This content originally appeared on diaTribe. Republished with permission.
By Andrew Briskin
In the search for new and innovative ways to treat type 1 diabetes, researchers have looked to develop therapies that protect or improve the body’s ability to produce its own insulin. Learn about the basics of a vaccine currently in development and how it could potentially slow or halt the progression of type 1 diabetes.
For decades, type 1 diabetes treatment has focused on treating the condition, mainly with insulin. In recent years, however, therapies that target the immune system (immunotherapies) have gained more and more traction in their potential to delay or prevent type 1.
You may have heard about a new drug called Tzield (teplizumab), the first – and so far only treatment – treatment to delay the onset of type 1 diabetes for two years or more. Another vaccine currently being studied is Diamyd, which also holds promise as a potential immunotherapy for type 1.
As a reminder, type 1 diabetes is a condition where the body’s immune system attacks and destroys the cells in the pancreas that produce insulin, known as beta cells. This occurs because of something called an auto-antibody. Antibodies are part of your immune system; their purpose is to identify and neutralize bacteria and viruses. Auto-antibodies, however, mistakenly target one or more of your body’s proteins, which may damage tissues and organs. One auto-antibody typically found in people with type 1 diabetes targets a type of protein known as GAD-65.
The destruction of the beta cells progresses at different speeds, depending on each individual. However, by the time type 1 diabetes is usually diagnosed, approximately 80% of beta cells have been destroyed. This damage continues until the person becomes completely dependent on insulin injections.
But what if a vaccine could stop this auto-immune destruction before it even occurs? Enter Diamyd Medical, a Swedish biotechnology company taking a unique approach to developing a type 1 vaccine: Diamyd.
How the vaccine works
Because GAD-65 is found in the beta cells of the pancreas, auto-antibodies against GAD-65 recognize the protein and damage beta cells.
“What we want to do is re-program the immune system, specifically how it reacts to GAD-65. It’s like a reverse, or therapeutic, vaccine,” said Ulf Hannelius, CEO of Diamyd Medical. “The objective is to change the pro-inflammatory, autoimmune reaction to GAD-65, and to skew that to an anti-inflammatory reaction.”
Researchers at Diamyd are currently taking the approach of injecting a small amount of the GAD-65 protein into a lymph node several times during the study (lymph nodes are small, bean-shaped structures throughout the body that contain some of the body’s immune cells).
The hope is that these immune cells will travel to the pancreas, encounter a beta cell with GAD-65, and instead of destroying the beta cells, work to reduce the attack and preserve them.
Where we are today
Over the past two decades, several obstacles have stood in the way of a type 1 vaccine, including a trial suspended in 2011 that failed to demonstrate the vaccine’s effectiveness. Since then, the company has made some changes Hannelius said, including the way that the vaccine is administered (it’s now injected directly into the lymph nodes rather than under the skin). Another research trial was put on a partial clinical hold in the U.S. in 2021, which was lifted in 2022.
“We haven’t made any actual change to the drug or formulation, but we now administer the vaccine directly to the lymph nodes, the site where the immune reaction happens, with a much smaller dose,” said Hannelius. “Even with the smaller dose, we are now seeing a much stronger immune response compared to when we injected [just under the skin].”
Additionally, the company now screens for the presence of a particular gene associated with a high risk for type 1 diabetes. According to Hannelius, this gene is found in up to 40% of people with type 1, with this sub-group showing a particularly positive response in clinical trials.
Data has been promising over the last few years. In 2021, the company published results from its phase 2b trial, DIAGNODE-2. This study, which included 109 study participants ages 12-24, showed that the vaccine improved glucose management (as measured by time in range) in recently diagnosed study participants compared to the placebo group.
In 2022, Diamyd announced results from a 14-person safety study with promising results in people diagnosed with latent autoimmune diabetes in adults (LADA). Like type 1, LADA is a form of autoimmune diabetes, but the attack on beta cells takes longer, with the diagnosis usually occurring in adults.
In progress: Diamyd clinical trials
Diamyd is in the midst of a new phase 3 trial (which is currently recruiting) called DIAGNODE-3. The trial is enrolling 330 participants at 60 locations across the globe, including the U.S., Czechia, Estonia, Germany, Hungary, the Netherlands, Poland, Spain, and Sweden, and plans to wrap up late 2025.
Another trial called DiaPrecise was launched in 2023 to evaluate the safety and feasibility of Diamyd in children and teens between ages 8-18 who carry the gene for type 1 diabetes. The FDA recently fast-tracked the review process for this specific trial, which is a promising step forward in a type 1 diabetes vaccine for children. This trial is currently recruiting in Sweden – here’s how to get involved.
In general, Diamyd represents another effort to find an immunotherapy that could potentially delay or prevent type 1 diabetes, and prevent complications in the future. Researchers continue to work towards new and innovative ways to treat type 1 diabetes, and the Diamyd vaccine might eventually become a treatment option that, unlike insulin, combats the immune response that leads to type 1 diabetes.
Learn more about therapies and research for type 1 diabetes cures here:
FDA Approves Lantidra, the First Ever Cell Therapy for Type 1 Diabetes
Vertex Releases New Data on Potential Cure for Type 1 Diabetes
Pathways to Stop Type 1 Diabetes: A Look Forward