Pre-Deimmunization of a Functional Therapeutic Report
Using our proprietary EpiMatrix platform, the immunogenicity experts at EpiVax can produce an “FDA Ready” PreDeFT Report for your R&D team. These reports are manuscripts which include detailed information about a protein therapeutic’s immunogenic potential along with an expert interpretation of the data and recommendations for next steps.
EpiVax PreDeFT Reports are used to:
- Assess a protein therapeutic’s overall and regional immunogenic potential
- Direct R&D strategies
- Support IND filings
- 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. The PreDeFT analysis relies on the EpiMatrix platform to parse a protein candidate into all possible 9-mer frames where each frame overlaps the last by 8 amino acids. Each frame is then assessed for its ability to bind with a set of eight common class II HLA alleles. These detailed findings are summarized, producing regional and overall assessments of T-cell dependent immunogenic potential. Any potential T-cell epitopes identified during the analysis are screened against the protein database at GenBank and against EpiVax’s own database of known MHC ligands and T-cell epitopes.
In the final report, we rank a protein candidate against other known immunogenic and non-immunogenic protein sequences; we then identify specific regions 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 Reports have been used to support regulatory filings and can increase the likelihood of a favorable review.
The PreDeFT Report can be formatted to fit any project. EpiVax will work with your team to understand your needs – concierge style. Most of our clients screen single candidates and/or their variants to produce a single detailed report. We also have the ability to screen a large set of candidates for relative immunogenic potential – called the ISPRI-HT (high throughput) Analysis.
We have successfully screened: Single mAbs, small and large sets of mAbs, fusion proteins, biosimilars, biobetters, plasma proteins, plant toxins, animal toxins, bacterial toxins, cell surface proteins, synthetic peptides and more.
If your candidate shows high risk, can EpiVax deimmunize a therapeutic? Yes we can! See our DeFT page for more information.
Sample PreDeFT Reports
Explore the sample reports below. Please note, the reports have been slightly redacted to protect confidentiality.
- EpiVax Sample PreDeFT Report – 1 mAb
- EpiVax Sample PreDeFT Report – 1 Protein
Printable PreDeFT Summary and Scope of Work Here. Contact Us Here for a Cost Estimate for your project.
Does your team have multiple (or large) projects? Want to bring our immunogenicity screening tools in-house? You need ISPRI!