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#ORPH Open Orphan – £5m RSV human challenge study contract win

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan, has signed a £5m respiratory syncytial virus (“RSV”) human challenge study contract with a European biotechnology company (“European biotech”) to test its intravenous antiviral candidate, using the hVIVO RSV Human Challenge Study Model.


The study is expected to commence this year and will test and assess the efficacy of the client’s antiviral candidate in a cohort of healthy young adult volunteers. This contract builds on Open Orphan’s existing relationship with this European biotech, following previous early clinical work completed by the Venn Breda team, highlighting the Company’s ability to maintain relationships with its clients over time and to cross sell services between brands. The Company expects the revenues from the contract to be recognised across 2022 and 2023.


The study will be conducted by hVIVO’s highly trained team of medics at its state-of-the-art quarantine facilities in London which was recently expanded in a cost-efficient manner from 43 to 62 beds, an increase of c. 45%. The Company’s specialised virology laboratories, hLAB, will provide qPCR (quantitative polymerase chain reaction), infectivity and serology data for the study.


Healthy volunteers for the study will be recruited through the Company’s volunteer recruitment arm, FluCamp. The FluCamp volunteer recruitment capacity was also recently expanded across its screening facilities in London and Manchester to enable larger cohorts to be recruited more quickly than before. The new screening facilities opened in Manchester expands the Company’s reach to facilitate the increasing demand for human challenge studies and allows the Company to recruit volunteers beyond the greater London area.


RSV is the main cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems, such as COPD. Globally it affects an estimated 50-million people annually, leading to 4 million hospitalisations and up to 75,000 in-hospital deaths in children under the age of 5 years. There is a lack of understanding and insight into RSV disease, especially in adult groups, despite its considerable impact on society and its high degree of infectivity.


hVIVO has a long history of challenge studies with its roots dating back to 1947 with the establishment of the UK Common Cold Clinic in Salisbury, which conducted some of the first influenza human challenge studies. Since its establishment, the Company has been conducting human challenge studies for a range of industry, governmental and academic clients, and has the most frequently used commercial challenge models on the market. hVIVO has expertise in conducting challenge studies in its highly controlled clinical environment, across a range of infectious and respiratory diseases, including influenza, RSV, human rhinovirus (HRV – common cold virus), malaria, SARS-CoV-2, asthma, COPD, and cough, and is continuing to expand its offering.


Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to announce this £5m contract to test our client’s antiviral candidate using the hVIVO RSV Human Challenge Study Model. RSV is a significant threat to public health, and we are delighted to support this European biotech in the development of its antiviral candidate.


“Following the recent expansion of our FluCamp facilities, which boosts our volunteer and patient recruitment capabilities as well as increasing our bed capacity by c.45%, we are now even better equipped to identify volunteers and to complete our growing pipeline of studies in a time efficient manner.


“Leveraging my extensive CRO experience, I look forward to continuing to drive further contract wins across our portfolio of infectious and respiratory disease challenge models.”


Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “This contract is a further demonstration of the significant value of human challenge studies. Efficacy data provided by the Company following the completion of the study can lead to entry into Phase II as well as optimisation of a Phase III programme. For Big Pharma as well as smaller biotechs, the substantial time and financial savings compared to typical field-based studies is increasingly making human challenge the trial design of choice for achieving early proof of concept data.”


Interested in becoming a volunteer?


hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.


Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.


For further information please contact:


Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman  
Yamin Khan, Chief Executive Officer  
Arden Partners plc (Nominated Adviser and Joint Broker)   +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Louisa Waddell  
finnCap plc (Joint Broker) +44 (0) 20 7220 0500
Geoff Nash / James Thompson/ Richard Chambers  
Davy (Euronext Growth Adviser and Joint Broker) +353 (0) 1 679 6363
Anthony Farrell  
Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0)

7747 515393

Open Orphan #ORPH – Positive Phase 1 study results published in The Lancet

Monday 15th June, 2020

Positive results from the Phase I study of the AGS-v vaccine developed by an Open Orphan joint venture, Imutex Limited, have been published in the peer reviewed journal The Lancet

AGS-v is a first-in-class mosquito saliva, standalone, vaccine candidate designed to protect against mosquito-borne diseases carried in the saliva such as Zika, Malaria, Dengue Fever and West Nile Virus

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge study models is pleased to announce that the results of a randomised, placebo-controlled, double-blind, phase 1 trial of AGS-v have been published in The Lancet. AGS-v has been developed by Imutex Limited, in which Open Orphan owns a 49% stake in conjunction with the SEEK Group.


·    The first trial of AGS-v, a first-in-class “mosquito saliva vaccine” in humans

·    The trial indicated that the vaccine is safe and induces a strong immune response in healthy volunteers

·    These positive findings suggest that AGS-v is now ready to advance to Phase II

Numerous studies have shown that protection from diseases carried in saliva is possible if you alter the immune response to saliva. Using natural saliva to achieve this not viable. AGS-v is designed as a transformational vaccine, the first ever mosquito synthetic saliva vaccine designed in to protect against mosquito-borne diseases carried in the saliva such as Zika, Malaria, Dengue Fever, West Nile Virus etc. AGS-v is designed to provoke an immune response against mosquito saliva, rather than any specific parasites, viruses, or bacteria the mosquito might transmit making it an important tool in the fight against mosquito-borne diseases.

In the new study published in The Lancet, NIAID scientists describe the results of the Phase 1 trial of the vaccine as “encouraging and worthy of further study”.

The Trial Results

The double-blind study, which began in 2017 at the NIH Clinical Center in Bethesda, Maryland, was the first trial of this so-called “mosquito saliva vaccine” in humans.

The volunteers’ blood tests showed that the vaccine in combination with the adjuvant produced a significant immune response to mosquito salivary peptides. Further, this immune response was not accompanied by a worse reaction to mosquito bites.

The study’s results are promising and suggest that further research to test the vaccine’s efficacy against individual pathogens, followed by larger field studies, would be worthwhile.  A widely available “universal” vaccine could provide protection against emerging and re-emerging mosquito-borne diseases as they arise, allowing public health officials to quickly respond to new outbreaks and epidemics without waiting for new treatments or vaccines to be developed.

Cathal Friel, Executive Chairman of Open Orphan, said:

“We are delighted with the results of this very important and successful trial of Imutex’s universal vaccine for mosquito-borne diseases. This further confirms and reinforces our belief that our 49% shareholding in Imutex has a lot of unrealised potential value and we look forward to working closely with Gregory Stoloff and his team in SEEK to see how we can commercialise and monetise the true value of Imutex over the coming months.”

Gregory Stoloff, Chief Executive Office, Imutex Ltd, said:

“We all know too well today the cost of pandemics to society and mosquitoes have been causing these problems for many countries for too long. It has been known for some time that injecting saliva in a particular way from an insect provides protection from the disease carried in that saliva. Harvesting natural saliva however, was not practical. We are very excited that our synthetic made saliva produced an immune response and was safe in humans. This makes a vaccine that can protect people against  so many diseases that plague the world, a step closer to reality. We are excited that we now are a step closer to making a vaccine that could deal with these issues.”


For further information please contact

Open Orphan plc

+353 (0)1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

+44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Experts seek approval for COVID-19 trials – China Daily

By ANGUS McNEICE in London

Medical community divided on issue of exposing humans to deadly virus

A laboratory in the United Kingdom is hoping to become the first in the world to intentionally infect volunteers with novel coronavirus in order to test the efficacy of COVID-19 vaccines.

Half of the participants in these so-called human challenge trials would be given a candidate vaccine for COVID-19, the other half would get a placebo, and all of them would then be exposed to novel coronavirus via a nasal spray.

The volunteers, aged 18 to 30, would then spend weeks quarantined at a private clinic, frequently checked on by researchers in hazmat suits running tests to determine if the vaccine provides protection against the disease. Those who display symptoms would be treated with antivirals or immunotherapeutics.

The human challenge model is a tried and tested way to assess vaccine efficacy. Such trials have previously been used in the study of influenza, malaria, typhoid, dengue fever, and cholera inoculations. Challenge studies have an advantage over traditional field trials when levels of a pathogen are low in the general population, as is the case with novel coronavirus during lockdown.

The method is also highly controversial, and the lab in question, London-based hVIVO, will have to navigate an ethical minefield to achieve its goal during this pandemic.

“We are the only place in the world that is well down the road to development for COVID-19 human challenge studies,” Cathal Friel, chief executive of hVIVO parent company Open Orphan, told China Daily. “We will be able to very quickly guarantee to any pharma company in the world if their vaccine works.”

Friel is currently in talks over running challenge trials for a dozen COVID-19 vaccine developers in Europe, North America, and Asia, three of which are from China. Before commencing the trials, hVIVO must gain approval from the ethics committee at the UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency.

Among a host of considerations, the committee will attempt to answer two core questions: is COVID-19 too dangerous for a challenge trial, and are existing treatments effective enough if and when volunteers fall ill.

Challenge trials generally involve around 100 volunteers and are typically used to test vaccines against non-lethal illnesses, such as the common cold, or diseases for which highly effective treatments exist, such as malaria. The trials are not considered for lethal diseases for which existing treatments are limited, such as Ebola or Marburg virus.

While severe cases of COVID-19 are rare among healthy young people, some in the medical community warn that not enough is yet known about the disease to run such trials, and doing so would be extremely risky. Others argue that this risk can be mitigated with well-designed trials, which would in turn greatly accelerate vaccine development, potentially saving hundreds of thousands of lives.

Vaccine developers are faced with a conundrum during this stage of the pandemic. Field trials involving tens of thousands of volunteers are most efficient when a pathogen is thriving in the general population. But lockdown measures in some regions have been so effective that there is not enough COVID-19 going around to challenge a vaccine’s efficacy.

Link here to the original story

Daily Mirror – Coronavirus: Inside UK clinic where volunteers get paid up to £4,000 to be infected in race to find vaccine

by Rhian Lubin

EXCLUSIVE: Infecting volunteers so they can be tested could help stop the spread of Covid-19 – so now 24 triallists face 14 days of solitary confinement and we took a look inside.

As I lie in a hospital bed in a sterile clinic room, a nurse in blue scrubs with a full face shield and ventilator peers through the glass.

The red tape around the door makes it crystal clear that this is a high contamination zone.

Mirror writer Rhian Lubin in one of the clinic rooms with Laura Krizman, Associate Director (Image: Adam Gerrard/Daily Mirror)

“This is a critical step to fast-track development of these anti-virals and vaccines,” explains Dr Andrew Catchpole, chief scientist at Hvivo which runs the facility. “We’re trying to use our expertise in this area to see what we can do.”

Volunteers will not be infected with Covid-19, but with “harmless” strains of the coronavirus – OC43 and 229E – which will cause a very mild respiratory illness.

The aim is to safely expose them to “close relatives” of the deadly strain, helping pharmaceutical firms test potential vaccines.

Dr Catchpole added: “If it can work on our virus, there’s no reason why it can’t work with Covid-19.”

Cathal Friel, executive chairman of Hvivo’s owner Open Orphan, added: “The company is starting the process of developing the world’s first coronavirus challenge study model – basically, we take a harmless version of the virus that we can use and monitor.

“This is a British company which is the world centre for virology.”

Hvivo, which has been running clinical trials on flu and cold viruses since 2001, has seen an unprecedented 10,000 apply for coronavirus tests at its site in Whitechapel, East London.

Link here for the full article

Shares Magazine Spotlight – Open Orphan lining up for coronavirus fight

BRR Media – Open Orphan #ORPH introduces Professor John Oxford

BRR Media introduces Open Orphan’s Professor John Oxford, consultant to the company and Virology expert. He discusses virology, and looks at recent virus epidemics, including influenza, AIDS, SARS and now Coronavirus. He explains how the hHIVO quarantine unit could play a key role in defeating Coronavirus...”This group (Open Orphan) is perfectly positioned, probably like no other, to move virology forward…particularly respiratory virology..”

Click on the image to watch

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