Open Orphan MHRA approval for nasal COVID-19 vaccine clinical trial

Open Orphan

Open Orphan plc (LON:ORPH), a rapidly growing specialist pharmaceutical services CRO which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials, announces the first in human (Phase I) study of Codagenix intranasal SARS-CoV-2 (COVID-19) vaccine candidate has received approval from the UK’s independent Medicines and Healthcare Products Regulatory Agency (MHRA).

Further to the Company’s announcement on 28 July 2020, hVIVO is working in collaboration with US biotech Codagenix Inc. to conduct this Phase I study of COVI-VAC, Codagenix’s intranasal SARS-CoV-2 (COVID-19) vaccine candidate. The study will evaluate safety and immunogenicity of a single-dose nasal vaccine candidate in 48 healthy young adult volunteers at hVIVO’s state-of-the-art Quarantine Facility in Whitechapel, London.

COVI-VAC is one of the few vaccines that uses the live-attenuated virus (i.e. the entire virus in a weakened form), unlike most other vaccines which only contain the viral spike. This vaccine, therefore, has 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 expects the study to commence in January 2021, the initial data expected in early Q2 2020. The Company has already begun enrolling volunteers for this study in its unique East London, 24-bedroom quarantine clinic through hVIVO’s dedicated volunteer recruitment website:

Cathal Friel, Executive Chairman of Open Orphan, said:

“We are delighted to have MHRA approval to begin recruiting volunteers for this much needed clinical trial. 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 II / Phase III programme.”

Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said:

“We are very excited to be moving forward with our collaboration with hVIVO for this first-in-human study of COVI-VAC, our live attenuated vaccine against COVID-19. The initial safety and immunogenicity data from healthy adults will position us well to move into larger studies in 2021 with our partners at Serum Institute of India. We believe COVI-VAC, a needle-free, single dose vaccine, is well-suited to address potential gaps in supplying the global community, as there is likely to be significant unmet need even after the initial roll-out of first generation COVID-19 vaccines.”

Dr. Rajeev Dhere, Executive Director, Serum Institute of India, said:

“We at the Serum Institute of India are pleased with the MHRA approval for initiating the first-in-human clinical trial for the novel intranasal product against COVID-19, developed by Codagenix in collaboration with SII. We are happy to have hVIVO conducting the clinical trial of this unique Intranasal vaccine.”

Cathal Friel, Open Orphan CEO told DirectorsTalk: “We are delighted to announce, further to our announcement in July, the Codagenix intranasal, single dose COVID-19 vaccine candidate has received MHRA approval to commence its first in human phase I trial at hVIVO’s 24 bed quarantine unit in White Chapel in January. This comes at an exciting time in the battle against COVID-19, in recent weeks the world has been relieved to see news of the first three COVD-19 vaccines publishing positive interim data results.

This Codagenix vaccine candidate, COVI-VAC, a codon deoptimized SARS-CoV-2 single-dose, intranasal vaccine candidate, is really exciting as we feel it is going to be one of the first second generation covid vaccines as not alone is it needle free due to he a spray that is inhaled via ones nose. It is also one of the first vaccines that may provide long term immunity protection from COVID possibly giving five to seven years of protection because it is one of few vaccines under development that uses the live attenuated Covid  virus (the entire virus in a weakened form), rather than only the viral spike (part of the viruses proteins). As such, many scientists deem it to be one of the most powerful vaccines in development. The first generation of Covid vaccines just approved seem to be giving in the region of just one years protection.”

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