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A vaccine for Type 1 diabetes? Provention Bio says a human trial is in sight

A nurse preparing a medical injection
Provention Bio is developing a coxsackievirus vaccine that it hopes could prevent up to 50% of Type 1 diabetes cases.

Type 1 diabetes, in which the immune system attacks insulin-producing beta cells of the pancreas, is caused by both genetic susceptibility and environmental factors, researchers believe. Biotech startup Provention Bio is trying to reduce the environmental risk by way of a vaccine scientists believe can prevent up to 50% of new Type 1 diabetes cases.

Previous epidemiological studies and experiments on animals and human tissues have suggested a possible link between enterovirus (EV) infections and Type 1 diabetes, according to a summary co-authored by Provention’s co-founder and chief scientific officer, Francisco Leon, M.D., Ph.D., which appeared recently in the journal Expert Review of Vaccines. EVs are known to infect the pancreas and cause a diabetes-like disease in animals. Additionally, scientists have prevented diabetes in mice with attenuated virus vaccines or recombinant VP1 viral proteins.

Based on those findings and with proceeds from an initial public offering, Provention is now advancing a multivalent group B coxsackieviruses (CVBs) vaccine candidate dubbed PRV-101 into the clinic for Type 1 diabetes, it announced.

Researcher Heikki Hyöty of the University of Tampere in Finland, who co-authored the current review, had previously found that people with markers of EV infections had an increased risk of Type 1 diabetes. He published that evidence in a 2017 paper in the journal Diabetologia.

In that study, Finnish scientists examined 1,673 longitudinal stool samples from 129 children who turned positive for autoantibodies against pancreatic islets—which is known as a pre-symptom phase of Type 1 diabetes—and compared them with 3,108 samples from 282 matched control children. The researchers observed an increased frequency of EV RNA in the children long before the emergence of autoimmunity.

What’s more, Hyöty and colleagues found that CVB1 antibodies in the mothers of the study subjects were associated with about 50% lower rate of autoimmunity in the children.

“This important observation suggests that a vaccine against CVB could prevent a substantial subset of T1D cases,” wrote the authors in the current study.

Still, there isn’t enough evidence to prove the observed CVB-diabetes link is indeed causal. That key question will likely only be answered by a clinical trial. That’s where Provention Bio comes in.

The company has developed PRV-101, a multivalent CVB vaccine made with the same formalin-inactivated whole-virus vaccine technology used in a polio inoculation. In a preclinical proof-of-concept study done by a team at the University of Tampere, a prototype of the vaccine successfully protected against virus-induced diabetes in a mouse model of Type 1 diabetes, the team reported in a Diabetologia paper.

Provention is on track to start human trials of PRV-101 soon, and its executives hope it will be the first vaccine to prevent up to 50% of Type 1 diabetes cases. “In addition to the potential prevention of T1D, this vaccine could have other important beneficial health effects generated by protection against acute CVB infections, which are frequent and cause significant morbidity particularly in young children,” Leon said in the announcement.