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WO 2015/103438 A2 9 July 2015 (09.07.2015) W P O P C T

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WO 2015/103438 A2 9 July 2015 (09.07.2015) W P O P C T (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2015/103438 A2 9 July 2015 (09.07.2015) W P O P C T (51) International Patent Classification: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, C07K 16/18 (2006.01) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (21) International Application Number: KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, PCT/US20 14/073088 MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, (22) International Filing Date: PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, 3 1 December 2014 (3 1.12.2014) SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of regional protection available): ARIPO (BW, GH, (30) Priority Data: GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 61/964,383 2 January 2014 (02.01 .2014) US TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, (71) Applicant: GENELUX CORPORATION [US/US]; 3030 DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, Bunker Hill Street, Suite 310, San Diego, CA 92109 (US). LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, (72) Inventors: SZALAY, Aladar, A.; 7704 North Fork Road, GW, KM, ML, MR, NE, SN, TD, TG). Highland, CA 92364 (US). CAPPELLO, Joseph; 3030 Bunker Hill Street, Suite 310, San Diego, CA 92109 (US). Declarations under Rule 4.17: CHEN, Nanhai, G.; 9167 Buckwheat Street, San Diego, — as to the applicant's entitlement to claim the priority of the CA 92129 (US). MINEV, Boris; 3030 Bunker Hill Street, earlier application (Rule 4.1 7(in)) Suite 310, San Diego, CA 92109 (US). Published: (74) Agents: SEIDMAN, Stephanie, L. et al; McKenna Long & Aldridge LLP, 4435 Eastgate Mall, Suite 400, San — without international search report and to be republished Diego, CA 92121 (US). upon receipt of that report (Rule 48.2(g)) (81) Designated States (unless otherwise indicated, for every — with sequence listing part of description (Rule 5.2(a)) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (54) Title: ONCOLYTIC VIRUS ADJUNCT THERAPY WITH AGENTS THAT INCREASE VIRUS INFECTIVITY (57) Abstract: Provided are adjunct therapies for use in combinations and compositions with an oncolytic virus, such as a vaccinia virus. The adjunct therapies include co-administration and co-formulation of a complement inhibitor and/or a lipid emulsion com position with the oncolytic virus. Also provided herein are therapeutic methods using the adjunct therapies for treatment of disease and conditions employing an oncolytic therapeutic virus, such as for the treatment of hyperproliferative diseases or conditions in cluding tumors or cancers. ONCOLYTIC VIRUS ADJUNCT THERAPY WITH AGENTS THAT INCREASE VIRUS INFECTIVITY RELATED APPLICATIONS Benefit of priority is claimed to U.S. provisional application Serial No. 61/964,383, filed January 02, 2014, to Aladar A. Szalay, Joseph Cappello, Nanhai G. Chen and Boris Minev, entitled "ONCOLYTIC VIRUS ADJUNCT THERAPY WITH AGENTS THAT INCREASE VIRUS INFECTIVITY." Where permitted, the subject matter of U.S. provisional application Serial No. 61/964,383 is incorporated by reference in its entirety. INCORPORATION BY REFERENCE OF SEQUENCE LISTING PROVIDED ELECTRONICALLY An electronic version of the Sequence Listing is filed herewith, the contents of which are incorporated by reference in their entirety. The electronic file was created on December 30, 2014, is 4,434 kilobytes in size, and titled 4847SEQPCl.txt. FIELD OF THE INVENTION Provided are adjunct therapies for use in combinations or compositions with an oncolytic virus, such as a vaccinia virus, to increase infectivity of the virus. The adjunct therapies include co-administration or co-formulation of a complement inhibitor and/or a lipid emulsion composition. Also provided herein are therapeutic methods using the adjunct therapies for treatment of disease and conditions with employing the combinations, compositions and methods, such as for the treatment of hyperproliferative diseases and conditions including tumors and cancers. BACKGROUND Oncolytic viral therapy is effected by administering a virus that accumulates in tumor cells and replicates in the tumor cells. For example, vaccinia is an oncolytic virus that accumulates in wounds and tumors. By virtue of replication in the cells, and optional delivery of therapeutic agents, tumor cells are lysed, and the tumor shrinks and can be eliminated. Vaccinia viruses are typically administered systemically or locally. There still exists a need for improved or alternative methods of administering vaccinia viruses for various therapeutic and diagnostic applications. Accordingly, it is among the objects herein, to provide virus compositions that can be employed for diagnostic and/or therapeutic methods. SUMMARY Provided are methods, uses, compositions, combinations for increasing the infectivity of oncolytic viruses, such as vaccinia viruses. Infectivity is increased by treating a subject with an anti-complement molecule, particularly an antibody, such as an anti-C5 antibody and/or other complement inhibitors known to those of skill in the art. Treatment can be effected simultaneously with administration of the virus, before, after and intermittently with administration of the viruses. Uses of the antibodies for such treatment, including treatment of tumors are provided. Infectivity can be increased by pretreatment, such as incubation, of the oncolytic viruses with a biocompatible lipid as described herein. The antibodies, biocompatible lipid compositions, and viruses include any and all described herein. Both modes of increasing infectivity can be employed together. These methods also can be used and combined with other methods for increasing infectivity as well as for use with viruses that are modified to have increased infectivity, such as, but not limited to, vaccinia viruses, such as vaccinia viruses with modified to increase the production of extracellular enveloped virus (EEV) forms. These include vaccinia virus in which the A34R polypeptide is modified, such as with the mutation K151E (see, U.S. Patent No. 8,329,164, which describes vaccinia viruses with increased infectivity by virtue of modification of the virus). Provided are uses of anti-complement molecules, such as antibodies, for increasing infectivity of oncolytic viruses. Anti-C5 antibodies, are used to increase the infectivity of oncolytic viruses, such as vaccinia viruses. Composition and combinations and kits containing the antibodies and viruses also are provided. In particular, provided are methods and uses of an anti-complement component 5 (C5) antibody for increasing infectivity of an oncolytic virus. Anti-C5 antibodies, include, for example, eculizumab, pexelizumab, TSA12/22 or MB12/122, and variants thereof that bind to C5. The antibodies for all methods and uses provided herein can be full-length antibodies or binding fragments thereof, such as Fabs and single chain antibodies. The antibodies and oncolytic virus can be provided in separate compositions or in a single composition. The antibodies increase the effectiveness of the oncolytic virus, such as by increasing the infectivity of the virus. Infectivity can be assessed by any suitable method, including measuring titer of the virus in a body fluid, such as blood or serum. The antibody and virus can be administered separately, in the same composition, sequentially or intermittently or in any suitable regimen. The antibody can be administered before the virus is administered or intermittently therewith or after the virus is ad ministered. The oncolytic virus can be pretreated with a lipid emulsion containing a biocompatible lipid that is comprised of fatty acids and/or fatty acid derivatives. The lipid emulsion is as described herein and comprises a biocompatible lipid that is comprised of fatty acids and/or fatty acid derivatives, wherein the composition is an emulsion. Also provided are the compositions containing an oncolytic virus; and an anti-complement component 5 (C5) antibody, such as, but not limited to, eculizumab, pexelizumab, TSA12/22 or MB12/122, and variants thereof that bind to C5 and antigen binding fragments thereof. The composition containing the antibody and the virus can also include the biocompatible lipid component that is comprised of fatty acids and/or fatty acid derivatives In general any therapeutic virus can be used in methods, uses, compositions and combinations provided herein. These include oncolytic viruses, and their use for treatment of tumors, as well as diagnosis and monitoring treatment. The viruses include any described herein, including, but not limited to, the LIVP strains of vaccinia virus described herein and known to those of skill in the art. such as other strains of vaccinia virus, herpes simplex viruses, oncolytic adenoviruses, measles virus, reoviruses and others. Provided are compositions that contain therapeutic viruses, particularly therapeutic oncolytic viruses, and methods of treatment by administering or using the compositions. The compositions, which contain a biocompatible lipid and/or lipid-treated virus, typically are emulsions. The compositions and/or methods provide the viruses whereby the infectivity of the virus is increased. It is increased such by virtue of increased half-life and/or changes to the virus that protect it from the immune system or enhance interaction and/or uptake by target cells, such as cells that are the target of therapy with therapeutic oncolytic viruses. Target cells include, but are not limited to, tumor cells, circulating tumor cells, metastasizing tumor cells, cells in wounded or inflamed tissue.
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