Open Orphan (ORPH) unveiled that its subsidiary, hVIVO, has signed a ‘significant’ contract win with ImmunoTech, a leading immuno-pharma firm, to test its antiviral candidate, Ampligen.

The antiviral study will see hVIVO test Ampligen using both the human Rhinovirus HRV (common cold virus) and Influenza human challenge study models as part of a single study.

ImmunoTech, or ‘AIM IT’, will be the study sponsor of the Phase 2 human challenge trial, which is expected to commence in 4Q21. Open Orphan highlighted to investors that it expects the majority of revenue from the contract to be recognised in the current financial year. 

The Group believes the contract win is a reflection of both the breadth of its service offering as well as its ability to test multiple pathogens at once in its state-of-the-art zoned unit.

Going forward, the Company said it expects to sign more contracts in this area due to the increased international focus on respiratory and infectious diseases following the outbreak of COVID-19 and as attention turns to potential future outbreaks of other viral diseases.

To date, hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of Influenza, Respiratory Syncytial Virus (RSV) and human Rhinovirus HRV (common cold virus). Back in October 2020, the Company’s challenge studies expanded to include the SARS-CoV-2 virus.
 
“Being able to test our client's product against multiple pathogens in a single study demonstrates our capability of our state-of-the-art London unit, our industry leading experience, and our position as the go to provider of human challenge studies for biotech and pharmaceutical companies globally,” said Cathal Friel, Executive Chairman of Open Orphan.

“Fortunately, with our access to three challenge study clinics in London, we were able to find a small gap in our schedule later this year to slot this particular study in at short notice,” he said.

Friel told investors that hVIVO’s London facilities are comprehensively pre booked throughout this year and into next year. He added that the business, which was ‘solidly EBITDA profitable in 1H21’ currently remains on target “for a profitable and successful 2021” going forward. 

Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech Inc., commented: "It is our belief that Ampligen's mechanism of action regarding the human innate immune system gives Ampligen broad-spectrum capabilities as an antiviral prophylaxis and therapeutic.”

He added, “The ability to do a human challenge trial using HRV and Influenza allows us to test in humans Ampligen's potential role as a powerful prophylaxis and therapeutic for a wide range of respiratory viruses. It is our belief that if it works in these two viruses, then it will have the potential to have a similar impact in other respiratory viruses."

In a morning research note, UK broker finnCap said that while the contract value is undisclosed, based upon historic influenza studies, it estimates it to be worth c.£3m. 

‘Open Orphan’s strategy to spin out its various non-core assets is well underway, the first of which is Poolbeg Pharma. It also expects to sign more contracts in this area, as attention turns to future outbreaks of influenza, and we reiterate our target price of 47p,’ analysts wrote.

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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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