The iBox Scoring System is a novel composite biomarker endpoint predictive of long-term graft survival after kidney transplantation
On track to be the first qualified reasonably likely surrogate endpoint in transplant for use in the FDA accelerated approval pathway
FDA aims for a 10 month review of the Full Qualification Package
MOUNT LAUREL, N.J., July 30, 2025 /PRNewswire/ — The American Society of Transplant Surgeons (ASTS) and American Society of Transplantation (AST) announced today that the Transplant Therapeutics Consortium (TTC) received notification from FDA of the Reviewability of the Full Qualification Package (FQP) for the iBox Scoring System, a novel reasonably likely surrogate efficacy endpoint for kidney transplant clinical trials. The FDA Drug Development Tool qualification program aims to communicate the final decision within 10 months targeting April 2026. The Full Qualification Package is the final step in the FDA qualification process and iBox scoring system is the first transplant endpoint to reach this stage of qualification.
Improving the long-term survival of transplanted kidneys is an important area of unmet need for transplantation recipients. The current efficacy failure endpoint has typically shown non-inferiority of immunosuppressive regimens but the iBox Scoring System is proposed to be used to demonstrate the superiority of a new agents compared to the standard of care as a co-primary endpoint in pivotal drug therapeutic studies. As a reasonably likely surrogate endpoint, the iBox scoring system would be used in the Accelerated Approval Pathway at the FDA designed to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need.
“It’s not surprising that using a clinical trials endpoint that is nearly four decades old has been a significant impediment to the development of new therapeutics for maintenance immunosuppression and has contributed to the relatively stagnate long-term outcomes of kidney transplants. I applaud the FDA for working with the TTC to develop the iBox as a coprimary endpoint for clinical trials in kidney transplantation. We have recognized the strong push from the patient community for new agents that promote both longer survival of transplanted organs and improved safety and tolerability. I hope that this is the first of many collaborative efforts to validate and implement new drug development tools to achieve that end,” said Kenneth Newell, MD, PhD, Professor of Surgery, Emory University and Executive Committee Member of the TTC.
Paul T. Conway, Vice President and Chair of Policy and Global Affairs, American Association of Kidney Patients (AAKP) and a 28-year kidney transplant recipient stated, “For decades, bipartisan national policy priorities, across multiple presidential administrations and Congresses, have included transplantation and sustainable long-term transplant outcomes as a means for saving more lives, protecting livelihoods, and reducing patient and taxpayer burdens. Yet, due to policy barriers, the transplant drugs patients currently depend upon to avoid organ rejection and a return to the transplant waiting list have failed to evolve and pose serious risks to both organ recipients and grafts. AAKP is optimistic that recent FDA action on the iBox is a signal the agency is putting transplant patients first, accelerating transplant drug development and re-aligning internal FDA decision-making to better advance long-standing American policy priorities.” Conway previously served as the inaugural Chair of the FDA’s Patient Engagement Advisory Committee for medical devices.
“We celebrate this step toward a regulatory process that will allow for many more drugs to enter into the transplant drug development path. The patient community has been starved of new approaches to keep their precious grafts alive and thriving for a longer time, with fewer side effects and complications. As a person living with transplants derived from selfless individuals, I can speak for the transplant patient community in applauding this progress toward our goal of leveraging modern day science to achieve one transplant for life,” said Dr. Karin Hehenberger, President Lyfebulb, and a kidney and pancreas transplant recipient.
About iBox
The iBox scoring system is a composite endpoint that utilizes multiple clinically relevant features (estimated glomerular filtration rate (eGFR), proteinuria, anti-human leukocyte antigen donor-specific antibody, and kidney graft biopsy histopathology) at one-year post-transplant to predict 5-year graft survival. The iBox scoring system (NCT03474003), has been developed and validated in a landmark publication released in the BMJ by a team of researchers led by Professor Alexandre Loupy in Paris French NIH (Inserm), APHP and Université Paris Cité, comprising 7557 patients from 10 academic centers from Europe and the US and 3 Randomized controlled trials.
About FDA Accelerated Approval
The FDA Accelerated Approval Program is designed to facilitate and expedite development of drugs that treat serious conditions, and fill an unmet medical need based on a reasonable likely surrogate endpoint (RLSE) that is supported by strong mechanistic and/or epidemiologic rationale. The Qualification of the iBox would allow it to be used as a RLSE for accelerated approval of novel new immunosuppressants for kidney transplantation. The Accelerated Approval program has historically been successful advancing new innovative therapies for HIV and cancer and most recently promoted the introduction of 4 new drugs for IgA nephropathy, a chronic kidney disease with no approved therapies 5 years ago before the use of proteinuria as a surrogate endpoint.
About TTC
The Transplant Therapeutics Consortium (TTC) is a public-private partnership with the FDA founded in 2017 by the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS). This collaboration unites the transplant community, industry leaders, and regulatory agencies dedicated to the development of innovative tools, methods and processes for facilitating advancement of new innovative therapies to improve the lives of solid organ transplant recipients.
This submission of the FQP was accomplished by employing the resources of the TTC members and engaging with FDA throughout the biomarker qualification process. TTC is supported through funding and input from the AST*, ASTS*, argenx*, Arkana Laboratories*, Bristol Myers Squibb*, CareDx*, Critical Path Institute, CSL, CTI Clinical Trial Services, Inc.*, Eledon*, European Society of Organ Transplantation, the U.S. Food and Drug Administration (FDA), Hansa Biopharma*, HUS Helsinki University Hospital, Immucor, KU Leunven, Memo Therapeutics AG*, Natera, National Institutes of Health, Novartis, Paris Transplant Group, Pirche, Sanofi*, Takeda*, Talaris Therapeutics, Thermo Fisher Scientific, The Transplantation Society, Transplant Genomics*, University of Manitoba, and Veloxis Pharmaceuticals*. Any groups that would like to join in this effort or have information or data that may contribute to further advances, can contact JoAnn Gwynn at jgwynn@myast.org.
*Denotes Current TTC Members
The Transplant Therapeutics Consortium (TTC) was launched in April 2017 and co-founded by the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS). TTC brings together pharmaceutical companies, diagnostic companies, academic and nonprofit partners working toward a common goal of moving the field forward toward drug development solutions in transplantation.
American Society of Transplantation
Founded in 1982, the American Society of Transplantation (AST) is a non-profit, 501(c)3 organization dedicated to advancing the field of transplantation and improving patient care by promoting research, education, advocacy, organ donation, and service to the community through a lens of equity and inclusion. The society is the largest transplant organization in North America (consisting of nearly 5,000 professional members), representing a majority of the nation’s medical professionals engaged in the field of transplantation.
Learn more at myAST.org.
American Society of Transplant Surgeons
The American Society of Transplant Surgeons (ASTS) was founded in 1974 by 127 surgeons to unite the professionals who were advancing the fledgling field of organ transplantation.
From this small group of dedicated individuals, we have grown to represent over 2,000 transplant professionals who are dedicated to saving and improving lives through the transformative power of organ donation and transplant surgery. Learn more about ASTS by visiting our website at ASTS.org.
When I joined TransplantLyfe, I expected to find information and maybe a few people who understood what I’d been through. What I didn’t expect to find was Jeanmarie, a best friend, a soul sister, and living proof that hope and strength don’t just survive – they thrive when shared.
We connected through our transplant journeys, each of us carrying a story marked by loss, healing, and the fight to keep going. But what truly bonded us was something deeper: a shared passion for advocacy, a fierce desire to turn pain into purpose, and the comfort of knowing that someone else just gets it.
From late-night check-ins to spontaneous New York City adventures, our friendship became its own kind of medicine. One of my favorite memories is the day we took a bike tour through Central Park. With the wind in our faces and laughter echoing between the trees, it felt like reclaiming life on our own terms. It was a celebration of every moment we’ve fought to live.
Whether we were shopping at Tiffany’s or simply breathing in the magic of the city, we weren’t just passing time; we were honoring it. We were honoring every heartbeat, every second chance, and every moment our transplants gave back to us.
Jeanmarie’s strength inspires me daily. Even on her hardest days, she lifts others up. Her voice fights for the unheard, and her joy reminds me that light still lives in the hard places. She’s the friend who remembers the dates that matter, who checks in without being asked, and who makes you feel seen in a world that sometimes overlooks transplant warriors.
Our friendship is a reminder that healing doesn’t always come through medicine or milestones. Sometimes, it shows up in a person who walks beside you, believes in your tomorrow, and never lets you forget that your story still matters.
So if you’ve ever wondered what hope and strength look like… It’s not just from survival, but from a connection.
By: LaVise McCray
by Karin Hehenberger
I have lived three lives – at least.
My first was as a child – never worried about the future and only focusing on the now. I fought hard in sports and in school, but I was not wanting for much more than that. I did not have an inkling of how lucky I was. My parents tell me I was always smiling and always on the move.
Then came Type 1 Diabetes. Like a truck, it wheeled over me and I felt damaged and alone. I managed it conservatively and, while doing so, ruined the very part of me that was happy and free. T1D felt like a prison.
One day I just said “stop”. I started living freely and irreverently. Nothing could stop me. I was young, well-educated and out to conquer the world. Of course, this lifestyle was not sustainable. The complications hit me worse than the diabetes had as a teenager and now I was not just damaged through my disease but also through my behavior.
Transplantation saved my life three times but my daughter, Liv, makes my life worth living each day. Without her, I would not have been able to return to feelings of happiness and freedom from paranoia, control and thoughts of giving up.
Today, on Independence Day, I celebrate freedom, in all shapes and forms. It might be a day without pain, a walk after not being able to, advocacy to push for change for more than just yourself, courage to share your thoughts and dreams, or simply smiling in the morning when waking up.
by Karin Hehenberger
I have lived three lives – at least.
My first was as a child – never worried about the future and only focusing on the now. I fought hard in sports and in school, but I was not wanting for much more than that. I did not have an inkling of how lucky I was. My parents tell me I was always smiling and always on the move.
Then came Type 1 Diabetes. Like a truck, it wheeled over me and I felt damaged and alone. I managed it conservatively and, while doing so, ruined the very part of me that was happy and free. T1D felt like a prison.
One day I just said “stop”. I started living freely and irreverently. Nothing could stop me. I was young, well-educated and out to conquer the world. Of course, this lifestyle was not sustainable. The complications hit me worse than the diabetes had as a teenager and now I was not just damaged through my disease but also through my behavior.
Transplantation saved my life three times but my daughter, Liv, makes my life worth living each day. Without her, I would not have been able to return to feelings of happiness and freedom from paranoia, control and thoughts of giving up.
Today, on Independence Day, I celebrate freedom, in all shapes and forms. It might be a day without pain, a walk after not being able to, advocacy to push for change for more than just yourself, courage to share your thoughts and dreams, or simply smiling in the morning when waking up.
Lyfebulb Founder and kidney-pancreas transplant recipient Dr. Karin Hehenberger and TransplantLyfe Community Manager Kevin Schnurr sit down with Craig Pressley, LICSW, a seasoned transplant social worker at Beth Israel Deaconess Medical Center, to break down the financial realities of kidney transplantation.
Whether you’re pre- or post-transplant, this session offers a clear, accessible overview of:
Common transplant-related costs—from evaluations to lifelong medications
How Medicare Parts A, B, and D apply to transplant patients Commercial insurance, coordination of benefits, and supplemental coverage
Why applying for Medicare matters—even if you have private insurance Tips for finding trustworthy insurance information
This is Episode 1 of our transplant cost and insurance series, designed to equip patients and care partners with tools to better plan for the future.
Watch now and don’t forget to subscribe for updates on Episode 2, where we’ll explore real-world patient examples and financial assistance options. Learn more at TransplantLyfe.com and join our discussion forum to continue the conversation.
The Most Common Cancer in Immune-Suppressed Individuals
In 2024, more than 48,000 organ transplants were performed in the United States. Although solid organ transplant (SOT) is a life-saving treatment, unfortunately, recipients have elevated risk for many cancer types due to the medications transplant recipients take to avoid rejection of their new organ.
The highest increase in cancer rates for SOTs are most frequently associated with skin cancers. The immunosuppression medications (Tacrolimus, Mycophenolate, Cyclosporine, Azathioprine and others) impair the capacity of the immune system to repair UV-damaged cells, allowing these damaged cells to develop into cancers.
The four main types of skin cancer in organ recipients are:
Squamous Cell Carcinoma (SCC): 100x higher risk
Merkel Cell Carcinoma (MCC): 24x higher risk
Basal Cell Carcinoma (BCC): 16x higher risk
Melanoma: 2x higher risk
Monitoring
Symptoms of skin cancer include new bumps or patches on the skin, or changes in the size, shape or color of skin growths. Frequent self-exams and (full body) screening examinations performed by a dermatologist are recommended for all SOTs. Generally speaking, an annual exam is sufficient. However, if any SCC is suspected/discovered during an exam, more frequent checks by a transplant dermatologist may make more sense (3/6/9-month intervals).
When performing self-exams, all skin should be checked for any changes in size, shape or color of skin growths or the development of new skin spots. This includes the scalp, ears (including on the insides), palms of hands, soles of feet, between toes, genital area and the area between the buttocks. Skin cancers may even manifest inside the eyes. Mirrors, magnifying glasses and even taking photographs can help to identify changes in skin over time.
Treatment
Most skin cancer is treatable if it’s caught early. Treatments include Mohs surgery, cryotherapy, chemotherapy and radiation.
The most common treatment for SCC is having the Mohs procedure/surgery performed. This procedure involves removal of thin layers of cancerous skin, one at a time. Each layer is examined under a microscope until normal tissue is found. Sometimes multiple sessions may be necessary. Unfortunately, the removal of tissue often leads to deficits that might require reconstructive surgery. Non-cancerous spots/markings that are identified may be “frozen” (cryotherapy) to destroy the affected cells. Early detection and treatment are critical for managing skin cancer, post-transplant.
Prevention
In most cases, skin cancer can be prevented. The best way to protect ourselves to avoid too much sunlight and sunburns. It is very important to implement effective sun protection strategies which most certainly should be prioritized. Some strategies include using broad-spectrum sunscreen with an SPF of 30 or higher, wearing protective clothing and sunglasses, avoiding the sun during peak hours, and steering clear of tanning beds. However, much of the damage detected in an adult has been caused by sun exposure as a child, which is the reason why skin cancers in non-transplant recipients also occur to a higher extent in the elderly.
Transplant recipients wear a badge of honor everyday of their lives and are grateful to their organ donors and donor families for making the Gift of Life available to them. Prevention and close monitoring are key to avoid adding the term “cancer survivor” to the list of medical conditions.
Two years ago, I wasn’t sure what the future would hold. Sitting upright felt like running a marathon. I relied on a wheelchair to get around, and even the simplest tasks left me exhausted. Yet amid that uncertainty, one thing remained: hope. Hope is made possible by the life-changing gift of organ donation.
Recently, I completed my very first 5K walk.
That moment wasn’t just about miles. It was about the meaning behind each step. Every stride I took was a powerful symbol of resilience, gratitude, and transformation.
My transplant journey has been anything but easy. It’s been filled with moments of fear, physical setbacks, and emotional weight. There were days I wasn’t sure how I’d keep going. But I chose to rise anyway. With the unwavering support of my medical team, my family, and the transplant community, I kept moving forward—one step at a time.
Walking that 5K wasn’t just a personal milestone—it was a tribute. A tribute to my donor, whose selfless gift gave me a second chance at life. A tribute to those still waiting for their miracle. And a message to the world that life after transplant is not just possible—it’s powerful.
To anyone facing a health battle of their own: don’t give up. Don’t count yourself out. Your body is capable of incredible things. Your spirit, even more so. With faith, determination, and a circle of support, healing can happen. I am walking and living proof of it.
My journey is far from over, but that day, I walked with strength, with purpose, and with deep, unshakable gratitude.
By: LaVise McCray
In early May, I celebrated 11 years with my living donor kidney. I received the Gift of Life courtesy of my close friend, Matthew, in 2014. I’m often asked how he came to give me a second chance at life and the truth is I owe it all to an electronics retail job we shared after college. We started as strangers but spent 40+ hour weeks together, endured stressful holiday sales, and forged a bond that only working in retail can provide.
As I reflect on the time since my surgery, I’m reminded of the ups and downs and all the major and miniscule moments along the way. I feel overly compelled to write a note to the version of Kevin who awoke in a recovery room with a freshly-transplanted kidney on May 6, 2014. I want to let him know what to expect and, most importantly, that things are going to be different, but OK!
The nurse has been calling your name for a few seconds, but with the general anesthesia wearing off and your hearing loss, it’s going to take a few extra moments for you to wake up and snap to attention. You’ll immediately recite your name and date of birth, before the nurse even gets the chance to ask you, and she’ll laugh. Your mind will immediately think of Matthew and you’ll learn he’s doing well in recovery. Your new kidney is making urine right away. Lots of it.
A few days later, back at home, you’ll hate walking up steps but the pain will subside in time. You’ll endure a temporary bout of insomnia but that’ll pass. A weekly pill organizer will become a part of your life as much as brushing your teeth.
You’ll be scared to be around large crowds, so you’ll mask in a society that hasn’t yet endured a devastating global pandemic. One time you won’t have a mask on and a small child will sneeze directly in your face at a pharmacy. You’ll be emotionally shaken but fine.
You’ll be scared to see the results of routine lab work…actually you’ll stay scared over the years. Sorry about that one. But you’ll trust your care team and listen to your body and that’s a solid plan. Eventually, you’ll become more accustomed to falling asleep without plugging into a dialysis cycler than the way it used to be for you.
You’ll get sick with random illnesses, as folks do, and require hospitalization. You’ll catch a virus that will cause the world to go on pause.
Connecting with fellow transplant patients will change your outlook on everything. One day you’ll talk less about transplant with these individuals and more about your favorite new TV shows. You’ll wish them Happy Transplantiversary every year and celebrate the birth of their children.
Working a typical 9-5 won’t be for you, so you’ll fall into renal patient advocacy and meet researchers, and nephrologists, and driven individuals who want to make life better for patients like you. You’ll travel all over the country and be inspired by too many folks to count.
You’ll go on vacation and swim with tropical fish and that moment of tranquility will be ingrained in your brain forever.
Your transplant-centric milestones and gratitude will only grow over time, as will your friendship with your donor and friend.
One day, you’ll write a blog about this long, strange trip and won’t be able to imagine life without it.
Welcome to DonorTalks, a podcast that intimately explores the experiences of living donors. Join us for raw and real discussions about life after donating. Featuring a new guest each episode, this is your go-to podcast on everything living donor-related.
In Episode 1, Alex speaks with Michael, the father of our founder, Karin, who gave his daughter the gift of life through kidney donation. These deeply personal stories show what it truly means to step up for someone you love —and even a stranger.
In Episode 2, Alex Berrios speaks with his close friend Matt—a living donor who once considered giving Alex his kidney. These deeply personal stories show what it truly means to step up for someone you love —and even a stranger.
By Taryn Servold
Every April, we observe Donate Life Month, a national campaign to raise awareness about organ, eye, and tissue donation. It’s a time to honor the donors who gave the gift of life and to encourage others to consider registering as donors.
For me, Donate Life Month hits home. I’m living proof of what’s possible when someone chooses to give — even in the midst of unthinkable loss.
Organ Donation: The Facts That Matter
Organ donation often gets overlooked in everyday conversations, but the need is real — and urgent:
There are over 100,000 people waiting for a transplant in the U.S., and around 85% of them need a kidney.
Every 8 minutes, another person is added to the national transplant waiting list.
17 people die each day waiting for an organ that never comes.
One organ donor can save up to 8 lives — and improve the lives of 75 or more through eye and tissue donation.
Most people can be donors, regardless of age or medical history. Each case is reviewed individually at the time of death.
Living donors can also save lives — particularly when it comes to kidney and partial liver transplants.
Despite all this, only about 60% of Americans are registered as organ donors, and the demand far exceeds the supply.
My Life After August 14, 2022
Since my transplant, everything has changed. I no longer need insulin. My kidney function is strong. I feel better than I ever imagined possible — not just physically, but mentally and emotionally, too.
Before the surgery, every day was filled with uncertainty. Now, I can plan. I can work. I can travel. I can enjoy life without constantly managing blood sugar and anticipating the fatigue of kidney failure.
And most importantly, I carry the legacy of my donor with me every single day. Their decision gave me a second chance, and not a day goes by that I don’t think of them — and their family — with the deepest gratitude.
How You Can Make a Difference
If you’ve ever wondered about becoming a donor, here’s how you can help:
Share your decision with your family. In a time of loss, knowing your wishes can bring peace and clarity to your loved ones.
Become a living donor. If you’re healthy, you could be the match someone desperately needs — today.
Spread awareness, especially during April. Wear blue and green on April 19th for National Donate Life Blue & Green Day, and share your story or support online.
Final Thoughts
It’s easy to take life for granted — until you’re faced with losing it. I got my life back on August 14, 2022, thanks to someone I will never meet but will forever honor. That person — that donor — gave me more than just organs. They gave me freedom. They gave me time. They gave me tomorrows.”
