WO2007056847A1 - Stabilizing formulations for recombinant viruses - Google Patents

Stabilizing formulations for recombinant viruses Download PDF

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Publication number
WO2007056847A1
WO2007056847A1 PCT/CA2006/001855 CA2006001855W WO2007056847A1 WO 2007056847 A1 WO2007056847 A1 WO 2007056847A1 CA 2006001855 W CA2006001855 W CA 2006001855W WO 2007056847 A1 WO2007056847 A1 WO 2007056847A1
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WIPO (PCT)
Prior art keywords
spp
formulation
virus
antigen
hepatitis
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.)
Ceased
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PCT/CA2006/001855
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English (en)
French (fr)
Inventor
Sandrine Cigarini
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.)
Sanofi Pasteur Ltd
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Sanofi Pasteur Ltd
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 CA002630349A priority Critical patent/CA2630349A1/en
Priority to EP06804724A priority patent/EP1951865A4/en
Priority to KR1020087014882A priority patent/KR101357685B1/ko
Priority to BRPI0618850-8A priority patent/BRPI0618850A2/pt
Priority to AU2006315026A priority patent/AU2006315026B2/en
Priority to US12/094,302 priority patent/US20090169581A1/en
Application filed by Sanofi Pasteur Ltd filed Critical Sanofi Pasteur Ltd
Priority to JP2008541555A priority patent/JP5138601B2/ja
Publication of WO2007056847A1 publication Critical patent/WO2007056847A1/en
Priority to IL191595A priority patent/IL191595A/en
Anticipated expiration legal-status Critical
Priority to US14/728,567 priority patent/US20150265688A1/en
Ceased legal-status Critical Current

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Definitions

  • This invention relates to preparations of viruses, e.g. for vaccine or other pharmaceutical or research use, to their stabilization, and to processes of producing such preparations, as well as to their use, e.g. as vaccines or as virus vectors.
  • recombinant viruses have been stored as freeze-dried pellets containing sucrose, hydrolysates of casein and/or collagen in phosphate-buffered physiological saline (PBS). These pellets are then re-hydrated in a pharmaceutically acceptable solution such as 0.4-0.9% NaCI.
  • PBS phosphate-buffered physiological saline
  • a pharmaceutically acceptable solution such as 0.4-0.9% NaCI.
  • the present invention provides stabilizing formulations ("stabilizers”) for preserving viruses, such as viral vectors, for various uses including within immunological formulations and vaccines.
  • the formulation comprises a sugar, a preservative, a dispersing agent, a thermal stability agent, a buffer, and up to three distinct types of amino acids (i.e., one, two or three distinct types of amino acid(s)).
  • the formulation comprises three distinct types of amino acids.
  • the formulation comprises two distinct types of amino acids.
  • the formulation comprises only a type of amino acid. It is preferred that the amino acid(s) is / are arginine, alanine, serine or glycine.
  • the amino acid(s) is / are arginine, serine or glycine.
  • the virus is added to the stabilizing formulation and retains particular, measurable characteristics (i.e., viability, infectivity) for a desired amount of time.
  • Preferred formulations retain certain desirable and measurable characteristics such as favorable appearance and dissolution times under specific conditions in the presence of a virus, which are described below.
  • Other embodiments of the present invention will be evident from the description, examples and claims shown below.
  • recombinant viruses such as the avipox virus ALVAC have been stored as freeze-dried pellets containing sucrose, hydrolysates of casein and/or collagen in phosphate-buffered physiological saline (PBS). These pellets are then re-hydrated in a pharmaceutically acceptable solution such as 0.4-0.9% NaCI.
  • PBS phosphate-buffered physiological saline
  • the present invention provides formulations for stably storing and preserving a virus, including a recombinant virus, for use as expression vectors, immunological formulations, and/or vaccines.
  • the formulations are useful in methods of preparing, storing, and using such viruses with greater ease, at a lesser cost, and without a significant decrease in viral activity as compared to presently available formulations.
  • Such formulations may be referred to as "stabilizing formulations" and typically include a sugar (i.e., sucrose or sorbitol, trehalose, saccharose, mannitol, lactose), a preservative (which may be a sugar, amino acid, other component), a dispersing agent (i.e., polyvinyl pyrrolidone 40, dextran, PEG), a thermal stability agent (i.e., urea), a buffer (i.e., Tris, phosphate-buffered saline (PBS), sodium phosphate, acetate, Borate, Hepes, MOPS, PEG) and one or more amino acids.
  • a sugar i.e., sucrose or sorbitol, trehalose, saccharose, mannitol, lactose
  • a preservative which may be a sugar, amino acid, other component
  • a dispersing agent i.e., polyvinyl
  • the formulation includes at least one of arginine, serine or glycine. In a more preferred embodiment, the formulation comprises a single amino acid which is arginine, serine or glycine.
  • the amino acid(s) are preferably present in the formulation at or under about 100 mg / ml. More preferably, the amino acid(s) is present in the formulation at about 90-95 mg/ml, about 85-90 mg/ml, about 80-85 mg/ml, or about 80 mg / ml. Individual amino acids are widely available to those of skill in the art.
  • [Para 1 1 ]A stabilizing formulation is preferably used to store a virus as a liquid, freeze- dried preparation, lyophilized preparation, or other form.
  • the liquid formulation is a pharmaceutical formulation.
  • the freeze-dried or lyophilized preparation is typically converted to a liquid form by reconstituting it using a liquid, such as a pharmaceutically acceptable carrier.
  • the pharmaceutically acceptable carrier may be a liquid carrier that contains a buffer and a salt, for instance (i.e., PBS). Examples of suitable buffers and salts, as well as other types of pharmaceutically acceptable carriers, are well known in the art.
  • dissolution time is a very important characteristic of a suitable formulation. It is preferred that, following lyophilization of the virus preparation, the formulation have a dissolution time in a pharmaceutically acceptable carrier such as PBS of about 20-25 seconds, about 1 5-20 seconds or, preferably, about 1 5 seconds or less after storage for about 52 weeks at about 5 0 C. This provides the skilled artisan with a formulation that is rapidly useable in the field.
  • a pharmaceutically acceptable carrier such as PBS of about 20-25 seconds, about 1 5-20 seconds or, preferably, about 1 5 seconds or less after storage for about 52 weeks at about 5 0 C.
  • the temperature at which the virus is maintained in the stabilizing formulation is any suitable for maintaining the virus / formulation in a desired state (i.e., determined by observing appearance, dissolution time, titre or other characteristic of the preparation) over the time period of storage (i.e., up to about 52 weeks).
  • the formulation is typically and most conveniently maintained at a temperature below about 1 O 0 C, (i.e., about 5°C). In certain situations, the formulation will be maintained at -2O 0 C.
  • a suitable pH for the formulation following reconstitution is any pH at which the virus is maintained in a desired state (i.e., viability, infectious titer, dissolution time) over the time period of storage (i.e., up to about 52 weeks).
  • the pH of the liquid formulation desirably is about 6-9, 6-8.5 , 6.5-8.5 , 7-8.5, 7.5-8.5, 6-8, 6.5-8, 7-8, 7.5- 8, or 7-7.5. It is preferred that the formulation have a pH of about 7.5.
  • the liquid formulation can be placed (e.g., maintained or stored) in any suitable container.
  • the container will comprise, consist essentially of, or consist of glass or plastic in the form of a vial or other storage container.
  • viruses include, for example, Adenoviruses, Arboviruses, Astroviruses, Bacteriophages, Enteroviruses, Gastroenteritis Viruses, Hantavirus, Coxsackie viruses, Hepatitis A Viruses, Hepatitis B Viruses, Hepatitis C Viruses, Herpesviruses (for example, Epstein Barr Virus (EBV), Cytomegalovirus (CMV) and Herpes Simplex Virus (HSV)), Influenza Viruses, Norwalk Viruses, Polio Viruses, Chordopoxviridae (i.e., 5 Orthopoxvirus, vaccinia, MVA, NYVAC, Avipoxvirus, canarypox, ALVAC, ALVAC(2), fowlpox, Rhabdoviruses, Reoviruses, Rhinoviruses,
  • viruses include, for example, Adenoviruses, Arbo
  • Preferred viruses for use in practicing the present invention are poxvirases, in particular ALVAC.
  • Other suitable viruses are known in the art as described in, for example, Fields et al., Virology (34th ed., Lippincott Williams & Wilkins (2001 )).
  • the recombinant virus contains within its genome nucleic acid sequence encoding an antigen or immunogen, such that the virus may be used in an immunological formulation or vaccine.
  • the term "recombinant virus” refers to any virus having inserted into the viral genome a heterologous gene that is not naturally part of the viral genome.
  • An immunological formulation is one that, upon administration to a host, results in an immune response directed or reactive to the antigen or immunogen encoded by the virus. This immune response may or may not be protective or provide immunity to the host.
  • a vaccine is a formulation that causes the host to develop a protective immune response directed or reactive to the antigen or immunogen encoded by the host. Immune responses may be measured by any of the many techniques available to one of skill in the art, including but not limited to ELISA, BIACORE, DOT-BLOT, immunodiffusion techniques. [Para 18] In certain cases, the recombinant virus may encode one or more tumor antigens ("TA").
  • TA includes both tumor-associated antigens (TAAs) and tumor-specific antigens (TSAs), where a cancerous cell is the source of the antigen.
  • TAA tumor-associated antigens
  • TSA tumor-specific antigens
  • a TAA is an antigen that is expressed on the surface of a tumor cell in higher amounts than is observed on normal cells or an antigen that is expressed on normal cells during fetal development.
  • a TSA is an antigen that is unique to tumor cells and is not expressed on normal cells.
  • TA further includes TAAs or TSAs, antigenic fragments thereof, and modified versions that retain their antigenicity.
  • TAs are typically classified into five categories according to their expression pattern, function, or genetic origin: cancer-testis (CT) antigens (i.e., MAGE, NY-ESO-I ); melanocyte differentiation antigens (i.e., Melan A/MART-1 , tyrosinase, gpl OO); mutational antigens (i.e., MUM-I , p53, CDK-4); overexpressed 'self antigens (i.e., HER-2/neu, p53); and, viral antigens (i.e., HPV, EBV).
  • CT cancer-testis
  • MAGE MAGE
  • NY-ESO-I melanocyte differentiation antigens
  • mutational antigens i.e., MUM-I , p53, CDK-4
  • overexpressed 'self antigens i.e., HER-2/neu, p53
  • viral antigens i.e., HPV, EBV
  • a suitable TA is any TA that induces or enhances an anti-tumor immune response in a host to whom the TA has been administered.
  • Suitable TAs include, for example, gpl 00 (Cox et al., Science, 264:716-719 (1994)), MART-I /Melan A (Kawakami et al., y. Exp. Med., 180:347- 352 (1994)), gp75 (TRP-I ) (Wang et al., y. Exp. Med., 186:1 1 31 -1 140 (1996)), tyrosinase (Wolfel et al., Eur. J.
  • carcinoma- associated mutated mucins i.e., MUC-I gene products; Jerome et al., /.
  • Patent No. 5,348,887 kinesin 2 (Dietz, et al. Biochem Biophys Res Commun 2000 Sep 7;275(3):731 -8), HIP-55, TCF ⁇ -1 anti-apoptotic factor (Toomey, et al. BrJ Biomed Sci 2001 ;58(3):1 77-83), tumor protein D52 (Bryne J.A., et al., Genomics, 35:523-532 (1 996)), Hl FT, NY-BR-I (WO 01 /47959), NY-BR-62, NY-BR-75, NY-BR-85, NY-BR-87, NY-BR-96 (Scanlan, M.
  • the recombinant virus may encode an antigen or immunogen derived from an pathogenic organism.
  • infectious disease agents include bacteria, viruses, fungi, parasites, and the like.
  • Particular exemplary infectious agents include Bacillus spp. (i.e., B. anthracis), Bordetella spp. (i.e., B. brochiseptica, B. parapertussis, B. pertussis), Borellia (i.e., B. burgdorferi), Brucella spp., Campylobacter spp., Chalmydia spp. (i.e., C. trachomatis), Clostridium spp.
  • Clostridium botulinum Corynebacterium (i.e., C. diphtheria), Enterobacter spp., Escherichia spp. (i.e., E. coli), Haemophilus spp. (i.e., H. influenzae), Helicobacter spp. (i.e., H. pylori), Klebsiella spp., Legionella spp., Listeria spp., Mycobacterium spp. (i.e., M. tubercolosis), Mycoplasma spp., Neisseria spp. (i.e., N. meningitidis, N.
  • Corynebacterium i.e., C. diphtheria
  • Haemophilus spp. i.e., H. influenzae
  • Nocardia spp. Pasteurella spp., Proteus spp., Rickettsia spp., Salmonella spp. (i.e., S. entiriditis, S. typhi), Shigella spp. (i.e., Shigella flexneri), Staphylococcus spp. (i.e., S. aureus), Streptococcus spp. (i.e., S. pneumoniae), Vibrio spp. (i.e., V.
  • cholerea Coronavirus
  • CMV Dengue virus
  • Ebola virus EBV
  • Hepatitis virus i.e., Hepatitis A, B, C, D, and E
  • Herpes virus HIV, Influenza virus, Measles virus, Mumps virus, Papillomaviruses (human), pox viruses (i.e., vaccinia, smallpox), polio virus, rabies virus, RSV, West Nile virus, Yellow Fever virus, Aspergillus spp., Blastomyces spp., Candida spp., Coccidioides spp., Cryptococcus spp., Histoplasma spp., Coccidia spp., Cryptosporidum spp., Entamoeba spp.
  • an immunogenic formulation or vaccine of the present invention may be administered in combination with one or more adjuvants to boost the immune response.
  • adjuvants are shown in Table 1 below: [Para 21 ] Table 1 - Types of Immunologic Adjuvants
  • EAA Lit Number 3065605 Gibco
  • Glycine Powder Lit Number 32K2502 Sigma
  • Tris Lit
  • ZapCap ® ALVAC Virus vCP307 encoding the HIV antigen gpl 20, Lot Number PX-0246 and
  • Lot Number PX-0230 was utilized as the exemplary virus for the experiments described below.
  • Osmolality is the total solute concentration of an aqueous solution. Osmometers measure the number of solute particles irrespective of molecular weight or ionic charge. This study used the Advanced Micro-Osmometer Model 3300, which relies on freezing-point depression to measure osmolality. The osmometer was calibrated using 50mOsm/kg and 850 m ⁇ sm/kg Calibration Standards as per manufacturing instructions. Calibration was verified by running Clinitrol 290 reference Solution. 20 ⁇ L samples were loaded into the plunger and inserted into the osmometer sample port for measurement. When the digital display shows a constant reading, the reading is recorded. [Para 291 Residual Moisture
  • Residual moisture is the amount of bound water that remains in a freeze- dried product following primary drying.
  • the Karl Fisher Technique for testing for residual moisture used in this study, determines water content by volumetric titration. This is measured as the weight percentage of water remaining compared to the total weight of the dried product.
  • RM is an indicator of stability as exposure to moisture during storage can destabalize a product.
  • the European Pharmacopea (V Edition) recommends an RM below 3%. This RM helps avoid microorganism development as well as preventing chemical and physical degradation.
  • the Karl Fisher Coulometric Method is used with a test method designed for use with the Mitsubishi, Model CA-06 Automatic Titration system which determines the end point amperometrically.
  • CCIDso is a technique used to determine the titre (infectivity) of a virus, in this case, titre of the freeze-dried ALVAC formulation following dissolution. Titre is reflected by the dilution of a virus required to infect 50% of a given batch of inoculated cell cultures. The assay relies on the presence and detection of cytocidal virus particles (those capable of causing a cytopathic effect (CPE)). Host cells are grown in confluent healthy monolayers, typically in 96-well plates, to which aliquiots of virus dilutions are added. On incubation, the virus replicates and progeny virions are released, which in turn infect healthy cells.
  • CPE cytopathic effect
  • the CPE is allowed to develop over a period of time, and wells are scored for the presence or absence of CPE.
  • the method becomes more accurate with increasing number of wells per dilution. This test is crucial for determining the loss of activity of the attenuated ALVAC virus during storage.
  • Lyophilization is a dehydration technique in which a dry state is achieved by freezing a wet substance and evaporating the resulting ice under vacuum through a sublimation process (without melting). This process is conventionally divided into three stages: pre-freezing, primary or sublimation drying and secondary or desorption drying. The 24 hours freeze-drying cycle of ALVAC-based expression vectors was run as summarized in Table 2 below: [Para 36] Table 2 - Freeze Dryer Cycle
  • Dissolution time for formulations F9 was slightly increased following 52 weeks of storage at -20°C and 5°C compared with the other stabilizers (Fl 0-1 2), which dissolved in less than 1 5 seconds.
  • Each vial was reconstituted with 1 ml of NaCI 0.4% and mixed manually until dissolution of the entire cake. It was concluded that the inclusion of PVP40 positively effects on the dissolution time of the final product. For those samples stored under stress conditions (35-37°C), the dissolution time was considerably increased for all of the formulations, from 1 5 seconds to more than one minute. Furthermore, where the appearance of the cake was melted, the product stuck to the vials making it difficult to reconstitute the lyophilizate.
  • freeze-dried Fl 2 showed similar titres as the liquid formulation at 2-8 0 C (as well as control temperatures -2O 0 C and -7O 0 C) and superior titres to the liquid formulation at 25°C and 37 0 C.
  • Fl 2 is a freeze-dried formulation, which is the formulation format favored by those of skill in the art, it can be concluded that Fl 2 is superior to the previously available liquid formulation.

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JP2009516519A (ja) 2009-04-23
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BRPI0618850A2 (pt) 2011-09-13
IL191595A (en) 2012-05-31
US20150265688A1 (en) 2015-09-24
KR101357685B1 (ko) 2014-02-06
CA2630349A1 (en) 2007-05-24
JP5138601B2 (ja) 2013-02-06
US20090169581A1 (en) 2009-07-02
CN104984352A (zh) 2015-10-21
KR20080070866A (ko) 2008-07-31
CN101360821A (zh) 2009-02-04

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