Transplant Therapeutics Consortium Receives FDA Review for Innovative iBox Scoring System

FDA Notifies iBox Scoring System Reviewability

On July 30, 2025, the American Society of Transplant Surgeons (ASTS) and the American Society of Transplantation (AST) announced a significant milestone for kidney transplant science. The Transplant Therapeutics Consortium (TTC) has been informed by the FDA about the Reviewability of their Full Qualification Package (FQP) for the innovative iBox Scoring System. This system has been developed as a potentially revolutionary composite biomarker endpoint that could change how long-term graft survival is predicted after kidney transplantation.

The iBox Scoring System is the first of its kind to reach this crucial stage in the FDA qualification process. Designed to predict long-term graft success, it uses a combination of clinical indicators to assess a kidney transplant’s viability over time.

Addressing a Critical Need in Transplantation

The long-term survival of transplanted kidneys is an area lacking in effective solutions, thus creating a critical need for improved approaches. Traditionally, efficacy endpoints in transplant research have been inadequate, often focusing only on the non-inferiority of current immunosuppressive treatments. In contrast, the iBox Scoring System aims to demonstrate the superiority of new agents against standard treatments, potentially reshaping clinical trial outcomes.

Dr. Kenneth Newell, a key member of the TTC and a surgical professor at Emory University, highlighted the stagnation in the development of new therapeutics, attributing this to outdated clinical trial methodologies. He praised the FDA for advancing the iBox as a coprimary endpoint, emphasizing the role patient advocacy plays in pushing for innovative therapies that benefit transplant recipients.

Major hurdles have historically impeded improvements in transplant drug effects, yet the latest decision from the FDA indicates a promising shift. With a targeted approval review timeline of 10 months, aiming for a conclusion by April 2026, the iBox system holds the potential to be a game-changer for patients reliant on organ transplants.

Collaborations and Promising Developments

In the context of national policies that govern health outcomes for transplant recipients, Paul T. Conway, Vice President of the American Association of Kidney Patients, reflected on decades of bipartisan focus on organ transplantation and patient sustainability. He expressed hope that recent FDA actions signal a more patient-centered approach in drug development for transplant therapies, thereby enhancing long-term outcomes for the transplant community.

Dr. Karin Hehenberger, President of Lyfebulb and kidney-pancreas transplant recipient, emphasized the excitement surrounding the iBox’s potential to usher in new therapeutic options for patients. Living with transplants herself, she advocates for a future where patients experience better survival rates of their grafts with fewer adverse effects.

Understanding the iBox Scoring System

The iBox Scoring System uniquely considers various clinically relevant factors such as estimated glomerular filtration rate (eGFR), levels of proteinuria, and donor-specific antibodies one year post-transplant to predict graft survival over a five-year period. This comprehensive approach was developed through extensive research led by Professor Alexandre Loupy and has been validated through studies involving thousands of transplant patients across the United States and Europe.

Accelerated Approval Process

The FDA's Accelerated Approval Program facilitates quicker access to therapies addressing serious health conditions, grounded in reasonably likely surrogate endpoints backed by robust mechanistic analysis. If approved, the iBox could pave the way for expedited access to new immunosuppressants designed specifically for kidney transplantation — a much-required advancement in therapies that aim to ease the lives of transplant patients.

The Role of the TTC

Established by the AST and ASTS in 2017, the Transplant Therapeutics Consortium is a collaboration between the transplant field, industry, and regulatory bodies, focused on fostering innovative solutions to enhance transplant recipients' quality of life. The successful submission of the FQP utilized the vast resources and collaborative efforts of TTC members, creating a responsible pathway toward major advancements in drug development.

For further engagement or resources on the iBox Scoring System and its development, stakeholders are encouraged to reach out to the TTC, as many iconic organizations stand behind this initiative aimed at transforming transplant therapies.