Open Orphan plc (ORPH) , has announced a new contract to conduct a first in human (Phase I) trial of a SARS-CoV-2 (COVID-19) vaccine candidate for Codagenix Inc, a leading US based vaccine developer.
The Contract marks the first Phase I trial evaluating safety and immunogenicity of a single-dose, intranasal in human study of CodaVax-COVID, a codon deoptimized SARS-CoV-2 of SARS-CoV-2 (COVID-19) vaccine candidate to be carried out at the state-of-the-art Quarantine Facility in Whitechapel in London.
CodaVax-COVID is a’ live-attenuated vaccine’ that replicates very slowly, but contains all SARS-CoV-2 proteins, unlike most other vaccines that only contain the viral spike. This vaccine has the potential to induce broad antibody, cellular and mucosal immunity with a single intranasal dose
hVIVO, part of Open Orphan, is already ‘kicking off’ the initial steps of the study and expects to start the 48-patient trial in the quarantine unit this autumn with initial data expected by the end of 2020.
Cathal Friel, Executive Chairman, Open Orphan, 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.
hVIVO, with its unique quarantine facility, is one of the few organisations in the world that has now publicly stated that it is working on testing COVID-19 vaccines for efficacy using human challenge model clinical trials.
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.”
Shares in ORPH have traded strongly over the past three months from 8.36p to close on Monday at 12.46p
Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said: “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.”