Herpesvirus compositions and related methods
Inventors
Anderson, Stephen • Delagrave, Simon • Hamberger, John • Li, Qinglian • Mundle, Sophia • Rahman, Nausheen
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11260123-B2
Publication Date
2022-03-01
Expiration Date
Abstract
The present disclosure relates to liquid and dried compositions comprising a live, attenuated or genetically modified herpesvirus and methods of preparing such compositions, in one aspect, the composition comprises at least two or more pharmaceutically acceptable exctpients, at least one of which is histidine and at least one of which is a sugar or sugar alcohol. The compositions retain a sufficiently high infectious titre following storage or large-scale manufacturing steps, such as lyophilization.
Core Innovation
The invention relates to herpesvirus liquid and dried formulations that include a live, attenuated or genetically modified herpes simplex virus type-2 (HSV-2) or herpes simplex virus type-1 (HSV-1). The formulations are stabilized using excipients comprising histidine together with sucrose or trehalose, sodium chloride, and glutamate, and are characterized by a pH of about 6.5 to 7.5 in dried form.
The dried formulations maintain infectious titre after drying and after storage. Reported stability includes retention of infectious titre after freeze-drying (lyophilization) and other drying formats including foam-drying and spray-drying, and the formulations are described as stable over refrigerated and elevated temperatures, including during temperature excursion studies.
The disclosure also describes embodiments with controlled formulation features that include residual moisture and defined buffer compositions. The virus-containing formulations are combined with excipients and then dried, and the content emphasizes comparisons to alternative stabilizer systems while still maintaining infectious titre.
Claims Coverage
The independent claims cover three core composition categories for live, attenuated or genetically modified HSV-1 or HSV-2 in dried form, each defined by a controlled pH and a stabilizing excipient set. Across the independent claims, the inventive features focus on histidine or histidine/glutamine, sucrose or trehalose, sodium chloride, glutamate, and compositional constraints for the dried compositions.
Dried HSV composition stabilized with histidine, sucrose or trehalose, sodium chloride, and glutamate at defined pH
A composition consisting of a live, attenuated or genetically modified herpes simplex virus type-2 (HSV-2) or herpes simplex virus type-1 (HSV-1), 1 mM to 50 mM histidine, sucrose or trehalose, sodium chloride, and glutamate, wherein the composition is in dried form and has a pH of about 6.5 to 7.5.
Dried HSV composition stabilized with histidine or glutamine, sucrose or trehalose, sodium chloride, and glutamate at defined pH
A composition consisting of a live, attenuated or genetically modified herpes simplex virus type-2 (HSV-2) or herpes simplex virus type-1 (HSV-1), 1 mM to 50 mM histidine or glutamine, sucrose or trehalose, sodium chloride, and glutamate, wherein the composition is in dried form and has a pH of about 6.5 to 7.5.
Dried HSV composition with approximately 10 mM histidine, about 10% w/v sucrose or trehalose, and about 50 mM glutamate at defined pH
A composition consisting of a live, attenuated or genetically modified herpes simplex virus type-2 (HSV-2) or herpes simplex virus type-1 (HSV-1), about 10 mM histidine, about 10% w/v sucrose or trehalose, sodium chloride, and about 50 mM glutamate, wherein the composition is in dried form and has a pH of about 6.5 to 7.5.
The claim coverage is centered on dried formulations of live, attenuated or genetically modified HSV-1 or HSV-2 that include sucrose or trehalose, sodium chloride, and glutamate, with histidine or histidine/glutamine present within defined ranges and the composition maintained at a pH of about 6.5 to 7.5.
Stated Advantages
Retains infectious titre after drying and after storage in both liquid and dried formulations.
Provides stability across refrigerated and elevated temperatures, including during temperature excursion studies.
Documented Applications
Vaccine and kits are described, including formulations with reconstitution and delivery guidance.
Interested in licensing this patent?