This content material initially appeared on diaTribe. Republished with permission.
By Andrew Briskin
Within the seek for new and revolutionary methods to deal with kind 1 diabetes, researchers have seemed to develop therapies that shield or enhance the physique’s skill to supply its personal insulin. Study concerning the fundamentals of a vaccine presently in growth and the way it might probably sluggish or halt the development of kind 1 diabetes.
For many years, kind 1 diabetes therapy has targeted on treating the situation, primarily with insulin. Lately, nonetheless, therapies that focus on the immune system (immunotherapies) have gained increasingly traction of their potential to delay or forestall kind 1.
You will have heard a few new drug referred to as Tzield (teplizumab), the primary – and thus far solely therapy – therapy to delay the onset of kind 1 diabetes for 2 years or extra. One other vaccine presently 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, referred to as 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 establish 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 folks with kind 1 diabetes targets a kind of protein referred to as 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 identified, roughly 80% of beta cells have been destroyed. This injury 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 method 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 towards GAD-65 acknowledge the protein and injury 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 alter the pro-inflammatory, autoimmune response to GAD-65, and to skew that to an anti-inflammatory response.”
Researchers at Diamyd are presently taking the method 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 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 right this moment
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 did not display 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 immediately 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 positioning 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 once 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 scientific trials.
Information has been promising over the previous couple of years. In 2021, the corporate revealed 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 not too long ago identified examine members in comparison with the placebo group.
In 2022, Diamyd introduced outcomes from a 14-person security examine with promising leads to folks identified 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 part 3 trial (which is presently recruiting) referred to as DIAGNODE-3. The trial is enrolling 330 members 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 security and feasibility of Diamyd in youngsters and teenagers between ages 8-18 who carry the gene for kind 1 diabetes. The FDA not too long ago fast-tracked the evaluation course of for this particular trial, which is a promising step ahead in a kind 1 diabetes vaccine for youngsters. This trial is presently recruiting in Sweden – right here’s how to become involved.
On the whole, 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 revolutionary methods to deal with kind 1 diabetes, and the Diamyd vaccine would possibly ultimately grow to be a therapy possibility that, in contrast to insulin, combats the immune response that results in kind 1 diabetes.
