Anti-polyethylene glycol (PEG) antibody mouse model for rigorous assessment of PEG-based therapies
AssigneeNorthwestern University
InventorsEvan A. Scott, Guillermo A. Ameer, Jacqueline A. Burke, Helena Freire Haddad
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Abstract
The present invention provides methods of making an in vivo animal model for detecting anti-poly(ethylene glycol) (PEG) antibodies. The methods of the disclosure comprises administering subcutaneously to an animal model a composition comprising antibodies against poly(ethylene glycol) chains with a molecular weight of at least 550 Da to maintain an anti-PEG antibody level within the animal model. The in vivo animal model can be used for testing and screening drugs and other compositions for adverse reactions, bioavailability, and immunogenicity prior to administration to a human subject.
Claims19
A method of making an in vivo model for detecting and monitoring anti-poly(ethylene glycol) (PEG) antibodies and an immune response to antigens recognized by the anti-PEG antibodies, the method comprising:
- (a) administering subcutaneously to an animal model a composition comprising at least one commercially available antibody against poly(ethylene glycol) chains with a molecular weight of at least 550 Da, wherein the at least one commercially available antibody is selected from antibody clone 1D9-6, antibody clone 5E10E9, antibody clone 5D6-3, and antibody clone 09F02;
- and
- (b) detecting anti-PEG antibodies within the animal model at a level of at least 44 ng/ml.
A method of making an in vivo model for detecting anti-poly(ethylene glycol) (PEG) antibodies and an immune response to PEG-containing compounds recognized by the anti-PEG antibodies, the method comprising:
- (a) administering subcutaneously to an animal model a composition comprising at least one commercially available antibody against one or more poly(ethylene glycol) chains with a molecular weight of at least 550 Da, wherein the at least one commercially available antibody is selected from antibody clone 1D9-6, antibody clone 5E10E9, antibody clone 5D6-3, and antibody clone 09F02;
- (b) administering one or more booster injections subcutaneously at least 14 days after step (a);
- and
- (c) detecting anti-PEG antibodies within the animal model at a level of at least 44 ng/ml.
Dependencies are inferred from the claim text.