Open Orphan (ORPH ) has announced, its wholly owned subsidiary hVIVO, has been selected on behalf of HIC-Vac and the Wellcome Trust, to lead the consortium and generate regulatory style guidelines on the manufacture of human challenge agents for subsequent use in controlled human infection studies. 

Industry Recognition 

HIC-VAC, the international network of researchers who are developing Human Infection Case (“HIC”) studies to accelerate the development of vaccines, and the Wellcome Trust, one of the World’s leading research-charities that spends more than £1 billion per year to fund medical research to improve human and animal health, have both recognised hVIVO’s leadership in the area of clinical vaccine trials, and under the leadership of hVIVO, will now begin to generate regulatory style guidelines on the manufacture of human challenge agents for subsequent use in controlled human infection studies. 

Cathal Friel, Executive Chairman of Open Orphan, said: 

‘We are proud to have been selected to work alongside HIC-Vac and the Wellcome Trust to lead the consortium on this important and much needed guideline. hVIVO is at the forefront of human challenge studies and has world leading capabilities, this collaboration is recognition of the work we do in the scientific community.” 

The Clinical Trial Consortium 

The Clinical Trial Consortium aims to develop international standards that pertain to challenge agent manufacture and storage, extending the current general World Health Organisation (“WHO”) guidelines relating to challenge studies. 

This consortium intends to create guidance fulfilling existing Good Manufacturing Practice (“GMP”) requirements as much is practically possible without necessarily being GMP certified. 

Such ‘GMP-like’ guidance will allow flexibility to manufacture challenge agents outside of GMP-certified premises, but with guidance to ensure safety, quality and consistency are maintained. 

The guidance will be produced in consultation with a range of researchers currently working with different challenge agents as well as with input from regulatory experts and, where possible, regulatory or advisory bodies such as the WHO. 

There will also be wider engagement beyond the core consortium members with the specific intent of aiming to ensure its’ full applicability to all currently used challenge agents and its potential for wide adoption globally by local regulatory bodies and non-governmental institutions involved in the provision of guidance associated with CHIM studies. 

Andrew Catchpole, Chief Scientific Officer, hVIVO, said:“We are delighted to be collaborating with the members of the international consortium with specific input from low-to-Middle income countries (LMIC’s).  

Today’s announcement shows the continued commitment of the infectious disease community in progressing designs and capabilities for research into bacteria, parasites and viruses.” 

Shares in ORPH have performed exceptionally strongly since the first CV19 study in March at 6p, achieving 52-wk highs of 30p over the past month, to close at 24.25p yesterday. 

Today’s announcement positions hVIVO front and centre in setting international standard guidance for development of human challenge agents for human challenge studies going forward.  

Whilst no value is ascribed to the position, it will clearly position hVIVO as a leader amongst the international pharma companies as well as with many of the worldwide researchers who the Company would not usually have the opportunity to engage with in the normal course of business.  

We understand several larger CRO’s and multi-national organisations around the world would have pitched for this prestigious and very important leadership role within the consortium and therefore goes a long way to illustrating the leadership hVIVO has in the area of human challenge studies.  

hVIVO is therefore now at the centre of the expansion of challenge studies for the development of vaccines and antivirals around the world beyond the immediate opportunity of CV19 vaccine development. 

3 Reasons to Follow Open Orphan: 

Open Orphan is a rapidly growing CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. 

Open Orphan comprises of 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 

The Company 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, Open Orphan is also rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. 

No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. hVIVO also works with companies in the UK and Ireland 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 Regular 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, Open Orphan now 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 should result in the hIVO facility being booked out for months, if not years, in advance going forward. 

The Company is committed to providing regular Newsflow to ensure investors of all classes are fully briefed on the Investment opportunity for Open Orphan.