This content material initially appeared on diaTribe. Republished with permission.
By Andrew Briskin
Within the seek for new and modern methods to deal with kind 1 diabetes, researchers have regarded to develop therapies that defend or enhance the physique’s potential to supply its personal insulin. Be taught in regards to the fundamentals of a vaccine at the moment in growth and the way it may doubtlessly sluggish or halt the development of kind 1 diabetes.
For many years, kind 1 diabetes therapy has centered on treating the situation, primarily with insulin. Lately, nevertheless, therapies that focus on the immune system (immunotherapies) have gained an increasing number of traction of their potential to delay or stop kind 1.
You’ll have heard a few new drug known as Tzield (teplizumab), the primary – and to this point solely therapy – therapy to delay the onset of kind 1 diabetes for 2 years or extra. One other vaccine at the moment being studied is Diamyd, which additionally holds promise as a possible immunotherapy for kind 1.
As a reminder, kind 1 diabetes is a situation the place the physique’s immune system assaults and destroys the cells within the pancreas that produce insulin, often known as beta cells. This happens due to one thing known as an auto-antibody. Antibodies are a part of your immune system; their goal is to establish and neutralize micro organism and viruses. Auto-antibodies, nevertheless, mistakenly goal a number of of your physique’s proteins, which can harm tissues and organs. One auto-antibody sometimes present in individuals with kind 1 diabetes targets a kind of protein often known as GAD-65.
The destruction of the beta cells progresses at totally different speeds, relying on every particular person. Nonetheless, by the point kind 1 diabetes is normally recognized, roughly 80% of beta cells have been destroyed. This harm continues till the individual turns into fully depending on insulin injections.
However what if a vaccine may cease this auto-immune destruction earlier than it even happens? Enter Diamyd Medical, a Swedish biotechnology firm taking a singular strategy to creating a kind 1 vaccine: Diamyd.
How the vaccine works
As a result of GAD-65 is discovered within the beta cells of the pancreas, auto-antibodies in opposition to GAD-65 acknowledge the protein and harm beta cells.
“What we wish to do is re-program the immune system, particularly the way it reacts to GAD-65. It’s like a reverse, or therapeutic, vaccine,” mentioned Ulf Hannelius, CEO of Diamyd Medical. “The target is to vary the pro-inflammatory, autoimmune response to GAD-65, and to skew that to an anti-inflammatory response.”
Researchers at Diamyd are at the moment taking the strategy of injecting a small quantity of the GAD-65 protein right into a lymph node a number of occasions through the examine (lymph nodes are small, bean-shaped constructions all through the physique that comprise among the physique’s immune cells).
The hope is that these immune cells will journey to the pancreas, encounter a beta cell with GAD-65, and as an alternative of destroying the beta cells, work to cut back the assault and protect them.
The place we’re in the present day
Over the previous 20 years, a number of obstacles have stood in the way in which of a kind 1 vaccine, together with a trial suspended in 2011 that didn’t reveal the vaccine’s effectiveness. Since then, the corporate has made some adjustments Hannelius mentioned, together with the way in which that the vaccine is run (it’s now injected instantly into the lymph nodes relatively than beneath the pores and skin). One other analysis trial was placed on a partial medical maintain within the U.S. in 2021, which was lifted in 2022.
“We haven’t made any precise change to the drug or formulation, however we now administer the vaccine on to the lymph nodes, the positioning the place the immune response occurs, with a a lot smaller dose,” mentioned Hannelius. “Even with the smaller dose, we at the moment are seeing a a lot stronger immune response in comparison with after we injected [just under the skin].”
Moreover, the corporate now screens for the presence of a selected gene related to a excessive threat for kind 1 diabetes. In response to Hannelius, this gene is present in as much as 40% of individuals with kind 1, with this sub-group exhibiting a very constructive response in medical trials.
Information has been promising over the previous few years. In 2021, the corporate printed outcomes from its part 2b trial, DIAGNODE-2. This examine, which included 109 examine members ages 12-24, confirmed that the vaccine improved glucose administration (as measured by time in vary) in just lately recognized examine members in comparison with the placebo group.
In 2022, Diamyd introduced outcomes from a 14-person security examine with promising ends in individuals recognized with latent autoimmune diabetes in adults (LADA). Like kind 1, LADA is a type of autoimmune diabetes, however the assault on beta cells takes longer, with the prognosis normally occurring in adults.
In progress: Diamyd medical trials
Diamyd is within the midst of a brand new part 3 trial (which is at the moment recruiting) known as DIAGNODE-3. The trial is enrolling 330 members at 60 areas throughout the globe, together with the U.S., Czechia, Estonia, Germany, Hungary, the Netherlands, Poland, Spain, and Sweden, and plans to wrap up late 2025.
One other trial known as DiaPrecise was launched in 2023 to guage the security and feasibility of Diamyd in kids and youths between ages 8-18 who carry the gene for kind 1 diabetes. The FDA just lately fast-tracked the assessment course of for this particular trial, which is a promising step ahead in a kind 1 diabetes vaccine for youngsters. This trial is at the moment recruiting in Sweden – right here’s how to become involved.
Basically, Diamyd represents one other effort to search out an immunotherapy that would doubtlessly delay or stop kind 1 diabetes, and forestall problems sooner or later. Researchers proceed to work in the direction of new and modern methods to deal with kind 1 diabetes, and the Diamyd vaccine may finally turn out to be a therapy choice that, not like insulin, combats the immune response that results in kind 1 diabetes.
Be taught extra about therapies and analysis for kind 1 diabetes cures right here:
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