Methods and products for evaluating an immune response to a therapeutic protein
US9709575B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Jul 14, 2014 |
| Grant date | Jul 18, 2017 |
| Priority date | — |
| Expiry date | Jul 14, 2034 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG01N2800/52
- WIPO fieldMeasurement
- WIPO sectorInstruments
Abstract
The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. A first aspect of the invention relates to methods and compositions for identifying a clinically significant immune response in patients treated with therapeutic amounts of VLA4 binding antibody (e.g., natalizumab). A second aspect of the invention concerns the chronological details of sample collection for determining the titer of antibodies against the therapeutic protein, e.g. the collection of at least two samples at two different time points. A third aspect of the invention relates to the selection of the critical threshold level, which corresponds to the antibody titer of untreated patients increased by the double of the standard deviation of this control antibody titer.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.