Open Orphan PLC (LON:ORPH) said COVI-VAC, an intranasal vaccine candidate for coronavirus (COVID-19), has been approved for human trials by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
The pharmaceutical firm said hVIVO, part of the Open Orphan group, is working with US biotech group Codagenix Inc to conduct the phase one study, which will evaluate safety and immunogenicity of a single dose of the vaccine candidate in 48 healthy young adult volunteers at hVIVO's state-of-the-art quarantine facility in Whitechapel, East London.
READ: Open Orphan unit Venn Life Sciences lands two new clients
COVI-VAC is one of a few vaccines that use the live-attenuated virus (the entire virus in a weakened form), unlike other vaccines which only contain the viral spike. As a result, Open Orphan said the vaccine has the potential to induce broad antibody, cellular and mucosal immunity with a single intranasal dose and “could be one of the first vaccines to provide long-term immunity from COVID-19”.
The firm said hVIVO expects the study to commence in January next year, with initial data expected in the early second quarter, adding that it has already begun enrolling volunteers.
"We are delighted to have MHRA approval to begin recruiting volunteers for this much needed clinical trial. The volunteers who attend our unique quarantine facility in East London are expertly supervised in a safe, controlled clinical environment and could be contributing to the development of a new breakthrough vaccine candidate that has the potential to confer immunity to individuals over a much longer timescale”, Open Orphan executive chairman Cathal Friel said in a statement.
"We hope to demonstrate safety and immunogenicity through this trial, which will then allow us to support Codagenix as they move into a larger Phase II / Phase III programme", the chairman added.