tegoprubart

Tracking Tegoprubart, CD40L blockade, and the move toward CNI free transplant immunosuppression in kidney, islet, and liver transplantation $ELDN Opinions only

[tegoprubart @tegoprubart]

Comment on reclassifying using the link below

[Breakthrough T1D @BreakthroughT1D]

The T1D community has been clear: deceased donor islets (DDIs) must be accessible for those who qualify. Earlier this year, Breakthrough T1D went to work, submitting a proposal to the Department of Health and Human Services (HHS) and meeting with FDA and the Health Resources and Services Administration to urge a change. Today we’re seeing real, tangible movement.

HHS published a Request for Information on potential changes to the regulation of deceased donor islets—the first step toward a policy change.

In other words, they want to hear from you.

Read the RFI and submit your comments here. Look for the comment button on the top left of the page: https://t.co/CIrblz2P89

[tegoprubart @tegoprubart]

Finally some progress on islet cell reclassification. Currently it is very hard to access this treatment because islet cells are classified as a drug and use tacrolimus for immunosuppression

[Breakthrough T1D Advocacy @BT1D_Advocacy]

Major update on deceased donor islet reclassification. Campbell Hutton, SVP of Global Advocacy has the details. #t1d

[tegoprubart @tegoprubart]

Should help islet reclassification and also help with stem cell derived islet trials

[Breakthrough T1D @BreakthroughT1D]

The Food and Drug Administration is a critical partner in accelerating cures and therapies for type 1 diabetes. The nominee to run FDA knows first-hand how important that is. Dr. Heidi Overton, nominee to be the next FDA Commissioner, has shared with us that she lives with type 1 diabetes.

[Mindreader Biotech @MindreaderBio]

$ELDN updated Bestow extension data yesterday at Transplant Society meeting in Sydney.Tegoprubart statistically significant improvement on kidney function advantage over tacrolimus. No rejections 7 for tacrolimus.Picked up FDA fast track for kidney transplant rejection

[tegoprubart @tegoprubart]

$ELDN We are pleased to share that long-term data from our Phase 2 BESTOW clinical program evaluating our investigational #immunosuppression therapy, tegoprubart, in #KidneyTransplantation will be presented at #TTS2026

[Sernova @Sernovabio]

We have signed a definitive merger agreement with Seraxis.

We aim to form a new company focused on the advancement of a differentiated approach to type 1 diabetes islet cell replacement.

A webinar will be held on September 11, at 10 a.m. EDT.

Read more: https://t.co/13ERD4Us6d

[Breakthrough T1D @BreakthroughT1D]

An exciting step forward for cell therapies! Swipe to learn the latest, and be sure to stay tuned to learn more! Want to learn more about the research we’re funding? Visit the link below!

https://t.co/LhAXTQ7LYb

[tegoprubart @tegoprubart]

A functional cure for T1D

[Camillo Ricordi, MD, FNAI @CamilloRicordi]

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.

@Diabetes Research Institute Foundation 

@Breakthrough T1D 

@TheCureAlliance

[BiotechTV @BiotechTV]

𝐂𝐨𝐦𝐩𝐚𝐧𝐲 𝐍𝐞𝐰𝐬: Renowned scientist and entrepreneur Greg Verdine announced $263M in new funding for his company LifeMine Therapeutics. Participating investors include names like Bezos and Gates.

See the full interview: https://t.co/rhO25S5aZa

[tegoprubart @tegoprubart]

Islets getting closer to reclassification

[Breakthrough T1D @BreakthroughT1D]

We’re partnering across HHS to support the T1D community! Today, Breakthrough T1D leaders - including CEO Aaron Kowalski, Chief Global Advocacy Officer Lynn Starr, CSO Sanjoy Dutta, CMO Thomas Danne , and Campbell Hutton, SVP, Global Advocacy - met with senior leadership of the FDA. They discussed the unmet needs of the T1D community and highlighted the necessity of a robust FDA to quickly and safely deliver next-generation cures and therapies currently in development.

Separately, the leadership team met with the Health Resources and Services Administration, HHS - the agency responsible for the organ transplant system. Breakthrough T1D advocated for reclassifying deceased donor cells as organs, placing them under HRSA’s oversight to expand accessibility for qualifying transplant candidates.

With innovators actively advancing T1D cures, collaborating across HHS, the FDA, and HRSA ensures we are ready to efficiently test and approve incoming therapies to ultimately end this disease.

Breakthrough T1D Advocacy

Read the full statement here: https://t.co/Mv1D9fdJAx

[tegoprubart @tegoprubart]

$NCEL stem cell derived islets are needed for a cure that can apply to the masses

[NewcelX Ltd @newcelXltd]

NewcelX has priced a $1.4M private placement, with participation from existing and new long-term investors. Proceeds will advance NCEL-101 toward IND-enabling studies in collaboration with @Eledon_Pharma for type 1 diabetes.
#Type1Diabetes #CellTherapy #Biotech #Nasdaq

[tegoprubart @tegoprubart]

$ELDN @SecKennedy this needs to be done asap to find a cure for T1D

[Mike Lee @BasedMikeLee]

We’re on the verge of a functional cure for type-1 diabetes.

To make that cure a reality, we need @HHSGov to use its existing authority to acknowledge that pancreatic islet cells are organs—not drugs or biologics—and should be treated as such for regulatory purposes, just as they are in every other civilized country.

I had a good chat with @SecKennedy about this yesterday.

I won’t speak for him, but I’m optimistic that he’ll reach the right conclusion.

This is a really, really big deal.

I’m convinced that, should he make this decision, @SecKennedy will not regret doing so.

To the contrary, he’ll be honored to have played a truly pivotal role in improving the lives of millions of Americans.

Raise your hand if you agree.

[tegoprubart @tegoprubart]

$ELDN $NCEL

[NewcelX Ltd @newcelXltd]

Newcelx ($NCEL) welcomes a true pioneer in diabetes cure research, Dr. Camillo Ricordi, M.D., widely regarded as one of the world's foremost authorities in islet transplantation and beta-cell replacement, to the $NCEL Scientific Advisory Board. #CellTherapy #Biotech #Nasdaq

[tegoprubart @tegoprubart]

The question now is …..can Tegoprubart be used alone as a therapy for organ transplant rejection

[tegoprubart @tegoprubart]

$ELDN going to be the future of transplant medicine (kidney, islets, liver)

[tegoprubart @tegoprubart]

@BreakthroughT1D @SenatorShaheen @SenatorCollins @RobertKennedyJr

[tegoprubart @tegoprubart]

Islets going to be reclassified soon

[Breakthrough T1D @BreakthroughT1D]

Great news! Senate Diabetes Caucus co-chairs @SenatorShaheen and @SenatorCollins have sent a letter to Acting FDA Commissioner Diamantas urging the reclassification of deceased donor islets as organs.
Momentum is building. These islets can help some people living with T1D today.

The regulatory pathway needs to catch up, and Breakthrough T1D will keep pushing until it does.

Thank you to our champions in the Senate! Use your voice: https://t.co/fsHfD6cTo5

[Eledon Pharmaceuticals, Inc. @Eledon_Pharma]

We’re pleased to announce the $ELDN team will present results from our Phase 2 BESTOW extension trial in #KidneyTransplantation at the American Transplant Congress in Boston. For presentation details, see our press release: https://t.co/DXY9MPRkSJ @ASTSChimera @AST_info

[Eledon Pharmaceuticals, Inc. @Eledon_Pharma]

Today marks the 1-year anniversary of Tim Andrews throwing the first pitch at @fenwaypark after his historic kidney #xenotransplant. We’re proud to have supported his groundbreaking procedure with our investigational #immunosuppression therapy tegoprubart: https://t.co/exJoiovl6O

[Ginger Vieira @GingerVieira]

Congrats to the 12th participant who is officially insulin independent in the Eledon clinical trial using Tegoprubart — an investigational therapy that works as a very targeted and relatively gentler form of immunosuppressive therapy.

All 12 participants in this groundbreaking trial are successfully producing enough insulin from the transplanted cadaver islet cells they received over the last year.

#t1d #t1dcure #diabetes #cureresearch #diabetesnerd