Transplant Therapeutics Consortium Receives Acceptance of Letter-of-Intent for the iBox Scoring System

Critical Path Institute(C-Path) announced today that its Transplant Therapeutics Consortium (TTC) has received a positive response to its Letter of Intent (LOI) from the U.S. Food and Drug Administration (FDA) detailing the decision to accept the iBox Scoring System (Composite Biomarker Panel) into the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program (BQP).

The iBox Scoring System is a risk prediction tool that combines measurements of kidney function, immunological status, and pathological assessment of kidney biopsy histology to predict the risk of graft-loss up to seven years after the time of risk assessment. The iBox Scoring System has been extensively validated for use in the treatment of individual patients in the clinical care setting. The TTC, in close collaboration with the Paris Transplant Group, is seeking to translate this work into the regulatory setting for use in drug development programs. If qualified as a reasonably likely surrogate endpoint, the Composite Biomarker Panel will be publicly available and facilitate any drug sponsor seeking accelerated approval of novel agents, significantly reducing the time required to bring a new therapeutic agent to patients.

Co-founded by AST and ASTS, the TTC is a collaboration within the transplant community including clinicians, surgeons, industry scientists, and others.