Open Orphan upbeat on progress with nasal Covid-19 vaccine
Specialist pharmaceuticals contract research organisation Open Orphan announced on Monday that the first in-human study of the Codagenix intranasal SARS-CoV-2 vaccine candidate for Covid-19 had gained approval from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA).
The AIM-traded firm said its subsidiary hVIVO was working with US biotechnology company Codagenix to conduct the phase 1 study of ‘Covi-Vac’ - Codagenix's intranasal SARS-CoV-2 vaccine candidate.
It said the study would evaluate safety and immunogenicity of a single-dose nasal vaccine candidate in 48 healthy young adult volunteers at hVIVO's quarantine facility in Whitechapel, London.
Open Orphan said Covi-Vac was one of the few vaccines that used the live-attenuated virus, unlike most other vaccines which only contained the viral spike.
It said the vaccine, therefore, had 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.
hVIVO was expecting the study to start in January, with initial data expected early in the second quarter of 2021.
The company said it had already started enrolling volunteers for the study in its 24-bedroom East London quarantine clinic, through hVIVO's dedicated volunteer recruitment website.
“We are delighted to have MHRA approval to begin recruiting volunteers for this much needed clinical trial,” said executive chairman Cathal Friel.
“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.
“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 2 and 3 programme.”
At 1129 GMT, shares in Open Orphan were down 0.22% at 22.45p.