Provention’s lead program in type 1 diabetes (T1D) exemplifies the company’s unique, paradigm-shifting approach to preventing debilitating chronic diseases before they start.
We are developing an enteroviral vaccine targeting Coxsackievirus B (CVB) infection as a potential protection for at-risk individuals against T1D. Our development of a CVB vaccine to pre-empt the onset of T1D is based on innovative research demonstrating a link between CVB infection and the development of T1D. This research indicates that CVB infection could be a potential trigger for onset in more than half of T1D cases.
Our CVB vaccine is currently in the IND-enabling stage, with animal models of safety and efficacy demonstrating that the vaccine is able to protect genetically predisposed mice from T1D triggered by CVB. Upon regulatory approval, we intend to initiate a clinical development plan involving streamlined first-in-human, proof-of-mechanism and proof-of-concept studies. These studies will not only evaluate our CVB vaccine as a preventative measure against T1D, but will also investigate its ability to protect individuals against the risk of serious complications and hospitalizations from acute CVB infection.
T1D is a life-impacting chronic disease caused by immune destruction of the insulin-producing cells in the pancreas. Today, there is no cure. The only means for managing this devastating disease is life-long blood glucose monitoring and insulin replacement by way of injection/infusion or, potentially, whole organ pancreas or pancreatic islet cell transplantation.
However, global longitudinal studies of more than 200,000 children screened and more than 17,000 followed over two decades in Finland by Vactech’s scientific founders and their collaborators have identified CVB infection as a likely trigger for T1D onset. From this research, it was discovered that insulin-producing cells in the pancreas express specialized receptors used for cellular infection by CVB. As a result, an exacerbated immune reaction against the virus may be involved in triggering the autoimmunity targeting the pancreas and gut, which appears to precede the onset of T1D.
Importantly, CVB-associated risk of T1D was significantly reduced in children whose mothers had a prior CVB infection, thereby suggesting a transfer of protective CVB antibodies to their offspring via placenta and breast milk. This observation suggests the potential benefit of CVB vaccination for children.