• PRV-101 was well tolerated and elicited high titers of virus-neutralizing antibodies in a dose-dependent fashion in healthy volunteers
• Positive results support further development activities

Tampere, Finland – Vactech Oy (Vactech), a biotechnology company focused on development of vaccines against Type 1 Diabetes and other immune-mediated diseases, announced today that as a result of a strategic partnership between Vactech and Provention Bio, Inc. (Nasdaq: PRVB), the first-in-human study with PRV-101, a polyvalent inactivated coxsackievirus B (CVB) vaccine candidate, has been completed in Finland. Interim analysis results of this study carried out in healthy adult volunteers are positive both in terms of efficacy and safety.

In this interim analysis, PRV-101 met the primary endpoint demonstrating tolerability, 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,developed by Provention using patents, technology and know-how licensed from Vactech, 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.

This phase 1 trial is a placebo-controlled, double-blind, randomized first-in-human study being conducted at Clinical Research Services Turku - CRST Oy, a clinical trials unit in Turku, Finland. The study's primary endpoint is the safety and tolerability of two dose levels of PRV-101 in healthy adult volunteers provided three administrations with 4-week intervals. Immunogenicity was also evaluated. The interim analysis was conducted after all trial participants completed 4 weeks of follow-up after their 3rd dose (Week 12) to assess vaccine responses and safety. An additional 6-month safety follow up is under way and final trial results are expected in the first half of 2022.

“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 CVB infections,” said Heikki Hyöty, PhD, professor of virology at Tampere University and scientific co-founder of Vactech Oy.

"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 continue the advancement of PRV-101."

“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.”

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 about 60% of patients with T1D and the gut of about 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 about 50% of T1D and about 20% of celiac disease. 

About Vactech Oy (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 is engaged in a strategic partnership with Provention Bio, Inc. especially in the field of PRV-101.

For additional information on Vactech Oy, please, visit www.vactech.fi or contact:

Raimo Harju, CEO

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 Provention on Twitter: @ProventionBio.

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