An international biotech company, headquartered in the EU approached hVIVO to explore the possibility of performing a RSV Phase IIa challenge study. The investigational product was a novel recombinant modified vaccinia virus Ankara RSV vaccine candidate. The company wanted to obtain proof of efficacy and additional safety data by Dec-21, (building on data from their initial “In-Human” study) before launching a global Phase III programme.
The client’s aim was to speed up the development process. In order to do this, they needed to achieve a quick proof of efficacy so that they could move forward with further regulatory discussions. There were certain challenges related to achieving this goal.
Open Orphan (LON:ORPH) was founded in 2017, with the goal of rapidly building Europe’s leading pharma services company by a management team with extensive industry and financial expertise. The company comprises of two commercial specialist CRO services businesses (Venn Life Sciences and hVIVO) and is also developing a genomics data platform business (Genomic Health Data).