IL302098A - Composition and method for treating cancer using a vaccine as a first therapueutic active ingredient in combination with a second active ingredient - Google Patents

Composition and method for treating cancer using a vaccine as a first therapueutic active ingredient in combination with a second active ingredient

Info

Publication number
IL302098A
IL302098A IL302098A IL30209823A IL302098A IL 302098 A IL302098 A IL 302098A IL 302098 A IL302098 A IL 302098A IL 30209823 A IL30209823 A IL 30209823A IL 302098 A IL302098 A IL 302098A
Authority
IL
Israel
Prior art keywords
vaccine
hpv
inhibitor
composition
immune
Prior art date
Application number
IL302098A
Other languages
Hebrew (he)
Inventor
Tim Ioannides
Evangelos V Badiavas
Original Assignee
Hpvvax Llc
Tim Ioannides
Evangelos V Badiavas
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US17/068,087 external-priority patent/US11813329B2/en
Application filed by Hpvvax Llc, Tim Ioannides, Evangelos V Badiavas filed Critical Hpvvax Llc
Publication of IL302098A publication Critical patent/IL302098A/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14Blood; Artificial blood
    • A61K35/17Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/193Colony stimulating factors [CSF]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/20Interleukins [IL]
    • A61K38/208IL-12
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/20Interleukins [IL]
    • A61K38/2086IL-13 to IL-16
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • A61K38/212IFN-alpha
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55522Cytokines; Lymphokines; Interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/80Vaccine for a specifically defined cancer
    • A61K2039/876Skin, melanoma
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011Details
    • C12N2710/20011Papillomaviridae
    • C12N2710/20034Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Virology (AREA)
  • Cell Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (31)

1. A method for treating a patient having skin cancer, cancerous tumor, or cancerous lesion, said method comprising administering to the patient, an HPV vaccine which is free of host-cell peptide, polypeptide, or protein or a degradant product thereof in combination with a second active ingredient which is an immune-based therapeutic selected from an Immune Checkpoint Inhibitor, CAR T-cells, N-acetyl cysteine, or mRNA encoding a cytokine.
2. The method of claim 1 wherein the Immune Checkpoint Inhibitor is selected from the group consisting of a Programed Death 1 inhibitor, a Programed Death Ligand inhibitor, and a Cytotoxic T-lymphocyte-Associated Protein 4 inhibitor.
3. The method of claim 2 wherein the Programed Death 1 inhibitor or Programed Death Ligand inhibitor is Cemiplimab, Atezolizumab, Avelumab, Bavencio, Durvalumab, Imfinzi, Keytruda, Nivolumab, Opdivo, Pembrolizumab, or Tecentriq.
4. The method of claim 1 wherein the CAR T-cells are bispecific antibodies or monoclonal antibodies.
5. The method of claim 4 wherein the bispecific antibodies are Catumaxomab.
6. The method of claim 4 wherein the monoclonal antibodies are Campath, Brutuximab, Vismodigib, Vemurafenib, Dabrfenib,or ecorafenib.
7. The method of claim 6 wherein the N-acetyl cysteine administered orally from 600-1200 mg per day.
8. The method of claim 1 wherein the cytokine encoded by mRNA is selected from interleukin, interferon, or granulocyte-macrophage colony-stimulating factor.
9. The method of claim 8 wherein the interleukin is IL-12 or IL-15.
10. The method of claim 8 wherein the interferon is IFN-α
11. The method of claim 1 wherein the HPV vaccine is selected from the group consisting of HPV quadrivalent (types 6, 11, 16, and 18) recombinant vaccine comprising HPV L1 proteins and HPV multivalent (types 16, 18, 31, 33, 45, 52, and 58) recombinant vaccine comprising HPV L1 proteins.
12. The method of claim 1 wherein the vaccine is substantially free of host-cell early antigen, E6 or E7.
13. The method of claim 1 wherein the skin cancer, cancerous tumor, or cancerous lesion is substantially reduced in size or eliminated.
14. The method of claim 1 wherein an effective dose of HPV vaccine is 0.5 ml.
15. The method of claim 1 wherein the cancer or cancerous lesion is selected from the group consisting of squamous cell carcinoma, basal cell carcinoma, melanoma, glandular tumor, and adenoma.
16. The method of claim 1, wherein the patient is 27 years of age or older or is previously not immunized with an HPV vaccine.
17. The method of claim 1 wherein the method further comprises: establishing a positive diagnosis of skin cancer, diagnosis of benign or cancerous tumor, or diagnosis of HPV infection, prior to administering the first dose of HPV vaccine.
18. The method of claim 1, said method comprising administering a dose of an HPV vaccine or immune-based therapeutic directly to a tumor or skin cancer lesion or an area immediately surrounding the tumor, or skin cancer lesion.
19. The method of claim 1 wherein the vaccine or immune-based therapeutic is administered by injection.
20. The method of claim 1 wherein the method comprises administering an immunomodulatory agent or adjuvant to the patient.
21. The method of claim 1 wherein the vaccine and immune-based therapeutic are administered to the patient in a fixed-dose combination product.
22. The method of claim 1, wherein the patient is administered a second dose of vaccine and immune-based therapeutic at least one month following the first administration, and optionally is administered a third dose of vaccine and immune-based therapeutic at least one month following the second administration.
23. A pharmaceutical composition comprising: at least one purified viral L1 protein or fragment thereof; a second active pharmaceutical ingredient which is an immune-based therapeutic selected from an Immune Checkpoint Inhibitor, CAR T-cells and mRNA encoding cytokine; and a pharmaceutically-acceptable carrier.
24. The composition of claim 23 wherein the Immune Checkpoint Inhibitor is selected from the group consisting of a Programed Death 1 inhibitor, a Programed Death Ligand inhibitor, and a Cytotoxic T-lymphocyte-Associated Protein 4 inhibitor.
25. The composition of claim 24 wherein the Programed Death 1 inhibitor or Programed Death Ligand inhibitor is Cemiplimab, Atezolizumab, Avelumab, Bavencio, Durvalumab, Imfinzi, Keytruda, Nivolumab, Opdivo, Pembrolizumab, or Tecentriq.
26. The composition of claim 23 wherein the CAR T-cells are bispecific antibodies which is Catumaxomab or monoclonal antibodies Campath, Brutuximab, Vismodigib, Vemurafenib, Dabrfenib,or ecorafenib.
27. The composition of claim 23 wherein the cytokine encoded by the mRNA is selected from interleukin, interferon, or granulocyte-macrophage colony-stimulating factor.
28. The composition of claim 27 wherein the interleukin is IL-12 or IL-15.
29. The composition of claim 27 wherein the interferon is IFN-α.
30. The composition of claim 23 wherein the HPV vaccine is selected from the group consisting of HPV quadrivalent (types 6, 11, 16, and 18) recombinant vaccine comprising HPV L1 proteins and HPV multivalent (types 16, 18, 31, 33, 45, 52, and 58) recombinant vaccine comprising HPV L1 proteins.
31. The composition of claim 23 wherein the vaccine is substantially free of host-cell early antigen, E6 or E7.
IL302098A 2020-10-12 2021-10-12 Composition and method for treating cancer using a vaccine as a first therapueutic active ingredient in combination with a second active ingredient IL302098A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17/068,087 US11813329B2 (en) 2014-10-24 2020-10-12 Method and composition for treating cancer or skin lesion using a vaccine
PCT/US2021/054622 WO2022081604A1 (en) 2020-10-12 2021-10-12 Composition and method for treating cancer using a vaccine as a first therapueutic active ingredient in combination with a second active ingredient

Publications (1)

Publication Number Publication Date
IL302098A true IL302098A (en) 2023-06-01

Family

ID=81208565

Family Applications (1)

Application Number Title Priority Date Filing Date
IL302098A IL302098A (en) 2020-10-12 2021-10-12 Composition and method for treating cancer using a vaccine as a first therapueutic active ingredient in combination with a second active ingredient

Country Status (16)

Country Link
EP (1) EP4225351A1 (en)
JP (1) JP2023546073A (en)
KR (1) KR20230117106A (en)
AU (1) AU2021360676A1 (en)
CA (1) CA3195478A1 (en)
CO (1) CO2023006083A2 (en)
CY (1) CY20232200001T2 (en)
DE (1) DE21880926T1 (en)
DK (1) DK4225351T1 (en)
ES (1) ES2962700T1 (en)
FI (1) FI4225351T1 (en)
HU (1) HUE21880926T1 (en)
IL (1) IL302098A (en)
MX (1) MX2023004285A (en)
PL (1) PL4225351T1 (en)
WO (1) WO2022081604A1 (en)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10162480A1 (en) * 2001-12-19 2003-08-07 Ingmar Hoerr The application of mRNA for use as a therapeutic agent against tumor diseases
US9504657B2 (en) * 2012-01-12 2016-11-29 Pharmatwob Ltd. Fixed dose combination therapy of Parkinson's disease
CA2871774C (en) * 2012-04-26 2021-05-18 Sentient Lifesciences, Inc. Use of n-acetylcysteine amide in the treatment of disease and injury
US10799574B2 (en) * 2014-10-24 2020-10-13 Hpvvax. Llc Method and composition for treating cancer or skin lesion using a vaccine
CA3019149A1 (en) * 2016-04-01 2017-10-05 Kite Pharma, Inc. Chimeric antigen and t cell receptors and methods of use
CA3020330A1 (en) * 2016-04-07 2017-10-12 Bluebird Bio, Inc. Chimeric antigen receptor t cell compositions

Also Published As

Publication number Publication date
JP2023546073A (en) 2023-11-01
MX2023004285A (en) 2023-06-19
AU2021360676A1 (en) 2023-06-15
WO2022081604A1 (en) 2022-04-21
CY20232200001T2 (en) 2024-02-16
PL4225351T1 (en) 2023-12-11
CO2023006083A2 (en) 2023-08-18
KR20230117106A (en) 2023-08-07
CA3195478A1 (en) 2022-04-21
HUE21880926T1 (en) 2024-04-28
EP4225351A1 (en) 2023-08-16
DK4225351T1 (en) 2023-10-23
ES2962700T1 (en) 2024-03-20
DE21880926T1 (en) 2024-01-11
FI4225351T1 (en) 2023-10-20

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