• Potential to be the first vaccine for the prevention of coxsackievirus B, a presumed infectious trigger in the development of Type 1 Diabetes (T1D) and Celiac Disease

Tampere, Finland – Vactech Oy (Vactech), a biotechnology company focused on development of vaccines against Type 1 Diabetes and other immune-mediated diseases, announced today that as a result of the strategic partnership between Vactech and Provention Bio, Inc. (Nasdaq: PRVB) the first-in-human study with its polyvalent inactivated coxsackievirus B (CVB) vaccine candidate, PRV-101, has been initiated in Finland.

CVB is a common enterovirus that frequently causes acute morbidity such as respiratory disease, meningitis, pericarditis, otitis, and hand-foot-mouth disease. CVB is also the leading cause of viral myocarditis, a common condition that can cause fatal arrythmia and lead to a serious chronic myocarditis that often needs heart transplantation. CVB infection is significantly associated with the development of T1D and Celiac Disease.

"The PRV-101 investigational vaccine is specifically designed to prevent autoimmunity by primary prevention of a putative infectious trigger," said Heikki Hyöty, co-founder of Vactech, Professor of Virology at Tampere University, Finland. "A substantial body of evidence points to the role of CVB as a trigger in the initiation of two common autoimmune diseases, T1D and Celiac Disease. Based on these data, PRV-101 represents an exciting vaccine candidate to intercept the development of these autoimmune disorders. In addition, it has the potential to target several acute CVB diseases and myocarditis."

“The PRV-101 vaccine is based on a long track of scientific research that has shown an association between CVB infections and Type 1 Diabetes. Finnish scientists have been in the frontline of this research driving the development of the vaccine against T1D-associated CVBs” said Mikael Knip, emeritus professor of Pediatrics at the University of Helsinki. “Vactech has played a central role in this mission by carrying out the early development of the vaccine and by bringing together the parties that have now started the phase 1 clinical trial in Finland”, said Raimo Harju, CEO of Vactech.

This Phase I trial named PROVENT (PROtocol for coxsackievirus VaccinE in healthy voluNTeers) is a placebo-controlled, double-blind, randomized first-in-human study being conducted at the Clinical Research Services Turku - CRST Oy, a clinical trial unit in Turku, Finland. The study's primary endpoint is the safety of two dose levels of PRV-101 in healthy adult volunteers provided three administrations with 4-week intervals. Tolerability and immunogenicity will also be evaluated. Results of PROVENT are expected in the second half of 2021.

"Initiation of this first-in-human clinical trial is a significant milestone in full alignment with Provention's foundational vision to seek out autoimmunity early to intercept and prevent debilitating and life-threatening diseases," said Francisco Leon, MD, Ph.D., chief scientific officer, and co-founder, Provention Bio. "We look forward to continuing to advance the development of PRV-101 to determine whether a common autoimmune disease can be delayed or prevented with a vaccine against an infectious trigger. If successful, PRV-101 has the potential to be the first vaccine to prevent CVB and could potentially decrease the incidence of T1D and Celiac Disease."

About Coxsackievirus B (CVB) Infection and Immunity:

CVB is a common, potentially serious infection that damages insulin-producing cells and gut-lining cells, triggering a T-cell immune response that is believed to cause autoimmunity in predisposed individuals. The only persistent infection significantly associated with the development of type 1 diabetes (T1D) and celiac autoimmunity, CVB has been found in the pancreas of about 60% of patients with T1D and the gut of around 20% of patients with Celiac Disease.

About PRV-101:

PRV-101 is an investigational polyvalent vaccine being developed for the prevention of acute coxsackievirus B (CVB) infection and the potential delay or prevention of Type 1 Diabetes (T1D) and Celiac Disease. It is specifically designed to prevent autoimmunity by the primary prevention of a putative infectious trigger. PRV-101 has the potential to be the first vaccine to prevent CVB as well as up to 50% of T1D and up to 20% of Celiac Disease. Patents covering the use of PRV-101 in these indications have been licensed from Vactech to Provention.

About Vactech Ltd.

Vactech develops and licenses vaccines and novel technologies for vaccines and diagnostics with a pipeline of early stage product candidates focused on Type 1 Diabetes, Celiac Disease, Asthma & Allergy and diagnostics. Vactech is a privately owned company having a track record of collaboration with both industrial and academic partners. Vactech has engaged in strategic partnership with Provention Bio, Inc. especially in the field of PRV-101.

For additional information on Vactech Oy, please, visit www.vactech.fi or contact:

Raimo Harju, CEO

About Provention Bio, Inc.

Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated disease. FDA has recently accepted the Biologics License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals, with priority review and setting a user fee goal date of July 2, 2021. The Company's pipeline includes additional clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.