PEGylated Adenoviruses: From Mice to Monkeys
Abstract
:1. Introduction
2. PEGylation: The Early Years
2.1. The Chemistry
2.2. Tolerization to Antigens, Tissues and Cells
3. PEGylation in the Pharmaceutical Industry
Parent Molecule | Generic name | Trade name (company) | Size of PEG moiety (kDa) | Indication | Year of approval |
---|---|---|---|---|---|
Adenosine deaminase | Pegademase bovine | AdagenÒ (Enzon) | 5 | Severe combined immunodeficiency disease (SCID) | 1990 |
L-asparaginase | Pegaspargase | OncasparÒ (Enzon) | 5 | Acute lymphoblastic leukemia | 1994 |
Interferon α-2b | Peginterferon α-2b | PegIntronÒ (Schering-Plough) | 12 | Hepatitis C | 2000 |
Interferon α-2a | Peginterferon α-2a | PegasysÒ (Genetech) | 40 | Hepatitis C | 2001 |
G-CSF | Pegfilgrastim | NeulastaTM (Amgen) | 20 | Neutropenia | 2002 |
hGH | Pegvisomant | SomavertTM (Pfizer Pharmacia) | 5 | Acromegaly | 2003 |
Erythropoietin | Methoxy polyethylene glycol-epoetin beta | Mircera (Roche) | 40 | Anemia | 2007 |
Anti-TNF α Fab | Certolizumab pegol | Cimzia (UCB) | 40 | Rheumatoid arthritis and Crohn’s disease | 2008 |
Pharmacokinetic Parameter | IFN-α | PegIntron (PEG-IFN α-2b) | Pegasys (PEG-IFN α-2a) |
---|---|---|---|
Elimination half life (hours) | 6-9 | 32-40 | 72-96 |
Clearance (ml/hour) | 6,000 | 725 | 60-100 |
Volume of distribution (L) | 25-30 | 20-40 | 8 |
Tmax (hours) | 7-12 | 20 | 80 |
4. PEGylation and Gene Therapy in the 21st Century
4.1. Non-Viral Vectors.
Virus | Model | Biological effects | Ref. |
---|---|---|---|
Adeno-associated virus | in vitro | Conjugation of AAV with monomethoxy poly(ethylene) glycols activated by tresyl chloride (TMPEG) and succinimidyl succinate (SSPEG) chemistries did not compromise transduction efficiency. | 66 |
PEGylation with either 2 kDa or 5 kDa PEG at 1:1, 10:1, 100:1 and 1000:1 PEG:lysine ratios did not compromise transduction efficiency. Conjugation of rAAV with 2 kDa PEG at the 1000:1 PEG lysine ratio protected from serum neutralization. | 67 | ||
in vivo | SSPEG and TMPEG improved gene transduction in the lung without compromising transduction efficiency in the liver and muscle. TMPEG reduced Th1-type response. Successful readministration of virus after iv injection was achieved by modification with TMPEG. | 66 | |
Lentivirus | in vitro | Transduction efficiency of PEGylated virus was not compromised in the presence of neutralizing antibodies PEGylation provided a 20 fold resistance to antiserum and extended circulatory half-life by a factor of 5 with no observable loss in titer and prevented interaction with antibodies and inactivation of virus by complement in human and mouse sera. | 68 |
in vivo | PEGylation extended the circulation half-life by a factor of 5 PEGylation improved transduction efficiency in the bone marrow and in the spleen 14 days after systemic administration of virus. | 68 | |
Retrovirus | in vitro | Coating of retrovirus with PEG-poly(L-lysine)(PLL) block copolymer improved transduction efficiency 3 to 7 fold without increasing cytotoxicity. | 69 |
Conjugation of a (1,2-distearoyl-sn-glycero-3-phosphoethanolamine), polyethylene glycol and biotin complex[DSPE-PEG-biotin] increased the number of viruses that bound to streptavidin coated plates by more than three-fold. | 70 | ||
Baculovirus | in vitro | Transduction efficiency was deceased with an increased amount of PEG added to the virus surface. | 71 |
in vivo | PEGylation improved transduction efficiency in the lung and brain. | 71 | |
Influenza virosomes | in vitro | Reconstituted viral membranes containing 3 mol% poly(ethylene –glycol) grafted phosphatidylethanolamine retained 40% of their fusion activity. | 72, 73 |
4.2. The Adenovirus
4.3. Characterization of PEGylated Adenoviruses
4.4. Pharmacology of Adenovirus-Pharmacokinetics and Biodistribution
↑AUC | ↓CL | ↑Half-life | |||||
---|---|---|---|---|---|---|---|
PEG size | 3.4 kDa | 5 kDa | 5 kDa | 20 kDa | |||
Degree of modification | - | - | 30% | 60% | 90% | 100% | 45% |
Fold change in Pharmacokinetic parameter | 12 | 4 | 1.3 | 2 | 3 | 22 | 25 |
4.5. Toxicology of PEGylated Adenovirus
4.6. The Immune Response
5. Re-Directing Adenovirus by Physical Means: Effect of Molecular Size and Degree of PEGylation
Re-Directing Adenovirus by Chemical Means: Use of PEG as a “Linker” for Attachment of Receptor-Specific Conjugates
6. PEGylated Adenovirus-Based Vaccines
7. The Future of PEGylation of Viruses for Gene Transfer and Vaccine Applications
Acknowledgments
References
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Wonganan, P.; Croyle, M.A. PEGylated Adenoviruses: From Mice to Monkeys. Viruses 2010, 2, 468-502. https://doi.org/10.3390/v2020468
Wonganan P, Croyle MA. PEGylated Adenoviruses: From Mice to Monkeys. Viruses. 2010; 2(2):468-502. https://doi.org/10.3390/v2020468
Chicago/Turabian StyleWonganan, Piyanuch, and Maria A. Croyle. 2010. "PEGylated Adenoviruses: From Mice to Monkeys" Viruses 2, no. 2: 468-502. https://doi.org/10.3390/v2020468