Open Orphan (ORPH ) has highlighted a published editorial opinion piece from the New England Journal of Medicine (NEJM) which has shown support for the UK Government's Human Challenge Programme of which the company’s hVIVO division is a crucial part of. 

NEJM’s editorial piece, titled 'Establishing the Model during an Evolving Pandemic', explores the extensive preliminary review process which was commissioned by the UK Government and delivered by the coalition involved in the COVID-19 Human Challenge Programme.  

The NEJM, which has been established for over 200 years and is recognised as one of the leading medical journals globally, delivers peer-reviewed research and interactive clinical content to physicians, educators, researchers, and the global medical community. 

The Company explained that the paper’s intention is to justify the research and manage and minimise the risks associated with the trial, as well as arguments supporting the inclusion of a SARS-CoV-2 human challenge research program as part of the pandemic response. 

The UK’s Human Challenge Programme is a collaboration between the UK Government, the Royal Free London NHS Foundation Trust, Imperial College London and hVIVO, a subsidiary of Open Orphan, to deliver the world's first human challenge study for the COVID-19 virus. 

Executive Chairman of Open Orphan, Cathal Friel, said, "We are delighted to see support for the COVID-19 Human Challenge Programme in a publication such as the New England Journal of Medicine.  

He added, “The piece articulates the considerable review process commissioned by the UK Government and delivered by hVIVO, in collaboration with the Royal Free London NHS Foundation Trust, and Imperial College London. We believe the UK Government's COVID-19 Human Challenge Programme will play a vital role in trialling the vaccines and antivirals which continue to support our effective pandemic response in the UK and abroad." 

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. 

Earlier this month, the UK Government said it had 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 Group said 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.  

View from Vox 

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.   

On Monday, Open Orphan’s spin out, Poolbeg Pharma, announced that it had raised £25 million on its first day of dealings as part of its floatation on London’s junior AIM market. 

In recent weeks, the Company has informed investors that it has earmarked some of the £25m proceeds to fund clinical trials for its advanced pipeline therapy for severe influenza.  

Open Orphan said Poolbeg’s IPO 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.   

Open Orphan’s Board has said it believes that the assets in Poolbeg would be ‘best developed separately from the core services business’ to maximise 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 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.’  

Reason to  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 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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