CN115335085A - 用编码gm-csf的多核苷酸和额外药剂治疗癌症的方法 - Google Patents

用编码gm-csf的多核苷酸和额外药剂治疗癌症的方法 Download PDF

Info

Publication number
CN115335085A
CN115335085A CN202180009173.8A CN202180009173A CN115335085A CN 115335085 A CN115335085 A CN 115335085A CN 202180009173 A CN202180009173 A CN 202180009173A CN 115335085 A CN115335085 A CN 115335085A
Authority
CN
China
Prior art keywords
cancer
individual
patients
cells
dose
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN202180009173.8A
Other languages
English (en)
Chinese (zh)
Inventor
J·尼穆奈缇斯
E·博格纳尔
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Gradalis Inc
Original Assignee
Gradalis Inc
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
Application filed by Gradalis Inc filed Critical Gradalis Inc
Priority claimed from PCT/US2021/013130 external-priority patent/WO2021146213A1/en
Publication of CN115335085A publication Critical patent/CN115335085A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/0083Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the administration regime
    • 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
    • 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
    • A61K35/13Tumour cells, irrespective of tissue of origin
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/0005Vertebrate antigens
    • A61K39/0011Cancer antigens
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/0008Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition
    • A61K48/0016Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition wherein the nucleic acid is delivered as a 'naked' nucleic acid, i.e. not combined with an entity such as a cationic lipid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/005Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'active' part of the composition delivered, i.e. the nucleic acid delivered
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/005Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'active' part of the composition delivered, i.e. the nucleic acid delivered
    • A61K48/0066Manipulation of the nucleic acid to modify its expression pattern, e.g. enhance its duration of expression, achieved by the presence of particular introns in the delivered nucleic acid
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/53Colony-stimulating factor [CSF]
    • C07K14/535Granulocyte CSF; Granulocyte-macrophage CSF
    • 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
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/11DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
    • C12N15/1137Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing against enzymes
    • 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
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/515Animal cells
    • A61K2039/5152Tumor cells
    • 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
    • C12N2310/00Structure or type of the nucleic acid
    • C12N2310/10Type of nucleic acid
    • C12N2310/14Type of nucleic acid interfering nucleic acids [NA]
    • C12N2310/141MicroRNAs, miRNAs
    • 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
    • C12N2310/00Structure or type of the nucleic acid
    • C12N2310/30Chemical structure
    • C12N2310/34Spatial arrangement of the modifications
    • C12N2310/344Position-specific modifications, e.g. on every purine, at the 3'-end
    • 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
    • C12N2310/00Structure or type of the nucleic acid
    • C12N2310/50Physical structure
    • C12N2310/53Physical structure partially self-complementary or closed
    • C12N2310/531Stem-loop; Hairpin
    • 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
    • C12N2310/00Structure or type of the nucleic acid
    • C12N2310/50Physical structure
    • C12N2310/53Physical structure partially self-complementary or closed
    • C12N2310/533Physical structure partially self-complementary or closed having a mismatch or nick in at least one of the strands

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Wood Science & Technology (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Cell Biology (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Plant Pathology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physics & Mathematics (AREA)
  • Mycology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Toxicology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
CN202180009173.8A 2020-01-13 2021-01-12 用编码gm-csf的多核苷酸和额外药剂治疗癌症的方法 Pending CN115335085A (zh)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US202062960583P 2020-01-13 2020-01-13
US62/960,583 2020-01-13
US202063034868P 2020-06-04 2020-06-04
US63/034,868 2020-06-04
US202063061634P 2020-08-05 2020-08-05
US63/061,634 2020-08-05
PCT/US2021/013130 WO2021146213A1 (en) 2020-01-13 2021-01-12 Methods for treating cancers using gm-csf encoding polynucleotide and additional agents

Publications (1)

Publication Number Publication Date
CN115335085A true CN115335085A (zh) 2022-11-11

Family

ID=76857765

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180009173.8A Pending CN115335085A (zh) 2020-01-13 2021-01-12 用编码gm-csf的多核苷酸和额外药剂治疗癌症的方法

Country Status (5)

Country Link
US (1) US11400170B2 (https=)
EP (1) EP4090380A1 (https=)
JP (1) JP7815124B2 (https=)
CN (1) CN115335085A (https=)
CA (1) CA3158900A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4440704A2 (en) * 2021-11-30 2024-10-09 Gradalis, Inc. Methods for treatment response to cancers
WO2025117756A1 (en) * 2023-11-28 2025-06-05 Gradalis, Inc. Neoantigen immunotherapy

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101918003A (zh) * 2007-11-12 2010-12-15 彼帕科学公司 单独使用parp抑制剂或与抗肿瘤剂组合治疗子宫癌和卵巢癌
US20110262408A1 (en) * 2009-12-23 2011-10-27 Gradalis, Inc. Furin-knockdown and gm-csf-augmented (fang) cancer vaccine
US20150368651A1 (en) * 2009-12-23 2015-12-24 Gradalis, Inc. Furin-knockdown bi-functional rna
CN109640992A (zh) * 2016-06-29 2019-04-16 泰萨罗公司 治疗卵巢癌的方法

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8916530B2 (en) 2005-11-18 2014-12-23 Gradalis, Inc. Individualized cancer therapy
US8906874B2 (en) 2006-11-09 2014-12-09 Gradalis, Inc. Bi-functional shRNA targeting Stathmin 1 and uses thereof
US8758998B2 (en) 2006-11-09 2014-06-24 Gradalis, Inc. Construction of bifunctional short hairpin RNA
US8252526B2 (en) 2006-11-09 2012-08-28 Gradalis, Inc. ShRNA molecules and methods of use thereof
US8969068B2 (en) 2008-04-30 2015-03-03 Gradalis, Inc. Processes for the preparation of highly pure plasmid compositions by enzymatic digestion of colanic acid
CA2772057C (en) 2009-09-03 2016-02-02 Strike Bio, Inc. Targeted delivery using tissue-specific peptidomimetic ligands
KR101543350B1 (ko) 2009-10-30 2015-08-11 베이롤 칼리지 오브 메드신 Pdx-1을 발현하는 신경내분비 종양에서 pdx-1 종양유전자를 표적화한 신규한 치료용 rna 간섭 기법
WO2015086473A1 (en) 2013-12-09 2015-06-18 Institut Curie Methods for detecting inactivation of the homologous recombination pathway (brca1/2) in human tumors

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101918003A (zh) * 2007-11-12 2010-12-15 彼帕科学公司 单独使用parp抑制剂或与抗肿瘤剂组合治疗子宫癌和卵巢癌
US20110262408A1 (en) * 2009-12-23 2011-10-27 Gradalis, Inc. Furin-knockdown and gm-csf-augmented (fang) cancer vaccine
CN102917709A (zh) * 2009-12-23 2013-02-06 格兰达利斯有限公司 弗林蛋白酶敲减和gm-csf增强的(fang)癌症疫苗
US20150368651A1 (en) * 2009-12-23 2015-12-24 Gradalis, Inc. Furin-knockdown bi-functional rna
US20180073038A1 (en) * 2009-12-23 2018-03-15 Gradalis, Inc. Furin-knockdown and gm-csf-augmented (fang) cancer vaccine
CN108295087A (zh) * 2009-12-23 2018-07-20 格兰达利斯有限公司 弗林蛋白酶敲减和gm-csf增强的(fang)癌症疫苗
CN109640992A (zh) * 2016-06-29 2019-04-16 泰萨罗公司 治疗卵巢癌的方法

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
JONATHAN OH等: "Clinical trial in progress: A phase 3 study of maintenance bi-shRNA-furin/GM-CSF-expressing autologous tumor cell vaccine in women with stage IIIb-IV high-grade epithelial ovarian cancer", JOURNAL OF CLINICAL ONCOLOGY, vol. 35, 20 May 2017 (2017-05-20) *
MELISSA K.FREY等: "Homologous recombination deficiency (HRD) testing in ovarian cancer clinical practice: a review of the literature", GYNECOLOGIC ONCOLOGY RESEARCH AND PRACTICE, vol. 4, 22 February 2017 (2017-02-22) *
OH J等: "Phase II study of Vigil® DNA engineered immunotherapy as maintenance in advanced stage ovarian cancer", GYNECOLOGIC ONCOLOGY, vol. 143, 1 January 2017 (2017-01-01) *

Also Published As

Publication number Publication date
EP4090380A1 (en) 2022-11-23
US20210220488A1 (en) 2021-07-22
US11400170B2 (en) 2022-08-02
JP2023510853A (ja) 2023-03-15
CA3158900A1 (en) 2021-07-22
JP7815124B2 (ja) 2026-02-17

Similar Documents

Publication Publication Date Title
JP7831948B2 (ja) 個別化された免疫原性ペプチドの同定のプラットフォーム
JP7197481B2 (ja) 反復性がん突然変異を標的とする免疫原性組成物およびその使用の方法
IL280908A (en) Combination therapy with neoantigen vaccine
EA037217B1 (ru) Композиция и вакцина для лечения рака легких
JP2024508677A (ja) 個別化がんワクチン用ネオアンチゲンのランク付け
US20240317830A1 (en) Multi-domain protein vaccine
JP2023549342A (ja) 個別化されたがんワクチンのためのネオアンチゲンの選択
US20180128833A1 (en) Methods of treating with tumor membrane vesicle-based immunotherapy and predicting therapeutic response thereto
US20220008510A1 (en) Manipulation of meningeal lymphatic vasculature for brain and cns tumor therapy
CN115335085A (zh) 用编码gm-csf的多核苷酸和额外药剂治疗癌症的方法
JP2024512462A (ja) 不均一な悪性腫瘍についての腫瘍ワクチン抗原カバレッジを最適化するための方法
US20220265792A1 (en) Methods for treating solid tumors
WO2021146213A1 (en) Methods for treating cancers using gm-csf encoding polynucleotide and additional agents
EP4431153A1 (en) Mutants of a ligand-dependent corepressor (lcor) and uses thereof
AU2024251286A1 (en) Methods and compositions for cancer treatment using recombinant polypeptides
US20260034201A1 (en) Combination therapy with neoantigen vaccine
EP3793571A1 (en) Vaccination with cancer neoantigens
WO2025199395A1 (en) Use of cytomegalovirus immunity against tumors
Hosseini et al. Checkpoint Inhibitors in Non-small Cell Lung Cancer: Potentials and Challenges
JP2026513981A (ja) 組換えポリペプチドを使用するがん処置のための方法および組成物
EP4496584A2 (en) Low-dose neoantigen vaccine therapy
WO2018209015A1 (en) Dendritic cells as a novel delivery system for immunotherapy

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination