CA2473135A1 - Stabilised mrna tumour vaccine - Google Patents

Stabilised mrna tumour vaccine Download PDF

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Publication number
CA2473135A1
CA2473135A1 CA002473135A CA2473135A CA2473135A1 CA 2473135 A1 CA2473135 A1 CA 2473135A1 CA 002473135 A CA002473135 A CA 002473135A CA 2473135 A CA2473135 A CA 2473135A CA 2473135 A1 CA2473135 A1 CA 2473135A1
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Prior art keywords
pharmaceutical composition
tumour
composition according
mrna
cdna library
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Granted
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CA002473135A
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French (fr)
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CA2473135C (en
Inventor
Ingmar Hoerr
Florian Von Der Mulbe
Steve Pascolo
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Curevac SE
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Individual
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Expired - Fee Related legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/0005—Vertebrate antigens
    • A61K39/0011—Cancer antigens
    • A61K39/001102—Receptors, cell surface antigens or cell surface determinants
    • A61K39/001129—Molecules with a "CD" designation not provided for elsewhere
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/193—Colony stimulating factors [CSF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/53—DNA (RNA) vaccination
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55522—Cytokines; Lymphokines; Interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/572—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 cytotoxic response
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/70—Multivalent vaccine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Oncology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

The present invention relates to a pharmaceutical composition comprising at least one mRNA comprising at least one coding region for at least one antigen from a tumour, in combination with an aqueous solvent and preferably a cytokine, e.g. GM-CSF, and a process for the preparation of the pharmaceutical composition. The pharmaceutical composition according to the invention is used in particular for therapy and/or prophylaxis against cancer.

Claims (7)

1 claims 1. Pharmaceutical composition comprising at least one mRNA comprising at least one coding region for at least one antigen from a tumour, wherein the mRNA of at least one contains at least one analogue of nucleotides which actually occur, in combination with an aqueous solvent.
2. Pharmaceutical composition according to claim 1, wherein the coding region for the antigen(s) from a tumour and/or the 5' and/or the 3' untranslated region of the mRNA is modified compared with the wild-type mRNA, wherein the modification(s) stabilize(s) the mRNA.
3. Pharmaceutical composition according to claim 2, wherein the modification(s) has/have an effect on the translation efficiency of the mRNA.
4. Pharmaceutical composition according to one of claims 1 to 3, wherein the analogue is chosen from the group consisting of phosphorothioates, phosphoroamidates, peptide nucleotides, methylphosphonates, 7-deazaguanosine, 5-methylcytosine and inosine.
5. Pharmaceutical composition according to one of claims 1 to 4, wherein the mRNA
has a 5'-cap structure and/or a poly(A+) tail of at least about 25 nucleotides and/or at least one IRES and/or at least one 5'-stabilizing sequence and/or at least one 3'-stabilizing sequence.
6. Pharmaceutical composition according to claim 5, wherein the 5'- and/or the 3'-stabilizing sequence(s) is/are chosen from the group consisting of untranslated sequences (UTR) of the .beta.-globin gene and a stabilizing sequence of the general formula (C/U)CCAN x CCC(U/A)Py x UC(C/U)CC.
7. Pharmaceutical composition according to one of claims 1 to 6, wherein the antigen(s) from a tumour is/are a polyepitope of antigens from a tumour.

17. Pharmaceutical composition according to one of claims 1 to 16, which comprises a plurality of mRNA molecules which represent a cDNA library, or a part thereof, of a tumour tissue.
18. Pharmaceutical composition according to claim 17, wherein the part of the cDNA
library codes for the tumour-specific antigens.
19. Pharmaceutical composition according to one of claims 1 to 18, wherein the antigen(s) from a tumour is/are chosen from the group consisting of 707-AP, AFP, ART-4, BAGE, .beta.-catenin/m, Bcr-abl, CAMEL, CAP-1, CASP-8, CDC27/m, CDK4/m, CEA, CT, Cyp-B, DAM, ELF2M, ETV6-AML1, G250, GAGE, GnT-V, Gp100, HAGE, HER-2/neu, HLA-A*0201-R1701, HPV-E7, HSP70-2M, HAST-2, hTERT (or hTRT), iCE, KIAA0205, LAGE, LDLR/FUT, MAGE, MART-1/melan-A, MC1R, myosin/m, MUC1, MUM-1, -2, -3, NA88-A, NY-ESO-1, p190 minor bcr-abl, Pml/RAR.alpha., PRAME, PSA, PSM, RAGE, RU1 or RU2, SAGE, SART-1 or SART-3, TEL/AML1, TPI/m, TRP-1, TRP-2, TRP-2/INT2 and WT1.
20. Pharmaceutical composition according to one of claims 1 to 19, comprising at least one further pharmaceutically acceptable carrier and/or at least one further pharmaceutically acceptable vehicle.
21. Pharmaceutical composition according to one of claims 1 to 20, for therapy and/or prophylaxis of cancer.
22. Process for the preparation of a pharmaceutical composition according to one of claims 1 to 21, comprising the steps:
(a) preparation of a cDNA library, or a part thereof, from tumour tissue of a patient, (b) preparation of a matrix for in vitro transcription of RNA with the aid of the cDNA library or a part thereof and (c) in vivo transcribing of the matrix.
23. Process according to claim 22, wherein the part of the cDNA library of the tumour tissue codes for the tumour-specific antigens.

24. Process according to claim 23, in which the sequences of the tumour-specific antigens are determined before step (a).

25. Process according to claim 24, wherein the determination of the sequences of the tumour-specific antigens comprises an alignment with a cDNA library from healthy tissue.

26. Process according to claim 24 or 25, wherein the determination of the sequences of the tumour-specific antigens comprises a diagnosis by a microarray.
CA2473135A 2001-12-19 2002-12-19 Stabilised mrna tumour vaccine Expired - Fee Related CA2473135C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10162480A DE10162480A1 (en) 2001-12-19 2001-12-19 The application of mRNA for use as a therapeutic agent against tumor diseases
DE10162480.8 2001-12-19
PCT/EP2002/014577 WO2003051401A2 (en) 2001-12-19 2002-12-19 Stabilised mrna tumour vaccine

Publications (2)

Publication Number Publication Date
CA2473135A1 true CA2473135A1 (en) 2003-06-26
CA2473135C CA2473135C (en) 2012-05-08

Family

ID=7709862

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2473135A Expired - Fee Related CA2473135C (en) 2001-12-19 2002-12-19 Stabilised mrna tumour vaccine

Country Status (8)

Country Link
US (9) US8217016B2 (en)
EP (4) EP1458410B1 (en)
AT (1) ATE382712T1 (en)
AU (1) AU2002360055B2 (en)
CA (1) CA2473135C (en)
DE (2) DE10162480A1 (en)
ES (1) ES2298418T3 (en)
WO (1) WO2003051401A2 (en)

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US10188748B2 (en) 2001-06-05 2019-01-29 Curevac Ag Pharmaceutical composition containing a stabilised mRNA optimised for translation in its coding regions
US10273269B2 (en) 2017-02-16 2019-04-30 Modernatx, Inc. High potency immunogenic zika virus compositions
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