Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk
Public support
Provider
Ministry of Education, Youth and Sports
Programme
—
Call for proposals
IMI-JU-2010
Main participants
Univerzita Karlova / 1. lékařská fakulta
Contest type
RP - Co-financing of EC programme
Contract ID
MSMT-35199/2012-32
Alternative language
Project name in Czech
Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk
Annotation in Czech
Clinical development of new biopharmaceutical products (BPs) offers the opportunity to biologically treat entirely new classes of diseases than ever before. As advances in the design and development of these complex biologic entities evolve, the ability to assess, or even predict, the immunogenicity potential of each new product must be considered. Through this ABIRISK Consortium we are bringing together in a very significant way, a world class group of clinicians with experience administering BPs, access to clinical samples from large cohorts of treated patients, leading EFPIA companies with extensive experience in development of medicines and the regulatory aspects of drug registration, renowned academic scientists, immunologists, database experts, and statisticians. Collectively, this group will critically evaluate the immunogenicity of existing BPs for Hemophilia A, Multiple Sclerosis, and Inflammatory Diseases, and develop standardized Anti-Drug-Antibody assays, including Neutralizing Antibody Assays, for each BP. Novel integrated approaches to characterize anti-drug lymphocyte responses will be used to provide insight into the basic mechanisms by which BPs drive immune cell activation. The predictive value of existing as well as new tools used for prediction of protein drug immunogenicity will be explored and evaluated, including T cell assays, in silico prediction, in vitro generated BP-derived agretopes generated by processing in human dendritic cells, measurement of peptide affinity for HLA class II molecules, modulation of dendritic cell function and activation by BPs, human in vitro PBMC assays, use of artificial lymph nodes, animal models, and generation of post-translational modifications and aggregates and characterizing them in various models.
Scientific branches
R&D category
AP - Applied research
CEP classification - main branch
FH - Neurology, neuro-surgery, nuero-sciences
CEP - secondary branch
FH - Neurology, neuro-surgery, nuero-sciences
CEP - another secondary branch
FH - Neurology, neuro-surgery, nuero-sciences
OECD FORD - equivalent branches <br>(according to the <a href="http://www.vyzkum.cz/storage/att/E6EF7938F0E854BAE520AC119FB22E8D/Prevodnik_oboru_Frascati.pdf">converter</a>)
30103 - Neurosciences (including psychophysiology)<br>30210 - Clinical neurology
Completed project evaluation
Provider evaluation
U - Uspěl podle zadání (s publikovanými či patentovanými výsledky atd.)
Project results evaluation
Following the condition that the candidate of financial contribution was evaluated and afterwards selected by international provider in accordance with the rules of the program the Ministry of Education, Youth ans Sports does not realize the evaluation of project results. The project is evaluated only after its approval by an international provider.
Solution timeline
Realization period - beginning
Oct 1, 2012
Realization period - end
Feb 27, 2017
Project status
U - Finished project
Latest support payment
Feb 15, 2017
Data delivery to CEP
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data delivery code
CEP18-MSM-7H-U/01:1
Data delivery date
Jun 11, 2018
Finance
Total approved costs
2,629 thou. CZK
Public financial support
2,629 thou. CZK
Other public sources
0 thou. CZK
Non public and foreign sources
8,448 thou. CZK