WO2020252029A1 - Anti-pcrv antibodies that bind pcrv, compositions comprising anti-pcrv antibodies, and methods of use thereof - Google Patents

Anti-pcrv antibodies that bind pcrv, compositions comprising anti-pcrv antibodies, and methods of use thereof Download PDF

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Publication number
WO2020252029A1
WO2020252029A1 PCT/US2020/037008 US2020037008W WO2020252029A1 WO 2020252029 A1 WO2020252029 A1 WO 2020252029A1 US 2020037008 W US2020037008 W US 2020037008W WO 2020252029 A1 WO2020252029 A1 WO 2020252029A1
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WIPO (PCT)
Prior art keywords
amino acid
seq
acid sequence
antibody
antigen
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Ceased
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PCT/US2020/037008
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English (en)
French (fr)
Inventor
Christos Kyratsous
Alida Coppi
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.)
Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals 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
Priority to BR112021023335A priority Critical patent/BR112021023335A2/pt
Priority to SG11202112462RA priority patent/SG11202112462RA/en
Priority to CA3140075A priority patent/CA3140075A1/en
Priority to AU2020292283A priority patent/AU2020292283A1/en
Priority to MA54975A priority patent/MA54975B1/fr
Priority to CN202080042874.7A priority patent/CN113966343A/zh
Priority to KR1020227000136A priority patent/KR20220019755A/ko
Priority to MX2021015156A priority patent/MX2021015156A/es
Priority to EP20751363.1A priority patent/EP3983015A1/en
Application filed by Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Priority to JP2021571690A priority patent/JP2022536469A/ja
Priority to PH1/2021/552903A priority patent/PH12021552903A1/en
Priority to EA202192810A priority patent/EA202192810A1/ru
Publication of WO2020252029A1 publication Critical patent/WO2020252029A1/en
Priority to CONC2021/0015254A priority patent/CO2021015254A2/es
Priority to IL288727A priority patent/IL288727A/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/12—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1203—Gram-negative bacteria
    • C07K16/1214—Pseudomonadaceae (F)
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/40—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum bacterial
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Definitions

  • HCVR heavy chain variable region
  • LCVR light chain variable region
  • antibodies, or antigen-binding fragments thereof comprising an HCVR and an LCVR amino acid sequence pair (HCVR/LCVR) comprising any of the HCVR amino acid sequences listed in Table 1 paired with any of the LCVR amino acid sequences listed in Table 1 .
  • the present disclosure provides antibodies, or antigen-binding fragments thereof, comprising an HCVR/LCVR amino acid sequence pair contained within any of the exemplary anti-PcrV antibodies listed in Table 1 .
  • the HCVR/LCVR amino acid sequence pair is selected from the group consisting of SEQ ID NOs: 2/10 (H1 H29329P), 18/26 (H1 H29332P), 34/42 (H1 H29336P), and 50/58 (H1 H29339P).
  • the pharmaceutical composition may be administered subcutaneously, intravenously, intradermally, intramuscularly, intranasally, or orally.
  • the identified antibodies can be used prophylactically (before infection) to protect a subject, e.g. a mammal, from infection, or can be used therapeutically (after infection is established) to ameliorate a previously established infection, or to ameliorate at least one symptom associated with the infection.
  • the anti-PcrV antibodies and antibody fragments disclosed herein encompass proteins having amino acid sequences that vary from those of the described antibodies, but that retain the ability to bind PcrV. Such variant antibodies and antibody fragments comprise one or more additions, deletions, or substitutions of amino acids when compared to parent sequence, but exhibit biological activity that is essentially equivalent to that of the described antibodies.
  • the antibody-encoding DNA sequences of the present disclosure encompass sequences that comprise one or more additions, deletions, or substitutions of nucleotides when compared to the disclosed sequence, but that encode an antibody or antibody fragment that is essentially bioequivalent to an antibody or antibody fragment disclosed herein.
  • antibodies or antigen-binding fragments thereof that neutralize P. aeruginosa PcrV-mediated toxicity, for example, in A549 cells as shown in Example 6.
  • the antibodies exhibit a neutralization potency against P. aeruginosa strain 6077 with an IC 50 ranging from about 10 -11 M to about 10 -7 M.
  • the antibodies exhibit a neutralization potency against P. aeruginosa strain ATCC 700888 with an IC 50 ranging from about 10 -9 M to about 10 -7 M.
  • the antibodies provided herein also neutralize P. aeruginosa PcrV-mediated RBC hemolysis as shown in Example 7.
  • the above-described binding methodology is performed in two orientations: In a first orientation, the reference antibody is allowed to bind to a PcrV protein under saturating conditions followed by assessment of binding of the test antibody to the PcrV protein. In a second orientation, the test antibody is allowed to bind to a PcrV protein under saturating conditions followed by assessment of binding of the reference antibody to the PcrV protein. If, in both orientations, only the first (saturating) antibody is capable of binding to the PcrV protein, then it is concluded that the test antibody and the reference antibody compete for binding to PcrV.
  • the initial dose may be followed by administration of a second or a plurality of subsequent doses of the antibody or antigen binding fragment thereof in an amount that can be approximately the same or less than that of the initial dose, wherein the subsequent doses are separated by at least 6 hours to 24 hours, at least 1 day to 3 days; at least one week, at least 2 weeks; at least 3 weeks; at least 4 weeks; at least 5 weeks; at least 6 weeks; at least 7 weeks; at least 8 weeks; at least 9 weeks; at least 10 weeks; at least 12 weeks; or at least 14 weeks.
  • a pharmaceutical composition can be delivered subcutaneously or
  • anti-PcrV antibodies disclosed herein prophylactically to subjects at risk for developing infection such as a subject undergoing surgery, a subject being treated for a major illness, a subject having severe burns, a subject using a breathing machine, a subject with a catheter, a subject undergoing chemotherapy, a subject having diabetes, a subject with cystic fibrosis, a subject with tuberculosis, a subject with HIV, or a subject with a compromised immune system.
  • administering the components in a single dosage from, in separate dosage forms by the same route, or in separate dosage forms by different routes are all considered “concurrent administration,” for purposes of the present disclosure.
  • administration of an anti-PcrV antibody "prior to”, “concurrent with,” or “after” (as those terms are defined herein above) administration of an additional therapeutically active component is considered administration of an anti- PcrV antibody "in combination with” an additional therapeutically active component.
  • the present disclosure includes pharmaceutical compositions in which an anti- PcrV antibody described herein is co-formulated with one or more of the additional therapeutically active component(s) as described elsewhere herein.
  • the amount of anti-PcrV antibody contained in the initial, secondary and/or tertiary doses varies from one another (e.g., adjusted up or down as appropriate) during the course of treatment.
  • two or more (e.g., 2, 3, 4, or 5) doses are administered at the beginning of the treatment regimen as "loading doses" followed by subsequent doses that are administered on a less frequent basis (e.g., "maintenance doses").
  • the methods may comprise administering to a patient any number of secondary and/or tertiary doses of an anti-PcrV antibody.
  • any number of secondary and/or tertiary doses of an anti-PcrV antibody may comprise administering to a patient any number of secondary and/or tertiary doses of an anti-PcrV antibody.
  • only a single secondary dose is administered to the patient.
  • two or more (e.g ., 2, 3, 4, 5, 6, 7, 8, or more) secondary doses are administered to the patient.
  • only a single tertiary dose is administered to the patient.
  • two or more (e.g., 2, 3, 4, 5, 6, 7, 8, or more) tertiary doses are administered to the patient.
  • compositions comprising the anti-PcrV antibodies can vary. Routes of administration include oral, rectal,
  • kits comprising an anti-PcrV antibody.
  • the kit comprises the antibody in a vessel or injection device (e.g., pre-filled syringe or autoinjector).
  • the kit can include a package insert including information concerning the pharmaceutical compositions and dosage forms in the kit. Generally, such information aids patients and physicians in using the enclosed pharmaceutical compositions effectively and safely.
  • any of the following information regarding antibodies provided herein may be supplied in the insert: pharmacokinetics, pharmacodynamics, clinical studies, efficacy parameters, indications and usage, contraindications, warnings, precautions, adverse reactions, overdosage, proper dosage and administration, how supplied, proper storage conditions, references, manufacturer/distributor information and patent information.
  • Table 1 sets forth the amino acid sequence identifiers of the heavy and light chain variable regions and CDRs of selected exemplary anti-PcrV antibodies of the invention.
  • the corresponding nucleic acid sequence identifiers are set forth in Table 2.
  • Table 3 provides sequence identifiers for full length heavy and light chain amino acid sequences.
  • Anti-PcrV monoclonal antibodies were assessed by ELISA for their ability to bind to recombinant PcrV proteins.
  • Nunc MicroSorpTM 96-well plates were coated with 0.2 pg per well of recombinant full-length P. aeruginosa PcrV (GenScript) (SEQ ID NO: 77) or a truncated form of the protein (encompassing amino acids 136 to 233 of the mature protein; GenScript) (SEQ ID NO: 81 ) and incubated overnight at 4°C.
  • Luminescence was detected using a plate reader (Victor, Perkin Elmer) and luminescence values were analyzed by a four-parameter logistic equation (GraphPad Prism).
  • Anti-PcrV monoclonal antibodies were assessed for their ability to prevent PcrV-mediated lysis of rabbit red blood cells (rRBCs; Colorado Serum Co.).
  • Table 14 Bacterial burden in the lungs of mice administered 0.1 or 0.2 mg/kg anti-PcrV mAb prophylactically in an acute pneumonia model using P. aeruginosa strain 6206
  • anti-PcrV mAb H1 H29336P decreased the bacterial burden in the lungs of mice infected with noncytotoxic P. aeruginosa strain PA01 approximately 2 logs more than control anti-PcrV mAb (Control V - REGN7070) and 4 logs more than the no antibody or isotype control mAb (Control IV) groups.
  • Table 15 Bacterial burden in the lungs of mice administered 25 mg/kg anti-PcrV mAb prophylactically in an acute pneumonia model using P. aeruginosa strain PA01
  • HDX-MS Hydrogen-Deuterium Exchange Mass Spectrometry

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
PCT/US2020/037008 2019-06-11 2020-06-10 Anti-pcrv antibodies that bind pcrv, compositions comprising anti-pcrv antibodies, and methods of use thereof Ceased WO2020252029A1 (en)

Priority Applications (14)

Application Number Priority Date Filing Date Title
EP20751363.1A EP3983015A1 (en) 2019-06-11 2020-06-10 Anti-pcrv antibodies that bind pcrv, compositions comprising anti-pcrv antibodies, and methods of use thereof
CA3140075A CA3140075A1 (en) 2019-06-11 2020-06-10 Anti-pcrv antibodies that bind pcrv, compositions comprising anti-pcrv antibodies, and methods of use thereof
AU2020292283A AU2020292283A1 (en) 2019-06-11 2020-06-10 Anti-PcrV antibodies that bind PcrV, compositions comprising anti-PcrV antibodies, and methods of use thereof
MA54975A MA54975B1 (fr) 2019-06-11 2020-06-10 Anticorps anti-pcrv qui se lient à pcrv, compositions comprenant des anticorps anti-pcrv, et leurs méthodes d'utilisation
CN202080042874.7A CN113966343A (zh) 2019-06-11 2020-06-10 结合PcrV的抗PcrV抗体、包含抗PcrV抗体的组合物及其使用方法
KR1020227000136A KR20220019755A (ko) 2019-06-11 2020-06-10 PcrV에 결합하는 항-PcrV 항체, 항-PcrV 항체를 포함하는 조성물, 및 이의 사용 방법
MX2021015156A MX2021015156A (es) 2019-06-11 2020-06-10 Anticuerpos anti-pcrv que se unen a pcrv, composiciones que comprenden anticuerpos anti-pcrv, y metodos de uso de estos.
BR112021023335A BR112021023335A2 (pt) 2019-06-11 2020-06-10 Anticorpos recombinante isolado ou seu fragmento de ligação ao antígeno e monoclonal isolado ou seu fragmento de ligação ao antígeno, composição farmacêutica, molécula polinucleotídica isolada, vetor, célula, método de diminuição do risco de adquirir infecção por p. aeruginosa, e, métodos de diminuição da carga bacteriana em um sujeito com uma infecção por p. aeruginosa, de aumento da sobrevida ou da probabilidade de sobrevida de um sujeito que sofre de infecção por p. aeruginosa ou de um sujeito que corre risco de infecção por p. aeruginosa, para melhorar ou reduzir a gravidade, a duração ou a frequência de ocorrência de pelo menos um sintoma de uma infecção por p. aeruginosa, para aumentar a sobrevida ou a probabilidade de sobrevida de um sujeito que sofre de fibrose cística
JP2021571690A JP2022536469A (ja) 2019-06-11 2020-06-10 ＰｃｒＶに結合する抗ＰｃｒＶ抗体、抗ＰｃｒＶ抗体を含む組成物、およびその使用方法
SG11202112462RA SG11202112462RA (en) 2019-06-11 2020-06-10 Anti-pcrv antibodies that bind pcrv, compositions comprising anti-pcrv antibodies, and methods of use thereof
PH1/2021/552903A PH12021552903A1 (en) 2019-06-11 2020-06-10 Anti-pcrv antibodies that bind pcrv, compositions comprising anti-pcrv antibodies, and methods of use thereof
EA202192810A EA202192810A1 (ru) 2019-06-11 2020-06-10 АНТИТЕЛА К PcrV, КОТОРЫЕ СВЯЗЫВАЮТ PcrV, КОМПОЗИЦИИ, СОДЕРЖАЩИЕ АНТИТЕЛА К PcrV, И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
CONC2021/0015254A CO2021015254A2 (es) 2019-06-11 2021-11-11 Anticuerpos anti-pcrv que se unen a pcrv, composiciones que comprenden anticuerpos anti-pcrv, y métodos de uso de estos
IL288727A IL288727A (en) 2019-06-11 2021-12-06 Anti-pcrv antibodies that bind pcrv, compositions comprising anti-pcrv antibodies, and methods of use thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962860146P 2019-06-11 2019-06-11
US62/860,146 2019-06-11

Publications (1)

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WO2020252029A1 true WO2020252029A1 (en) 2020-12-17

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US (2) US11655286B2 (https=)
EP (1) EP3983015A1 (https=)
JP (1) JP2022536469A (https=)
KR (1) KR20220019755A (https=)
CN (1) CN113966343A (https=)
AU (1) AU2020292283A1 (https=)
BR (1) BR112021023335A2 (https=)
CA (1) CA3140075A1 (https=)
CL (4) CL2021003215A1 (https=)
CO (1) CO2021015254A2 (https=)
EA (1) EA202192810A1 (https=)
IL (1) IL288727A (https=)
MA (2) MA56205A (https=)
MX (1) MX2021015156A (https=)
PH (1) PH12021552903A1 (https=)
SG (1) SG11202112462RA (https=)
WO (1) WO2020252029A1 (https=)

Cited By (2)

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WO2022074348A1 (fr) 2020-10-08 2022-04-14 Université De Tours Combinaison d'anticorps inhalés avec des agents immunomodulateurs pour le traitement ou la prévention d'infections respiratoires
WO2025003381A1 (en) 2023-06-28 2025-01-02 Universität Zu Köln Neutralizing human monoclonal antibodies against p. aeruginosa

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HRP20201370T1 (hr) 2011-11-07 2020-11-27 Medimmune Limited Kombinacijske terapije koje koriste anti-pseudomonas psl i pcrv vezujuće molekule
CN114404614B (zh) * 2022-01-28 2024-04-23 上海交通大学 一种靶向铜绿假单胞菌的免疫脂质体及其制备方法和应用
CN117222740A (zh) * 2022-06-07 2023-12-12 南方科技大学 编码PcrV和/或OprF-I蛋白的mRNA疫苗
WO2024206669A2 (en) * 2023-03-29 2024-10-03 Virtuoso Binco, Inc. Antibodies for targeting cd47 and b7h3 and methods of use thereof
CN118440191B (zh) * 2024-05-11 2025-06-10 重庆原伦生物科技有限公司 一种抗铜绿假单胞菌PcrV抗体的制备及其应用
CN118530352B (zh) * 2024-05-11 2025-03-25 重庆原伦生物科技有限公司 一种特异性识别铜绿假单胞菌PcrV的抗体及其应用

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