Open Orphan PLC (ORPH.L) Contract for COVID-19 Vaccine Trial

This RNS is the very exciting start to a substantial amount of COVID-19 work that we will be doing for the remainder of this year and throughout next year.

This first in human (Phase I) trial will be completed at our state of the art hVIVO facility in London and will be commencing in Autumn of this year. This contract is particularly exciting because should this phase I trial go well, there is an increase chance that a full challenge study will come on the back of it. 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 and this contract reinforces Open Orphan position as the world leader in the testing of vaccines and antivirals.

In this trial will be tested for both safety immunogenicity. 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.

Awarded Contract from Codagenix Inc. New York USA for COVID-19 Vaccine Trial

Open Orphan plc (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 is pleased to announce a new contract with Codagenix Inc. (“Codagenix”) 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.

Highlights:

· 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 Open Orphan, 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 Open Orphan’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.”


Linking Shareholders and Executives :Share Talk

If anyone reads this article found it useful, helpful? Then please subscribe www.share-talk.com or follow SHARE TALK on our Twitter page for future updates.

Terms of Website Use

All information is provided on an as-is basis. Where we allow Bloggers to publish articles on our platform please note these are not our opinions or views and we have no affiliation with the companies mentioned

Share via
Copy link
Malcare WordPress Security