Open Orphan (LSE:ORPH) was looking strong at 13.3p a share on Tuesday following a major breakthrough in its coronavirus operations.
The business has signed a deal with biology company Codagenix to conduct a first in human (Phase I) trial on a Covid-19 vaccine.
The single-dose, intranasal medicine will be administered to 48 healthy young adult volunteers to test its safety and immune effectiveness (“immunogenicity”).
Unlike many other vaccines being put forward, CodaVax-COVID – as the product is known – replicates very slowly and contains all of Covid-19’s proteins.
Open Orphan said most alternatives only contain the “viral spike”, adding:
“This vaccine has the potential to induce broad antibody, cellular and mucosal immunity with a single intranasal dose. hVIVO is currently kicking off the initial steps of this exciting study and are expected to start the trial in the quarantine unit this autumn.”
The vaccine will be trialled at Open Orphan company hVIVO’s state-of-the-art quarantine facility in Whitechapel, London, in early Autumn.
Initial data is expected by the end of 2020 and will determine whether a full challenge study will follow.
hVIVO is one of the few organisations in the world that has now publicly states that it is working on testing Covid-19 vaccines for efficacy using human challenge model clinical trials.
With Tuesday’s news potentially heralding an exciting start to a substantial amount of Covid-19 work for Open Orphan, the firm’s share price was up 4.9% in morning trading.
It is now up 177.9% so far this year, on track to retract highs of 16p a share hit towards the end of May.
Executive chairman Cathal Friel said: “We are proud to be conducting this Phase I study for Codagenix, a leader in their field, as it will help bring a promising vaccine candidate to the public to help combat the COVID-19 pandemic as quickly as possible.
Today’s announcement also shows that hVIVO’s quarantine facility is uniquely suited to conducting Phase I studies for infectious disease vaccines such as this.
Codagenix’s expertise in viral design technology, combined with hVIVO’s Phase I trial capability, gives us confidence that this trial will be successful and a step forward for the world as it seeks to develop a COVID-19 vaccine to bring the pandemic to a close.”
Meanwhile, Codagenix’s chief medical officer Sybil Tasker added: “We are very excited to be collaborating with hVIVO for the first-in-human study of CodaVax-COVID. hVIVO is world-recognized for expertise in evaluation of live viruses in human volunteers. Based on our animal data we expect this vaccine to be effective with a single dose, but will also evaluate a repeat dose to assess potential for boosting and as a model for protection from wildtype challenge.
We plan to move quickly from this initial demonstration of safety and immunogenicity in a controlled inpatient setting to larger Phase 2/3 program in conjunction with our partners at Serum Institute of India who are currently scaling up manufacturing to support rapid acceleration of our joint development program.”