Open Orphan plc (LON:ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials has announced a new contract with Codagenix Inc. to conduct a first in human (Phase I) trial evaluating safety and immunogenicity of a single-dose, intranasal SARS-CoV-2 (COVID-19) vaccine candidate in 48 healthy young adult volunteers.
· First in human (Phase I) study of CodaVax-COVID, a codon deoptimized SARS-CoV-2 (COVID-19) single-dose, intranasal vaccine candidate
· Vaccine being trialled at hVIVO’s state-of-the-art Quarantine Facility in Whitechapel in London
· Phase I study to start in early Autumn with initial data expected by the end of 2020
· Study will include second dose as surrogate viral challenge at Day 28
hVIVO, part of ORPH, will conduct the COVID-19 vaccine trial for Codagenix at its state-of-the-art Quarantine Facility. 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 is currently kicking off the initial steps of this exciting study and are expected to start the trial in the quarantine unit this autumn.
This contract reinforces the company’s position as the world leader in the testing of vaccines and antivirals.
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.”
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.”