Cell therapy first: transplanted islets working without immunosuppressives

On Jan 7, 2025 (Sweden)Sana Biotechnology released significant clinical data: the first person with type 1 diabetes (T1D) who received deceased donor islets engineered to evade the immune system is producing insulin without immunosuppression.

The details

This is a big step for cell-based therapies for potentially curing T1D. Sana’s first-in-human study consists of allogeneic islets, meaning they are derived from an external source, which in this case is the pancreases of deceased donors. These islets were engineered to avoid recognition by the immune system (hypoimmune) and were implanted intramuscularly into a person with T1D. After four weeks, circulating C-peptide increased, meaning that the beta cells are alive, healthy, and producing insulin—all without the need for immunosuppression and no safety issue. This is the first evidence of engineered islets successfully avoiding immune destruction.

What this means for the T1D community

While this is an incredibly promising step forward for the T1D community, to have allogenic cells survive without the use of immunosuppressants, this trial relied on deceased donor cells, of which there will never be enough to provide to everyone living with T1D.  The trial was done in a single participant and is reporting only 4-weeks of data – this is a proof-of-concept study that is promising but very preliminary.

What’s next: lots to look forward to

Breakthrough T1D believes that the best chance for T1D cures lies in stem cell-based therapies since deceased donor islets are in short supply, while stem cell-derived islets can be produced at scale. Engineering cells to evade immune attack is a new path forward to protect the insulin-producing beta cells and avoid the use of immunosuppressants. Most importantly, this technology is being studied to apply to stem cell-based therapies, which is a scalable solution for many more people with T1D. This hypoimmune technology moves us closer to the possibility of having enough immune-evading cells for everyone with T1D.

Another trial is in progress testing a similar approach (CRISPR) in Canada – https://clinicaltrials.breakthrought1d.ca/clinical-trial/NCT05565248

While this approach will take significant time, effort, and money, every day we take another step toward a possible life-changing T1D cure. 

Breakthrough T1D’s Role

The primary objective of Breakthrough T1D’s beta cell replacement efforts is to place insulin-producing cells into people with T1D without the use of immunosuppressants. Breakthrough T1D strongly supports the development of stem cell-based therapies that do not require broad immunosuppression and Breakthrough T1D International based out of the US recently launched an initiative to accelerate this faster than ever (Project ACT – Accelerate Cell Therapies). To contribute to the advancement of these game-changing therapies, the T1D Fund: A Breakthrough T1D Venture invested in Sana recognizing that their hypoimmune engineering technology held significant promise for T1D cell therapies. We look forward to seeing how the trial progresses.

2024 Year in Review

2024 was certainly a year of transformation. We recognized 50 years of grassroots fundraising and advocacy in Canada and in November we became Breakthrough T1D™ Canada. And while we now have a new name and look, our mission remains the same. We are as steadfast as ever about reaching our ultimate goal, a world free from type 1 diabetes (T1D).

Watch: We are Breakthrough T1D

And it is always because of our incredible community of donors, volunteers, and supporters that we never wavered in our mission, seeing progress and breakthroughs across all fields of T1D research. And with successful events and advocacy initiatives across the country, we continued to strengthen our relationship with the amazing T1D community.   

From the generosity of our donors, Breakthrough T1D Canada witnessed another transformative year– committing substantive funding to research, developing our partnerships in academia with new fellowships and grants, continuing to support both newly diagnosed families, and our adult T1D community, reinforcing our commitment to being there for anyone living with T1D at any age and any stage of their journey.

And while we work relentlessly towards cures, we continue to try to improve the lives today of the estimated 300,000 Canadians with T1D, through research, advocacy and community engagement.

Highlights from the past year included: 

T1D research highlights 

In cell replacement: 

In disease-modifying therapies: 

In treatments to improve lives: 

  • The Breakthrough T1D-CIHR Partnership to Defeat Diabetes announce 5 new grants in Knowledge Mobilization,  to provide researchers and knowledge users the opportunity to work together to use research evidence to improve health services, programs, and policies.
  • Funding programs devoted to improving mental health care and outcomes for people with T1D.
  • Renewed our funding of the BETTER project, a Canadian research initiative aimed at improving the lives of people with T1D.

In screening: 

  • Breakthrough T1D Canada and Sanofi Canada partner to raise awareness about autoimmune type 1 diabetes and the critical role of screening in its early detection.
  • Continued work by CanScreen T1D, a new Canadian T1D screening research consortium led by Dr. Diane Wherrett.  
  • Breakthrough T1D continues to help facilitate screening for relatives of those with T1D across Canada via TrialNet.

In clinical trials: 

To read more about research updates and stories of people living with T1D, please visit www.breakthrought1d.ca/blog

As we head into 2025, we pause and reflect on how truly grateful we are for the support of our donors, volunteers and the commitment of the T1D community. Thank you! Together, as we drive toward curing type 1 diabetes, we help to make every day better for the people living with it.