09/04/2026
WE DID IT!
A remarkable milestone for islet transplantation and the pursuit of a functional cure for Type 1 diabetes.
The journey began in 2018, when I reviewed Anelixis Therapeutics and its re-engineered anti-CD40L antibody, AT-1501, as a member of Noble Capital Markets’ Scientific Advisory Board. I immediately recognized its potential for transplantation and became an enthusiastic supporter of its development.
Anelixis was subsequently acquired and became part of Eledon Pharmaceuticals, and AT-1501 evolved into tegoprubart.
This was particularly exciting because Dr. Norma Kenyon, our collaborators and I at the University of Miami Diabetes Research Institute (UM-DRI) had worked for over two decades on CD40/CD40L blockade and its potential to protect transplanted islets while avoiding the toxicity of conventional calcineurin inhibitors such as tacrolimus.
The next challenge was bringing tegoprubart to patients.
With the support of the Diabetes Research Institute Foundation, Breakthrough T1D and The Cure Alliance, we helped launch the first clinical pilot in islet transplantation, led by Dr. Piotr Witkowski at the University of Chicago, in collaboration with our Cell Transplant Center at UM-DRI.
The results have been extraordinary: all 12 transplanted patients achieved insulin independence, with no reported graft-rejection episodes or de novo donor-specific HLA antibodies.
And now comes another historic step:
Eledon has submitted an IND to the FDA for an Eledon-sponsored registrational study of tegoprubart in islet transplantation for Type 1 diabetes.
We are profoundly grateful to Eledon for making this extraordinary commitment and to everyone who believed in and supported this work along the way.
We especially congratulate Piotr Witkowski for his remarkable leadership in translating decades of collaborative research into results for patients.
The next goal is equally important: modernizing the U.S. regulatory framework for deceased-donor islets and ultimately developing strategies that can eliminate the need for chronic anti-rejection therapy altogether.
Anelixis → AT-1501 → Eledon → tegoprubart → insulin independence → registrational pathway.
Now we need HHS and FDA to RECLASSIFY ISLETS similarly to organ transplants like in other developed countries, like Canada, France and China, allowing US academic centers to be competitive again, on the path to a cure and most importantly making it accessible to many more people living with Type 1 diabetes.
Research Institute Foundation
T1D
Pharmaceuticals, Inc.
Action Coalition
