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(12) United States Patent (10) Patent No.: US 9,539,217 B2 Sosin Et Al

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(12) United States Patent (10) Patent No.: US 9,539,217 B2 Sosin Et Al USO09539217B2 (12) United States Patent (10) Patent No.: US 9,539,217 B2 Sosin et al. (45) Date of Patent: Jan. 10, 2017 (54) NANOPARTICLE COMPOSITIONS (56) References Cited (71) Applicant: ALLERTEIN THERAPEUTICS, U.S. PATENT DOCUMENTS LLC, Fairfield, CT (US) 3,977,794. A 8/1976 Liedholz 4,191,743 A 3, 1980 Klemm et al. (72) Inventors: Howard Sosin, Southport, CT (US); 4,270,537 A 6, 1981 Romaine Michael Caplan, Woodbridge, CT 4,316,885. A 2f1982 Rakhit (US); Tarek Fahmy, Fairfield, CT (US) 4,384,996 A 5/1983 Bollinger et al. 4,596,556 A 6, 1986 Morrow et al. (73) Assignee: Allertein Therapeutics, LLC, Fairfield, SS s 38. Stet al. CT (US) 4,790,824. A 12/1988 Morrow et al. 4,798,823. A 1, 1989 Witzel (*) Notice: Subject to any disclaimer, the term of this 4,886,499 A 12/1989 Cirelli et al. patent is extended or adjusted under 35 is: A 3. thatara et al.al U.S.C. 154(b) by 0 days. 4.940,460 A 7/1990 Casey et al. 4.941,880 A 7, 1990 Burns (21) Appl. No.: 14/782.285 4.956,352. A 9/1990 Okuhara et al. 5,008, 110 A 4, 1991 Benecke et al. 22) PCT Fed: Apr.p 3, 2014 5,015,235 A 5/1991 Crossman 5,064,413 A 11/1991 McKinnon et al. (86). PCT No.: PCT/US2O14/O32838 (Continued) S 371 (c)(1), FOREIGN PATENT DOCUMENTS (2) Date: Oct. 2, 2015 EP 1752151 A1 2, 2007 (87) PCT Pub. No.: WO2014/165679 WO WO-92,051.79 A1 4f1992 PCT Pub. Date: Oct. 9, 2014 (Continued) (65) Prior Publication Data OTHER PUBLICATIONS US 2016/O113881 A1 Apr. 28, 2016 Aguado et al., Controlled release vaccines biodegradable polylactide/polyglycolide (PL/PG) microspheres as antigen vehicles, Immunobiology, 184(2-3): 113-25 (1992). Related U.S. Application Data Anderson and Shive, et al., Biodegradation and biocompatibility of PLA and PLGA microspheres, Adv Drug Deliv Rev. 28(1):5-24 (60) Provisional application No. 61/808,118, filed on Apr. (1997). 3, 2013. Apostolopoulos, V. et al., Structural implications for the design of molecular vaccines, Curr. Opin. Mol. Ther. 2(1): 29-36 (2000). (51) Int. Cl. Aziz et al., Oral Vaccines: New Needs, New Possibilities, BioEs A6 IK 9/14 (2006.01) BlanchetteR R. et Ea.al., Cellular evaluation offoral oral chemotherapychemoth carriers, A6 IK 9/16 (2006.01) J. Biomed. Mater. Res. A., 72(4): 381-388 (2005). A 6LX 9/50 (2006.01) B1anchette et al., Oral chemotherapeutic delivery: designas and cel A 6LX 39/35 (2006.01) lular response, Ann. Biomed. Eng., 33(2): 142-149 (2005). A 6LX 9/5 (2006.01) (Continued) A6 IK 39/02 (2006.01) A6 IK 39/45 (2006.01) Primary Examiner — Robert A Wax A 6LX 39/39 (2006.01) Assistant Examiner — Quanglong Truong CI2N 7/00 (2006.01) (74) Attorney, Agent, or Firm — Brenda Herschbach A61 K 39/00 (2006.01) Jarrell; Brian E. Reese; Choate, Hall & Stewart LLP (52) U.S. Cl. CPC ........... A6IK 9/5031 (2013.01); A61K 9/5153 (57) ABSTRACT (2013.01); A61K 39/025 (2013.01); A61 K The present invention provides, among other things, nano 39/145 (2013.01); A61K 39/35 (2013.01); particle compositions including a plurality of nanoparticles, A61K 39/39 (2013.01): CI2N 7/00 (2013.01); each of which is comprised of a biodegradable O biocom A61K 2039/5258 (2013.01); A61 K 2039/54 patible polymer arranged in a nanoparticle structure defining (2013.01); A6 IK 2039/542 (2013.01); A61 K an internal lumen and an external Surface and one or more 2039/545 (2013.01); A61 K 2039/555 II of a preparation of hydrophilic cellular components and a (2013.01); A61 K 2039/55516 (2013.01); A61 K preparation of hydrophobic cellular components. In some 2039/55555 (2013.01); A61 K 2039/55561 embodiments, the preparation of hydrophilic cellular com (2013.01); A61 K 2039/55566 (2013.01); A61 K ponents is encapsulated within the internal lumen and the 2039/57 (2013.01); C12N 2760/16034 preparation of hydrophobic cellular components is associ s (2013.01) ated with the external surface. Various methods of making (58) Field of Classification Search and using disclosed nanoparticle compositions are also None provided. See application file for complete search history. 20 Claims, 29 Drawing Sheets US 9,539,217 B2 Page 2 (56) References Cited 7.534449 B2 5/2009 Saltzman et al. 7.550,154 B2 6/2009 Saltzman et al. U.S. PATENT DOCUMENTS 8,802.375 B2 8/2014 Sampson et al. 8,815,251 B2 8/2014 Caplan et al. 5,100,883. 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