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28-Jan-2019

Provention Bio Receives Notice of Allowance from United States Patent and Trademark Office for Patent on Multi-Strain Coxsackievirus B Vaccine for Preventing or Treating Type 1 Diabetes (T1D)

OLDWICK, N.J., Jan. 28, 2019 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a clinical-stage biopharmaceutical company dedicated to developing novel therapeutics aimed at intercepting and preventing immune-mediated diseases, announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application titled, "Multi-CBV Vaccine for Preventing or Treating Type 1 Diabetes."  The patent application covers methods of use involving the development of a coxsackievirus B (CVB) vaccine for the prevention and/or treatment of type 1 diabetes (T1D).

Provention Bio is developing PRV-101 as a vaccine for acute coxsackie virus infection and potentially as the first-ever vaccine designed to prevent T1D.  Epidemiological and experimental studies indicate that approximately half of all T1D cases could be triggered by a CVB infection in early childhood.  Based on this research, which was recently the subject of a peer-reviewed paper in Expert Review of Vaccines (Developing a Vaccine for Type 1 Diabetes by Targeting Coxsackievirus B), Provention Bio is developing PRV-101 to reduce the onset of T1D by vaccinating at-risk populations against CVB infection.  PRV-101 is currently in an IND-enabling stage prior to initiation of first-in-human studies.

"This Notice of Allowance from the USPTO is a significant advancement in the ongoing development of PRV-101 and emboldens Provention's vision to develop a vaccine for CVB that could potentially prevent up to 50% of worldwide T1D cases," said Ashleigh Palmer, Provention Bio's Co-Founder and Chief Executive Officer.  "As we advance PRV-101 towards the clinic, we will continue to aggressively pursue opportunities to strengthen the intellectual property estate surrounding this technology and the use of a polyvalent CVB vaccine to prevent T1D."          

About Provention Bio, Inc.
Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy that is focused on the prevention or interception of immune-mediated disease.  Provention's mission is to in-license, transform and develop therapeutic candidates targeting the high morbidity, mortality and escalating costs of autoimmune and inflammatory diseases including: type 1 diabetes (T1D), Crohn's disease, ulcerative colitis, celiac disease, lupus, and certain life-threatening viral diseases. Provention's diversified portfolio includes advanced-stage product development candidates that have undergone clinical testing by other companies. For more information on Provention Bio, please visit www.proventionbio.com.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. 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 failure to obtain FDA approvals or clearances and noncompliance with FDA regulations; uncertainties of patent protection and litigation; limited research and development efforts and dependence upon third parties; substantial competition; our need for additional financing and the risks listed under "Risk factors" in our quarterly report on Form 10-Q for the quarter ended September 30, 2018 and any subsequent filings with the Securities and Exchange Commission (SEC). 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.

Media & Investor Contacts
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
T: 212 375 2665 / 212 375 2664
jrando@tiberend.com
jdrumm@tiberend.com

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Last Updated: 28-Jan-2019