WO2018112360A1 - Polythérapies pour le traitement du cancer - Google Patents

Polythérapies pour le traitement du cancer Download PDF

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Publication number
WO2018112360A1
WO2018112360A1 PCT/US2017/066701 US2017066701W WO2018112360A1 WO 2018112360 A1 WO2018112360 A1 WO 2018112360A1 US 2017066701 W US2017066701 W US 2017066701W WO 2018112360 A1 WO2018112360 A1 WO 2018112360A1
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WO
WIPO (PCT)
Prior art keywords
bcg
bacterial composition
cancer
carcinoma
immune checkpoint
Prior art date
Application number
PCT/US2017/066701
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English (en)
Inventor
Brian Goodman
Peter SANDY
Jacqueline PAPKOFF
Holly PONICHTERA
Original Assignee
Evelo Biosciences, 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 Evelo Biosciences, Inc. filed Critical Evelo Biosciences, Inc.
Publication of WO2018112360A1 publication Critical patent/WO2018112360A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Definitions

  • At least 50%, 60%, 70%, 80%, 85%, 90%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% of the bacteria in the bacterial composition are mycobacterium (e.g. mycobacterium bovis such as BCG) and/or one of the aforementioned strains of BCG.
  • all or substantially all of the bacteria in the bacterial formulation are mycobacterium (e.g. mycobacterium bovis such as BCG) and/or one of the aforementioned strains of BCG.
  • the immune checkpoint inhibitor is an inhibitor nucleic acid (e.g., an siRNA molecule, an shRNA molecule or an antisense RNA molecule) that inhibits expression of an immune checkpoint protein (e.g., CTLA4, PD-1 , PD-Ll, PD-L2, A2AR, B7-H3, B7-H4, BTLA, KIR, LAG3, TIM-3 or VISTA).
  • an immune checkpoint protein e.g., CTLA4, PD-1 , PD-Ll, PD-L2, A2AR, B7-H3, B7-H4, BTLA, KIR, LAG3, TIM-3 or VISTA.
  • cyclosphosphamide busulfan, improsulfan, piposulfan, benzodopa, carboquone, meturedopa, uredopa, altretamine, triethylenemelamine, trietylenephosphoramide,
  • the bacterial composition and the other cancer therapy can be administered to the subject in any order. In some embodiments, the bacterial composition and the other cancer therapy are administered conjointly. In some embodiments, the bacterial composition and the other cancer therapy are administered to the subject at about the same time.
  • the term "antibody” may refer to both an intact antibody and an antigen binding fragment thereof.
  • Intact antibodies are glycoproteins that include at least two heavy (H) chains and two light (L) chains inter-connected by disulfide bonds.
  • Each heavy chain includes a heavy chain variable region (abbreviated herein as VH) and a heavy chain constant region.
  • Each light chain includes a light chain variable region (abbreviated herein as VL) and a light chain constant region.
  • the VH and VL regions can be further subdivided into regions of hypervariability, termed complementarity determining regions (CDR), interspersed with regions that are more conserved, termed framework regions (FR).
  • CDR complementarity determining regions
  • cancer refers to all types of cancer or neoplasm or malignant tumors including leukemias, carcinomas and sarcomas, whether new or recurring. Specific examples of cancers are: carcinomas, sarcomas, myelomas, leukemias, lymphomas and mixed type tumors.
  • the term "increase” means a change, such that the difference is, depending on circumstances, at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 2-fold, 4-fold, 10- fold, 100-fold, 10 ⁇ 3 fold, 10 ⁇ 4 fold, 10 ⁇ 5 fold, 10 ⁇ 6 fold, and/or 10 ⁇ 7 fold greater after treatment when compared to a pre-treatment state.
  • Properties that may be increased include immune cells, bacterial cells, stromal cells, myeloid derived suppressor cells, fibroblasts, metabolites, and cytokines.
  • OTUs may also be characterized by any combination of nucleotide markers or genes, in particular highly conserved genes (e.g., "house-keeping" genes), or a combination thereof.
  • Operational Taxonomic Units (OTUs) with taxonomic assignments made to, e.g., genus, species, and phylogenetic clade are provided herein.
  • Ipilimumab can be found in PCT patent application publication WO 2001/014424 and US Patent Nos. 6,984,720, 7,605,238, 5,811 ,097, 5,855,887 and 6,051 ,227 each of which are hereby incorporated by reference in their entirety.
  • immune checkpoint inhibitors can be an inhibitory nucleic acid molecule (e.g., an siRNA molecule, an shRNA molecule or an antisense RNA molecule) that inhibits expression of an immune checkpoint protein that inhibits expression of an immune checkpoint protein.
  • an inhibitory nucleic acid molecule e.g., an siRNA molecule, an shRNA molecule or an antisense RNA molecule
  • shRNA duplexes may comprise 3' overhangs of about 1 to about 4 nucleotides or about 2 to about 3 nucleotides on the antisense strand and/or 5 '-phosphate termini on the sense strand.
  • the shRNA comprises a sense strand and/or antisense strand sequence of from about 15 to about 60 nucleotides in length (e.g., about 15-60, 15-55, 15- 50, 15-45, 15-40, 15-35, 15-30, or 15-25 nucleotides in length),or from about 19 to about 40 nucleotides in length (e.g., about 19-40, 19-35, 19-30, or 19-25 nucleotides in length), or from about 19 to about 23 nucleotides in length (e.g., 19, 20, 21, 22, or 23 nucleotides in length).
  • the composition comprises a binder as an excipient.
  • suitable binders include starches, pregelatinized starches, gelatin, polyvinylpyrolidone, cellulose, methylcellulose, sodium carboxymethylcellulose, ethylcellulose, polyacrylamides, polyvinyloxoazolidone, polyvinylalcohols, C12-C18 fatty acid alcohol, polyethylene glycol, polyols, saccharides, oligosaccharides, and combinations thereof.
  • the bacterial composition administered by injection into or proximal to a tumor while the immune checkpoint inhibitor is administered via intravenous or intramuscular injection.
  • the bacterial composition is administered to the subject via an injection into a tumor or an injection proximal to the tumor.
  • the dosage regimen can be any of a variety of methods and amounts, and can be determined by one skilled in the art according to known clinical factors. As is known in the medical arts, dosages for any one patient can depend on many factors, including the subject's species, size, body surface area, age, sex, immunocompetence, and general health, the particular microorganism to be administered, duration and route of administration, the kind and stage of the disease, for example, tumor size, and other compounds such as drugs being administered concurrently. In addition to the above factors, such levels can be affected by the infectivity of the microorganism, and the nature of the microorganism, as can be determined by one skilled in the art.
  • the rechallenged mice are injected with the same number of tumor cells used during the previous inoculation, and a control group includes naive mice with no previous exposure to these same inoculated tumor cells. Tumor growth is measured on a regular basis in both groups.
  • Example 7 BCG and checkpoint blockade in a hepatocellular carcinoma mouse model
  • Example 16 BCG in a mouse melanoma model

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La présente invention concerne des méthodes et des compositions associées à l'utilisation du bacille de Calmette et Guérin (BCG) dans le traitement d'un cancer autre que celui de la vessie.
PCT/US2017/066701 2016-12-16 2017-12-15 Polythérapies pour le traitement du cancer WO2018112360A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662435420P 2016-12-16 2016-12-16
US62/435,420 2016-12-16

Publications (1)

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WO2018112360A1 true WO2018112360A1 (fr) 2018-06-21

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112516319A (zh) * 2020-12-08 2021-03-19 华中农业大学 用于治疗乳腺癌的组合药剂
WO2021163602A1 (fr) * 2020-02-13 2021-08-19 The Johns Hopkins University Interventions thérapeutiques recombinantes contre le cancer
CN114080228A (zh) * 2019-07-09 2022-02-22 武田药品工业株式会社 Sting激动剂和检查点抑制剂的施用
US20220288182A1 (en) * 2019-07-18 2022-09-15 Nantcell, Inc. Bacillus calmette-guerin (bcg) and antigen presenting cells for treatment of bladder cancer
US11810650B2 (en) 2017-04-03 2023-11-07 Gusto Global, Llc Rational design of microbial-based biotherapeutics

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