Provention Bio Announces Positive Interim Results from First-In-Human Study of Coxsackievirus B Vaccine Candidate PRV-101

PRV-101 was well tolerated and elicited high titers of virus-neutralizing antibodies in a dose-dependent fashion in healthy volunteers

Positive data supports further development activities

RED BANK, NJ, USA I October 26, 2021 I Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced positive interim results from PROVENT (PROtocol for coxsackievirus VaccinE in healthy voluNTeers), a first-in-human study of PRV-101, a polyvalent inactivated coxsackievirus B (CVB) vaccine candidate targeting all five key CVB strains associated with type 1 diabetes (T1D) autoimmunity. Provention is developing PRV-101 for the prevention of acute CVB infection and the potential delay or prevention of T1D and celiac disease.

In this interim analysis, PRV-101 met the primary endpoint demonstrating that it was well tolerated in this study, with no treatment-emergent Serious Adverse Events, Adverse Events of Special Interest, or Adverse Events that led to study drug discontinuation or study withdrawal. PRV-101 also met the secondary efficacy endpoint as it induced high titers of viral-neutralizing antibodies against all CVB serotypes included in the vaccine in a dose- dependent fashion.

PRV-101, licensed from Vactech Oy (Tampere, Finland), is designed to prevent acute CVB infections and, in individuals at increased risk due to genetic susceptibility, to prevent CVB-triggered autoimmune damage to pancreatic beta cells that often progresses to T1D and damage to intestinal cells that may lead to celiac disease.

PROVENT is a Phase 1 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 were also evaluated.  The interim analysis was conducted after all trial participants completed 4 weeks of follow-up after the 3rd dose (Week 12) to assess vaccine response and safety. An additional 6-month safety follow up will be conducted and final trial results are expected in the first half of 2022.

"These interim results from this first-in-human trial are incredibly exciting," said Francisco Leon, MD, PhD, chief scientific officer and co-founder of Provention Bio. "We thank our collaborators for their pioneering efforts, enabling PRV-101 to take a significant stride forward to producing clinical data to demonstrate its potential to be the first vaccine to prevent CVB and ultimately decreasing the global incidence of T1D and celiac disease.  We look forward to the final results of this trial next year and continuing the advancement of PRV-101."

"This is a very important milestone creating a solid basis for the continuation of the development program. We are delighted to see that the PRV-101 vaccine induced high neutralizing antibody titers against CVBs since these antibodies mediate protection against CVBs," said Heikki Hyoty, PhD, professor of virology, Tampere University, Finland, and scientific co-founder of Vactech Oy.

"The causal link between CVB infection in childhood and the onset of T1D is compelling", said Jeffrey Almond, PhD, visiting professor of microbiology, University of Oxford and former global head of research at Sanofi Pasteur. "Provention Bio has taken the lead by producing a CVB vaccine that is already showing very good results in a Phase 1 study.  I look forward to seeing the rapid further development of this vaccine and its use to reduce the burden of T1D in children."

The Company has posted an update to its corporate slide presentation containing additional details pertaining to the information commented on within this press release.  The presentation can be found at www.proventionbio.com in the Investor's section.

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 ~60% of patients with T1D and the gut of ~20% of patients with celiac disease. A 50% reduction in T1D autoimmunity was observed in the offspring of mothers with CVB immunity during pregnancy.

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 ~20% of celiac disease.

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. The Company's pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including type 1 diabetes, celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.

SOURCE: Provention Bio

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