Open Orphan plc (AIM: ORPH ), has announced the first in human (Phase I) study of the Codagenix intranasal SARS-CoV-2 (COVID-19) vaccine candidate has received approval from the UK’s independent Medicines and Healthcare Products Regulatory Agency (MHRA).
The approval from MHRA enables the Phase I study to comment to 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.
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.
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.
Further to the Company’s announcement on 28 July 2020, hVIVO, the wholly owned subsidiary of Open Orphan, is working in collaboration with US biotech Codagenix Inc. ("Codagenix") to conduct this Phase I study of “COVI-VAC”, Codagenix’s intranasal SARS-CoV-2 (COVID-19) vaccine candidate.
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.
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.”
Cathal added: “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.”
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.”
Shares in ORPH have performed exceptionally strongly since the beginning of the COVID-19 crisis, rising from less than 5p in January to closing at 22.5p prior to this announcement. News of this this Phase I trial comes at an exciting time in the battle against COVID-19, when interim test data from the first three COVD-19 vaccines has been astonishingly positive. This Codagenix vaccine candidate, COVI-VAC, a codon deoptimized SARS-CoV-2 single-dose, is particularly exciting as it is going to be one of the first second generation COVID vaccines as it is both needle free (intranasal vaccine candidate) and one of the first vaccines that may provide long term immunity protection from COVID 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 currently in development.
3 Reasons to Follow Open Orphan:
Open Orphan is a rapidly growing CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials.
Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO and Venn Life Sciences and is also building out a valuable data platform business. All businesses are now working closely together to offer upselling and cross selling opportunities.
World Class Facilities
Open has Europe's only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and specialist laboratory facilities. The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development.
Largest Test Portfolio
The Company has a leading portfolio of 8 viral challenge study models, which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March 2020, Open Orphan is also rapidly advancing several Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines.
No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering.
Rapidly Expanding Market with Regular Positive Newsflow
The market for vaccine development and testing has grown rapidly over the past six months, largely due to the outbreak of Covid-19.
However, Open Orphan now believes Governments and International pharmaceutical companies around the world will be making enormous ‘catch-up investments’ in all types of vaccine development to ensure the effects of any pandemic can be mitigated in the future, which should result in the hVIVO facility being booked out for months, if not years, in advance going forward.
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