Provention, a clinical stage biopharmaceutical company dedicated to sourcing, developing and commercializing novel therapeutics aimed at intercepting and preventing immune-mediated diseases, announced that it has selected Netherlands-based Intravacc to lead product development and manufacturing of clinical trial material for Provention\u2019s Coxsackievirus B (CVB) vaccine (PRV-101).<\/p>\n
France-based L2D Services SARL\/Leads-To-Development (L2D) is providing expert development, regulatory and project management support to ensure rapid progress of PRV-101 into clinical development. CVB, an enterovirus, has been identified as a possible common trigger for type 1 diabetes (T1D) onset. Vaccination of at-risk populations against CVB infection may lead to the prevention or delay in onset of T1D. The CVB vaccine was developed initially by Vactech Ltd. of Finland and licensed to Provention in April, 2017.<\/p>\n
Provention is planning to initiate first in-human clinical trials in 2020. Enteroviruses are responsible for an estimated 30 million infections annually in the US. CVB contributes significantly to enteroviral healthcare costs, since it can result in hospitalization and severe morbidity. Usually asymptomatic or presenting as cold-like symptoms, fever, rash, hand-foot-mouth disease, and\/or mild gastrointestinal distress, CVB infections can occasionally cause more serious and sometimes lifethreatening illnesses including pericarditis, myocarditis, meningitis and pancreatitis.<\/p>\n
Provention, in partnership with Intravacc, Vactech and L2D is now developing its CVB vaccine for large scale manufacture of clinical trial material in accordance with current Good Manufacturing Practices (cGMP). Intravacc was chosen as Provention\u2019s manufacturing partner based on its expertise and excellent track in enterovirus vaccine development, including IPV, sIPV, EV-71, and CV-A16, as well as Intravacc\u2019s state-of-the-art vaccine cGMP production facilities. PRV-101 will be developed using Intravacc\u2019s proven and well-established platform technology, including certain proprietary cell lines and production processes.<\/p>\n
Ashleigh Palmer, co-founder and CEO of Provention Bio, stated, \u201cSelecting Intravacc for PRV-101\u2019s cGMP production is an important next step in our plan to initiate a potentially transformative clinical program to develop a vaccine to prevent acute coxsackievirus B infection and, ultimately, prevent or delay the onset of as much as half of the world\u2019s cases of T1D. We welcome this opportunity to work alongside Intravacc, Vactech and L2D to advance our PRV-101 program to the clinic.\u201d<\/p>\n
Intravacc\u2019s CEO Thijs Veerman, MSc, commented, \u201cWe are very excited to be involved in this project. Intravacc is uniquely positioned to develop cGMP clinical material for this vaccine and ensure its specifications, quality and patient-readiness. We have the necessary knowledge, expertise and experience to advance Provention\u2019s PRV-101 program to the next stage and beyond.\u201d<\/p>\n