Development of a vaccine against type 1 diabetes
A vaccine to slow and prevent type 1 diabetes in newly diagnosed people is advancing in advanced clinical studies, in hopes of using precision medicine to help preserve insulin-producing beta cells in the body and prolong the full onset of T1D. the longest time possible.
This potential vaccine is being developed by the Swedish biotechnology start-up Diamyd Medical, which has been working on this particular treatment for several years. Despite delays and disappointing results earlier in the last decade, the latest studies show promising results and new clinical trials have started in Europe and the United States in 2021.
“We’ve gone to great lengths to design this latest trial with our collaborative partners, digging deeper into the data to make sure we don’t cut corners,” Diamyd CEO Ulf Hannelius told DiabetesMine. “Without all the data and knowing how to use it, we wouldn’t be where we are today.”
DiabetesMine spoke with Diamyd’s CEO about the company’s research and what it means for people with diabetes (PWD), and what we can expect as we move forward. Those Q&A are below, but let’s start by delving into some of the scientific details about what Diamyd’s main vaccine candidate is and how it would work.
At a high level, the Diamyd vaccine aims to stop the destruction of insulin-producing beta cells that lead to T1D. The how is more nuanced and more scientific.
In clinical trials, the Diamyd vaccine was injected directly into the lymph node of children and young adults (12 to 24 years old) who had been diagnosed with T1D within the past 6 months. They received four injections over a 15-month period, according to information from the trial.
This active ingredient in the vaccine is known as GAD65 (or glutamic acid decarboxylase-65), an enzyme in pancreatic beta cells that helps them function properly and continue to produce insulin naturally. Because the majority of T1Ds have antibodies that target this GAD enzyme and cause the immune system to attack itself and these insulin-producing cells, supplementing this GAD65 is how this vaccine would work. The Diamyd vaccine uses GAD65 to stop the attack on the immune system and prolong the time to onset of T1D by helping beta cells continue to produce insulin.
Although there have been starts and stops in this research for more than a decade, the latest results analyzing past clinical trials seem more promising for those of Diamyd.
In the coming months of 2021, Diamyd plans to start its major Phase III trials in Europe and the United States.
No, it wouldn’t. But it’s a start to learning more about what leads to T1D and how to delay it, and may contain major clues to preventing autoimmune disease from developing later.
Currently, Diamyd is focusing its research on people newly diagnosed in the last semester.
But Diamyd is also working on its vaccine for people with latent autoimmune diabetes in adults (LADA) as well as another clinical research arm for people with long-term T1D using an oral tablet that may have a impact on hypoglycemia and eventually establish T1D by helping to regenerate. beta cells in the pancreas.
Of course, this Diamyd research fits into the biggest Type 1 research puzzle around the world. It is therefore no exaggeration to think that what is learned here may have an impact on further research to come.
Precision medicine is a new approach to the treatment and prevention of disease that focuses on a person’s individual genes, environment or lifestyle in order to target their treatment.
in this Diamyd vaccine, that means the company is focusing on newly diagnosed T1Ds that have a very specific type of gene that has been proven to show more impact from this particular treatment. Specifically, it’s for those who carry the HLA DR3-DQ2 haplotype, which the researchers say plays a central role in immunity. Hannelius of Diamyd says their research shows that it significantly influences the effect of the vaccine.
This particular haplotype is evaluated by blood screening for clinical studies to determine if someone is eligible for this precision medicine vaccine.
“This is the definition of precision medicine, being the right treatment for the right person at the right time,” said Hannelius. “I think this will drive the future of pharmaceutical development.”
You might have heard of Diamyd before, because they’ve been in the diabetes research scene for quite some time.
The company itself has been around for over two decades, and this GAD-specific line of research dates back to the early 2000s. In 2011-12, headlines reported disappointing clinical trial results that led investors to flee – including Johnson and Johnson, who had once supported vaccine development. But for most of the past few years, Diamyd has quietly pursued his research.
Hannelius became CEO in 2016.
The name itself has a personal connection to diabetes, as it is a mashup of “Diabetes My Gad” – Myd being the name of the founder, Anders Essen-Möller, the youngest girl living with T1D. . His dianography was a pivotal event that led him to found the company and begin work on this potential diabetes vaccine.
“The fact that we are now ready to enter Phase 3 development with a precision medicine approach is very exciting and a fantastic achievement from the team,” said CEO Hannelius. “It’s very exciting to see that we are growing as a company and investing in our own pharmaceutical manufacturing. There are so many skills in the company that I am both proud and amazed at the enthusiasm and all that the team has accomplished to move our programs forward.