Patent SG-11201901979S-A (SG)
Title: Immunogenic compositions targeting recurrent cancer mutations and methods of use thereof
Inventor: BALLI DAVID
IPC: C12N15/74
Filed: 2017-11-30
Abstract: E E 1500 E 2 1000 0 E (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 07 June 2018 (07.06.2018) WIP0 I PCT D IV °nolo Em mourn° oimIE (10) International Publication Number WO 2018/102584 Al (51) International Patent Classification: C12N 15/74 (2006.01) A61K 39/00 (2006.01) C07K 14/47 (2006.01) A61K 48/00 (2006.01) A61K 35/74 (2006.01) (21) International Application Number: PCT/US2017/064015 (22) International Filing Date: 30 November 2017 (30.11.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/428,515 30 November 2016 (30.11.2016) US 62/443,483 06 January 2017 (06.01.2017) US 62/583,292 08 November 2017 (08.11.2017) US (71) Applicant: ADVAXIS, INC. [US/US]; 305 College Road East, Princeton, New Jersey 08540 (US). (72) Inventors; and (71) Applicants: PETIT, Robert [US/US]; 149 Parsons Lane, Newtown, Pennsylvania 18940 (US). PRINCIOTTA, Michael F. [US/US]; 222 Mercer Street, Hightstown, New Jersey 08520 (US). CODER, Brandon [US/US]; 71 Clark Street, #401, Trenton, New Jersey 08611 (US). BALLI, David [US/US]; 301 Washington Street, Apt. 1328, Con- shohocken, Pennsylvania 19428 (US). (74) Agent: SCHILLING, Stephen H. et al.; Alston & Bird LLP, Bank of America Plaza, 101 South Tryon Street, Suite 4000, Charlotte, North Carolina 28280-4000 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, (54) Title: IMMUNOGENIC COMPOSITIONS TARGETING RECURRENT CANCER MUTATIONS AND METHODS OF USE THEREOF - e- PBS LmddA-274 - KRAS_G12D_Kd_minigene KRAS_G12D_Dd_minigene - KRAS_G12D 21mer 11 14 17 22 26 29 33 36 Day FIG. 1 (57) : Provided herein are recombinant fusion polypeptides comprising one or more antigenic peptides (e.g., fused to a PEST- containing peptide) from cancer-associated proteins. The antigenic peptides can comprise one or more or all of an antigenic peptide comprising a recurrent cancer mutation, an antigenic peptide comprising a heteroclitic mutation, or an antigenic peptide fused to a ubiquitin protein. For example, provided herein are recombinant fusion polypeptides comprising two or more antigenic peptides (e.g., fused to a PEST-containing peptide), wherein each antigenic peptide comprises a recurrent cancer mutation, and wherein at least two of the antigenic peptides are fragments of the same cancer-associated protein. Also provided are nucleic acids encoding such fusion polypeptides, recombinant bacteria or Listeria strains comprising such fusion polypeptides or such nucleic acids, and cell banks com- prising such recombinant bacteria or Listeria strains. Also provided herein are methods of generating such fusion polypeptides, such nucleic acids, and such recombinant bacteria or Listeria strains. Also provided are immunogenic compositions, pharmaceutical com- positions, and vaccines comprising such fusion polypeptides, such nucleic acids, or such recombinant bacteria or Listeria strains. Also provided are methods of inducing an anti-tumor-associated-antigen immune response in a subject, methods of inducing an anti-tumor [Continued on next page] WO 2018/102584 Al MIDEDIM01101 DIV IIMEN301011111111111011111111111111110111111111111 CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, 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. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, 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, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: as to the identity of the inventor (Rule 4.17(0) of inventorship (Rule 4.17(iv)) Published: with international search report (Art. 21(3)) before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) with sequence listing part of description (Rule 5.2(a)) or anti-cancer immune response in a subject, methods of treating a tumor or cancer in a subject, methods of preventing a tumor or cancer in a subject, and methods of protecting a subject against a tumor or cancer using such recombinant fusion polypeptides, nucleic acids, recombinant bacteria or Listeria strains, immunogenic compositions, pharmaceutical compositions, or vaccines.