Open Orphan doses first Codagenix COVID-19 vaccine patient in clinical trial
(ORPH ) has announced the first volunteer has now been dosed with the Codagenix needle free, intranasal COVID-19 vaccine, COVI-VAC.
The Phase I clinical trial of COVI-VAC is currently being carried out by the hVIVO - Open Orphan’s commercial specialist CRO services businesses - at their facility in the UK.
COVI-VAC is a single-dose, intranasal, live attenuated (meaning exposing the entire virus in a weakened form) vaccine against SARS-CoV-2, the virus that causes COVID-19 in humans.
The clinical study will also evaluate the vaccine’s ability to provoke an immune response - measuring neutralising antibodies, mucosal immunity in the airway and cellular immunity.
hVIVO first said it was working in collaboration with US biotech Codagenix to conduct a Phase 1 trial evaluating the safety and immunogenicity of a single-dose vaccine back in July 2020.
The trial is a randomised, double-blinded, placebo-controlled dose-escalation study, and will evaluate the safety and tolerability of the single-dose intranasal vaccine candidate in 48 healthy young adult volunteers at hVIVO's Quarantine Facility in Whitechapel in London.
Open Orphan highlighted to investors that COVI-VAC ‘has the potential to address several key logistical challenges to immunisation against SARS-CoV-2 at a global scale.’
It added, ‘As a single-dose, intranasally-delivered vaccine, COVI-VAC will not require a needle and syringe to be administered, nor ultra-low temperature freezers for storage.’
The vaccine can also be manufactured ‘on a large scale and supports ease of administration in a mass vaccination campaign.’ Codagenix expects to report initial study data by mid-2021.
Cathal Friel, Executive Chairman of ORPH, described the single dose, needle free, intranasal, live attenuated vaccine as “one of the first of the next generation COVID-19 vaccines”.
He said, “In our opinion, because it is a live attenuated virus vaccine, COVI-VAC has the potential to give much longer-lasting cellular immunity against COVID-19 than many of the first-generation vaccines.”
He added, “Codagenix sought an inpatient facility for the first in human evaluation of COVI-VAC to allow for thorough evaluation of product safety and real-time volunteer monitoring, and our unique state-of-the-art quarantine facility in East London is one of the few facilities in the world suitable to conduct this trial safely and successfully.”
Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said: "Dosing of the first patients in the Phase 1 clinical trial of COVI-VAC, our single-dose, intranasal, live attenuated vaccine against COVID-19, is an important milestone for Codagenix and the hVIVO team.”
“As a live attenuated vaccine, COVI-VAC has the potential to provide a broader immune response in comparison to other COVID-19 vaccines that target only a portion of the virus, which could prove critical as new variants of SARS-CoV-2 have begun to emerge.
Additionally, we believe COVI-VAC can address potential gaps in supplying the global immunization effort against COVID-19, especially in developing countries,” he added.
Shares in Open Orphan have increased by over 300% in value since the beginning of April 2020, increasing by nearly 10% in the last two weeks.
Codagenix sought an inpatient facility for the first in human evaluation of COVI-VAC to allow for thorough evaluation of product safety and real-time volunteer monitoring, and OPEN ORPHAN’S unique state-of-the-art quarantine facility in East London is one of the few facilities in the world suitable to conduct this trial safely and successfully.
Furthermore, this study is not just a challenge study primarily testing efficacy and would normally be classified as a phase IIa or IIb - but is rather a phase I randomised, double-blinded, placebo-controlled dose-escalation study will evaluate the safety and tolerability of this single dose, intranasal vaccine in 48 young healthy adult volunteers.
For investors, this announcement demonstrates the unique value proposition the Whitechapel quarantine facility presents to its customers and this event will certainly mark an insignificant and exciting milestone in the corporate development of the Group.
Reasons to Follow ORPH
Open Orphan is a rapidly growing Contract Research Organisation and world leader in the testing of vaccines and antivirals using human challenge clinical trials.
The Group comprises 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
Open Orphan 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, it is rapidly advancing several COVID-19 challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines.
hVIVO works with UK and Irish companies 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 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, ORPH 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 it said should result in the hIVO facility being booked out for months, if not years, in advance going forward.
Planned Disposal
When Open Orphan acquired hVIVO in January 2020, hVIVO also came with a number of non-core assets including a 62.6% stake in PrEP Biopharm. However, the new Open Orphan Board and management team are primarily focussed upon cementing its position as a unique CRO and ‘world leader vaccine and antiviral testing using human challenge study models, and therefore earmarked all non-core assets for disposal.
The options for disposal of this unique asset are exciting, numerous and particularly timely given its mode of action. These options could include a trade sale to a Big-Pharma for cash, reverse the asset into the resurgence of listed SPACs and Cash Shells, or even Spin the asset out into a newly listed entity delivering investors dividends in specie of newly formed companies.
In any event, OPRH shareholders would do well to remain on the Shareholder register when this transaction takes place as, whilst the valuation of PrEP Biopharm is currently unknown, with little carrying value on the Open Orphan balance sheet, it should advance the share price accordingly.
Disclaimer & Declaration of Interest
The information, investment views and recommendations in this article are provided for general information purposes only. Nothing in this article should be construed as a solicitation to buy or sell any financial product relating to any companies under discussion or to engage in or refrain from doing so or engaging in any other transaction. Any opinions or comments are made to the best of the knowledge and belief of the writer but no responsibility is accepted for actions based on such opinions or comments. Vox Markets may receive payment from companies mentioned for enhanced profiling or publication presence. The writer may or may not hold investments in the companies under discussion.