This content material initially appeared on diaTribe. Republished with permission.
By Andrew Briskin
Within the seek for new and progressive methods to deal with kind 1 diabetes, researchers have appeared to develop therapies that shield or enhance the physique’s means to provide its personal insulin. Study in regards to the fundamentals of a vaccine at the moment in growth and the way it might probably gradual or halt the development of kind 1 diabetes.
For many years, kind 1 diabetes remedy has centered on treating the situation, primarily with insulin. In recent times, nonetheless, therapies that concentrate on the immune system (immunotherapies) have gained increasingly more traction of their potential to delay or forestall kind 1.
You might have heard a few new drug referred to as Tzield (teplizumab), the primary – and up to now solely remedy – remedy 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 called beta cells. This happens due to one thing referred to 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, nonetheless, mistakenly goal a number of of your physique’s proteins, which can injury tissues and organs. One auto-antibody sometimes present in individuals with kind 1 diabetes targets a kind of protein often called GAD-65.
The destruction of the beta cells progresses at completely different speeds, relying on every particular person. Nevertheless, by the point kind 1 diabetes is normally recognized, roughly 80% of beta cells have been destroyed. This injury continues till the particular person 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 novel strategy to growing 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 injury 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,” 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 research (lymph nodes are small, bean-shaped buildings all through the physique that include a few 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 immediately
Over the previous twenty years, a number of obstacles have stood in the best way of a kind 1 vaccine, together with a trial suspended in 2011 that did not exhibit the vaccine’s effectiveness. Since then, the corporate has made some modifications Hannelius stated, together with the best way that the vaccine is run (it’s now injected instantly into the lymph nodes moderately than beneath the pores and skin). One other analysis trial was placed on a partial scientific 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 location the place the immune response occurs, with a a lot smaller dose,” stated 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 specific gene related to a excessive threat for kind 1 diabetes. In accordance with Hannelius, this gene is present in as much as 40% of individuals with kind 1, with this sub-group displaying a very constructive response in scientific trials.
Information has been promising over the previous couple of years. In 2021, the corporate printed outcomes from its section 2b trial, DIAGNODE-2. This research, which included 109 research contributors ages 12-24, confirmed that the vaccine improved glucose administration (as measured by time in vary) in lately recognized research contributors in comparison with the placebo group.
In 2022, Diamyd introduced outcomes from a 14-person security research with promising leads to 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 analysis normally occurring in adults.
In progress: Diamyd scientific trials
Diamyd is within the midst of a brand new section 3 trial (which is at the moment recruiting) referred to as DIAGNODE-3. The trial is enrolling 330 contributors at 60 places 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 referred to as DiaPrecise was launched in 2023 to judge the protection and feasibility of Diamyd in kids and teenagers between ages 8-18 who carry the gene for kind 1 diabetes. The FDA lately fast-tracked the overview course of for this particular trial, which is a promising step ahead in a kind 1 diabetes vaccine for kids. This trial is at the moment recruiting in Sweden – right here’s how to become involved.
Usually, Diamyd represents one other effort to search out an immunotherapy that would probably delay or forestall kind 1 diabetes, and forestall problems sooner or later. Researchers proceed to work in the direction of new and progressive methods to deal with kind 1 diabetes, and the Diamyd vaccine may ultimately develop into a remedy choice that, in contrast to insulin, combats the immune response that results in kind 1 diabetes.
