Historic diabetes treatment focuses on treating the condition with insulin. However, recent immunotherapies move towards the potential to delay or prevent type 1 diabetes (T1D). Provention Bio, Inc. is a biopharmaceutical company focused on the interception and prevention of immune-mediated disease.* In March 2022 they announced positive results in their first in-human study of PRV-101, a coxsackievirus B (CVB) vaccine that addresses all key strains associated with T1D. CSO and co-founder Dr Francisco Leon describes these results as “incredibly exciting”.
So, what are the links between CVB and diabetes, and how is a vaccine going to disrupt them? CVB is common but serious, and damages insulin-producing and gut-lining cells. It can trigger autoimmune damage to the pancreatic beta cells, sometimes leading to T1D and intestinal damage that can cause celiac disease. CVB was identified in the pancreas of around 60% of patients with T1D.
Dr Jeffrey Almond of the University of Oxford stated that the “causal link between CVB infection in childhood and the onset of T1D is compelling”. PRV-101 is polyvalent vaccine that is specifically designed to prevent a putative infectious trigger, and data thus far suggests that it “induced high neutralising antibody titres against CVBs”, said Dr Heikki Hyoty of Tampere University.
Diamyd Medical are also developing a type 1 vaccine to “reprogram the immune system”, according to CEO Ulf Hannelius. He describes the objective as changing the “pro-inflammatory, autoimmune reaction to GAD-65″ to an anti-inflammatory reaction. In the US the trial is on “partial clinical hold” as the FDA reported insufficient information on the drug. Hannelius stated that Diamyd would “treat the FDA’s questions with the highest priority”. On May 19th 2022 Diamyd announced that a new phase III trial was beginning across several European countries with the ambition of including around 330 participants.
Researchers inject small amounts of the GAD-65 protein into a lymph node; the intention is for these immune cells to migrate to the pancreas and preserve, instead of attack, beta cells with GAD-65. This administration sees a “stronger immune response” than subcutaneous injections. Data are promising, revealing ameliorated glucose management compared to the placebo group. In July 2022 Diamyd announced further results from a 14-person study and will expand on these in the EASD 2022 in September. The expectation is that the Diamyd vaccine might become a therapeutic solution that would combat the immune response that leads to T1D and prevent further complications.
As an estimated 8% of the British population currently live with type 1 diabetes these developments present an opportunity to manage or prevent the multitude of life-altering consequences that T1D brings.
*To hear Dr Miguel Sanjuan of Provention Bio at the World Vaccine Congress Europe in October 2022 secure your tickets here.