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

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

RED BANK, N.J., March 28, 2022 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced positive results from the final analysis of its first-in-human PROVENT study of PRV-101, a polyvalent inactivated coxsackievirus B (CVB) vaccine candidate targeting all key CVB strains associated with type 1 diabetes (T1D) autoimmunity. Provention is developing PRV-101 for the prevention of acute CVB infection and its complications, as well as for the potential delay or prevention of associated autoimmune disorders T1D and celiac disease.

In this final analysis, 6 months following the last dose of the vaccine, PRV-101 met the primary endpoint confirming the tolerability observed in the previously reported interim analysis, with no Treatment-Emergent Serious Adverse Events, Adverse Events of special interest, or Adverse Events leading to study drug discontinuation or study withdrawal.

The results also showed durability of viral neutralizing antibody (VNT) responses. At this 6-month post-final dosing time point, the percentages of subjects in the high-dose PRV-101 arm who maintained high titers of VNT were 100% for the majority of serotypes included in the vaccine and no less than 90% for all.

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 conducted at the Clinical Research Services Turku - CRST Oy, a clinical trial unit in Turku, Finland. The study's primary endpoint was 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.

"These final results from this first-in-human trial of PRV-101 are extremely encouraging," said Francisco Leon, M.D., Ph.D., chief scientific officer and co-founder of Provention Bio. "We appreciate all of our collaborators and partners on this program who enabled 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 decrease the global incidence of T1D and celiac disease. We look forward to potentially partnering to advance this program in the future."

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, its potential to be the first vaccine to prevent CVB and ultimately decrease the global incidence of T1D and celiac disease, and potentially partnering to advance this program in the future. 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, risks related to clinical research and development including that results of future clinical trials may not be consistent with prior results, be positive or may not support regulatory approval or commercialization, 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 annual report on Form 10-K for the period ended December 31, 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 Contact:

Robert Doody, VP of Investor Relations
[email protected]
484-639-7235

SOURCE Provention Bio, Inc.