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
October 26, 2021

RED BANK, N.J., Oct. 26, 2021 /PRNewswire/ -- 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.

Internet Posting of Information

Provention Bio, Inc. uses its website, www.proventionbio.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation F.D. Such disclosures will be included on the Company's website in the "News" section. Accordingly, investors should monitor this portion of the Company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

Forward-Looking Statements:

Certain statements in this press release are forward-looking, including but not limited to, statements relating to the potential of PRV-101 for the prevention of acute CVB infection and the potential delay or prevention of type 1 diabetes (T1D) and celiac disease and future development plans. These statements may be identified by the use of forward-looking words such as "will," "believe," and "may," among others. These forward-looking statements are based on the Company's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to,  interim data referenced in this release could change as these data are finalized;  the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance;  uncertainties of patent protection and litigation; the Company's dependence upon third parties; substantial competition; the Company's need for additional financing and the risks listed under "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2021 and any subsequent filings with the Securities and Exchange Commission. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Provention does not undertake an obligation to update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. The information set forth herein speaks only as of the date hereof.

Investor Contacts:

Robert Doody, VP of Investor Relations
rdoody@proventionbio.com
484-639-7235

Sam Martin, Argot Partners
sam@argotpartners.com   
212-600-1902

Media Contact:

Lori Rosen, LDR Communications
lori@ldrcommunications.com  
917-553-6808

SOURCE Provention Bio, Inc.