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(12) United States Patent (10) Patent No.: US 9.498,544 B2 Ennis Et Al

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(12) United States Patent (10) Patent No.: US 9.498,544 B2 Ennis Et Al USOO949854.4B2 (12) United States Patent (10) Patent No.: US 9.498,544 B2 Ennis et al. (45) Date of Patent: Nov. 22, 2016 (54) GENETICALLY MODIFIED HUMAN (56) References Cited UMIBILICAL CORD PERVASCULAR CELLS FOR PROPHYLAXIS AGAINST OR U.S. PATENT DOCUMENTS TREATMENT OF BIOLOGICAL, OR 5,158,867 A 10/1992 McNally et al. CHEMICAL AGENTS 5,919,702 A 7/1999 Purchio et al. 6,132,724 A 10/2000 Blum (71) Applicant: Tissue Regeneration Therapeutics 7,122,178 B1 10/2006 Simmons et al. 7,547,546 B2 6/2009 Davies et al. Inc., Toronto (CA) 2003.0161818 A1 8, 2003 Weiss et al. 2004/O136967 A1 7/2004 Weiss et al. 2004/O137612 A1 7/2004 Baksh et al. (72) Inventors: Jane Elizabeth Ennis, Oakville (CA); 2005/OO 19911 A1 1/2005 Gronthos et al. Jeffrey Donald Turner, 2005, 0148074 A1 7/2005 Davies et al. Chute-a-Blondeau (CA); John Edward 2005/O158289 A1 7/2005 Simmons et al. Davies, Toronto (CA) 2005/0281790 A1 12/2005 Simmons et al. 2006, OOO8452 A1 1/2006 Simmons et al. 2006, O193840 A1 8, 2006 Gronthos et al. (73) Assignee: Tissue Regeneration Therapeutics 2006, O199263 A1 9/2006 Auger et al. Inc., Toronto (CA) 2006/0286O77 A1 12/2006 Gronthos et al. 2007/0134205 A1 6/2007 Rosenberg 2008.0020459 A1 1/2008 Baksh et al. (*) Notice: Subject to any disclaimer, the term of this 2008.0113434 A1 5/2008 Davies et al. patent is extended or adjusted under 35 2009/0047277 A1 2/2009 Reed et al. U.S.C. 154(b) by 0 days. 2009,0269318 A1 10/2009 Davies et al. 2009/0275127 A1 11/2009 Ennis et al. 2009,0285842 A1 11/2009 Davies et al. (21) Appl. No.: 14/657,102 FOREIGN PATENT DOCUMENTS (22) Filed: Mar. 13, 2015 WO WO-01 (11011 A2 2, 2001 WO WO-02/086.104 A1 10, 2002 (65) Prior Publication Data WO WO-2004/072273 A1 8, 2004 WO WO-2004/094599 A2 11/2004 US 2015/O182636 A1 Jul. 2, 2015 WO WO-2005/001076 A2 1, 2005 WO WO-2005/027633 A2 3, 2005 WO WO-2005/038O12 A2 4/2005 WO WO-2005/085428 A1 9, 2005 Related U.S. Application Data WO WO-2006/OO2627 A2 1, 2006 WO WO-2006/O12404 A2 2, 2006 (63) Continuation of application No. 12/988,909, filed as WO WO-2006/O19357 A1 2, 2006 application No. PCT/CA2009/000528 on Apr. 20, WO WO-2007/071048 A1 6, 2007 2009, now Pat. No. 9,005,599. WO WO-2007/099534 A2 9, 2007 (60) Provisional application No. 61/046,630, filed on Apr. WO WO-2007/128115 A1 11, 2007 21, 2008. OTHER PUBLICATIONS (51) Int. Cl. Hu et al. (Vaccine 25, 2007: published online Jan. 22, 2007 A6 IK 4.8/00 (2006.01) 3210-3214).* CI2N 5/073 (2010.01) Aggarwal et al., “Human mesenchymal stem cells modulate C07K 6/10 (2006.01) allogeneic immune cell responses.” Blood 105(4): 1815-1822 A6 IK 35/44 (2015.01) (2005). A6 IK 39/2 (2006.01) Aubin, “Bone stem cells,” J Cell Biochem Suppl. 30-31:73-82 C07K I4/56 (2006.01) (1998). CI2N 5/0775 (2010.01) (Continued) A61 K 35/12 (2015.01) A61 K 39/00 (2006.01) (52) U.S. Cl. Primary Examiner — Scott Long CPC ........... A61K 48/0008 (2013.01); A61K 35/44 (74) Attorney, Agent, or Firm — Clark & Elbing LLP (2013.01); A61K 39/12 (2013.01); C07K 14/56 (2013.01); C07K 16/1081 (2013.01); C12N 5/0605 (2013.01); C12N 5/0668 (2013.01); (57) ABSTRACT A61 K 2035/124 (2013.01); A6 IK 2039/505 The invention provides methods of preventing or treating (2013.01); A61 K 2039/5156 (2013.01); C07K diseases or disorders caused by biological agents or chemi 2317/14 (2013.01); C12N 2510/00 (2013.01); cal agents in a subject (e.g., a mammal. Such as a human) by CI2N 2760/14134 (2013.01); C12N administering genetically modified human umbilical cord 2770/36134 (2013.01) perivascular cells. (58) Field of Classification Search CPC ....... A61K 48/00; C12N 5/073; C07K 16/10 See application file for complete search history. 20 Claims, No Drawings US 9.498.544 B2 Page 2 (56) References Cited Geyer et al., “Plant-derived human butyrylcholinesterase, but not an organophosphorous-compound hydrolyzing variant thereof, pro tects rodents against nerve agents.” Proc Natl Acad Sci U S A. OTHER PUBLICATIONS 107(47):20251-6 (2010). Gronthos et al., “Postnatal human dental pulp stem cells (DPSCs) in Baksh et al., "Comparison of proliferative and multilineage differ vitro and in vivo,” Proc. Natl. Acad. Sci. USA97(25): 13625-13630 entiation potential of human mesenchymal stem cells derived from (2000). umbilical cord and bone marrow,” Stem Cells. 25(6): 1384-1392 Hamada et al., “Mesenchymal stem cells (MSC) as therapeutic (2007). cytoreagents for gene therapy,” Cancer Sci. 96(3):149-156 (2005). 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Ilyushin et al., “Recombinant human butyrylcholinesterase as a Can et al., “Concise Review: Human Umbilical Cord Stroma with new-age bioscavenger drug: development of the expression sys Regard to the Source of Fetus-Derived Stem Cells,” Stem Cells tem.” Acta Naturae. 5(1):73-84 (2013). 25:2886-2895 (2007). International Preliminary Report on Patentability and Written Opin Canfield et al., “Osteogenic Potential of Vascular Pericytes' Bone ion of the International Searching Authority for International Appli Engineering, JE Davies, Toronto, EM Squared 143-151 (2000). cation No. PCT/CA2006/002092 issued Jun. 24, 2008 (7 pages). Capasso et al., “The evolution of adenoviral vectors through genetic International Preliminary Report on Patentability and Written Opin and chemical surface modifications,” Viruses. 6(2): 832-55 (2014). ion of the International Searching Authority for International Appli Caplan, "Mesenchymal Stem Cells,” J. Orthop. 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Chilukuri et al., “Adenovirus-transduced human International Search Report for International Application No. PCT/ butyrylcholinesterase in mouse blood functions as a bioscavenger of CA2009/000528 mailed Jul. 28, 2009 (5 pages). chemical warfare nerve agents.” Mol Pharmacol. 76(3):612-7 Karahuseyinoglu et al., “Functional structure of adipocytes differ (2009). entiated from human umbilical cord stroma-derived stem cells,” Chilukuri et al., “Polyethylene glycosylation prolongs the circula Stem Cells. 26(3):682-691 (2008). tory stability of recombinant human butyrylcholinesterase.” Chem Kogler et al., “A new human Somatic stem cell from placental cord Biol Interact. 157-8:115-21 (2005). blood with intrinsic pluripotent differentiation potential.” J Exp Conget and Minguell, “Phenotypical and Functional Properties of Med. 200(2): 123-135 (2004). Human Bone Marrow Mesenchymal Progenitor Cells,” J. Cell Kronman et al., "Hierarchy of post-translational modifications Physiol. 181:67-73 (1999). involved in the circulatory longevity of glycoproteins. Demonstra Corcione et al., “Human Mesenchymal StemCells Modulate B-Cell tion of concerted contributions of glycan sialylation and Subunit Functions.” Blood 107:367-372 (2006). assembly to the pharmacokinetic behavior of bovine Di Nicola et al., “Human bone marrow stromal cells suppress acetylcholinesterase.” J Biol Chem. 275(38): 29488-502 (2000). T-lymphocyte proliferation induced by cellular or nonspecific Kulkarni et al., “Absence of Wharton's jelly around the umbilical mitogenic stimuli.” Blood. 99(10):3838-3843 (2002). arteries.” Indian J Pediatr. 74(8):787-89 (2007). Djouad et al., “Immunosuppressive Effect of Mesenchymal Stem Li et al., “High-level expression of functional recombinant human Cells Favors Tumor Growth in Allogenic Animals.” Blood butyrylcholinesterase in silkworm larvae by Bac-to-Bac system.” 102:3837-3844 (2003).
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