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The Sun – COVID-19: UK scientists to infect volunteers with coronavirus in world first vaccine trial

Would you lock yourself in a room for two weeks after being infected with COVID-19? Chris Holdsworth did, and he hopes that come January that’s exactly what he’ll be doing. Chris has volunteered to be a guinea pig for a world-first study that could take place in the UK in January. It’s called a Human Challenge Trial, and it involves shutting healthy volunteers in an isolation unit like this one and deliberately infecting them with coronavirus. The Sun went inside a Human Challenge Trial isolation unit to find out more. Thanks to https://www.1daysooner.org/ 

Open Orphan #ORPH – Directors Change

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 clinical trials is pleased to announce the appointment of Elaine Sullivan as a Non-Executive Director to the Board of Open Orphan.

Elaine is a business leader and senior scientist with international experience in the pharmaceutical industry and Biotech and is the CEO of Curadh Pharmaceuticals. Elaine has an in-depth background and knowledge of virology having received a PhD from the University of Edinburgh in Molecular Virology. She has been a member of the most senior R&D management teams in Lilly and AstraZeneca. Elaine also has extensive start-up experience having been a founder of Carrick Therapeutics and helped to raise over €100m of investor funds as CEO of Carrick in recent years. Elaine is a Non-Executive Director at IP Group plc and Active Biotech AB and is a member of the Supervisory Board at Evotec which is listed on the Frankfurt Stock Exchange.

The Company also announces that Mark Warne, Non-Executive Director, will be stepping down from the Board of Open Orphan on the 31st of December. Mark had been on the Board of hVIVO plc prior to its acquisition by Open Orphan and assisted with the integration of hVIVO with the Open Orphan group.

Cathal Friel, Executive Chairman, Open Orphan, said:

“We are delighted to announce the appointment of Elaine to the Open Orphan board. Her level of expertise in virology alongside her exceptional career in the industry will be an excellent addition to the Company. We look forward to working closely with Elaine who brings with her a wealth of knowledge and experience and will be invaluable addition to the Company as we now grow Open Orphan substantially in its next phase of rapid development.”  

“We would like to thank Mark Warne for his service to the Company and for remaining on the Board to allow for a smooth integration of the companies during the transition period following the acquisition of hVIVO.”

Elaine Sullivan, Incoming Non-Executive Director, Open Orphan, said:

“I am delighted to join the board of Open Orphan. I have been impressed by the outstanding

 progress that Cathal Friel, the Board and the team have made in such a short time. I look forward to working with them in the next stage of the evolution of Open Orphan.”

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

 

Full Name: Elaine Sullivan (née McGlynn)

Age: 59

Current directorships / partnerships

Directorships / partnerships within the last five years

Active Biotech AB

Carrick Therapeutics UK Limited

Curadh Pharmaceuticals Limited

Evotec AG

IP Group plc

Dargle Therapeutics Limited

 

Elaine Sullivan does not hold any shares or options over shares in the Company.

There is no further information to be disclosed in relation to Elaine Sullivan’s appointment pursuant to AIM Rule 17, paragraph (g) of Schedule Two of the AIM Rules for Companies or Rule 5.22 (b), Schedule 2 paragraph (g) of Chapter 5: Additional Rules for the Euronext Growth Market operated by Euronext Dublin.

Notes to Editors – Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com . 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.  Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

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, Open Orphan is 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.  

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. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 in January 2020. Venn is an integrated drug development consultancy firm which 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.

Open Orphan #ORPH – Collaboration Agreement with HIC-VAC and Wellcome Trust

Open Orphan, a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials is pleased to announce that its subsidiary hVIVO has been selected to lead a consortium, on behalf of HIC-Vac, an international network of researchers who are developing human infection challenge (HIC) studies to accelerate the development of vaccines against pathogens,and the Wellcome Trust, to generate regulatory style guidelines on the manufacture of human challenge agents for subsequent use in controlled human infection studies (CHIM).

Highlights:

  • This consortium aims to develop international standards that pertain to challenge agent manufacture and storage, extending the current general WHO guidelines relating to challenge studies.
  • The consortium intends to create guidance fulfilling Good Manufacturing Practice (GMP) requirements to as much as is practically possible without necessarily being GMP certified, ‘GMP-like’ guidance. This 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. Learn more about the consortium at hvivo.com/aboutus/clinical-trial-consortium/

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.”

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.”

Footnote

CHIM – controlled human infection studies are when a well-characterised strain of an infectious agent is given to carefully selected adult volunteers in order to better understand human diseases, how they spread, and find new ways to prevent and treat them. These studies play a vital role in helping to develop vaccines for infectious diseases.

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

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

 

Notes to Editors – Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp , learn more at www.FluCamp.com. 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.  Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

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, Open Orphan is 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.

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. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 in January 2020. Venn is an integrated drug development consultancy firm which 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.

Notes to Editors – HIC-Vac:

HIC-Vac is an international network of researchers who are developing human infection challenge (HIC) studies to accelerate the development of vaccines against pathogens of high global impact.

Open Orphan #ORPH Announces New £2.5m Influenza Challenge Study Contract Win

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 clinical trials is pleased to announce the signing of a £2.5 million contract by hVIVO, a subsidiary of Open Orphan, to conduct an Influenza human challenge study with a US biotechnology company. 

The study is expected to commence at hVIVO’s 24-bedroom quarantine clinic in East London in H2 2021 and to be fully completed by year end 2021, generating £2.5m of revenue. This contract builds on the Company’s recent challenge study contract wins in RSV and COVID-19 and demonstrates the breadth of Open Orphan’s service offering and the expertise within the Group as a world leader in its field.  

For this study, Venn Life Science ‘s Paris team will complete the biometrics, demonstrating how the various parts of the Open Orphan plc Group can work together to deliver high-quality services to clients. Venn’s Paris team are highly regarded in the field as one of the leading providers in this area which is a perfect complement to the London offering. 

Cathal Friel, Executive Chairman, Open Orphan, said:

“We are delighted to be conducting this influenza challenge study, recent events have highlighted the importance of treatments for viral infections such as influenza and we are seeing an increased level of interest amongst both pharma and biotech in developing innovative new vaccines, antivirals, and therapeutics. 

The Company is pleased to be continuing to deliver on our pipeline of opportunities. This has been due to the exceptional work from the hVIVO   team, building on the Company’s long history as the world leading challenge study provider. Both the team and I are excited to see the progress being made by the Group and look forward to continuing the momentum as we rapidly grow the business to maximise shareholder value.”

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 . hVIVO welcomes volunteers to take part in our clinical trials under expertly supervised conditions, to further medical research, and help us to take the understanding of respiratory illnesses to a new level. Volunteers are central to the work that we do; our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment. 

Further details on all aspects of our volunteer programs including testimonials from previous volunteers can be found at www.flucamp.com .

If you are interested in being contacted and provided with details about future COVID-19 human challenge study research, please leave your contact details at  www.UKCovidChallenge.com .

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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 

Notes to Editors – Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com . 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.  Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

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, Open Orphan is 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.  

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. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 in January 2020. Venn is an integrated drug development consultancy firm which 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.

Open Orphan #ORPH / hVIVO Signs Contract with UK Government for the Development of a COVID-19 Human Challenge Study Model

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 studies, is pleased to announce the signing of a contract by hVIVO, a subsidiary of Open Orphan, with the UK Government to develop a COVID-19 (SARS-CoV-2) human challenge study model. The model development involves the manufacture of the challenge virus and the first-in-human characterisation study for this virus. The contract starts immediately and could be worth approximately £10 million to hVIVO depending upon the final number of volunteers that are included in the characterisation study. In addition, the Government has secured the first three slots to test vaccines using hVIVO’s COVID-19 challenge study, which we expect start in 2021, each slot reservation has been secured at a cost of £2.5m each bringing the total value of these slot reservations to £7.5m. 

The characterisation study, which is expected to complete in May 2021 and will require regulatory and ethical approval, enables identification of the most appropriate dose of the challenge virus for use in future human challenge studies which play a vital role in helping to develop vaccines and antivirals for infectious diseases such as COVID-19.

The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital’s specialist research unit in London, under the scrutiny of highly trained scientists and medics. hVIVO will also be expanding its Clinical Operations in London to facilitate work at this site. hVIVO’s state of the art, category 2 facility at Queen Mary’s Bioenterprise Centre, London, will continue to be used to deliver the Company’s traditional challenge study contracts, particularly respiratory syncytial virus (RSV) and is booked to maximum capacity until Summer 2021.

hVIVO has a long history of successfully delivering human challenge studies. The Company, formerly called Retroscreen Virology, was originally established in 1989 as a spin out from Queen Mary University, London. Prior to this hVIVO’s founders worked at the common cold unit at Harvard Hospital, near Salisbury. The Salisbury Flu Clinic, as it is more commonly known, has a history of running human challenge studies since 1945. hVIVO has the world’s leading portfolio of 8 human challenge study models developed to date and has safely run more human challenge studies than any other company globally. The expertise built up over this long history underpins hVIVO position as the market leader in the provision of human challenge studies. 

If you are interested in being contacted and provided with details about future COVID-19 human challenge study research, please leave your contact details at www.UKCovidChallenge.com.

Cathal Friel, Executive Chairman, Open Orphan, said:

“At Open Orphan we are pleased to be working on behalf of the UK Government and in partnership with two great institutions, Imperial College London and The Royal Free Hospital. We look forward to working with our partners to develop a COVID-19 human challenge study model which will be used to safely accelerate the discovery of effective vaccines and antivirals against COVID-19. 

“We hope our work will reduce the impact of COVID-19 on individuals and communities, and our thoughts go out to the many people whose lives have been affected by the pandemic.”

Alok Sharma, Business Secretary, UK Government, said: 

“We are doing everything we can to fight coronavirus, including backing our best and brightest scientists and researchers in their hunt for a safe and effective vaccine. 

“The funding announced today for these ground-breaking but carefully controlled studies marks an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life.”

Conference call for sell-side analysts and investorsThe Company will hold a conference call for sell-side analysts and investors at 11:00 Thursday 22nd of October. Details for the conference call can be found at: https://www.speakservecloud.com/register-for-call/ecd1cd54-503e-4be0-8f00-3d0a0f92b6a1

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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 

Notes to Editors – Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com. 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.  Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

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, Open Orphan is 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.

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. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 in January 2020. Venn is an integrated drug development consultancy firm which 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.

Most people try to avoid Covid-19. But thousands are signing up to be deliberately exposed – CNN

By Mick KreverPhil Black and Cristiana Moisescu,

London (CNN) – As most of us obsess with avoiding Covid-19 at all costs, a rapidly growing group of people around the world say they are prepared to deliberately take on the virus.

Tens of thousands of people have signed up to a campaign by a group called 1 Day Sooner to take an experimental vaccine candidate and then face coronavirus in a controlled setting. 

Among them is Estefania Hidalgo, 32, a photography student in Bristol, England, who works at a gas station to pay the bills. 

“I do night shifts there, and it can be very lonely,” she recalled on a sunny day near her home.

Passing those long lockdown hours with just podcasts to keep her company, she describes discovering the challenge trial movement — and hearing volunteers’ motivations — as a revelatory moment. 

“I was shaken,” she said. “No one should be left behind. Old people, poor people, people of color. Everyone just deserves to be healthy.”

“This was a way for me to take back control of the situation, to feel like I was in a less hopeless place, and a less hopeless world, and be like, OK, I can do this. To make it better, I chose not to be in fear.” 

So-called human challenge trials, while sometimes controversial, are nothing new. They have been used for cholera, typhoid, malaria, and even the common cold. But unlike for those diseases, we do not yet have a completely effective treatment for Covid-19, should the experimental vaccine fail. 

Volunteers in challenge trials are typically compensated for their time and participation, experts say, but organizers must be careful not to pay an amount that could edge on coercive. Critics also say that challenge trials have limited use because the young, healthy people who take part don’t represent the broader population. 

Full CNN article here

Daily Telegraph – When will a Covid-19 vaccine be ready in the UK? Latest updates from around the world

ByAnnelies Gartner ; Lizzie Roberts and Christopher Hope, 

Volunteers could soon be deliberately infected with coronavirus in trials to speed up a vaccine and discover if people are protected if they have already had the disease.

In a groundbreaking trial, scheduled to begin in January at the Royal Free Hospital in London, patients will be inoculated with a vaccine developed by Imperial College, and then exposed to coronavirus.

“Challenge trials” are controversial, but can give a quick answer about whether a vaccine is effective and several Nobel laureates have called for them to take place.

Oxford University is also intending to use a similar “challenge trial” to test whether people have protective immunity from the disease if they have been previously infected.

Both groups of researchers are currently hunting for a “salvage therapy” that would be given as a last resort if the vaccine did not work before they can begin the trials and will need approval. The trials will be funded by the Government.

….

What’s the latest news in the hunt for a vaccine?

The Imperial trial is being run by hVIVO, a spin-off company from Queen Mary University of London. Already roughly 2,000 people have signed up to take part in challenge studies in Britain through the group 1Day Sooner. 

Those testing the vaccine will be given the jab and will then wait a month for antibodies to build. The volunteers will then be exposed to the virus…

Link here to view the full Telegraph article

Open Orphan #ORPH – Interim Results for 6 months ended 30 June, will be operationally profitable in Q4

Open Orphan Plc, a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical studies is pleased to announce its interim results for the six months ended 30 June 2020. The interim results include the first six months of hVIVO group (“hVIVO”) following its acquisition by Open Orphan Plc on the 17 January 2020.

Operational Highlights:

·    Completed the acquisition of hVIVO plc for an aggregate consideration of approximately GBP£13 million in equity on 17 January 2020 

·    Implemented a major restructuring and integration of our operations to drive efficiency and competitiveness which is now substantially completed

·    Successfully secured a number of RSV human challenge studies in the period including:

–      £3.4m contract with a major European biotech company, with anticipated £7m follow-on study  

–      £3.7m contract with a US biotechnology company 

·    Driving growth of Dutch early clinical development services while refocussing French operations towards biometry services

·    Large contract signed with a global leader in vaccine development 

·    Launch of COVID-19 Antibody testing partnership with Quotient Ltd

·    Appointment of Leo Toole as Group Chief Financial Officer enhancing the executive management team

Financial Highlights:

·    Cash and cash equivalents at half year end of GBP £14.7m following two successful placings:

–      Executed a fundraise on 31 January 2020 raising GBP £5.3 million at 6.1p per share (before expenses)

–      Executed a fundraise on 22 May 2020 raising GBP £12.6 million at 11p per share (before expenses)

·    Reported Interim Results

o  Revenue of GBP £7.1 m for H1 2020 – continued focus on delivering larger contracts

o  EBITDA loss of GBP £4.1m for H1 2020

o  Operating Loss of GBP £5.0m for H1 2020

·    Pro-forma Interim Results

o  Revenue of GBP £7.4m (H1 2019 Revenue of GBP £11.6m)

o  EBITDA Loss of GBP £4.7m (H1 2019 EBITDA loss of GBP £4.7m)

o  Operating Loss of GBP £5.6m (H1 2019 Operating Loss of GBP £6.3m)

·    Post completion of Merger, reduction in overheads on target to deliver annualized cost efficiencies of GBP £10.1m by end of 2020

Post Period End:

·    Acquired the CHIMagents team in July, reinforcing hVIVO’s position as the world leading services company in the testing of vaccines and antivirals through human challenge study clinical trials.

·    Integrated hVIVO’s unparalleled database of infectious diseases progression data into the Open Orphan data platform – expecting potential commercialisation in Q4, with some of the world’s largest wearable companies for this disease progression data.

·    Progressing as planned to monetise two of our non-core assets, the 49% stake in Imutex and the 62.6% stake in PrEP.

·    The Company continues to provide testing to large commercial employers in the UK and Ireland as part of a combined COVID-19 antibody and COVID-19 PCR (swab) testing offering. 

·    Contracts signed post period end include:

–      Laboratory services contracts signed with a number of parties – a key strategic growth area for Open Orphan taking advantage of our laboratory expertise.

–      Contract signed with Codagenix Inc. for a first-in-human Phase I COVID-19 vaccine study, demonstrating that hVIVO’s quarantine facility is uniquely suited to conducting Phase I studies for infectious disease vaccines such as this.

–      Further RSV human challenge study contract for £4m signed with a Top 3 global pharma company with hVIVO acting as sponsor for this study.

–      First-in-human clinical pharmacology trial signed with Carna BioSciences.

–      Contract signed with a major European pharmaceutical company for data management, statistics and medical writing to support a 750 subject oncology study.

–      Contract signed for a further £4.3m human challenge study with a top 10 global vaccine company.

Outlook:

·    The Group has a strong pipeline of contracted  work and new projects at an advanced stage of negotiation and is targeting growth with strong operating cash flow in the second half of 2020 and is on target to be operationally profitable in Q4.

·    As of September 2020, we are close to having the hVIVO quarantine clinic block booked with conventional challenge studies until December 2021. Quarantine clinic block expected to shortly be booked out for the next 18 months to two years with conventional challenge study contracts.

·    Further to its announcements of 9 March 2020 and 22 May 2020, the Company is well progressed in developing the world’s first Coronavirus human challenge study model to test a range of COVID-19 vaccines, complementing existing human challenge study models. We are in advanced discussions and negotiations with a range of potential customers, including the UK Government to test COVID-19 vaccines. 

Cathal Friel, Executive Chairman of Open Orphan, said: 

“Since we acquired hVIVO in January 2020, we have achieved what we set out to do. We have created a leaner more efficient businesses, removed excess costs and we are now a truly unique clinical research organisation (CRO) that is the world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. We have secured larger, more profitable contracts with both large pharma and the leading vaccine developers globally. We have delivered upon our aim of improving revenue streams through the delivery of several new revenue lines including the provision of laboratory services to third parties. We have reinvigorated both the Venn Life Sciences business and the hVIVO business during the first half of 2020 and have created a strong foundation for future growth.

Looking ahead, I am extremely excited by the potential for this business, we have entered a decade of significant spending on vaccines and antivirals by both governments and pharma companies around the world. The Open Orphan Group including hVIVO and Venn Life Sciences is ideally positioned to capitalise on this increase in vaccine development expenditure. Earlier this year we set ourselves the target of being profitable in the second half of 2020 and I am delighted to confirm that, despite profitability taking a few months longer than expected, we are on target to be operationally profitable in Q4 2020. 

None of the above would have been possible without the exceptional effort, dedication and professionalism shown by all hVIVO, Venn and Open Orphan team members. They have worked diligently through the past 6 months, despite the added difficulty of the pandemic, to ensure that we have delivered an excellent performance. The teams are really well positioned to thrive as the world leaders in the testing of vaccines and antivirals for the decade ahead.”

Conference call for sell-side analysts and investors

The Company will hold a conference call for sell-side analysts and investors at 10:30 today. 

Details for the conference call can be found at: https://www.speakservecloud.com/register-for-call/254ba4b5-e780-48fb-9142-c5762f4ef8ef

A corporate presentation is available to shareholders on the Group’s website at: https://www.openorphan.com/investors/reports-and-presentations/year/2020

Enquiries:

Open Orphan Plc Tel: +353 (0)1 644 0007

Cathal Friel, Executive Chairman

Arden Partners (Nominated Adviser and Joint Broker) Tel: +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) Tel: +353 (0)1 679 6363

Anthony Farrell (Corporate Finance)

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

Tom Huddart / Hugo Liddy

Notes to Editors ‐ Open Orphan:
Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com. 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.  Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

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, Open Orphan is 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. 

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. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 in January 2020. Venn is an integrated drug development consultancy firm which 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.

Executive Chairman’s Statement 

Dear Shareholder, 

As Executive Chairman, I am very happy to report the first set of combined results since Open Orphan plc’s (formerly Venn Life Sciences Holdings plc) acquisition of hVIVO plc (now hVIVO Limited) in January 2020.  

Summary

The 6 months to the end June 2020 have been a period of significant change initially focussed on progressing our strategy to sign contracts for our world leading human challenge studies clinical trials which are used to test vaccines and anti-virals. We are also signing new contracts for biometry services from our Paris office and early clinical development services from our Breda, Netherlands office while at the same time developing further new revenue streams such as laboratory services to complement our existing London business. This has all been done while at the same time we implemented a major restructuring and integration of our operations to drive efficiency and competitiveness which is now substantially completed. 

Also, in this period, the Company addressed the rapidly evolving COVID-19 pandemic event by enabling a safe and efficient working environment for our staff at home and in our clinic and laboratory facilities. We have worked proactively with our clients to manage project timetables to minimize the impact of Covid-19 on our revenues streams while continuing to build new relationships to expand our confirmed project pipeline well into 2021 and beyond. 

Other highlights include the completion of a placing of £12.6m (before expenses) at 11p per share in May 2020 allowing us to invest to accelerate the development of a world-first coronavirus challenge study model to test COVID-19 vaccines and antivirals. This was all done while also expanding our laboratory service offerings to offer enhanced external laboratory services and to develop testing services to support the nascent testing environment for Covid-19.  

Interim Results

Reported results for Open Orphan plc are summarized below and are covered by the schedules and notes from pages 6  to 14 of these Interim Financial Statements (and in particular reflect reverse merger accounting treatment under IFRS 3 and IFRS 10 of the combination of Venn Life Sciences Holdings plc and Open Orphan DAC as of 28 June 2019). We also share for reference the results for hVIVO plc (now hVIVO Limited), Open Orphan plc (formerly Venn Life Sciences Holdings plc) and Open Orphan DAC on a stand-alone basis.                                                                                                                                                                                                                                                                

 Open Orphan plc(As reported)hVIVO plc(Proforma results on standalone basis)Open Orphan plc(formerly Venn Life Sciences Holdings plc -proforma resultson a stand-alone basis) Open Orphan DAC (proforma resultson a stand-alone basis)Open Orphan plc(proforma results on a combined basis and including the impact of the 28 June 2019 and 17 January 2020 combinations)
 Unaudited6 months ended30 June2020£’000Unaudited6 months ended30 June2019£’000Unaudited6 months ended30 June2020£’000Unaudited6 months ended30 June2019£’000Unaudited6 months ended30 June2020£’000Unaudited6 months ended30 June2019£’000Unaudited6 months ended30 June2020£’000Unaudited6 months ended30 June2019£’000Unaudited6 months ended30 June2020£’000Unaudited6 months ended30 June2019£’000
Revenue (incl. Other income)7,0783,3796,4094,0625,1797,44111,588
Operating (Loss) (5,005)(156)(3,067)(4,224)(2,128)(1,965)(447)(159)(5,642)(6,348)
EBITDA before exceptional items(4,145)(156)(2,478)(3,192)(1,811)(1,340)(445)(159)(4,734)(4,691)
Loss for the period (6,490)(1,070)(2,934)(3,833)(2,408)(1,809)(458)(1,091)(7,136)(6,733)
           
 As at 30 June 2020€’000As at 30 June 2019€’000        
Non-current assets17,7215,250        
Current assets (excl. cash)3,6025,714        
Cash14,6514,540        
Total Assets35,97415,504        
Equity attributable to owners26,9947,576        
Non-current liabilities2,2713,304        
Current liabilities6,7094,624        
Total equity and liabilities35,97415,504        

Governance

The Board continues to recognise the importance of the high standards of corporate governance and considers that the Group’s success is enhanced by the imposition of a strong corporate governance framework. I am grateful for the contributions of the new Board formed after the acquisition in January 2020 and want to acknowledge the important service of Trevor Philips during his tenure on the Boards of hVIVO plc (now hVIVO Limited) and Open Orphan plc until he stepped down in May 2020. 

Outlook

Our business outlook has never been stronger. Demand and interest to complete Challenge studies in our 24-bed quarantine facilities in the UK is translating into a steady flow of signed new contracts and new customer engagement. As a result of the  fundraise at the end of May, Open Orphan now has a large, healthy cash balance and, as such, is very well capitalised and we are ideally placed to be providing such services to governments and pharma companies around the world who seek to address the current pandemic and mitigate the risk of future such events. We are progressing a number of encouraging avenues to rapidly develop a human challenge model specific to SARS CoV-2 to fast track the identification of efficacious vaccines and treatments for Covid-19.

Our early clinical development business based out of Breda in the Netherlands is showing strong year on year growth while our biometry services based out of our Paris office, now focussing on data management, biostatistics, medical writing and randomisation, are contributing strongly to generate synergies for our viral challenge studies and expand their pipelines.

Across the second half of 2020, we will see the impact of the major efforts undertaken across the Group to divest from underperforming businesses, reduce overheads, deliver merger integration savings and right-size the management team including combining senior roles in both Venn and hVIVO leading to operational profitability in Q4. Our renewed focus on reducing hierarchy has increased the speed of decision making while empowering our teams to deliver our ambitious goals.

In addition, data is an important upstream area of development for the Group where we believe there will be an important convergence of  hVIVO’s global infectious disease progression data with the digitization of other vital signs and biomarkers available through our challenge studies, all with the goal of creating a ground-breaking Open Orphan Health Data platform that can be monetized with major pharma players. 

I am very encouraged for the remainder of 2020 and our prospects in 2021. We have a world leading team, focused on ground-breaking work which will create sustainable value for all our stakeholders.

Cathal Friel

Executive Chairman

30 September 2020

Full results announcement with financial statements here

The Times – Trial to infect British volunteers with modified coronavirus at hVIVO Quarantine Centre

Scientists are planning to infect British volunteers with a weakened, computer-designed form of the coronavirus, which researchers believe could work as a vaccine.


The early-stage trial will take place in a special 24-bed quarantine clinic in Whitechapel, east London. The US biotech company behind it, Codagenix, is in talks with UK regulators and expects to begin before the end of the year.

The vaccine consists of an enfeebled version of the coronavirus, designed using special software and built in a laboratory. The aim is produce a cheap inoculation that would be administered as a nose drop.

Link here to view the full Times article.

Open Orphan #ORPH – New £4.3m Challenge Study Contract Win with Global Top 10 Vaccine Company

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 clinical trials is pleased to announce a new £4.3 million contract to conduct a human viral challenge study utilising one of our 8 traditional challenge study models for another of the global top 10 vaccine companies.    

This trial will be conducted in the Company’s dedicated human viral challenge quarantine unit in London with all volunteers recruited through hVIVO’s volunteer recruitment website, www.flucamp.com. The hVIVO unit is Europe’s only commercial 24-bedroom quarantine clinic with on-site virology laboratory. 

Work on this major new contract has started already and the contract is expected to be delivered in Q1 2021 with the majority of revenues being generated in H1 2021. It is a further example of Open Orphan delivering on its pipeline and stated strategy of winning sizeable contracts.  

The Company’s Interim Results will be published on the morning of Wednesday the 30th of September 2020, analyst conference call scheduled for 10.30am on the 30th of September.

Cathal Friel, Executive Chairman, Open Orphan, said:

“Open Orphan continues to execute on its substantial pipeline that has been built up by the expertise and experience of our professional and hardworking teams in hVIVO and Venn Life Sciences. We are focused on continuing to deliver large and profitable contracts which demonstrate hVIVO’s position as the world leader in the testing of vaccines and antivirals using human challenge clinical trials. 

Our stated objectives when we acquired hVIVO in January of this year was to increase its 24-bedroom quarantine clinic annual utilisation from its traditional 20-25% utilisation up to maximum capacity and to build out a clear pipeline of signed contracts going forward. With this contract, we are close to having the hVIVO quarantine clinic block booked with our conventional challenge studies until December 2021. Within a month or two we are likely to have our quarantine clinic block booked out for the next 18 months to two years with conventional challenge study contracts.

I am hugely excited by the progress we are making as a Group since our IPO in 2019 and I look forward to continuing to update shareholders on the work we are doing over the coming months.”

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. hVIVO welcomes volunteers to take part in our clinical trials under expertly supervised conditions, to further medical research, and help us to take the understanding of respiratory illnesses to a new level. Volunteers are central to the work that we do; our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment. Further details on all aspects of our volunteer programs including testimonials from previous volunteers can be found at www.flucamp.com.

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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 

Notes to Editors – Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com. 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.  Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

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, Open Orphan is 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. 

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. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 in January 2020. Venn is an integrated drug development consultancy firm which 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.

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