This content material initially appeared on diaTribe. Republished with permission.
By Andrew Briskin
Within the seek for new and modern methods to deal with sort 1 diabetes, researchers have seemed to develop therapies that defend or enhance the physique’s means to provide its personal insulin. Be taught concerning the fundamentals of a vaccine at the moment in improvement and the way it might probably gradual or halt the development of sort 1 diabetes.
For many years, sort 1 diabetes therapy has centered on treating the situation, primarily with insulin. In recent times, nevertheless, therapies that concentrate on the immune system (immunotherapies) have gained an increasing number of traction of their potential to delay or forestall sort 1.
You will have heard a few new drug known as Tzield (teplizumab), the primary – and to date solely therapy – therapy to delay the onset of sort 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 sort 1.
As a reminder, sort 1 diabetes is a situation the place the physique’s immune system assaults and destroys the cells within the pancreas that produce insulin, often called beta cells. This happens due to one thing known as an auto-antibody. Antibodies are a part of your immune system; their objective is to determine 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 folks with sort 1 diabetes targets a sort of protein often called GAD-65.
The destruction of the beta cells progresses at totally different speeds, relying on every particular person. Nevertheless, by the point sort 1 diabetes is normally identified, 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 might cease this auto-immune destruction earlier than it even happens? Enter Diamyd Medical, a Swedish biotechnology firm taking a singular strategy to creating a sort 1 vaccine: Diamyd.
How the vaccine works
As a result of GAD-65 is discovered within the beta cells of the pancreas, auto-antibodies towards GAD-65 acknowledge the protein and harm beta cells.
“What we need to do is re-program the immune system, particularly the way it reacts to GAD-65. It’s like a reverse, or therapeutic, vaccine,” stated 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 instances through the examine (lymph nodes are small, bean-shaped constructions all through the physique that comprise a number of 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 scale back the assault and protect them.
The place we’re at this time
Over the previous twenty years, a number of obstacles have stood in the way in which of a sort 1 vaccine, together with a trial suspended in 2011 that didn’t reveal the vaccine’s effectiveness. Since then, the corporate has made some modifications Hannelius stated, together with the way in which that the vaccine is run (it’s now injected instantly into the lymph nodes moderately than underneath 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,” stated Hannelius. “Even with the smaller dose, we are actually 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 sort 1 diabetes. In accordance with Hannelius, this gene is present in as much as 40% of individuals with sort 1, with this sub-group displaying a very optimistic response in medical trials.
Knowledge has been promising over the previous couple of years. In 2021, the corporate printed outcomes from its section 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 lately identified examine members in comparison with the placebo group.
In 2022, Diamyd introduced outcomes from a 14-person security examine with promising ends in folks identified with latent autoimmune diabetes in adults (LADA). Like sort 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 section 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 judge the protection and feasibility of Diamyd in youngsters and teenagers between ages 8-18 who carry the gene for sort 1 diabetes. The FDA lately fast-tracked the evaluation course of for this particular trial, which is a promising step ahead in a sort 1 diabetes vaccine for kids. This trial is at the moment recruiting in Sweden – right here’s how to get entangled.
Normally, Diamyd represents one other effort to seek out an immunotherapy that might probably delay or forestall sort 1 diabetes, and stop problems sooner or later. Researchers proceed to work in direction of new and modern methods to deal with sort 1 diabetes, and the Diamyd vaccine would possibly finally turn out to be a therapy possibility that, in contrast to insulin, combats the immune response that results in sort 1 diabetes.
