Open Orphan (ORPH)  said the world's first COVID-19 characterisation study is set to expand, with the Group’s subsidiary, hVIVO, investigating COVID-19 in up to 20 further volunteers. 

hVIVO was chosen to work alongside the UK Government earlier this year as part of the of the characterisation study where researchers would aim to identify a dose of the COVID-19 virus that causes a safe and reliable infection in unvaccinated COVID-19 naïve volunteers.

The Company said the UK Government has now decided to expand the Human Challenge Programme in order to answer further questions that can help in the fight against COVID-19.

The study, which is being conducted by hVIVO at the Royal Free Hospital and funded by the UK Government who have commissioned Imperial College London as the study sponsor, will initiate as soon as appropriate regulatory approvals and clinical preparations are complete.

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, Open Orphan outlined.

ORPH said that existing data from the characterisation study has already provided valuable insight into the biology of the virus which causes COVID-19. Further data is expected to improve the ability to manage the virus and deliver a range of treatment options in the future. 

Commenting on the characterisation study, Cathal Friel, Executive Chairman of Open Orphan said this study expansion “further illustrates the effectiveness and importance of this study." 

Caroline Clarke, Royal Free London’s Group Chief Executive, said: "Ultimately, we hope this research will give us more information about vaccines, as well as its impact on infection rates, and enable us to provide better treatments in the future for patients with COVID-19."

In a separate announcement, the Group announced that it had won a new contract worth of c. €0.9m with an existing customer for clinical trial management by its office in the Netherlands.

"This new contract demonstrates the ongoing and continued success of our Breda office which continues to sign multiple contracts and only those close to £1m and above are announced. Our Breda office is getting more and more integrated with our London business, and the entire Open Orphan group is excelling as the global leader in the testing of vaccines, antivirals and other infectious disease therapeutics,” commented Friel on the contract win.

Separately, and further to the Company's announcement in July 2020, the Group said it has completed its acquisition of CHIMagents Limited, a company which was established to assist in the design, manufacture and testing of challenge agents for use in challenge studies.

The Group outlined that the CHIMagents team has been working alongside the Open Orphan team since July 2020 ‘supporting the design, manufacture and testing of both new challenge agents and the Company's industry leading portfolio of existing challenge study agents.’

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The Group told investors in April 2021 that it was at “an advanced stage” of a possible spin out of some of its non-core development intellectual property assets which it believes would be ‘best developed separately from the core services business’ to drive shareholder value.  

A spin-out transaction could secure separate financial resources for the assets, enable their accelerated development and achieve commercial milestones, the Company told investors.   

In a separate statement released last month, Open Orphan said it would seek admission of its spin-out company, Poolbeg Pharma, to trade on the AIM, using the funds raised to meet the costs of the clinical trials costs for its flu treatment and to acquire and develop new assets. 

Addressing shareholders, the company explained that its investment comes at a time when, post-pandemic, there has been an explosion in the growth of the infectious disease pharmaceuticals market, which is estimated to grow to in excess of $250 billion by 2025. 

In a research note released at the time, analysts at UK broker finnCap wrote of the news: ‘Having demonstrated its ability to spin-out non-core assets through Poolbeg Pharma, we have confidence in assigning value to Open Orphan’s portfolio of non-core assets.’ 

Also commenting on ORPH’s outlook, analysts at research firm Arden Partners said the group’s pipeline is ‘continuing to grow through interactions with key global pharma players with signed deals in 2021 already ahead of 2020, underpinning confidence in the outlook.’ 

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 firstvolunteer 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.    

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