Provention Bio Initiates First-in-Human Study of Coxsackievirus B Vaccine Candidate PRV-101

Rhea-AI Summary

Provention Bio, Inc. (Nasdaq: PRVB) announced the initiation of PROVENT, a first-in-human study for its investigational vaccine candidate PRV-101 targeting coxsackievirus B (CVB). The study aims to evaluate PRV-101's safety and immunogenicity in healthy adults, potentially preventing acute CVB infections and delaying or preventing type 1 diabetes (T1D) and celiac disease. Conducted in Turku, Finland, results are expected in H2 2021. CVB infection is linked to T1D and celiac disease, making PRV-101 a significant advance in autoimmunity prevention.

Positive

• Initiation of first-in-human study for PRV-101 is a significant milestone.
• Potential to be the first vaccine to prevent CVB and associated autoimmune diseases.
• Study could lead to delaying or preventing T1D and celiac disease.

Negative

• Results from the PROVENT study are not expected until the second half of 2021, creating uncertainty.
• Regulatory approvals and market acceptance are uncertain.

RED BANK, N.J., Dec. 15, 2020 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the initiation of PROVENT (PROtocol for coxsackievirus VaccinE in healthy voluNTeers), a first-in-human study of its polyvalent inactivated coxsackievirus B (CVB) vaccine candidate, PRV-101. Provention is developing PRV-101 for the prevention of acute CVB infection and the potential delay or prevention of type 1 diabetes (T1D) and celiac disease.

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, MD, Ph.D., 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."

PROVENT 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 ~60% of patients with T1D and the gut of ~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 ~20% of celiac disease. Patents covering the use of PRV-101 in these indications have been licensed in from Vactech Ltd.

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 has submitted a BLA to the FDA for its lead investigational drug candidate, teplizumab, for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals. 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.

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 FD. 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.

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. Please see the company's website at www.vactech.fi for additional information.

Forward-Looking Statements:

Certain statements in this press release are forward-looking, including but not limited to, statements relating to the Company's studies, the potential health benefits of and planned research and development efforts for PRV-101. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Provention'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 delays in, or failure to obtain FDA approvals or clearances and noncompliance with FDA regulations; 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; dependence upon third parties; substantial competition; our need for additional financing and the risks listed under "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2019, our quarterly reports on form 10-Q, 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. The information set forth herein speaks only as of the date hereof.

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

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

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SOURCE Provention Bio, Inc.

FAQ

What is PRV-101 and its purpose?

PRV-101 is an investigational polyvalent vaccine developed by Provention Bio to prevent coxsackievirus B infections and potentially delay or prevent type 1 diabetes and celiac disease.

When is the PROVENT study expected to release results?

Results from the PROVENT study are expected in the second half of 2021.

Where is the PROVENT study being conducted?

The PROVENT study is being conducted at Clinical Research Services Turku in Turku, Finland.

How does coxsackievirus B relate to type 1 diabetes?

Coxsackievirus B infection is significantly associated with the development of type 1 diabetes and celiac disease, as it can damage insulin-producing and gut-lining cells.

What are the key endpoints of the PROVENT study?

The primary endpoints of the PROVENT study include the safety and tolerability of PRV-101 and evaluating its immunogenicity in healthy adult participants.