CONJUGATE FOR ANTIGEN DELIVERY AND ITS APPLICATION

RU2026105210A3Pending Publication Date: 2026-09-28LG KEM LTD

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Patent Information

Application Number: RU2026105210
Authority / Receiving Office: RU · RU
Patent Type: Applications
Current Assignee / Owner
Filing Date: 2024-07-26
Publication Date: 2026-09-28

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Claims

1. A conjugate containing mRNA of an antigenic protein; mRNA encoding the first carrier protein, attached to the 5' end of the antigen protein mRNA; and mRNA encoding a second carrier protein attached to the 3' end of the antigen protein mRNA.

2. The conjugate of claim 1, wherein the first carrier protein and the second carrier protein are the same or different and are at least one protein selected from Ub (ubiquitin), UbR (A77R ubiquitin mutant), Lamp, mODC (mouse ornithine decarboxylase), cmyc, SORT1 (sortilin 1), TRX (thioredoxin), PSBD (peripheral subunit binding domain), TRXwt-UbR, TRXwt-Lamp, TRXwt-mODC, TRXwt-cmyc, TRXwt-SORT1, SORT1 with TM and Lamp with TM, respectively.

3. The conjugate according to claim 2, wherein the first carrier protein and the second carrier protein are selected from the following combinations of proteins presented in Table 1: Table 1 CP set N-terminus (first carrier protein) C-terminus (second carrier protein) CP01 TRXmt PSBD CP11 UbR mODC CP12 UbR SORT1 CP13 Lamp mODC CP14 Lamp SORT1 CP21 UbR cmyc CP22 UbR Lamp CP23 mODC SORT1 CP24 cmyc mODC CP25 cmyc SORT1 CP26 Lamp Ub CP27 Lamp cmyc CP28 SORT1 mODC CP31 mODC Ub CP32 mODC cmyc CP33 mODC Lamp CP34 cmyc Ub CP35 cmyc Lamp CP36 SORT1 Ub CP37 SORT1 cmyc CP38 SORT1 Lamp CP41 TRXwt cmyc CP42 TRXwt Lamp CP43 TRXwt mODC CP44 TRXwt SORT1 CP45 TRXwt Ub CP46 cmyc TRXwt CP47 Lamp TRXwt CP48 mODC TRXwt CP49 SORT1 TRXwt CP50 UbR TRXwt CP112 TRXwt-UbR SORT1 CP113 TRXwt-Lamp mODC CP123 TRXwt-mODC SORT1 CP131 TRXwt-mODC Ub CP133 TRXwt-mODC Lamp CP134 TRXwt-cmyc Ub CP136 TRXwt-SORT1 Ub CP138 TRXwt-SORT1 Lamp CP201 TRXwt SORT1 with TM CP202 Lamp with TM TRXwt 4. The conjugate according to paragraph 2, where UbR comprises the amino acid sequence of SEQ ID NO: 1; Ub contains the amino acid sequence SEQ ID NO: 2; Lamp comprises the amino acid sequence of SEQ ID NO: 3 or 4; mODC comprises the amino acid sequence of SEQ ID NO: 5 or 6; cmyc comprises the amino acid sequence of SEQ ID NO: 7 or 8; SORT1 comprises the amino acid sequence of SEQ ID NO: 9 or 10; TRXwt comprises the amino acid sequence of SEQ ID NO: 11 or 12; PSBD comprises the amino acid sequence of SEQ ID NO: 13; TRXwt-UbR contains the amino acid sequence SEQ ID NO: 14; TRXwt-Lamp contains the amino acid sequence SEQ ID NO: 15; TRXwt-mODC contains the amino acid sequence of SEQ ID NO: 16; TRXwt-cmyc contains the amino acid sequence SEQ ID NO: 17; TRXwt-SORT1 contains the amino acid sequence SEQ ID NO: 18; SORT1 with TM contains the amino acid sequence SEQ ID NO: 19; Lamp with TM contains the amino acid sequence SEQ ID NO: 20 or TRXmt contains the amino acid sequence SEQ ID NO:

145.

5. The conjugate of claim 3, wherein the first carrier protein and the second carrier protein are selected from the following combinations of proteins presented in Table 22 Table 22 CP set N-terminus (first carrier protein) C-terminus (second carrier protein) CP12 UbR SORT1 CP13 Lamp mODC CP23 mODC SORT1 CP31 mODC Ub CP33 mODC Lamp CP34 cmyc Ub CP36 SORT1 Ub CP38 SORT1 Lamp CP47 Lamp TRXwt CP48 mODC TRXwt CP50 UbR TRXwt CP136 TRXwt-SORT1 Ub CP201 TRXwt SORT1 with TM CP202 Lamp with TM TRXwt 6. The conjugate of claim 2, wherein the antigenic protein comprises a T-cell epitope.

7. The conjugate of claim 6, wherein the T-cell epitope is derived from a tumor antigen, an infectious agent antigen, an autoantigen, or an allergy-causing antigen.

8. The conjugate of claim 7, wherein the tumor antigen comprises a tumor-associated antigen (TAA), a tumor-specific antigen (TSA), or a tumor-derived neoantigen.

9. The conjugate of claim 8, wherein the tumor-derived neoantigen comprises a mutation specifically expressed in a malignant cell.

10. The conjugate of claim 8, wherein the tumor-associated antigen (TAA) is mTrp2, CT (cancer-testicular) antigen, EGFR, Ova, Melan-A, PSMA (prostate-specific membrane antigen), Survivin, ADAbp (adenosine deaminase binding protein), cyclophilin b, gp100, CRC (colorectal associated antigen)-C017-1 A / GA733, CEA (carcinoembryonic antigen), CAP-1, CAP-2, etv6, AML1, PSA (prostate-specific antigen), PSA-1, PSA-2, PSA-3, MAGE (melanoma antigen E) (e.g., MAGE-A, MAGE-A3, etc.), GAGE (G antigen), BAGE (B-melanoma antigen), RAGE (renal tumor antigen), LAGE (L antigen), NAG, GnT-V, MUM-1, CDK4, p53, tyrosinase, Muc1 (mucin 1), HER2 / neu, p21ras, N-RAS, K-RAS, RCAS1, α-fetoprotein, E-cadherin, α-catenin, β-catenin, γ-catenin, p120ctn, PRAME, NY-ESO-1, TRP2, mammaglobin-A, metallopanthin-1 (MPS-1), cytochrome P450 isoform 1B1, binding protein 90K / Mac-2, Ep-CAM (MK-1), HSP-70, hTERT (TRT), LEA, TAGE-1, 5T4, gp70, SCP-1, cmyc, cyclin B1, MDM2, p62, Koc, IMP1, TA90, OA1, CT-7, HOM-MEL-40 / SSX-2, SSX-1, SSX-4, HOM-TES-14 / SCP-1, HOM-TES-85, HDAC5, MBD2, TRIP4, NY-CO-45, KNSL6, HIP1R, Seb4D, KIAA1416, IMP1, 90K / Mac-2 binding protein, MDM2 or LMNA.

11. The conjugate of claim 8, wherein the tumor-specific antigen (TSA) is M12, M20, M21, M30 or M44.

12. The conjugate of claim 7, wherein the infectious agent antigen is an antigen derived from a virus, bacterium, parasite or fungus.

13. The conjugate of any one of claims 1 to 12, wherein the conjugate has at least one carrier protein characteristic selected from the group consisting of the following (i) and (ii): (i) delivery of CD4 / CD8 via the processing and presentation pathway, respectively; and (ii) increased expression of the antigenic protein.

14. A composition for immunization comprising a conjugate according to any one of claims 1 to 12.

15. The immunization composition according to claim 14, wherein the immunization composition further comprises at least one component selected from the group consisting of antigen adjuvants, efficacy enhancers, preservatives, buffers, surfactants, carriers, osmotic agents, antioxidants and stabilizers.

16. The immunization composition according to claim 14, which is administered by at least one route selected from the group consisting of intranasal, intratracheal, oral, intradermal, intramuscular, intraperitoneal, intravenous, conjunctival and subcutaneous routes.

17. The immunization composition of claim 14, wherein the immunization composition is a composition for immunization against a malignant tumor.

18. A method of immunization against a malignant tumor, comprising administering a conjugate according to any one of claims 1 to 12 or a vaccine composition containing it to an individual.