Open Orphan (ORPH ) has received approval from a specially convened Research Ethics Committee ("REC") enabling it to initiate the world's first COVID-19 characterisation study.

The news follows a contract signed by hVIVO, a subsidiary of Open, in October 2020 with the UK Government to develop a COVID-19 (SARS-CoV-2) human challenge study model. 

The REC approval completes all the independent external body approvals necessary for the UK Government-funded study. Open said the study is now set to commence shortly.

The initial virus study will inoculate up to 90 volunteers, between the ages of 18 and 30 years old, in order to enable identification of the most appropriate dose of the virus needed to cause COVID-19 (SARS-CoV-2) infection in a safe and controlled environment. 

Imperial College London is the clinical study sponsor for the study which will be conducted by hVIVO at the Royal Free London NHS Foundation Trust's specialist clinical research unit, ‘under the scrutiny of highly trained scientists and medics,’ Open told investors.

The Company noted that the virus being used in the characterisation study has been produced under hVIVO's supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, with support from virologists at Imperial College London.

hVIVO’s Chief Scientific Officer, Dr Andrew Catchpole, said, "Ethical review of the research plan is a crucial part of conducting clinical studies and approval from the Ethics Committee represents a very important milestone in the development of the COVID-19 challenge model.

COVID-19 Human Challenge studies have the potential to play an important role in providing data and information that will help continue to develop vaccines to control the pandemic.”

Catchpole told investors that the characterisation study is “a key enabling study to establish the COVID-19 challenge model and determine the lowest possible dose of virus required.”

Data from the study is expected to immediately facilitate the challenge model for vaccine efficacy testing as well as address a range of fundamental scientific questions such as “what type of immunological response is required to confer protection from re-infection?”

Dr Chris Chiu, Clinical Reader, Honorary Consultant and Chief Investigator of the study said, “The recent worsening of the pandemic and urgent need to vaccinate people quickly and effectively have raised new questions about COVID-19 and how to best protect ourselves against it.” 

He highlighted that the characterisation study will “immediately tell us about mild and asymptomatic infection” which he cites as a major driver of continuing transmission. 

“While the first wave of vaccines are being rolled out, human challenge studies could also be pivotal in helping to shape the timings and doses of existing vaccines, finding out how long one dose is protective for, and if they are effective against new variants of the virus."

The Research Ethics Committee has provided detailed independent scrutiny. Their favourable opinion is a crucial step towards getting this study open and running, and greatly helps us in our efforts to minimise risks and enhance the quality of the research,” he added.

Exciting news for OPRH shareholders to see a UK company take the lead on the global stage. Shares in Open Orphan have increased by over 20% in value since the beginning of the month and have demonstrated more than four-fold increase since the start of April 2020. Open saw investors react positively to the news this morning with shares up 7.02% to 30.5p.

Reasons to Follow ORPH

Open Orphan is a rapidly growing Contract Research Organisation and world leader in the testing of vaccines and antivirals through the use of 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. 
The company announced that its first volunteer had been dosed with the Codagenix needle free, intranasal COVID-19 vaccine, COVI-VAC as part of a Phase I clinical trial of COVI-VAC currently being carried out by hVIVO, at its facility in the UK. 

Rapidly Expanding Market

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.