Intravacc Announces Completion of Formulation Development and Manufacturing Process of PRV-101 Vaccine Candidate for Provention Bio

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BILTHHOVEN, Netherlands, January 19, 2021 / PRNewswire / – Intravac, a global leader in translational research and vaccine development, today announced that a versatile vaccine candidate against inactivated coxsackievirus B (CVB) that it developed and manufactured for Provention Bio in less than 36 months, has entered in a first phase I clinical study in humans called PROVENT (PROtocol for the vaccine against the coxsackievirus in healthy volunteers).

Provention Bio is a clinical-stage biopharmaceutical company that selected Intravacc in 2018 to lead product development and clinical study material manufacturing for Provention’s vaccine candidate (PRV-101). This CVB vaccine candidate is being developed for the predicted prevention of acute CVB infection and the potential delay or prevention of type 1 diabetes (T1D) and celiac disease. Intravacc has used its proprietary, regulatory-approved Vero cell platform to develop a cGMP-grade viral vaccine production process for the versatile CVB vaccine candidate.

CVB is a common enterovirus that frequently causes acute morbidity such as respiratory disease, meningitis, pericarditis and otitis. CVB is also the leading cause of viral myocarditis, a common condition that can cause life-threatening arrhythmias and lead to severe chronic myocarditis that often requires heart transplantation. In addition, persistent CVB infection is significantly associated with the development of T1D and celiac disease. With currently no preventive or disease modifying treatment available for T1D, its complications present a serious unmet medical need and up to 2.3 million people may be at risk for T1D globally. PRV-101 has the potential to be the first vaccine to prevent up to about 50% of T1D and about 20% of celiac disease.

Dr. Jan Groen, CEO of Intravacc, said:

“We are very proud to have been able to complete the Provention Bio contract development and manufacturing project in such a short time and to allocate a substantial share to the first preventive vaccine candidate against T1D and celiac disease. This project provides further validation of Intravacc’s Vero cellular platform. ”

PROVENT is a first randomized, double-blind, placebo-controlled phase I clinical study conducted by the Turku Clinical Research Services – CRST Oy, a clinical trials unit in Turku, Finland. The primary endpoint of the study is the safety of two dose levels of PRV-101 in healthy adult volunteers given three administrations at 4 week intervals. Tolerance and immunogenicity will also be evaluated. PROVENT’s results are expected in the second half of 2021.

About PRV-101

PRV-101 is an investigational polyvalent vaccine in development for the prevention of acute coxsackie B virus (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. Patents covering the use of PRV-101 in these indications have been licensed by Provention Bio of Vactech Oy. NetherlandsIntravacc has been selected to lead the product development and manufacturing of clinical trial equipment for PRV-101.

About Provention Bio, Inc.

Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company focused on advancing the development of experimental therapies that can intercept and prevent debilitating and life-threatening immune-mediated diseases. 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 people at risk. The Company’s pipeline includes additional clinical stage product candidates that have demonstrated in preclinical 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. Twitter: @ProventionBio.

About Intravacc’s Vero Cellular Platform

Intravacc’s viral vaccine production process is based on a regulatory approved, cGMP grade Vero cell line. This proprietary platform is used for the manufacture of large-scale, routine commercial vaccines by Intravacc customers worldwide. In addition, virus seed lots and clinical lots have been routinely produced and validated on Vero cells, eg, poliovirus, enterovirus (EV71) and respiratory syncytial virus (RSV).

About Intravacc

Intravacc, located at Utrecht Science Park Bilthoven at the Netherlands, is a leading global organization in the development and contract manufacturing of innovative vaccines against infectious diseases. As an established independent CDMO with over 100 years of experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology related to polio vaccines, measles vaccines, DTP vaccines, Hib vaccines and influenza vaccines around the world. About 40% of childhood illness vaccines are based on Intravacc’s proprietary technology. Intravacc offers a wide range of expertise for independent vaccine development, from concept to phase I / II clinical studies for partners around the world, including universities, public health organizations (WHO, Bill & Melinda Gates Foundation) , biotechnology and pharmaceutical companies. For more information, please visit www.intravacc.nl.

Contacts:

Intravac
Dr. Jan Groen, CEO
Phone. : +31 30 7920 454

Mirjam Hartman, Media relations
Phone. : +31 6 115 969 94
E: [email protected]

LifeSpring Communication in Life Sciences, Amsterdam
Leon Melens
Phone. : +31 6 538 16427
E: [email protected].nl

Logo: https://mma.prnewswire.com/media/1334670/Intravacc_Logo.jpg

SOURCE Intravacc BV


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