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Race to stop the world getting sick: As coronavirus ravages the globe, experts work around the clock developing vaccines and trialling drugs in a desperate attempt to contain it

by Pat Hagan, Daily Mail

As the needle slipped into Jennifer Haller’s arm, the world watched and held its breath.

This was the moment last week when Jennifer became the first person to be injected with an experimental vaccine that scientists hope will help prevent future pandemics of the deadly Covid-19 coronavirus.

Mother-of-two Jennifer, 43, from Seattle, told reporters: ‘We all feel so helpless. But this is an amazing opportunity for me to do something.’

Over the next few months, hundreds more people — including many in the UK — are expected to sign up as human guinea pigs, just like Jennifer.

Last week, Boris Johnson announced that the first British patient has been put into a trial for drugs that may treat coronavirus. And a safety trial on humans, led by Oxford University, for a potential new vaccine is also expected to start next month.

This is part of a global effort, as the search gathers pace for new ways to detect, treat and prevent Covid-19.

Some, like Jennifer, will have vaccines that contain corona-like (albeit harmless) viruses injected into their bloodstream to see whether their immune systems can be trained to recognise and destroy the virus.

Others are likely to be deliberately infected with weaker versions of coronavirus and given a variety of drugs to try to stop it in its tracks. It will be science at Formula 1 pace — with some corners cut and rules bypassed.

But what does it mean to offer up your body for scientific exploration in the battle against the virus?

UK CENTRE RECRUITING HUNDREDS FOR TRIALS

In the UK, one of the centres leading the fight is FluCamp, a 24-bed privately run unit based in Whitechapel, East London, where for the past 30 years scientists have been carrying out research on cold and flu viruses.

It is the only research facility of its kind in Europe — and one of just four in the world — equipped to quarantine patients for weeks at a time while they are exposed to highly infectious viruses.

Confined to one room 24 hours a day for up to a fortnight, volunteers are subject to round-the-clock testing by health professionals clad in protective clothing.

FluCamp has announced plans to recruit hundreds of healthy volunteers over the next few months. The first stage is to select 24 participants and expose them to two virus strains that are related to Covid-19 but do not wreak the same degree of havoc on the body.

A spokesman said the clinic has been inundated with more than 20,000 enquiries from would-be human guinea pigs since it unveiled its plans on March 9.

Professor John Oxford, an expert in virology at Queen Mary, University of London and scientific adviser to hVivo — the company that runs FluCamp — says the selection process will begin in the next few weeks. ‘The plan is to test hundreds of patients but do 24 at a time, as that is how many beds the unit has,’ he says.

Link here for the full article

Wanted: People Willing to Get Sick to Find Coronavirus Vaccine

British lab is recruiting volunteers for study it says could speed development of Covid-19 vaccine

By Denise Roland March 19, 2020 7:00 am ET

Thousands of people have volunteered to be infected in the hope of finding a vaccine for the new coronavirus.

hVIVO, a clinical research group in London, has attracted more than 20,000 volunteers willing to be infected with tamer relatives of the virus that causes Covid-19 in exchange for a fee of £3,500 ($4,480). It says such experiments could play an important role in the development of a vaccine against the new coronavirus, for which there are no proven treatments or vaccines.

Unlike drugs, which are tested on people who already have a particular illness, vaccines have to be given to healthy people who are later exposed to a disease. Typically, this is done by giving an experimental vaccine to thousands of people in an area where an infection is circulating, and then tracking them for months or even years. The vaccine is considered successful if those who got the shot avoid infection.

One way of getting a quicker read on a vaccine’s effectiveness is by giving it to people who are then deliberately infected with the bug in question. Such challenge studies are routinely used in the development of vaccines for the flu, common cold and other respiratory illnesses.

Usually, a few dozen participants are tracked closely for a few weeks for signs of illness after infection. These trials don’t replace the larger field studies, but they help give direction on whether a vaccine is worth pursuing.

The CDC is updating its website each day with information about where people can be tested for the new coronavirus. However, the availability of tests varies widely, as does the time it takes to get results. Have you tried to get tested? Where did you go and what

For Covid-19, too little is known about who is most susceptible to serious illness or death to run a challenge study using the new coronavirus that causes the disease. Still, hVIVO hopes that using its relatives can nonetheless offer clues for vaccine development. Coronaviruses are a large family that cause a range of illnesses from the common cold to more serious diseases like SARS and MERS.

“It gives you a sieve and gives you some confidence that things are going to be all right,” said John Oxford, emeritus professor of virology at Queen Mary University of London, and chair of hVIVO’s advisory board. “There have been no human coronavirus vaccines, we don’t know what they’ll be like.” 

hVIVO—a subsidiary of pharmaceutical-services company Open Orphan ORPH PLC—is one of just a handful of companies that develop and run challenge studies for drug and vaccine makers.

Such studies are much faster and cheaper than full field studies and can help researchers select the most promising candidate vaccines to be taken forward into broader trials.

hVIVO is currently in early discussions with drugmakers racing to develop a coronavirus vaccine and says it will be ready to offer its challenge tests to clients in the next two to three months.

After advertising and media coverage, the company was inundated with volunteers. More than 20,000 signed up in the space of a few days, compared with a normal rate of a few people a day.

The Uncertainties of Self-Quarantine Amid Coronavirus 

Amid an increase in confirmed cases of the new coronavirus in the U.S., more companies, religious institutions and schools are asking people to stay at home if they may have come into contact with the virus. WSJ follows the case of one man under voluntary self-quarantine.

Those chosen for tests will be kept in isolation at the company’s facilities until they are no longer infectious, usually around two weeks, to mitigate the risk of them spreading the disease to friends and family.

Jamie Spicer-Lewis, a 32-year-old graphic designer and animator who lives in Birmingham, England, signed up this week after seeing an ad online while searching for information about coronavirus.

“It’s not much time out of my life and if it goes toward helping in any possible way—because there are people who are a lot more at risk than I am—then why not?” he said. The financial incentive was a “nice little cherry on top.” He said he had previously donated stem cells for blood cancer patients, a procedure that involved a three-day hospital stay, without any payment.

If chosen, he will undergo a battery of extra medical screening before joining any tests.

Still, studies using other coronaviruses may not give a good read on vaccines that specifically target the strain that causes Covid-19, said Matthew Memoli, director of the Laboratory of Infectious Diseases at the National Institute of Allergy and Infectious Diseases in Bethesda, Md.

The most advanced vaccines under development are specific to the new coronavirus, he said. Several groups, including Moderna Inc., MRNA 6.71% Sanofi SA SNY -4.37% and Johnson & Johnson JNJ -5.68% are working on new vaccines.

J&J said it isn’t planning to use human viral challenge tests, while Sanofi said it hasn’t yet finalized its plans but wouldn’t use a test not specific to Covid-19. The National Institute for Allergy and Infectious Disease, which is running the trials for Moderna’s vaccine, said it didn’t have plans to conduct infection challenge tests.

But challenge tests could be valuable in eventually developing a universal vaccine that works across the coronavirus family, Dr. Memoli said. He is developing his own challenge test for coronavirus using a related strain and hopes it will help scientists better understand how the viruses behave and inform longer-term development of treatments or vaccines.

In general, deliberate infection treads a fine ethical line and is only considered acceptable when the benefits to the wider population far outweigh the risks to participants.

For instance, ethicists say it would be difficult to justify a challenge study for a disease like Ebola because of its high death rate—about 50% on average compared with 2% to 3% so far for Covid-19.

When challenge studies have previously been used for more serious illnesses such as dengue fever and malaria, only participants deemed to be at low risk from serious illness or death were selected, and in some cases a weakened version of the pathogen was used.

“There’s a positive ethical rationale for doing challenge study experiments,” said Julian Savulescu, who leads research on collective responsibility in infectious disease at the University of Oxford. “This kind of research is one of the arrows in the quiver of tackling this kind of catastrophe.”

Link here to read the original WSJ article

Open Orphan #ORPH – Development of the World’s First Human Coronavirus Challenge Study Model

Open Orphan, the rapidly growing specialist Clinical Research Organisation (“CRO”) pharmaceutical services company whose London-based subsidiary hVIVO is the world leader in the provision of virology and vaccine challenge study services, is pleased to announce that it has commenced the development of the world’s first commercial human coronavirus challenge study model, also known as a Controlled Human Infection Model (CHIM). The Company has Europe’s only 24-bedroom quarantine clinic with onsite virology lab where the challenge model will be developed and used. The development of this coronavirus human challenge study model is being led by hVIVO’s Chief Scientist Andrew Catchpole and his team in conjunction with Open Orphan’s Scientific Advisory Board, which is led by world-renowned virologist Prof John Oxford, and builds upon work by hVIVO to potentially develop a Coronavirus challenge study model several years ago and hVIVO’s extensive knowledge in developing human challenge models.

The Company is in early discussions with King & Wood Mallesons, acting on behalf of selected Chinese pharmaceutical and life science clients, to secure funding for the further development of this Coronavirus challenge study. It is intended that the major cost of developing this Coronavirus human challenge model will be primarily funded by new Chinese pharmaceutical partner companies who will get a return on their investment from royalties on the sale of this particular challenge study model.

Open Orphan will utilise common coronavirus strains such as OC43 and 229E which are from the same family of viruses as the newly emerging Covid-19 virus but unlike Covid-19 these common coronaviruses have been widespread in the community for many years and cause only a mild cold-like respiratory illness. Consequently, these common coronaviruses, while closely related to the Covid-19 strain can safely be administered to volunteers in hVIVO’s highly controlled quarantine clinic, staffed by a highly experienced medical and scientific team who to date have already safely inoculated over 3,000 volunteers in hVIVO’s current range of respiratory virus challenge models.

For the purposes of the human challenge study model, the common coronavirus strains such as OC43 and 229E, will provide an effective tool to obtain fast proof-of-concept data against this important family of viruses.  It can be used to test the efficacy of both new novel and existing vaccines and anti-virals. This will allow the effective selection of the best candidates and the effective products to be fast-tracked for subsequent field testing against Covid-19. All of the human challenge studies can be run out of hVIVO’s quarantine clinic with onsite virology lab in London. Once developed, hVIVO will offer its coronavirus challenge study model as both a standalone service to customers or as part of a combined Phase 1 and human challenge study that can both be run out of its London quarantine clinic. Furthermore, hVIVO can also offer services in early phase vaccine development.

This news follows an announcement on Friday 6 March that the Company had signed a contract with a new client, which is a European Biotech company, for the provision of an RSV human challenge study. This study is projected to deliver 3.2m in revenue, all of which is expected to be recognised in 2020.  Furthermore, if that study is successful it is anticipated that an additional follow-on larger pivotal challenge study will commence end Q4 2020, delivering significant further revenue which is expected to be a minimum of £7m. This contract is significant as it the first that utilises the complementary in-house CRO services of both hVIVO and another of the Company’s subsidiaries, Venn Life Sciences, following the completion of the Company’s merger with hVIVO in late January and demonstrates the Company effectively converting its pipeline.

Cathal Friel, Executive Chairman of Open Orphan, commented:

“This is an important milestone in the development and evolution of Open Orphan and particularly the Company’s subsidiary hVIVO which is based in London, UK. We are very happy to be able to try and assist in the battle against Covid-19. Our hVIVO scientists and virologists, and especially hVIVO’s founder and the now Chairman of our Scientific Advisory Board Prof John Oxford, have a long history and experience of successfully developing challenge studies.

This development also reinforces the strength of hVIVO’s reputation as a world leader in providing services to global vaccine and anti-viral production companies and is another example of the growth potential for Open Orphan. A considerable amount of the work around this project has already been carried out and the project takes advantage of the significant knowledge and experience gained from hVIVO’s previous challenge virus manufacturing campaigns. We are delighted to be working with Mike Wang of the international law firm King & Wood Mallesons who is working with us to secure funders for this project from his network of Chinese pharmaceutical and life science companies.

Professor John Oxford, Chairman of Open Orphan’s Scientific Advisory Board, commented:

“After almost 5 years’ of absence from hVIVO, I’m delighted to be more involved again and particularly to be back involved as Chairman of the Scientific Advisory Board. Over the years, I have had extensive experience in dealing with novel and threatening viruses and in 2009 I was the first person, in conjunction with the hVIVO laboratory, to get permission from the government to bring the SARS virus into the country in order to analyse it as part of seeking a solution to the outbreak.

A couple of years ago, the hVIVO Scientific team started a project to potentially develop a Coronavirus challenge study model but after a certain amount of work and effort they suspended this project because they didn’t see sufficient market demand for a Coronavirus challenge study model. However, in recent weeks, the hVIVO scientific team led by their Chief Scientist Andrew Catchpole have reopened their Coronavirus challenge study project and work files. Given the unfortunate circumstances of Covid-19 now spreading around the world they and I felt that there was an obligation on us to reactivate the project and to do our best to now swiftly and effectively make a Coronavirus challenge study model available to the market as soon as possible.

I’m looking forward to working with the team in the days and weeks ahead to do our best to make the world’s first Coronavirus challenge study model available as soon as possible.”

For further information please contact

Open Orphan plc

Cathal Friel, Executive Chairman 

Trevor Phillips, Chief Executive Officer

 

+353 (0)1 644 0007

+44 (0)20 7347 5350

Arden Partners plc (Nominated Adviser and Joint Broker)

John Llewellyn-Lloyd / Benjamin Cryer

+44 (0)20 7614 5900

Davy (Euronext Growth Adviser and Joint Broker)

Anthony Farrell

+353 (0)1 679 6363

Camarco (Financial PR)

Tom Huddart / Daniel Sherwen

+44 (0)20 3757 4980

Notes to Editors:

Open Orphan  is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services  and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in London. hVIVO  supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of the Coronavirus in 2020. The company also 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.   No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.  

Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. In June 2019,   Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in   a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn, as an integrated drug development consultancy, offers CMC (c hemistry, manufacturing and controls) , preclinical, phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.

About Coronavirus

Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses are transmitted between animals and people and can evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus (2019-nCoV) was identified as the cause of pneumonia cases in Wuhan City, Hubei Province of China, and additional cases have been found in a growing number of countries.1,2

 1“Coronavirus.” World Health Organization, https://www.who.int/health-topics/coronavirus.

2“2019 Novel Coronavirus, Wuhan, China.” Centers for Disease Control and Prevention, https://www.cdc.gov/coronavirus/2019-nCoV/index.html.

Shares Magazine Spotlight – Open Orphan lining up for coronavirus fight

Built to sell – can dealmaker Cathal Friel build (and sell) a £80m company in two years?

by Sean Keyes | Financial Correspondant

Serial dealmaker Cathal Friel has an audacious plan: build and sell a pharma services company in two years. It could fetch as much as £100 million. What exactly is his plan? And will it work?

On the cover of the fifth edition of Dr John Oxford’s book Human Virology is a picture of the Wuhan strain of the coronavirus. It was published in 2016.

The virus spherical, with hundreds of nasty looking bulbous projections on its surface. Viewed through a microscope, the projections resemble the sun’s corona. Hence the name.

Showing me Dr Oxford’s book is Cathal Friel, the Chairman of the small cap pharma services company Open Orphan (LN:ORPH). Friel is showing me the book because five weeks ago his company, Open Orphan, acquired the virus-fighting company founded by Dr Oxford.

The company is called hViVo….

Link here to login and read full article

Open Orphan (ORPH) Appoints Professor Oxford as Chair of Advisory Board, with initial focus to help guide Open Orphan in the provision of solutions to Coronavirus outbreak

Open Orphan, the rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study servicesand has Europe’s only 24 bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London, is pleased to announce the appointment of Professor John Oxford as Chair of a newly established Advisory Board. The Advisory Board will focus initially on guiding Open Orphan in the provision of solutions to the current Coronavirus outbreak.

The Advisory Board has been established to help the Company support product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of the Coronavirus in 2020.

Professor John Oxford, a Professor at Queen Mary’s University London and one of the world’s leading experts on global diseases such as influenza, including bird flu, SARS, MERS and Coronavirus, will Chair the Advisory Board alongside Professor Brendan Buckley, a Director of Open Orphan.

For further information please contact

Open Orphan plc

Cathal Friel, Executive Chairman              

Trevor Phillips, Chief Executive Officer

 

+353 (0)1 644 0007

+44 (0)20 7347 5350

Arden Partners plc (Nominated Adviser and Joint Broker)

John Llewellyn-Lloyd / Benjamin Cryer

+44 (0)20 7614 5900

Davy (Euronext Growth Adviser and Joint Broker)

Anthony Farrell

+353 (0)1 679 6363

Camarco (Financial PR)

Tom Huddart / Daniel Sherwen

+44 (0)20 3757 4980

About RNS Reach announcements

This is an RNS Reach announcement. RNS Reach is an investor communication service aimed at assisting listed and unlisted (including AIM quoted) companies to distribute non-regulatory news releases into the public domain. Information required to be notified under the AIM Rules for Companies, Market Abuse Regulation or other regulation would be disseminated as an RNS regulatory announcement and not on RNS Reach.

Notes to Editors:

Open Orphan is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London. hVIVO supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of the Coronavirus in 2020. The company also 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.  No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. 

Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn, as an integrated drug development consultancy, offers CMC (chemistry, manufacturing and controls), preclinical, phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.

LSE interview – Cathal Friel refocuses Open Orphan #ORPH as he raises 5m and buys virology specialist hVIVO

In a wide-ranging interview with London South East, Open Orphan Executive Chairman Cathal Friel outlines his vision for the business and explains how the combined talents of Open Orphan, hVivo and Venn Life Sciences will create a soon to be profitable pharmaceutical services one-stop shop.

Friel says this acquisition is the last however, as he is a major shareholder and he doesn’t want to see his own shareholding diluted along with everyone elses. The focus has been on reducing head count and building revenues at Venn Life Sciences since the Open Orphan IPO last June. Now, with the £13M bolt-on acquisition of hVivo, the London-based virology specialist company, the game has changed once again.

Friel says he sees hVivo as a loss-making and hugely undervalued asset. hVIVO went from being a vaccines and virology specialist to a drugs discovery business five years ago, with Neil Woodford and other investors putting in 113m of investment. “I really like Trevor Phillips and Tim Sharpington who came in 18 month ago to turn it around. But the previous management team got lost and we have picked up a bargain”. So how much are the assets worth today? “It’s very hard to say” explained Cathal, “113M in five years is a lot to spend but you can’t blow it all.

We have a 24 bed quarantine clinic facility which is worth 25 million or so on replacement value, we have a virology lab with the world’s largest stock of virology models likewise worth 25 million, and 7 or 8 million, so we 50 or 60 million of real assets”.

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

Proactive Investors interview with the Open Orphan #ORPH team on its future and ‘the lottery ticket’ sitting within hVIVO

Open Orphan PLC‘s (LON:ORPH) Cathal Friel speaks to Proactive London’s Andrew Scott following the completion last week of its £5.3mln fundraise.

Also in studio is adviser to Open Orphan and founder of hVivo Professor John Oxford.

Professor Oxford’s been a leader in the field of vaccine and anti-viral clinical trials for the last 20 years.

hVivo, which has recently been acquired by Open Orphan, owns the largest commercial quarantine clinic in northern Europe and could play a role in treating patients affected by the recent outbreak of coronavirus.

BRR Media – Open Orphan #ORPH business update

Cathal Friel, Executive Chairman of Open Orphan, provides an update on developments at the company following the successful fundraising, and also introduces Professor John Oxford – a leading expert in the field of virology and an original founder of hVIVO – who will be working with the company as a consultant.

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