WO2018183488A1 - Human pd1 peptide vaccines and uses thereof - Google Patents

Human pd1 peptide vaccines and uses thereof Download PDF

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Publication number
WO2018183488A1
WO2018183488A1 PCT/US2018/024831 US2018024831W WO2018183488A1 WO 2018183488 A1 WO2018183488 A1 WO 2018183488A1 US 2018024831 W US2018024831 W US 2018024831W WO 2018183488 A1 WO2018183488 A1 WO 2018183488A1
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seq
cancer
peptide
cell
peptides
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PCT/US2018/024831
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English (en)
French (fr)
Inventor
Pravin T.P. Kaumaya
Tanios BEKAII-SAAB
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Mayo Foundation for Medical Education and Research
Ohio State Innovation Foundation
Mayo Clinic in Florida
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Mayo Foundation for Medical Education and Research
Ohio State Innovation Foundation
Mayo Clinic in Florida
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Priority to CN202410999144.6A priority Critical patent/CN118909082A/zh
Priority to AU2018243920A priority patent/AU2018243920B2/en
Priority to CA3058393A priority patent/CA3058393A1/en
Priority to KR1020197031158A priority patent/KR102653567B1/ko
Priority to RU2019131252A priority patent/RU2019131252A/ru
Priority to ES18778305T priority patent/ES2963635T3/es
Priority to CN201880022159.XA priority patent/CN110636855B/zh
Priority to BR112019020386-9A priority patent/BR112019020386A2/pt
Application filed by Mayo Foundation for Medical Education and Research, Ohio State Innovation Foundation, Mayo Clinic in Florida filed Critical Mayo Foundation for Medical Education and Research
Priority to JP2019553504A priority patent/JP7346302B2/ja
Priority to US16/498,929 priority patent/US11684660B2/en
Priority to EP18778305.5A priority patent/EP3600398B1/en
Publication of WO2018183488A1 publication Critical patent/WO2018183488A1/en
Anticipated expiration legal-status Critical
Priority to AU2025201760A priority patent/AU2025201760A1/en
Ceased legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70503—Immunoglobulin superfamily
    • C07K14/70521—CD28, CD152
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • 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
    • A61K39/001103—Receptors for growth factors
    • A61K39/001106—Her-2/neu/ErbB2, Her-3/ErbB3 or Her 4/ErbB4
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70503—Immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/71—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • 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
    • A61K2039/55566—Emulsions, e.g. Freund's adjuvant, MF59
    • 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
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral 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
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031—Proteins
    • A61K2039/6075—Viral proteins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • FIG. 17 shows the immunogenicity individual antigens in triple vaccine treated mice.
  • Sera pools from mice immunized with 3 peptides (HER-2(266-296), HER-2(597-626), and PD-1 (92-110)) were tested by ELISA on 200 ng/ well of MVF-peptide.
  • ABTS was used as a substrate in the assay the enzyme reaction was stopped after 10 minutes with a 0.1% SDS solution. Titers were defined as the final dilution that still had an absorbance > than 0.200 when read at 415nm.
  • Sera samples 1Y+3, 2Y+1, 2Y+3, and 3Y+2 were taken before CT-26 HER-2 neu tumor challenge. Samples 3Y+3 and 3 Y+5 were taken at 1 week and 3 weeks post challenge respectively.
  • FIG. 19A and 19B show that the combination HER-2 and PD-1 Vaccines show enhanced immunogenicity and inhibition of tumor growth.
  • Mice were challenged 15-18 days after 3rd vaccination with CT-26 HER-2 carcinoma cells (1x10 s ).
  • PBS Negative control
  • mice were monitored and scored for the formation of palpable tumors, then measured regularly using calipers. Error bars are a representation of Standard Error for the group of mice and p-values compare various groups to Negative control PBS treated mice.
  • a “subject” is meant an individual.
  • the “subject” can include domesticated animals (e.g., cats, dogs, etc.), livestock (e.g., cattle, horses, pigs, sheep, goats, etc.), laboratory animals (e.g., mouse, rabbit, rat, guinea pig, etc.), and birds.
  • “Subject” can also include a mammal, such as a primate or a human.
  • prevent or other forms of the word, such as “preventing” or “prevention,” is meant to stop a particular event or characteristic, to stabilize or delay the development or progression of a particular event or characteristic, or to minimize the chances that a particular event or characteristic will occur. Prevent does not require comparison to a control as it is typically more absolute than, for example, reduce. As used herein, something could be reduced but not prevented, but something that is reduced could also be prevented. Likewise, something could be prevented but not reduced, but something that is prevented could also be reduced. It is understood that where reduce or prevent are used, unless specifically indicated otherwise, the use of the other word is also expressly disclosed.
  • synthetic PD-1 peptides comprising one or more of SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO 12, SEQ ID NO: 13, SEQ ID NO: 14 and/or SEQ ID NO: 15; wherein the amino acids comprising the sequence are D amino acids.
  • a particularly preferred non-peptide linkage is --CH2NH-. It is understood that peptide analogs can have more than one atom between the bond atoms, such as b-alanine, g-aminobutyric acid, and the like.
  • synthetic PD-1 peptides comprising one or more of the sequences as set forth in SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, or SEQ ID NO:5; wherein the amino acids of the peptide are the D enantiomer.
  • the disclosed PD-1 peptides comprising pharmaceutical compositions are particularly useful in the treatment of diseases or conditions where PD-1 mediated immune suppression occurs.
  • the disclosed pharmaceutical composition comprising one or more of the PD-1 peptides disclosed herein can be combined with a disease-specific treatment or vaccine to further increase the efficacy of the PD-1 peptides.
  • a pharmaceutical composition comprising one or more of the PD-1 peptides can be combined with anti-HER2 antibodies or HER-2 B cell epitopes for use in treating, inhibiting, and/or preventing breast cancer.
  • compositions comprising MVF-PD1 (92-110) as set forth in SEQ ID NO: 11; a MVF-HER-2 (266-296) peptide (for example as set forth in SEQ ID NO: 28), and a MVF-HER-2 (597-626) peptide (for example as set forth in SEQ ID NO: 30).
  • Preparations for parenteral administration include sterile aqueous or non-aqueous solutions, suspensions, and emulsions.
  • non-aqueous solvents are propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable organic esters such as ethyl oleate.
  • Aqueous carriers include water, alcoholic/aqueous solutions, emulsions or suspensions, including saline and buffered media.
  • Parenteral vehicles include sodium chloride solution, Ringer's dextrose, dextrose and sodium chloride, lactated Ringer's, or fixed oils.
  • Formulations for topical administration may include ointments, lotions, creams, gels, drops, suppositories, sprays, liquids and powders.
  • Conventional pharmaceutical carriers, aqueous, powder or oily bases, thickeners and the like may be necessary or desirable.
  • compositions for oral administration include powders or granules, suspensions or solutions in water or non-aqueous media, capsules, sachets, or tablets. Thickeners, flavorings, diluents, emulsifiers, dispersing aids or binders may be desirable.
  • Antibodies that bind SEQ ID NO: 1, SEQ ID NO: 2, SEQID NO: 3, SEQ ID NO: 4, SEQID NO: 5, SEQ ID NO: 8, SEQ ID NO: 9.SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18, and/or SEQ ID NO: 19 involved in the interaction between PD-1 and PD-L1 are also disclosed.
  • the antibodies can be tested for their desired activity using the in vitro assays described herein, or by analogous methods, after which their in vivo therapeutic and/or prophylactic activities are tested according to known clinical testing methods.
  • antibody or fragments thereof encompasses chimeric antibodies and hybrid antibodies, with dual or multiple antigen or epitope specificities, and fragments, such as F(ab')2, Fab', Fab, Fv, sFv, and the like, including hybrid fragments.
  • fragments of the antibodies that retain the ability to bind their specific antigens are provided.
  • fragments of antibodies which maintain PD-1 binding activity or bind SEQ ID NO: 1, SEQ ID NO: 2, SEQID NO: 3, SEQ ID NO: 4, SEQID NO: 5, SEQ ID NO: 8, SEQ ID NO: 9.SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18, and/or SEQ ID NO: 19 are included within the meaning of the term "antibody or fragment thereof.”
  • Such antibodies and fragments can be made by techniques known in the art and can be screened for specificity and activity according to the methods set forth in the Examples and in general methods for producing antibodies and screening antibodies for specificity and activity (See Harlow and Lane. Antibodies, A Laboratory Manual. Cold Spring Harbor Publications, New York, (1988)).
  • Hydropathy profiles were generated over a seven residue span setting and then smoothed with a three-residue span using the scale of Kyte and Doolittle;
  • Hydrophilicity profiles over a six- residue window were generated using the program of Hopp and Woods;
  • Analysis of the exposure of an amino acid residue to water (1.4 A probe) was carried out by the solvent exposure algorithm of Rose et al.;
  • Protrusion indices were calculated by the method of Thornton et al.
  • the interaction is constructed around a central hydrophobic core contributed by both partners and constituted by nonpolar residues in the front sheet of PD-1 (Val64, Hel26, Leul28, Alal32, Ilel34) and those of the front sheet of PD-L1 (LHe54, LTyr56, LMetl 15, LAlal21, LTyrl23), including a characteristic alkyl-p interaction of the side chains of Hel34 and
  • mice mounted a robust antibody response to all 4 vaccines.
  • the immune response (Figure 9 and Table 6) to pooled sera were monitored at various intervals (2Y+1, 2Y+3, 3Y+1, 3Y+2, 3Y+3) against the vaccine constructs.
  • Antigen specific T cell proliferation reflects important effector function of T effector cells.
  • a CFSE-based proliferation assay was performed. In Proliferation assay splenocytes from naive MBP-specific TCR transgenic mice were labeled with CFSE and activated with MBP Acl-11 in the presence of 50mg/ml of a- huPD-1 antibodies or control rabbit IgG for 4 days. CFSE expression was analyzed by flow cytometry (Fig. 13).
  • Example 7 Preliminary screening efficacy studies in syngeneic Balb/c mice immunized with different PD-1 constructs and challenged with lxlO 5 murine colon carcinoma CT26 tumor cells
  • Example 9 Efficacy of Combination PD-1 and HER-2 vaccine constructs in syngeneic Balb/c mice challenged with lxlO 5 murine colon carcinoma CT26/HER-2 tumor cells (Scheme Fig.16).
  • CD8 + (Fig. 20B) cells were analyzed. Tregs were represented by CD4 + CD25 4 FoxP3 + cells (Fig. 20C).
  • GraphPad software GraphPad Prism Software, Inc.San Diego, CA, USA was utilized for statistical analysis. Group means were calculated and compared with Anova.
  • CD8+ T cells were significantly higher in combination vaccine group (HER-2/PD1-92 vaccinated group) compared to control pepti de-vaccinated group (Fig. 20B). There are no significant differences of CD4 T cells or Treg cells among all groups (Fig. 20A and 20B). However, the CD8/Treg ratio is significantly higher in combination vaccine group compared to control peptide-vaccinated group (Fig. 20D).

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PCT/US2018/024831 2017-03-28 2018-03-28 Human pd1 peptide vaccines and uses thereof Ceased WO2018183488A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
CN201880022159.XA CN110636855B (zh) 2017-03-28 2018-03-28 人pd1肽疫苗及其用途
CA3058393A CA3058393A1 (en) 2017-03-28 2018-03-28 Human pd1 peptide vaccines and uses thereof
KR1020197031158A KR102653567B1 (ko) 2017-03-28 2018-03-28 인간 pd1 펩티드 백신 및 이의 용도
RU2019131252A RU2019131252A (ru) 2017-03-28 2018-03-28 Пептидные вакцины на основе pd1 человека и их применение
ES18778305T ES2963635T3 (es) 2017-03-28 2018-03-28 Vacunas de péptido PD1 humano y usos de las mismas
BR112019020386-9A BR112019020386A2 (pt) 2017-03-28 2018-03-28 vacinas de peptídeos de pd-1 humana e usos das mesmas
JP2019553504A JP7346302B2 (ja) 2017-03-28 2018-03-28 ヒトｐｄ－１ペプチドワクチン及びその使用法
CN202410999144.6A CN118909082A (zh) 2017-03-28 2018-03-28 一种分离的肽
AU2018243920A AU2018243920B2 (en) 2017-03-28 2018-03-28 Human PD1 peptide vaccines and uses thereof
US16/498,929 US11684660B2 (en) 2017-03-28 2018-03-28 Human PD1 peptide vaccines and uses thereof
EP18778305.5A EP3600398B1 (en) 2017-03-28 2018-03-28 Human pd1 peptide vaccines and uses thereof
AU2025201760A AU2025201760A1 (en) 2017-03-28 2025-03-11 Human PD1 peptide vaccines and uses thereof

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US201762477895P 2017-03-28 2017-03-28
US62/477,895 2017-03-28

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US (1) US11684660B2 (enExample)
EP (1) EP3600398B1 (enExample)
JP (1) JP7346302B2 (enExample)
KR (1) KR102653567B1 (enExample)
CN (2) CN118909082A (enExample)
AU (2) AU2018243920B2 (enExample)
BR (1) BR112019020386A2 (enExample)
CA (1) CA3058393A1 (enExample)
ES (1) ES2963635T3 (enExample)
RU (1) RU2019131252A (enExample)
WO (1) WO2018183488A1 (enExample)

Cited By (3)

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WO2019153042A1 (en) * 2018-02-07 2019-08-15 Imugene Limited A vaccine composition and uses thereof
JP2022513340A (ja) * 2018-10-05 2022-02-07 アールエヌエージーン インコーポレイテッド 標的細胞特異的に結合して多重免疫機能が強化されたキメラ抗原及びこの用途
CN114630676A (zh) * 2019-09-17 2022-06-14 俄亥俄州创新基金会 人抗pd-l1肽疫苗及其使用方法

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US20260007730A1 (en) * 2022-04-21 2026-01-08 Ohio State Innovation Foundation Human ctla-4 peptide vaccines and uses thereof
WO2024211745A1 (en) * 2023-04-05 2024-10-10 Ohio State Innovation Foundation Human pd1, pd-l1, and ctla-4 combination peptide vaccines and uses thereof
CN119019569B (zh) * 2024-08-19 2025-10-24 中国人民解放军陆军军医大学 一种可定向增强胸腺新生t细胞杀伤乳腺癌的多肽及其应用

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