Predicting the risk of immune reactions to protein impurities in biosimilar drugs
ISPRI-HCP: CHO protein impurity immunogenicity risk prediction for improving biosimilar product development and assessing product interchangeability
['FUNDING_U01'] · EPIVAX, INC. · NIH-10620080
This study is working on a new online tool that helps make safer biosimilar drugs by predicting how likely certain proteins from the production process might cause immune reactions in patients.
Quick facts
| Phase | ['FUNDING_U01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | EPIVAX, INC. (nih funded) |
| Locations | 1 site (PROVIDENCE, UNITED STATES) |
| Trial ID | NIH-10620080 on ClinicalTrials.gov |
What this research studies
This research focuses on improving the development of biosimilar drugs by predicting the immunogenicity risk associated with host cell proteins (HCP) that may be present in these biologics. The team has created a web-based tool called ISPRI-HCP that evaluates the potential for immune reactions based on the characteristics of HCP sequences. By analyzing T cell epitope counts and their conservation in the human genome, the tool aims to classify HCP impurities and assess their risk of causing immune responses. This approach could enhance the safety and effectiveness of biosimilars for patients.
Who could benefit from this research
Good fit: Ideal candidates for this research are patients who may be prescribed biosimilar drugs, particularly those with conditions requiring biologic therapies.
Not a fit: Patients who are not candidates for biosimilar therapies or those who do not have conditions treated by biologics may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to safer biosimilar medications with reduced risk of immune reactions for patients.
How similar studies have performed: Previous research has shown promise in predicting immunogenicity using computational methods, suggesting that this approach could be effective.
Where this research is happening
PROVIDENCE, UNITED STATES
- EPIVAX, INC. — PROVIDENCE, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: DEGROOT, ANNE SEARLS — EPIVAX, INC.
- Study coordinator: DEGROOT, ANNE SEARLS
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.