A vaccine aimed at slowing down and preventing type 1 diabetes in newly diagnosed people is being advanced in late clinical trials with the hope of using precision medicine to preserve the insulin-producing beta cells in the body and achieve full T1D -Beginning to extend as long as possible.
This potential vaccine is being developed by the Swedish biotech startup Diamyd Medical, which has been working on this particular treatment for several years. Despite delays and disappointing results at the beginning of the last decade, the latest studies have begun promising results and new clinical trials in Europe and the US in 2021.
“We went to great lengths to develop this latest study with our collaborators. We looked at the data carefully to make sure we weren’t compromising,” said Ulyd Hannelius, CEO of Diamyd, to DiabetesMine. “Without all the data and knowing how to use it, we wouldn’t be where we are today.”
DiabetesMine spoke to Diamyd’s CEO about this company’s research and what it means for people with diabetes (PWDs) and what to expect as we move forward. You can find these questions and answers below. But first, let’s cover some of the science-intensive details about what Diamyd’s lead vaccine candidate is all about and how it would work.
At high levels, the Diamyd vaccine aims to stop the destruction of insulin-producing beta cells that lead to T1D. The how is more nuanced and more science-intensive.
In the clinical studies, the Diamyd vaccine was injected directly into the lymph nodes of children and young adults (12 to 24 years of age) who had been diagnosed with T1D in the past 6 months. They received four injections within 15 months according to the trial information.
This active ingredient in the vaccine is known as GAD65 (or glutamic acid decarboxylase-65), an enzyme in the beta cells of the pancreas that helps them work properly and keep making insulin naturally. Since most T1Ds have antibodies that target this GAD enzyme and cause the immune system to attack itself and these insulin-producing cells, this vaccine would work through GAD65. The Diamyd vaccine uses GAD65 to stop the immune system’s attack and prolong the onset of the T1D delay by helping the beta cells keep making insulin.
While this research has been started and stopped for more than the last decade, the latest results analyzing previous clinical studies look more promising for those at Diamyd.
In the coming months of 2021, Diamyd plans to begin its important Phase III trials in both Europe and the United States
No it wouldn’t. But it is a start to learning more about what causes T1D and how to delay it, and it could provide important clues as to how the autoimmune disease can develop later.
Right now, Diamyd is focusing on those who have been newly diagnosed within the past six months.
Diamyd is also working on its vaccine for people with latent autoimmune diabetes in adults (LADA), as well as another line of clinical research for people with longer-term T1D who are using an oral tablet that could affect hypoglycemia and possibly an established T1D by using for Regeneration helps beta cells in the pancreas.
Of course, this Diamyd research fits into the bigger puzzle of Type 1 research around the world. So it’s not hard to believe that what is learned here may have an impact on other research in the future.
Precision medicine is a newer approach to disease treatment and prevention that focuses on a person’s individual genes, environment, or lifestyle to target their treatment.
For this Diamyd vaccine, the company is focusing on newly diagnosed T1Ds with a very specific type of gene that has been shown to be more affected by this particular treatment. In particular, it is intended for those carrying the HLA DR3-DQ2 haplotype that researchers find to play a central role in immunity. Diamyds Hannelius says her research shows that it significantly affects the way the vaccine works.
This particular haplotype will be assessed through blood tests for the clinical trials to determine if someone is a candidate for this precision medicine vaccine.
“This is the definition of precision medicine, which is the right treatment for the right person at the right time,” said Hannelius. “I believe this will drive the future of pharmaceutical development.”
You may have heard of Diamyd as they have been on the diabetes research scene for a while.
The company itself has been around for more than two decades, and this line of GAD-specific research dates back to the early 2000s. In 2011-12, there were headlines about disappointing clinical trial results that drove investors – including Johnson and Johnson, who had once helped vaccine development – to flee. But in the past few years, Diamyd has been largely silent on his research.
Hannelius became CEO in 2016.
The name itself has a personal diabetes connection as it is a mashup of “Diabetes My Gad” – Myd is the name of founder Anders Essen-Möllers, the youngest daughter living with T1D. Their dianogesis was a key event that led him to found the company and start working on this potential diabetes vaccine.
“The fact that we are now ready to move into phase 3 development with a precision medicine approach is very exciting and a fantastic achievement for the team,” said CEO Hannelius. “It is very exciting to see that we are growing as a company and investing in our own pharmaceutical manufacturing. The company has so much expertise that I am both proud and amazed at the enthusiasm and how much the team has achieved to advance our programs. “