Provention Bio and Vactech Announce Publication of Proof-of-Concept Data for a Preclinical Prototype of Coxsackievirus B Vaccine


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— The preclinical prototype vaccine is well-tolerated and provides strong protection against coxsackievirus B infections and diabetes in relevant animal models

— Results provide a solid scientific basis for human trials with Provention’s PRV-101 vaccine


OLDWICK, N.J. and TAMPERE, FinlandMay 18, 2020 /PRNewswire/ —  Provention Bio, Inc. (Nasdaq: PRVB), a clinical-stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease and its licensor, Vactech Oy (Vactech), a Finnish biotechnology company focused on development of vaccines for Type 1 Diabetes (T1D) and other immune mediated diseases, today announced the publication of results demonstrating that a preclinical prototype of Provention’s polyvalent coxsackievirus B (CVB) vaccine, PRV-101, is well-tolerated, immunogenic and highly protective in relevant animal models. Provention is developing PRV-101 as a potential vaccine for acute coxsackievirus infection and for the potential prevention of T1D.

The paper, published in the peer-reviewed journal of Science Advances and titled “A Hexavalent Coxsackievirus B vaccine is Highly Immunogenic and has a Strong Protective Capacity in Mice and Nonhuman Primates,” evaluated the immunogenicity and safety of the prototype vaccine. The study was carried out in collaboration with Tampere Universityin Finland and Karolinska Institute in Sweden and supported by Vactech material, know-how and intellectual property rights.

“Our results provide a solid scientific basis for human trials with Provention’s PRV-101 vaccine.  Our observation showing that this prototype works in macaques is highly important since their immune system closely resembles the immune system of humans,” said Heikki Hyöty, Professor of Virology at Tampere University, co-founder of Vactech, and an author on the study.

In addition to immunogenicity and safety in non-human primates, the prototype vaccine was efficacious in three relevant murine species. In non-obese diabetic (NOD) mice, which are genetically at risk to develop diabetes, the prototype vaccine did not trigger or accelerate diabetes. In SOCS-1-tg mice, a murine model for virus-induced type 1 diabetes (T1D)  in which the insulin-producing beta cells are highly susceptible to CVB-induced destruction, the prototype prevented both infection by CVB and the development of CVB-induced diabetes. In BALB/c mice, a common wild-type murine strain, the prototype vaccine prevented infections known to cause CVB-induced myocarditis (heart infection), a serious complication of acute CVB infection in humans.

“We congratulate the investigators at Karolinska Institute and their collaborators at Tampere University for their compelling research, highly supportive of our PRV-101 vaccine program to prevent acute infection by CVB and the development of CVB-triggered complications such as T1D, celiac disease and myocarditis,” said Francisco Leon, M.D., Ph.D., Co-founder and Chief Scientific Officer of Provention Bio. “The published data shows that the vaccine is well tolerated, with no side effects noted in the pancreas or other organs, and effective in preventing acute infections. Importantly, the published results demonstrate the vaccine was effective in preventing the development of diabetes in a relevant mouse model, further validating Provention’s mission to intercept or prevent T1D.”

Professor Hyöty added, “In addition to preventing the onset of T1D, Provention’s PRV-101 vaccine program has potential for other applications and indications. We are encouraged by our published results demonstrating the prevention of infection by CVB strains known to cause myocarditis in humans, one of the most well-documented CVB-related diseases. Myocarditis can lead to dilated cardiomyopathy, a common cause of sudden cardiac deaths in young adults. CVB infection is the most commonly identified cause of this heart disease in developed countries.”

The senior authors of the article, Professor Heikki Hyöty and Professor Malin Flodström-Tullberg (Karolinska InstituteSweden, are members of Provention’s PRV-101 scientific advisory board. Professor Hyöty is also a co-founder of Vactech. Provention has licensed the exclusive worldwide rights to Vactech’s enterovirus vaccine platform targeting the prevention of CVB infections leading to the onset of T1D and celiac disease.