomegalovirus (CMV), rotavirus, influenza, Ebola virus, yellow fever virus, Zika virus, or Marburg virus.

8 . The recombinant adenovirus of claim 7 , wherein said viral protein, or fragment thereof, from HIV is Gag, Pol, Env, Nef, Tat, Rev, Vif, Vpr, or Vpu.

9 . A method of treating a subject having a disease, said method comprising administering the recombinant adenovirus of claim 5 to said subject.

10 . The method of claim 9 , wherein said recombinant adenovirus comprises an antigenic gene product, or fragment thereof, that promotes an immune response in said subject against an infective agent, wherein said infective agent is a bacterium, a virus, a parasite, or a fungus.

11 . The method of claim 9 , wherein:

(a) said subject is human;

(b) said adenovirus is administered intramuscularly; and/or

(c) said adenovirus is administered as a pharmaceutical composition comprising a pharmaceutically acceptable carrier.

12 . The method of claim 11 , wherein:

(i) said subject is administered at least one dose of said pharmaceutical composition;

(ii) said subject is administered at least two doses of said pharmaceutical composition; or

(iii) said pharmaceutical composition is administered to said subject as a prime boost.

13 . A method of producing a recombinant adenovirus comprising transfecting a cell with: (a) an isolated polynucleotide comprising a nucleotide sequence having at least 90% sequence identity over the entire sequence of any one of SEQ ID NOs: 10 and 12, or a complementary sequence to a nucleotide sequence having at least 90% sequence identity over the entire sequence of any one of SEQ ID NOs: 10 and 12 or (b) a recombinant vector comprising said polynucleotide; culturing said cell in a suitable medium to allow replication of said polynucleotide or vector in said cell; and harvesting produced recombinant adenovirus from said medium and/or said cell.

14 . The method of claim 13 , wherein said cell is a bacterial, plant, or mammalian cell, wherein optionally said mammalian cell is a PER.55K cell or a Chinese hamster ovary (CHO) cell.

15 . The recombinant adenovirus of claim 5 , wherein the viral gene product is an envelope glycoprotein or fragment thereof.

16 . A method of inducing an immune response against a flavivirus in a subject comprising administering the recombinant adenovirus of claim 5 to said subject, wherein the antigenic gene product, or fragment thereof, is a viral gene product from the flavivirus.

17 . The method of claim 16 , wherein the viral gene product is an envelope glycoprotein or fragment thereof.

18 . The method of claim 16 , wherein the subject is a human.

19 . The method of claim 16 , wherein the adenovirus is administered intramuscularly.

20 . The method of claim 16 , wherein the adenovirus is administered as a pharmaceutical composition comprising a pharmaceutically acceptable carrier.

21 . The method of claim 20 , wherein the subject is administered at least one or two doses of the pharmaceutical composition, optionally wherein the pharmaceutical composition is administered to the subject as a prime boost.

22 . A method of inducing an immune response against a retrovirus in a subject comprising administering the recombinant adenovirus of claim 5 to the subject, wherein the antigenic gene product, or fragment thereof, is a viral gene product from the retrovirus.

23 . The method of claim 22 , wherein the retrovirus is human immunodeficiency virus (HIV).

24 . The method of claim 22 , wherein the subject is a human.

25 . The method of claim 22 , wherein the viral gene product is an envelope glycoprotein or fragment thereof.

26 . The method of claim 25 , wherein the viral gene product is a protein or fragment thereof from HIV.

27 . The method of claim 22 , wherein the recombinant adenovirus is administered intramuscularly.

28 . The method of claim 22 , wherein the recombinant adenovirus is administered as a pharmaceutical composition comprising a pharmaceutically acceptable carrier.

29 . The method of claim 28 , wherein the subject is administered at least one or two doses of the pharmaceutical composition, optionally wherein the pharmaceutical composition is administered to the subject as a prime boost.

30. A vector comprising an E1 region of sAd4287, sAd4310A or sAd4312.

31. The vector of claim 30 , wherein the E1 region is the E1 region of sAd4287.

32. The vector of claim 31 , wherein the E1 region comprises nucleotides 474 to 3085 of SEQ ID NO: 1.

33. The vector of claim 30 , wherein the E1 region is the E1 region of sAd4310A.

34. The vector of claim 33 , wherein the E1 region comprises nucleotides 474 to 3088 of SEQ ID NO: 2.

35. The vector of claim 30 , wherein the E1 region is the E1 region of sAd4312.

36. The vector of claim 35 , wherein the E1 reoion comprises nucleotides 487 to 3100 of SEQ ID NO: 3.

37. A cell comprising a vector which comprises an E1 region of sAd4287, sAd4310A or sAd43120.

38. The cell of claim 37 , wherein the E1 region is the E1 region of sAd4287.

39. The cell of claim 38 , wherein the E1 region comprises nucleotides 474 to 3085 of SEQ ID NO: 1.

40. The cell of claim 37 , wherein the E1 region is the E1 region of sAd4310A.

41. The cell of claim 40 , wherein the E1 region comprises nucleotides 474 to 3088 of SEQ ID NO: 2.

42. The cell of claim 37 , wherein the E1 region is the E1 region of sAd4312.

43. The cell of claim 42 , wherein the E1 region comprises nucleotides 487 to 3100 of SEQ ID NO: 3.

44. A cell line comprising a portion of sAd4287, sAd4310A or sAd4312 that complements an E1-deficient sAd4287, sAd4310A or sAd4312, respectively.

45. The cell line of claim 44 , which is a PER.55K cell line.

46. The cell line of claim 44 , which is a 293 cell line.

47. The cell line of claim 44 , which complements an E1-deficient sAd4287.

48. The cell line of claim 47 , which comprises an sAd4287 E1 region.

49. The cell line of claim 44 , which complements an E1-deficient sAd4310A.

50. The cell line of claim 49 , which comprises an sAd4310A E1 reqion.

51. The cell line of claim 44 , which complements an E1-deficient sAd4312.

52. The cell line of claim 51 , which comprises an sAd4312 E1 region.

53. The method of claim 13 , wherein the isolated polynucleotide comprises a deletion in or of an E1 region as compared to sAd4287 or sAd4312, and wherein the cell comprises a rescue vector comprising an E1 region of sAd4287 or sAd4312.

54. The method of claim 53 , wherein the rescue vector comprises an E1 region of sAd4287.

55. The method of claim 54 , wherein the rescue vector comprises nucleotides 474 to 3085 of SEQ ID NO:1.

56. The method of claim 53 , wherein the rescue vector comprises an E1 region of sAd4312.

57. The method of claim 56 , wherein the rescue vector comprises nucleotides 487 to 3100 of SEQ ID NO:3.

58. A method of producinq a recombinant adenovirus comprisinq:

(a) transfecting a cell with an isolated polynucleotide having a deletion in or of an E1 region as compared to sAd4310 and comprising a nucleotide sequence havinq at least 90% sequence identity over the entire sequence of SEQ ID NO:11, or a complementary sequence to a nucleotide sequence havinq at least 90% sequence identity over the entire sequence of SEQ ID NO:11, wherein the cell comprises a rescue vector comprising an E1 region of sAd4310;

(b) culturing said cell in a suitable medium to allow replication of said polynucleotide in said cell; and

(c) harvesting produced recombinant adenovirus from said medium and/or said cell.

59. The method of claim 58 , wherein the vector comprises nucleotides 474 to 3088 of SEQ ID NO:2.

60. A replication-defective recombinant adenovirus whose genome comprises:

(a) a nucleotide sequence encoding a hexon protein comprising the amino acid sequence of any one of SEQ ID NQs: 25, 26 and 27;

(b) a deletion in or of an E1 region; and

(c) an expression cassette for a transgene in the deleted E1 region.

61. The replication-defective recombinant adenovirus of claim 60 , wherein the nucleotide sequence encodes a hexon protein comprising the amino acid sequence of SEQ ID NO:25.

62. The replication-defective recombinant adenovirus of claim 60 , wherein the nucleotide sequence encodes a hexon protein comprising the amino acid sequence of SEQ ID NO:26.

63. The replication-defective recombinant adenovirus of claim 60 , wherein the nucleotide sequence encodes a hexon protein comprising the amino acid sequence of SEQ ID NO:27.

64. A method of producing the replication-defective recombinant adenovirus of claim 60 , comprising:

(a) transfecting a cell that is enqineered to rescue the E1 deletion with a polynucleotide comprising the nucleotide sequence of the adenovirus genome;

(b) culturing said cell in a suitable medium to allow replication of said polynucleotide in said cell; and

(c) harvesting produced recombinant adenovirus from said medium and/or said cell.

65. The method of claim 64 , wherein the cell is a PER.55K cell.

66. The method of claim 64 , wherein the cell is a 293 cell.

67. The method of claim 14 , wherein said mammalian cell is a PER.55K cell or a Chinese hamster ovary (CHO) cell.

68. The method of claim 21 , wherein the pharmaceutical composition is administered to the subject as a prime boost.

69. The method of claim 29 , wherein the pharmaceutical composition is administered to the subject as a prime boost.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 22, 2025
From: VIRGIN, HERBERT, IV
To: WASHINGTON UNIVERSITY
Reel/Frame 072099/0989 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 22, 2025
From: BAROUCH, DAN H.; ABBINK, PETER
To: BETH ISRAEL DEACONESS MEDICAL CENTER, INC.
Reel/Frame 072100/0103 →
Continuity (3)
Continuation 14443299
Provisional Application 61727455 · Nov 16, 2012
Reissue 16159336 · Oct 12, 2018
References Cited (138)
US 4695623A · Stabinsky · 1987 [cited by applicant]
US 7247472B2 · Wilson et al. · 2007 [cited by applicant]
US 9718863B2 · Colloca et al. · 2017 [cited by applicant]
US 10106781B2 · Barouch et al. · 2018 [cited by applicant]
US 20040136963A1 · Wilson et al. · 2004 [cited by applicant]
US 20050232900A1 · Vogels et al. · 2005 [cited by applicant]
US 20100034774A1 · Vogels et al. · 2010 [cited by applicant]
US 20110000480A1 · Turner et al. · 2011 [cited by applicant]
US 20110306090A1 · Francky et al. · 2011 [cited by applicant]
US 20120027788A1 · Colloca et al. · 2012 [cited by applicant]
US 20120076812A1 · Barouch et al. · 2012 [cited by applicant]
US 20140348791A1 · Barouch et al. · 2014 [cited by applicant]
US 20150291935A1 · Barouch et al. · 2015 [cited by applicant]
US 20170119872A1 · O'Hagan et al. · 2017 [cited by applicant]
US 20190136205A1 · Barouch et al. · 2019 [cited by applicant]
CN 1578678A · 2005 [cited by applicant]
EP 1944043A1 · 2008 [cited by applicant]
JP 2005523730A · 2005 [cited by applicant]
WO WO9700326A1 · 1997 [cited by applicant]
WO WO0070071A1 · 2000 [cited by applicant]
WO WO0102607A1 · 2001 [cited by applicant]
WO WO0222080A2 · 2002 [cited by applicant]
WO WO0240665A2 · 2002 [cited by applicant]
WO WO03046124A3 · 2003 [cited by applicant]
WO WO2003046124A2 · 2003 [cited by applicant]
WO WO2004001032A2 · 2003 [cited by applicant]
WO WO2007104792A2 · 2007 [cited by applicant]
WO WO2008010864A2 · 2008 [cited by applicant]
WO WO2008010864A3 · 2008 [cited by applicant]
WO WO2011057248A2 · 2011 [cited by applicant]
WO WO2011057254A2 · 2011 [cited by applicant]
WO WO2011057248A3 · 2011 [cited by applicant]
WO WO2011129468A1 · 2011 [cited by applicant]
WO WO2012021730A2 · 2012 [cited by applicant]
WO WO2012024351A2 · 2012 [cited by applicant]
WO WO2012024351A3 · 2012 [cited by applicant]
WO WO2014078688A2 · 2014 [cited by applicant]
WO WO2014078688A3 · 2014 [cited by applicant]
Avvakumov N et al. “Comprehensive sequence analysis of the E1A proteins of human and simian adenoviruses.” Virology 329: 477-492. (Year: 2004). [cited by examiner]
GenBank, “KM591901.1—Rhesus adenovirus 51, complete genome.” Available online at < https://www.ncbi.nlm.nih.gov/nuccore/KM591901.1/ >. Downloaded from the Internet Jul. 10, 2024. (Year: 2015). [cited by examiner]
GenBank, “KM591902.1—Rhesus adenovirus 52, complete genome.” Available online at < https://www.ncbi.nlm.nih.gov/nuccore/KM591902.1/ >. Downloaded from the Internet Jul. 10, 2024. (Year: 2015). [cited by examiner]
GenBank, “KM591903.1—Rhesus adenovirus 53, complete genome.” Available online at < https://www.ncbi.nlm.nih.gov/nuccore/KM591903.1/ >. Downloaded from the Internet Jul. 10, 2024. (Year: 2015). [cited by examiner]
Abbink P et al. “Construction and Evaluation of Novel Rhesus Monkey Adenovirus Vaccine Vectors.” J Virol 89: 1512-1522. (Year: 2015). [cited by examiner]
PubMed, “Construction and Evaluation of Novel Rhesus Monkey Adenovirus Vaccine Vectors.” Available online at < https://pubmed.ncbi.nlm.nih.gov/25410856/ >. Downloaded from the Internet Jul. 10, 2024. (Year: 2014). [cited by examiner]
English Translation of Office Action for Japanese Patent Application No. 2022-057870, mailed Jul. 4, 2023 (8 pages). [cited by applicant]
Abbink et al. “Rapid Cloning of Novel Rhesus Adenoviral Vaccine Vectors,” J Virol. 92(6):e01924-17 (2018) (11 pages). [cited by applicant]
Bangari et al. “Development of nonhuman adenoviruses as vaccine vectors,” Vaccine 24(7):849-62 (2006) (21 pages). [cited by applicant]
Communication Pursuant to Rules 70(2) and 70a(2) EPC for International Patent Application No. PCT/US2013/070353, dated Jul. 5, 2016 (1 page). [cited by applicant]
Dicks et al. “A novel chimpanzee adenovirus vector with low human seroprevalence: improved systems for vector derivation and comparative immunogenicity,” PLOS One 7(7):e40385 (Jul. 2012) (12 pages). [cited by applicant]
Examination Review Report for Singaporean Patent Application No. 11201503864T, dated Apr. 22, 2019 (4 pages). [cited by applicant]
Extended European Search Report for European Patent Application No. 13854932.4, mailed Jun. 17, 2016 (8 pages). [cited by applicant]
Finkbeiner, et al., “Metagenomic analysis of human diarrhea: viral detection and discovery,” PLoS Pathog. 4(2):e1000011 (2008) (9 pages). [cited by applicant]
Geisbert et al. “Recombinant adenovirus serotype 26 (Ad26) and Ad35 vaccine vectors bypass immunity to Ad5 and protect nonhuman primates against ebolavirus challenge,” J Virol. 85(9):4222-33 (2011). [cited by applicant]
Handley et al., “Pathogenic simian immunodeficiency virus infection is associated with expansion of the enteric virome,” Cell. 151(2):253-66 (Oct. 2012). [cited by applicant]
Holterman et al., “Novel replication-incompetent vector derived from adenovirus type 11 (Ad11) for vaccination and gene therapy: low seroprevalence and non-cross-reactivity with Ad5,” J Virol. 78(23):13207-15 (2004). [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2018/064978 dated Apr. 24, 2019 (20 pages). [cited by applicant]
International Search Report and Written Opinion for International Patent Application No. PCT/US13/70353, mailed May 12, 2014 (17 pages). [cited by applicant]
Kass-Eisler et al., “Circumventing the immune response to adenovirus-mediated gene therapy,” Gene Ther. 3(2):154-62 (1996) (10 pages). [cited by applicant]
Lemckert et al., “Immunogenicity of heterologous prime-boost regimens involving recombinant adenovirus serotype 11 (Ad11) and Ad35 vaccine vectors in the presence of anti-ad5 immunity,” J Virol. 79(15):9694-701 (2005). [cited by applicant]
Liu et al., “Modulation of DNA vaccine-elicited CD8 [cited by applicant]
Notice of Reasons for Rejection for Japanese Patent Application No. 2015-542833, mailed Sep. 5, 2017 (20 pages). [cited by applicant]
Office Action for Chinese Patent Application No. 201380068078.0, mailed Apr. 4, 2018 (5 pages). [cited by applicant]
Office Action for Israeli Patent Application No. 238847, dated May 27, 2019 (5 pages). [cited by applicant]
Office Action for Japanese Patent Application No. 2015-542833, mailed Apr. 22, 2020 (4 pages). [cited by applicant]
Office Action for Japanese Patent Application No. 2015-542833, mailed Aug. 7, 2018 (8 pages). [cited by applicant]
Office Action for Japanese Patent Application No. 2018-038380, Mar. 12, 2019 (28 pages). [cited by applicant]
Setoguchi et al., “Intraperitoneal In Vivo Gene Therapy to Deliver alpha1-Antitrypsin to the Systemic Circulation,” Am J Respir Cell Mol Biol. 10(4):369-77 (1994). [cited by applicant]
Shiver et al., “Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity,” Nature. 415(6869):331-5 (2002). [cited by applicant]
Yei et al., “Adenovirus-mediated Gene Transfer for Cystic Fibrosis: Quantitative Evaluation of Repeated in Vivo Vector Administration to the Lung,” Gene Ther. 1(3):192-200 (1994). [cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/US2018/064978, dated Jun. 16, 2020 (9 pages). [cited by applicant]
Communication Pursuant to 164(1) EPC for European Patent Application No. 18889863.9, dated Nov. 3, 2021 (22 pages). [cited by applicant]
“UniProtKB: Q5C8P9,” UniProtKB, <https://www.uniprot.org/uniprot/Q5C8P9> (2005) (7 pages). [cited by applicant]
Pantó et al., “Taxonomy Proposal For Old World Monkey Adenoviruses: Characterisation of Several Non-Human, Non-Ape Primate Adenovirus Lineages,” Arch Virol. 160: 3165-77 (2015) (14 pages). [cited by applicant]
Extended European Search Report for European Patent Application No. 18889863.9, dated Mar. 10, 2022 (24 pages). [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US02/33645, mailed Sep. 30, 2003 (4 pages). [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2007/010347, mailed May 3, 2008 (4 pages). [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2010/055991, mailed Jun. 30, 2011 (6 pages). [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2011/048006, mailed Apr. 9, 2012 (3 pages). [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US13/70353, mailed May 12, 2014 (3 pages). [cited by applicant]
Wu et al., “Flexibility of the adenovirus fiber is required for efficient receptor interaction,” J Virol. 77(13):7225-35 (Jul. 2003). [cited by applicant]
Morris et al., “Simian adenoviruses as vaccine vectors,” Future Virol. 11(9):649-659 (Sep. 2016). [cited by applicant]
Awasthi et al., “A Dual-Modality Herpes Simplex Virus 2 Vaccine for Preventing Genital Herpes by Using Glycoprotein C and D Subunit Antigens To Induce Potent Antibody Responses and Adenovirus Vectors Containing Capsid a… [cited by applicant]
Office Action for Japanese Patent Application No. 2022-057870, Jan. 10, 2023 (3 pages). [cited by applicant]
Abbink et al., “Comparative seroprevalence and immunogenicity of six rare serotype recombinant adenovirus vaccine vectors from subgroups B and D,” J Virol. 81(9):4654-63 (2007). [cited by applicant]
Abbink et al., “Development of Novel Simian Adenovirus Based Vaccine Vectors.” Poster. 2013. <http://epostersonline.s3.amazonaws.com>. Retrieved on Apr. 16, 2014 (1 page). [cited by applicant]
Bangari and Mittal. “Development of nonhuman adenoviruses as vaccine vectors,”Vaccine 24(7):849-62 (2006) (21 pages). [cited by applicant]
Barouch et al., “Immunogenicity of recombinant adenovirus serotype 35 vaccine in the presence of pre-existing anti-Ad5 immunity.” J Immunol. 172(10):6290-7 (2004) (9 pages). [cited by applicant]
Barouch et al., “International seroepidemiology of adenovirus serotypes 5, 26, 35, and 48 in pediatric and adult populations,” Vaccine. 29(32):5203-9 (2011) (14 pages). [cited by applicant]
Communication Pursuant to 94(3) EPC for European Patent Application No. 13854932.4, dated Sep. 28, 2017 (8 pages). [cited by applicant]
Communication Pursuant to Rules 70(2) and 70a(2)EPC for International Patent Application No. PCT/US 13/70353, dated Jul. 5, 2016 (1 page). [cited by applicant]
EMBOSS Needle, “Pairwise Sequence Alignment (PROTEIN).” http://www.ebi.ac.uk/Tools/psa/emboss_needle/, retrieved Aug. 18, 2017 (40 pages). [cited by applicant]
Geisbert et al., “Recombinant adenovirus serotype 26 (Ad26) and Ad35 vaccine vectors bypass immunity to Ad5 anti protect nonhuman primates against ebolavirus challenge,” J Virol. 85(9):4222-33 (2011). [cited by applicant]
GenBank Accession No. AF326321.1. Retrieved on Apr. 16, 2014 (3 pages). [cited by applicant]
GanBank Accession No. AY771780.1. Retrieved on Apr. 16, 2014 (15 pages). [cited by applicant]
GenBank Accession No. AZ111781.1. Retrieved on Jul. 13, 2016 (2 pages). [cited by applicant]
GenBank Accession No. JA453575.1. Retrieved on Jul. 13, 2016 (8 pages). [cited by applicant]
GenBank Accession No. AY771780. Retrieved Oct. 24, 2017 (17 pages). [cited by applicant]
Hayes, “Zika virus outside Africa,” Emerg Infect Dis. 15(9):1347-50 (2009). [cited by applicant]
Holterman et al., “Novel replication-incompetent vector derived from adenovirus type 11 (Ad11) for vaccination and gene therapy: low seroprevalence and non-cross-reactivity with Ads,” J Virol. 78(23):13207-15 (2004). [cited by applicant]
International Preliminary Report on Patentability for International Patent Application No. PCT/US2013/070353. dated May 19, 2015 (8 pages). [cited by applicant]
International Search Report and Written Opinion for International Patent Application No. PCT/US13/70353. dated May 12, 2014 (17 pages). [cited by applicant]
Kovacs et al., “Complete genome sequence of simian adenovirus 1: an Old World monkey adenovirus with two fiber genes,” Journal of General Virology. 86(6):1681-6 (2005). [cited by applicant]
Lemckert et al., “Immunogenicity of heterologous prime-boost regimens involving recombinant adenovirus scrotype 11 (Ad11) and Ad35 vaccine vectors in the presence of anti-ad5 immunity,” J Virol. 79(15):9694-701 (2005). [cited by applicant]
Letvin et al., “Prospects for vaccine protection against HIV-1 infection and AIDS.” Annu Rev Immunol. 20:73-99 (2002). [cited by applicant]
Liu et al. “Modulation of DNA vaccine-elicited CD8+ T-lymphocyte epitope immunodominanee hierarchies.” J Virol. 80(24):11991-7 (2006). [cited by applicant]
Notice of Reasons for Rejection for Japanese Patent Application No. 2015-542833, dated Sep. 5, 2017 (20 pages). [cited by applicant]
Office Action for Chinese Patent Application No. 201380068078.0, dated Apr. 4, 2018 (5 pages). [cited by applicant]
Ostapchuk et al., “Pseudopackaging of adenovirus type 5 genomes into capsids containing the hexon proteins of adenovirus serotypes B, D, or E,” J Virol. 75(1):45-51 (2001). [cited by applicant]
Search Report for Singaporean Application No. 11201503864T, dated Feb. 29, 2016 (3 pages). [cited by applicant]
Shiver et al., “Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors,” Annu Rev Med. 55:355-72 (2004). [cited by applicant]
Sprangers et al., “Quantifying adenovirus-neutralizing antibodies by luciferase transgene detection: addressing preexisting immunity to vaccine and gene therapy vectors,”J Clin Microbiol. 41(11):5046-52 (2003). [cited by applicant]
Sumida et al., “Neutralizing antibodies to adenovirus serotype 5 vaccine vectors are directed primarily against the adenovirus hexon protein,” J Immunol. 174(11):7179-85 (2005). [cited by applicant]
Tripp et al., “Development of a Zika vaccine,” Expert Rev Vaccines. 15(9):1083-5 (2016). [cited by applicant]
Vogels et al., “Replication-deficient human adenovirus type 35 vectors for gene transfer and vaccination: efficient human cell infection and bypass of preexisting adenovirus immunity,” J Virol. 77(15):8263-71 (2003). [cited by applicant]
Wodrich et al., “Switch from capsid protein import to adenovirus assembly by cleavage of nuclear transport signals,” EMBO J. 22(23):6245-55 (2003). [cited by applicant]
Written Opinion for Singaporean Application No. 11201503864T, dated Apr. 1, 2016 (6 pages). [cited by applicant]
Dicks et al., “A novel chimpanzee adenovirus vector with low human seroprevalence: improved systems for vector derivation and comparative immunogenicity,” PLoS One 7(7):e40385 (2012) (12 pages). [cited by applicant]
Office Action for Israeli Patent Application No. 238847, dated May 27, 2019 (7 pages). [cited by applicant]
Examination Report for Australian Patent Application No. 2018229561, dated Jun. 21, 2019 (4 pages). [cited by applicant]
Examination Review Report for Singapore Patent Application No. 11201503864T, dated Apr. 22, 2019 (4 pages). [cited by applicant]
First Examination Report for New Zealand Patent Application No. 708144, dated Mar. 13, 2019 (5 pages). [cited by applicant]
Office Action for Japanese Patent Application No. 2018-038380, dated Mar. 12, 2019 (28 pages). [cited by applicant]
Extended European Search Report for European Patent Application No. 19179450.2, dated Oct. 9, 2019 (7 pages). [cited by applicant]
GenBank Accession No. AZI11781.1. Retrieved Jan. 7, 2020 (2 Pages). [cited by applicant]
“Sequence alignment results, EMBOSS Needle/Pairwise Sequence Alignment/EMBLE-EBI website,” <https://www.ebi.ac.uk/Tools/psa/emboss needle/nucleotide.html>, retrieved on Feb. 15, 2019 (10 pages). [cited by applicant]
Abbink et al., “Construction and Evaluation of Novel Rhesus Monkey adenovirus Vaccine Vectors,” J Virol. 89(3):1512-22 (2015) (11 pages). [cited by applicant]
EMBOSS Needle, “Pairwise Sequence Alignment (NUCLEO-TIDE),” www.ebi.ac.uk/Tools/psa/emboss_needle/nucleotide.html, retrieved Feb. 28, 2019 (10 pages). [cited by applicant]
Foy et al., “Probable Non-Vector-borne Transmission of Zika Virus, Colorado, USA,” Emerg Infect Dis. 17(5):880-2 (2011) (7 pages). [cited by applicant]
Kubo, “The Task of Isolating and Identifying Human Pathogenic Viruses,” Seikatsu Eisei. 50(5):381-6 (2006) (English language abstract included). [cited by applicant]
Kuno et al., “Full-length sequencing and genomic characterization of Bagaza. Kedougou, and Zika viruses,” Arch Virol. 152(4):687-96 (2007). [cited by applicant]
Larocca et al., “Vaccine protection against Zika virus from Brazil,” Nature. 536(7617):474-8 (2016) (15 pages). [cited by applicant]
Office Action for Japanese Patent Application No. 2018-038380, dated Mar. 10, 2020 (16 pages). [cited by applicant]
Poland et al., “Development of vaccines against Zika virus,” Lancet Infect Dis. 18(7):e211-e219 (2018) (9 pages). [cited by applicant]
Communication pursuant to Article 94(3) EPC for European Application No. 1979450.2. dated May 13, 2020 (5 pages). [cited by applicant]
Kass-Eisler et al., “The Impact of Developmental Stage, Route of Administration and the Immune System on Adenovirus-Mediated Gene Transfer,” Gene Ther. 1(6):395-402 (1994). [cited by applicant]
Office Action for Japanese Patent Application No. 2015-542833, dated Apr. 22, 2020 (4 pages). [cited by applicant]
Setoguchi et al., “Intraperitoneal In Vivo Gene Therapy to Deliver alphal-Antitrysin to the Systemic Circulation,” Am J Respir Cell Mol Biol. 10(4):369-77 (1994). [cited by applicant]
Zabner et al., “Safety and efficacy of repetitive adenovirus-mediated transfer of CFTR cDNA to airway epithelia of primates and cotton rats,” Nat Genet. 6(1):75-83 (1994). [cited by applicant]