Pre-Deimmunization of a Functional Therapeutic Report
Using our proprietary EpiMatrix platform, our immunogenicity experts can produce an “FDA Ready” PreDeFT Report for your R&D team. These reports are like manuscripts – they include detailed information about your protein therapeutics’ immunogenic potential along with an expert interpretation of the data with recommendations on the next steps.
EpiVax PreDeFT Reports are used to:
- Assess a protein therapeutics’ overall and regional immunogenic potential
- Direct R&D strategies
- Support IND fillings
- Evaluate candidates for deimmunization or redesign
- Support research grant applications
- Add immunogenicity data to your publications
A PreDeFT report is a concise description of a protein therapeutic candidate’s immunogenic potential. To complete a PreDeFT analysis we use our EpiMatrix platform to parse each input sequence into all possible “frames” of 9 amino acids, corresponding to the minimal length of an HLA-binding peptide. As each frame overlaps the previous by 8 amino acids, all possible frames are considered. Each frame is then assessed for its ability to bind with a set of eight common class II HLA alleles. These detailed findings are then summarized producing regional and overall assessments of T-cell dependent immunogenic potential. Any potential T-cell epitopes identified during the PreDeFT analysis are screened against the protein database at GenBank and against EpiVax’s own database of known MHC ligands and T-cell epitopes. In our final report we rank a protein candidate against other known immunogenic and non-immunogenic protein sequences; we then identify specific regions within a protein candidate that have the potential to trigger an immune response. Should you wish to go beyond in-silico screening the results of our analysis can be validated in-vitro and in-vivo (using our proprietary HLA binding assays and HLA transgenic mice). EpiVax’s PreDeFT analysis reports have been used to support regulatory filings and can increase the likelihood of a favorable review.
Please note that PreDeFT reports can be formatted to fit your project. We will work with your team to assess your candidate(s) needs – concierge style. Most of our clients typically screen single candidates and/or their variants to produce a single detailed report. We also have the ability to screen large numbers of candidates for their relative immunogenic potential – called an ISPRI-HT (high throughput) Analysis.
We have successfully have screened: Single mAbs, large and small sets of mAbs, fusion proteins, biosimilars/biobetters, various plasma proteins, plant toxins, animal toxins, bacterial toxins, cell surface proteins, synthetic peptides and many more.
What if your candidate(s) shows high risk? Can can EpiVax deimmunize a therapeutics? The answer is yes, please see our DeFT page for more information.
Sample PreDeFT Reports
Explore the sample report below. This particular report was for an antibody. Please note, the report has been slightly redacted to protect confidentiality.
Contact Us Here for a Cost Estimate for your project.
Are you part of team who has multiple (or large) projects? Want to bring our immunogenicity screening tools in-house? You need ISPRI!