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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 – Publication of positive FLU-v vaccine challenge study results in journal

Positive results from FLU-v vaccine challenge study (FLU-v 004), the second Phase IIb study of FLU-v, which has been developed by Imutex Limited, hVIVO’s 49% joint venture with the SEEK Group, have now been published in a peer review journal

FLU-v is a first-in-class ‘universal’, broad spectrum, standalone, influenza vaccine candidate

  • The publication in ‘npj Vaccines’ reported that one dose of FLU-v induced statistically significant reduction in mild to moderate influenza disease (MMID) defined as detection of viral shedding with at least one influenza symptom – reduction in confirmed influenza and symptoms
  • One dose of FLU-v also induced a statistically significant reduction in the number of subjects experiencing 2 or more influenza symptoms compared to placebo
  • This report follows recent publication of positive FLU-v Phase IIb field study results (FLU-v 003) demonstrating cellular and humoral immunogenicity of a single dose of adjuvanted FLU-v in 175 individuals
  • The npj Vaccines article concludes that the T-cell strategy employed by FLU-v has potential to offer protection against influenza infection as a vaccine and that larger studies can evaluate how the vaccine interacts with influenza strains in different cohorts
  • Imutex is currently scheduling meetings with key regulatory authorities, FDA and EMEA, hoping to gain confirmation of the remaining development pathway to approval for FLU-v

16 March 2020: Open Orphan plc (ORPH), 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 services, today announces publication of positive results of a Phase IIb challenge study of FLU-v 004 (Study 004, NCT03180801) in npj Vaccines.  The headline results from this study were previously announced by hVIVO on 10 January 2019. FLU-v is being developed by Imutex Limited, hVIVO’s 49% joint venture with PepTcell Limited, trading as the SEEK Group (“SEEK”).

The primary endpoint was achieved in the Phase IIb challenge study conducted by hVIVO using the National Institute of Allergy and Infectious Diseases (NIAID) Flu virus strain, methodology and analysis as a result of a collaboration between SEEK and the NIAID. The randomised, double-blind, placebo-controlled, single-centre, phase IIb efficacy and safety trial was designed and led by Matthew J. Memoli, M.D., NIAID. It was conducted in 153 healthy individuals between 18-55 years of age. They were randomised to receive one or two doses of adjuvanted FLU-v or adjuvanted placebo subcutaneously on days -43 and -22, prior to intranasal challenge on day 0 with the A/California/04/2009/H1N1 human influenza A challenge virus. The challenge virus strain was developed, tested and supplied by Dr. Memoli and co-workers from NIAID’s Laboratory of Infectious Diseases. The primary objective of the study was to identify a reduction in mild to moderate influenza disease (MMID) defined as having an influenza-like symptom with a confirmed influenza virus. Single dose adjuvanted FLU-v recipients (n=40) were significantly less likely to develop MMID after challenge vs placebo (n=42) (32.5% vs 54.8% p=0.035). The authors concluded that FLU-v should continue to be evaluated and cellular immunity explored further as a possible important correlate of protection against influenza. Additional endpoints were also achieved, including a statistically significant reduction in the number of volunteers who experienced two or more symptoms. Also, FLU-v performed better than placebo, although not to statistical significance, in a number of other key endpoints such as median duration of symptoms and severity of disease as measured by an NIAID-developed FLU-PRO questionnaire, as well as reduction in the mean total number of symptoms and mean peak symptoms, and total viral shedding.

Trevor Phillips, CEO of Open Orphan, said:

“Publication of these positive results for the second FLU-v Phase IIb study (FLU-v004; challenge study) follow on from the publication earlier this week of the FLU-v 003; field study, results. 

The results demonstrate that T-cell immunity against conserved regions of the influenza virus is an important component for “universal*” vaccine strategies. Progression to larger Phase III studies with FLU-v can further describe the cellular immune response and evaluate how the vaccine interacts with influenza disease.

The efficacy of FLU-v in this wild-type human influenza challenge study (FLU-v 004) along with the supporting data from previous trials in the field, should be further examined in larger field trials where efficacy of FLU-v can be evaluated against a broader set of influenza strains and wider spectrum of disease. Along with our partner SEEK we have confidence in the potential of FLU-v as a universal flu vaccine and we are in the process of requesting meetings to continue discussions with the key regulatory authorities on the pathway for completing development of this exciting product opportunity.”

Cathal Friel, Executive Chairman of Open Orphan, said:

“The need for better, more broadly protective vaccines against influenza is a high priority worldwide, and few new vaccines have demonstrated efficacy in humans as seen in the results of the challenge study for FLU-v 004.  This is the first universal influenza vaccine that has shown this protection from influenza and reduction of symptoms in late-stage studies and together with the highly statistical immune results reported in a peer review article earlier this week means that the risk of failure in a Phase III setting is greatly reduced compared with entering into Phase III studies with no efficacy data.

As previously stated, the additional investment or cost associated with commercialising FLU-v, will come from out-licencing the final stages of development including Phase III, to potential major international pharmaceutical companies, in Europe, North America and China. We remain excited about the potential for FLU-v and in a time when vaccine development is such a key focus globally.

* A universal flu vaccine is one that is effective against all strains of the virus and does not require changing from year to year

Abstract: https://www.nature.comDOI: 10.1038/s41541-020-0174-9. Efficacy of FLU-v, a Broad-Spectrum Influenza Vaccine, in a Randomized Phase IIb Human Influenza Challenge Study

Abstract:

FLU-v, developed by PepTcell (SEEK) is a novel peptide vaccine aiming to provide a broadly protective cellular immune response against influenza A and B.

Primary objective: To identify a reduction in mild to moderate influenza disease (MMID) defined as the presence of viral shedding and clinical influenza symptoms.

Design: Randomized, double-blind, placebo-controlled, single-center, phase IIb efficacy and safety trial. (ClinicalTrials.gov:NCT03180801, EudraCT: 2016-002134-74)

Setting: hVIVO Services Ltd (London, UK)

Participants: 153 healthy individuals 18-55 years.

Intervention: One or two doses of adjuvanted FLU-v or adjuvanted placebo subcutaneously on days-43 and-22, prior to intranasal challenge on day 0 with the A/California/04/2009/H1N1 human influenza A challenge virus.

Results:  Single dose adjuvanted FLU-v recipients (n=40) were significantly less likely to develop MMID after challenge vs placebo (n=42) (32.5% vs 54.8% p=0.035).

Primary Funding Source: This research was funded in part by the Intramural Research Program of the NIH, NIAID as well as a CRADA with SEEK   

Registration: NCT03180801, EudraCT: 2016-002134-74

For further information please contact

 

Open Orphan plc  

Cathal Friel, Executive Chairman                                                                           +353 (0)1 644 0007

Trevor Phillips, Chief Executive Officer                                                                 +44 (0)20 7347 5350

Arden Partners plc (Nominated Adviser and Joint Broker)                            +44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer

Davy (Euronext Growth Adviser and Joint Broker)                                          +353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)                                                                                          +44 (0)20 3757 4980

Tom Huddart / Daniel Sherwen

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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

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

BRR Media – Cathal Friel & hVIVO Chief Scientist Andrew Catchpole discuss the Coronavirus Challenge Study and the FLU-V Vaccine

Cathal Friel & hVIVO Chief Scientist Andrew Catchpole discuss recent developments and the Coronavirus Challenge Study and the FLU-V Vaccine with the BRR Media team.

Proactive Investors – Open Orphan #ORPH catching global attention with ‘stunning’ FLU-v results & world-first coronavirus study

Open Orphan PLC‘s (LON:ORPH) Cathal Friel and its subsidiary hVIVO’s chief scientist Dr Andrew Catchpole sat down with Proactive London’s Andrew Scott.

This morning Open Orphan announced the results from a clinical trial of a broad-spectrum flu jab that they’re jointly developing have been published in a peer-reviewed journal.

The data from the FLU-v 003 phase IIb study of the FLU-v vaccine appeared in the Annals of Internal Medicine periodical.

Also this week hVIVO began developing the world’s first human coronavirus challenge study.

hVIVO owns Europe’s only quarantine clinic with an onsite virology lab where the challenge model will be developed and used.

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.

Sunday Times – Coronavirus vaccine race: volunteers to be infected in the UK

Human guinea pigs in a London lab are to be given a form of the killer virus as the search for a lucrative jab hots up

It sounds tempting: a payment of £3,500 to spend two weeks relaxing in front of the television, playing video games or catching up on some reading. There is a catch, however — you will be infected with a coronavirus and banned from physical contact with the outside world.

As part of a global experiment, up to 24 people at a time will be paid to be infected with a coronavirus in a $2bn (£1.53bn) race to find a vaccine for Covid-19.

hVIVO, the company that runs a quarantine unit in East London, is one of 20 sector companies and public organisations taking part in a global effort to develop a vaccine to the virus, which has already killed 3500 people…

Link here to read the full article.

Open Orphan tip of the year update on mega contract win

by Tom Winnifrith

Open Orphan (ORPH) was one of my tips of the year at a 4.6p offer. The shares are now 5.5p bid – the recent market sell off hitting it like nearly all other stocks. But the news today of a contract potentially worth £10 million plus really does slam home the message of how cheap the shares are.

There are currently no broker forecasts out there but that is something that I expect to change in the next few weeks. For what it is worth, in my late December share tip I wrote:

But it too has been hacking at its costs and would, I guess, have made it through to profitability in 2020 on a stand-alone basis. Put the two enterprises together and cut out some easy cost overlaps and you will create a business that will deliver, I reckon, sales this calendar year of c£30 million and a pre-tax profit of £2-3 million. And the next year those numbers could well be £40 million+ and £5 million. These are, I stress, my forecasts and the company is not allowed to comment on them or validate them, it is my work alone.

Ends.

Today’s news is, in the context of those forecasts, pretty stunning. We are told:

Open Orphan is pleased to announce the signing of a new contract with a European Biotech Company for the provision of a RSV human challenge study. The study is projected to deliver £3.2 million in revenue all of which is expected to be recognised in 2020.  If the study is successful, it is anticipated that an additional follow-on larger pivotal challenge study will commence end Q4 2020, delivering significant further revenue and expected to be a minimum of £7 million

Ends.

So that is at least £3.2 million top line new business this year (possibly more) and potentially an eve bigger boost in the first half of next year. I am not altering my forecasts on the basis of today’s news but it is an indication that they are all the more credible.

In addition we are reminded, in the context of the Coronavirus pandemic that Open owns “Europe’s only commercial 24-bed quarantine clinic and on-site virology laboratory and is the only company globally with the capability to run an RSV human challenge study.” I’d imagine that it should be doing something of a roaring trade.

Open sits on net cash of c£5 million. At the current mid it is valued at just under £30 million so ex cash it trades on well under 1 times current year sales and on a PE of 8-12 falling to just 5. That is clearly far far too low and the shares remain a strong buy with a target of at least 10p if not more.

Link here to view on ShareProphets website

Alan Green talks Coronavirus and markets, plus Open Orphan #ORPH & Metro Bank #MTRO on the UK Investor Magazine podcast

Alan Green discusses Coronavirus and markets, plus Open Orphan #ORPH & Metro Bank #MTRO with Jonathan Roy on the UK Investor Magazine podcast. Link on the image to listen.

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