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Open Orphan #ORPH – £7.2m RSV human challenge study contract

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan, has signed a £7.2m contract with an existing top 5 global pharmaceutical company to test its orally administered antiviral product, using hVIVO’s respiratory syncytial virus (“RSV”) Human Challenge Study Model.

The Phase 2a double-blinded placebo-controlled human challenge study will take place at the Company’s specialist quarantine facilities in Whitechapel and will evaluate the safety and efficacy profile of the antiviral against RSV. The study will commence in June 2022, with the revenue being recognised in 2022 and 2023. As part of the study, hVIVO will recruit healthy volunteersvia the Company’s dedicated volunteer recruitment arm, FluCamp.

The client’s antiviral is presently in Phase III clinical trials for another infectious disease indication and the client will use human challenge to assess the efficacy of their antiviral drug candidate against RSV quickly and efficiently, highlighting the value that human challenge studies can bring within the drug development process. The repeat business from this top 5 global pharmaceutical company underlines the Company’s world leading expertise and its ability to attract additional contracts from its existing Big Pharma clients.

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “We’re delighted to be working with this top 5 global pharmaceutical client again to test their antiviral candidate using the hVIVO RSV Human Challenge Study Model. I am especially proud that our world-class offering and customer service has secured repeat business from another Big Pharma client, and that we are seen as the ‘go-to’ partner for an increasing number of global drug developers. The client’s drug has already been shown to be an effective antiviral in certain disease indications, and we’re pleased to now test its efficacy against RSV infection. RSV continues to be a serious global health threat causing an estimated 100,000 annual deaths in children under the age of five.”

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “This contract is a strong example of where human challenge studies can provide significant value. With a drug that has existing safety data and has been approved for one indication, human challenge studies can provide fast, cost-effective efficacy data within a new indication. The data will then indicate whether the candidate is viable for a wider Phase II study, providing substantial time and financial savings compared to traditional field-based studies.”

Interested in becoming a volunteer? 

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

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

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Yamin ‘Mo’ Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

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

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /
+44 (0) 7747 515393

Notes to Editors 

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models, such as malaria and COVID-19, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.

About RSV

RSV is the main cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems, such as COPD. Globally it affects an estimated 50-million people annually, leading to 4 million hospitalisations and an estimated 100,000 deaths in children under the age of 5 years. There is a lack of understanding and insight into RSV disease, especially in adult groups, despite its considerable impact on society and its high degree of infectivity.

Open Orphan #ORPH – £7.3m Influenza human challenge study contract win

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan, has signed a £7.3m influenza human challenge study (“Study”) contract with a leading biotechnology company to test its antiviral product using the hVIVO Influenza Human Challenge Study Model. 

The randomised, double-blinded, placebo-controlled study will test and assess the antiviral prophylactic and post-inoculation treatment activity of the antiviral in healthy adult volunteers enrolled through the Company’s specialist, tech-enabled volunteer recruitment arm,FluCamp. The Study will be conducted by hVIVO’s team of medics at its state-of-the-art quarantine facilities in London and is expected to commence next year. Revenue from the contract is expected to be recognised across FY23 and FY24.

The Company’s specialised virology laboratories, hLAB, will determine the viral load of the influenza challenge agent used to inoculate volunteers, hLAB will also provide serology services and virology services (viral infectivity assay) for the study. 

Influenza is a contagious respiratory illness caused by influenza viruses that affect the nose, throat and the lungs. It can cause mild to severe illness, and occasionally lead to death. According to Financial Times1 analysis of official data in England, since the development of effective vaccines and the emergence of the less severe Omicron variant, influenza is now more lethal than COVID-19. For every 100,000 Omicron infections, 35 will result in death, while the equivalent number of flu infections will lead to around 40 fatalities.

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to sign a contract with this leading biotechnology company to test its antiviral product using the hVIVO Influenza Human Challenge Study Model. hVIVO has seen a steady increase in flu studies, a reflection of the shift in market sentiment following recent scrutiny of infectious disease data that has outlined the significant threat of flu and the potential of human challenge studies to the advancement of drug development candidates.”

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “We are excited to test the antiviral prophylactic and post inoculation treatment activity against flu infection using the hVIVO Influenza Human Challenge Study Model. hVIVO has pioneered influenza human challenge studies for decades, with our history dating back to the Salisbury Common Cold Clinic.

“Since the advent of effective vaccines and treatments for COVID-19, there has been renewed focus on influenza and official data shows flu is now a more lethal threat. After completing the study, we hope to provide positive data and early proof of concept for our client’s product, in order to accelerate its development into a Phase II programme.” 

1‘Vaccines and Omicron mean Covid now less deadly than flu in England’, The Financial Times, by Burn-Murdoch, John, and Barnes, Oliver. Link: https://www.ft.com/content/e26c93a0-90e7-4dec-a796-3e25e94bc59b

 

Interested in becoming a volunteer?

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

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

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

  +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

 

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

 

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

 

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

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

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /
+44 (0) 7747 515393  

 

Notes to Editors 

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models, such as Malaria and COVID-19, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.

hVIVO has a long history of testing influenza vaccines and treatments, with its history dating back to the Common Cold Unit in Salisbury. The Common Cold Unit was established following the end of the Second World War to investigate the microorganisms which cause typical cold symptoms. It was through this research that the first human coronavirus was discovered in 1960.

#ORPH Open Orphan – Vaccine field study contract

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO , a subsidiary of Open Orphan, has been awarded a new study with an existing Big Pharma client to act as a vaccination site for a Phase II field study of the client’s respiratory syncytial virus (RSV) vaccine candidate.

 

As part of the study, hVIVO will recruit 60 healthy volunteers to the Company’s new site clinic at Plumbers Row, where they will then be inoculated with either the RSV vaccine candidate or a placebo. As opposed to a human challenge study, where volunteers would then be challenged and quarantined within hVIVO’s FluCamp facilities, these participants will then be free to leave the facilities. Participants will then be monitored for RSV symptoms over the following months, with regular clinical check-ups at Plumbers Row, to assess the efficacy of the vaccine candidate and its ability to prevent illness through RSV. The study is expected to begin in Q3 2022 with the majority of revenue from the contract recognised in 2023.

 

This is the first vaccine field study the Company has been awarded since it announced the expansion of its facilities on 8 March 2022 . In addition to the core human challenge studies the expansion has enabled Open Orphan to provide a larger service offering including non-first in human Phase I trials such as PK (pharmacokinetics) studies, bridging studies and Phase II trials in patients and healthy volunteers.  

 

The volunteers for the study will be recruited through the Company’s specialist volunteer recruitment arm, FluCamp . FluCamp has decades of experience attracting suitable healthy subjects to meet recruitment requirements, primarily sourcing subjects for hVIVO trials to date. FluCamp’s large database, tech-enabled platform and recently improved screening capabilities will mean that hVIVO is able to efficiently recruit and assess potential volunteers for its client’s field studies in a timely and cost-effective manner.

 

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said : “This is a significant award for Open Orphan as it is our first study as a site. To date we have mainly acted as a Contract Research Organisation to provide either challenge studies, laboratory or consulting services. Although we have acted as a site as part of the challenge studies, we have not provided stand-alone site services.  We expanded our facilities at Plumbers Row in March of this year with the aim to provide site services. It is a great testament to the team that they have been able to fulfil site activity work in such a short timeframe. There are a great number of synergies between our core challenge study activities and new the site services, this will help us to conduct the new work in an efficient manner.”

 

Interested in becoming a volunteer?

 

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

 

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

 

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

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

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /
+44 (0) 7747 515393  

Open Orphan #ORPH – Presentation at World Vaccine Congress

open orphan

Presentation at World Vaccine Congress 

hVIVO presents on the outcomes from the world’s first COVID-19 characterisation study

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, a subsidiary of Open Orphan plc, will be delivering a presentation at the World Vaccine Congress, Washington D.C., United States, titled ‘Outcome of the world’s first SARS-CoV-2 viral challenge and its utility for vaccine testing’. 

Dr Catchpole will be presenting the results from the world’s first COVID-19 characterisation study, which was a partnership between hVIVO, Imperial College London, the Vaccine Taskforce and Department of Health and Social Care (DHSC), and the Royal Free London NHS Foundation Trust. The landmark study, published in Nature Medicine on 31 March 2022, found that a SARS-CoV-2 human challenge is safe in healthy young adults and provided detailed insights into the course of COVID-19 infection with potential positive public health implications, which will also be outlined in Dr Catchpole’s presentation. 

Full details of the presentation are included below: 

Title

Outcome of the world’s first SARS-CoV-2 viral challenge and its utility for vaccine testing

Date/Time

Wednesday 20 April 2022, 09.40 am (ET)

The World Vaccine Congress will take place at the Marriott Marquis in Washington DC between 18-21 April 2022. hVIVO will be at booth 410 during the congress for potential partnering discussions. 

The World Vaccine Congress is the largest and most established meeting dedicated to vaccines and has run for 21 years. In that period, it has evolved and grown into the leading vaccines congress globally, with hundreds of speakers and thousands of attendees from leading global vaccines developers, academia and policymakers. 

More information about the event, including attendance, can be found here . 

Yamin ‘Mo’ Khan, Chief Executive Officer at Open Orphan, said: “I am delighted that Andrew will be presenting at the largest vaccine event of the year, highlighting the pivotal role hVIVO played in the world’s first COVID-19 characterisation study.”  

Interested in becoming a volunteer?

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

For further information please contact: 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman
Yamin ‘Mo’ Khan, Chief Executive Officer

Arden Partners plc (Nominated Adviser and Joint Broker)

 +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

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

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

+44 (0)7747 515 393

Open Orphan #ORPH – COVID-19 Characterisation Study peer reviewed results published in industry leading periodical Nature Medicine

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that the results from the world’s first COVID-19 characterisation study have been peer reviewed and published in the scientific journal Nature Medicine.

‘Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge’ by Killingley, B. et al. is available in Nature Medicine, https://www.nature.com/articles/s41591-022-01780-9 DOI: 10.1038/s41591-022-01780-9

The study, which was conducted by hVIVO, a subsidiary of Open Orphan, in partnership with Imperial College London, the Vaccine Taskforce and Department of Health and Social Care (DHSC), and the Royal Free London NHS Foundation Trust, showed that the SARS-CoV-2 human challenge was safe in healthy young adults and provided detailed insights into the course of COVID-19 infection with potential positive public health implications. The study results had previously been published on Research Square whilst the peer review process was concluding.

As part of the characterisation study, researchers aimed to identify a dose of COVID-19 that caused a safe and reliable infection in unvaccinated volunteers with no prior SARS-CoV-2 infection. hVIVO clinicians closely monitored volunteers in a controlled quarantined setting and collected disease progression data to provide insights into COVID-19 infection.

With the characterisation study disease modelling data completed, and a COVID-19 Human Challenge Model now established, Open Orphan should be able to contract / conduct COVID-19 human challenge studies in 2022, subject to individual ethics and regulatory approvals. 

Dr Andrew Catchpole, Co-investigator on the study and Chief Scientific Officer of hVIVO, said : “The SARS-CoV-2 characterisation study has provided invaluable insights into the progression of COVID-19 infection in healthy young adults. We are delighted to see the peer reviewed results published in Nature Medicine, which is one of the most influential and highly-cited medical research journals, and is an indication of how important the study was in helping deepen our understanding of SARS-CoV-2.”

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to see the characterisation study paper successfully complete the peer review process and be published in such a prestigious journal. Looking forward to the rest of the year, the COVID-19 human challenge model has the potential to accelerate the development of novel therapeutics and vaccines. We look forward to updating the market in due course.”

Interested in becoming a volunteer?

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

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Yamin Khan, Chief Executive Officer

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

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

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

7747 515393 

Notes to Editors

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models, such as malaria and COVID-19, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.

Open Orphan #ORPH – Trading Update, Volunteer Recruitment and Laboratory Facilities Expansion

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, provides a trading update for the year ended 31 December 2021. The Company also announces it will be opening a new primary FluCamp volunteer recruitment screening facility in Plumbers Row, London (“Plumbers Row Facility”) and a secondary FluCamp recruitment facility in Manchester.

Trading Update

Subject to completion of the audit, the Company expects both revenues and EBITDA to be in line with the expectation detailed at the time of the interim results.  Accordingly the Company expects 2021 to be EBITDA positive with revenues of approximately £40m. Cash and cash equivalents as of 31 December 2021 was £15.6m (30 June 2021: £14.9m). The Company further expects to be in line with management expectations for year-ending 31 December 2022, targeting revenues in the region of £50m in non-COVID-19 work. COVID-19 revenue for 2022 will be in addition to this and will depend on the eventual timing of these studies.

Facilities Expansion

The new facilities will double the Company’s previous volunteer screening capacity, significantly boosting its ability to identify and enrol study volunteers and patients and further strengthening its world leading human challenge capabilities.

As part of the opening of a new specialised volunteer recruitment facility in London, the Whitechapel quarantine clinic and the Queen Mary’s Bioenterprises Centre (“QMB”) clinic will both be exclusively dedicated to conducting human challenge studies going forward. The space at QMB currently providing volunteer screening will be converted into further quarantine bedrooms. As such, the Company’s QMB facility will expand to 31 beds, adding to the Whitechapel Clinic’s 19 beds and the Plumbers Row Facility’s 12; in total the Company’s bed count will reach 62. These new facilities offer an opportunity to the Company to expand the scope of the business to offer Phase I and Phase II vaccine field trials, PK (pharmacokinetics) studies, bridging studies, and patient trials (as opposed to healthy volunteer human challenge trials) as part of large international multi-centre studies which do not require a quarantine setting.

The increase in volunteer recruitment capacity will enable the Company to recruit larger cohorts more quickly than before and cement Open Orphan’s world leading position and reputation in volunteer recruitment. Particularly in Manchester, the secondary facility extends the Company’s reach for more volunteers and facilitates the increasing demand for human challenge studies. During volunteer screening there are large numbers of volunteers that are ineligible to take part in challenge studies for a variety of reasons, such as previous infection by the virus under investigation. By broadening the business offering to include Phase I and Phase II field trials, a large proportion of the volunteers already in the FluCamp facility could be eligible to take part in these studies.

The Plumbers Row Facility, London, plus the volunteer recruitment facility in Manchester, will have additional laboratory capacity, meaning samples collected during volunteer screening visits can be processed and stabilised on site. As a result, the primary laboratory at QMB has the capacity to expand its virology lab services business and increases its biomarker and molecular testing capabilities.

In addition, the Company’s corporate office will move from Alie Street to an upper floor in Plumbers Row. Both London and Manchester facilities offered attractive terms; the new Plumbers Row space is c. 9,000 sq ft and is a third of the cost of the current space of 4,000 sq ft; the new Manchester facility comes at the same cost as the old facility, but with four times the floor space at c. 2,000 sq ft.

Cathal Friel, Executive Chairman of Open Orphan, said: “Despite difficult market conditions during the year, which have continued into 2022, I am pleased with the performance of the Open Orphan team and during 2021 we signed an impressive number of human challenge study contracts with Big Pharma and biotechnology clients.

“We have continued our strong work at the start of this year, and our new facilities in both London and Manchester will not only enable the Company to screen a greater number of potential volunteers, it will also increase our total bed count to 62. Considering the greater size and functionality of the new facilities, as well as their cost, the Company has executed the expansion in a highly cost-efficient manner.”

Yamin Khan, Chief Executive Officer of Open Orphan, said: “I am delighted to be opening a new primary FluCamp volunteer recruitment and screening facility within walking distance from our other Whitechapel facilities as well as a new, larger Manchester volunteer recruitment facility. These facilities double our volunteer screening capacity and importantly, expand on our already world leading clinical trial and laboratory services offering.

“As a result of the changes, we have the potential to expand the scope of our business as we head into a crucial period of substantial growth across the infectious disease market. I believe we are now very well positioned with an enhanced clinical trial offering and unique volunteer and patient recruitment capacity, which will enable us to serve an increasing pool of Big Pharma and biotechnology clients seeking to test novel therapeutics against different infectious and respiratory diseases.”

Robin Rogiers, Director of Clinical Delivery & Innovation of hVIVO, said: “The opening of the new primary and secondary FluCamp volunteer facilities means we now boast a truly world class clinical trial offering. With quarantine capacity significantly increased and volunteer recruitment capacity doubled, we will be able to expand the scope of our clinical trial business to include vaccine field trials, PK studies, bridging studies and patient trials as part of large international multi-centre studies. The increased scope also includes an enhanced virology lab services offering at QMB, which will now be able to increase its biomarker and molecular testing capabilities.”

Interested in becoming a volunteer?

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

 

For further information please contact:

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Yamin Khan, Chief Executive Officer

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

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

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

7747 515393 

Notes to Editors

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been significant growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma, and biotech companies.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing, and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts

Open Orphan #ORPH – FDA Breakthrough Designation for Big Pharma RSV candidate

Vaccine candidate assessed in successful human challenge trial conducted by hVIVO 

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes the announcement dated 14 February 2022 from Bavarian Nordic A/S (“Bavarian Nordic”) (OMX: BAVA), reporting that the US Food and Drug Administration (“FDA”) has granted Breakthrough Therapy Designation for Bavarian Nordic’s respiratorysyncytial virus (“RSV”) vaccine candidate, MVA-BN® RSV. hVIVO, a subsidiary of Open Orphan, successfully conducted a Phase 2, double-blinded, placebo controlled human challenge trial to assess MVA-BN® RSV using its RSV Human Challenge Study Model.

A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition. The designation has been granted upon the assessment of preliminary clinical evidence for MVA-BN RSV, indicating that the vaccine candidate may demonstrate substantial improvement over available therapy on a clinically significant endpoint. A significant portion of this preliminary evidence was the successful challenge study conducted by hVIVO. The designation provides an option to work more closely with FDA for the development and review of MVA-BN RSV.

The challenge study conducted by hVIVO to assess MVA-BN® RSV demonstrated a significant reduction in viral load in vaccinated subjects versus placebo, thus meeting the primary endpoint of the study. At the same time, vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections. The MVA-BN RSV vaccine demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections. No vaccine-related serious adverse events were observed, and the vaccine was well tolerated, consistent with the safety profile previously reported in Phase 1 and Phase 2 clinical studies.

RSV is a contagious, common respiratory virus that usually causes mild, cold-like symptoms and affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation to at-risk older adults.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of infectious and respiratory disease areas, including various strains of influenza, RSV, HRV, COVID-19, asthma and malaria, etc.

Cathal Friel, Executive Chairman, said: “We are pleased to see Bavarian Nordic achieve Breakthrough Therapy Designation for its RSV vaccine candidate, MVA-BN® RSV. hVIVO successfully conducted a human challenge trial on behalf of Bavarian Nordic in 2021, where the candidate showed a significant reduction in clinical symptoms associated with RSV.

“The data from this human challenge trial was part of the body of evidence provided by Bavarian Nordic to the FDA in order to secure its Breakthrough Therapy Designation, which could ultimately result in an expedited regulatory review of MVA-BN® RSV. This highlights a major benefit of human challenge trials, in that they enable drug developers to obtain Phase 2/2a efficacy data for their vaccine and antivirals candidates in a fast, cost-effective manner ahead of larger scale studies. This data can then strengthen submissions for important regulatory programmes such as the Breakthrough Therapy Designation.”

Interested in becoming a volunteer?

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

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

For further information please contact:

 

Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser and Joint Broker)    +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Louisa Waddell
 
finnCap plc (Joint Broker) +44 (0) 20 7220 0500
Geoff Nash / James Thompson / Richard Chambers
 
Davy (Euronext Growth Adviser and Joint Broker) +353 (0) 1 679 6363
Anthony Farrell
 
Walbrook PR (Financial PR & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus/ Sam Allen / Louis Ashe-Jepson +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393

Notes to Editors

Open Orphan plc 

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been an explosion in the growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

Open Orphan #ORPH – Results from the world’s first COVID-19 Characterisation Study

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces the results from the world’s first COVID-19 characterisation study, which was a partnership between hVIVO, Imperial College London, the Vaccine Taskforce and Department of Health and Social Care (DHSC), and the Royal Free London NHS Foundation Trust. The results from this landmark study, show that a SARS-CoV-2 human challenge is safe in healthy young adults and provide detailed insights into the course of COVID-19 infection with potential positive public health implications.

As part of the characterisation study, researchers aimed to identify a dose of COVID-19 that caused a safe and reliable infection in unvaccinated volunteers with no prior SARS-CoV-2 infection. The results published today detail the outcome of the 36 healthy male and female volunteers aged 18-29 years which were infected with the original SARS-CoV-2 strain challenge virus. hVIVO clinicians closely monitored volunteers in a controlled quarantined setting and collected disease progression data to provide insights into COVID-19 infection. Volunteers will be followed up for 12 months after discharge from the quarantine facility.

The key clinical insights were as follows:

Viral load (“VL”)

· 18 volunteers (50%) became infected with viral load (VL) rising steeply and peaking at ~five days post-inoculation

· No quantitative correlation was noted between VL and symptoms

Symptoms

·No serious symptoms

·  Mild-to-moderate cold like symptoms were reported by 16 (88%) of 18 infected volunteers including a stuffy or runny nose, sneezing, and a sore throat. Some experienced headaches, muscle/joint aches, tiredness and fever

·   Anosmia (lost or changed sense of smell) occurred in 13 (72% of infected) volunteers

Virus detection

· Average time from first exposure to viral detection and early symptoms (incubation period) was 42 hours

· Virus was detected earliest in the throat but at significantly greater levels in the nose;

Virus detected in the throat on average after 40 hours

Virus detected in the nose on average after 58 hours

· High levels of viable (infectious) virus was seen for approximately nine days post-inoculation, and up to a maximum of 12 days

· Modelling using the study data indicated that regular asymptomatic lateral flow testing (“LFT”) would diagnose infection before 70-80% of infectious virus had been generated, thus if isolation was triggered would decrease community transmission to others

Importantly, no serious adverse events (SAEs) occurred, and the SARS-CoV-2 human challenge study model was shown to be safe and well tolerated in healthy young adults. With the characterisation study disease modelling data completed, and a COVID-19 Human Challenge Model now established, the Company should be able to contract / conduct COVID-19 human challenge studies in 2022, subject to individual ethics and regulatory approvals. The Company is already developing a Delta strain of the COVID-19 virus in partnership with Imperial College London and funded by the Wellcome Trust, which could be used in future trials.

The data published today supports the safety of the infection challenge model which could theoretically provide a ‘plug and play’ platform for testing therapies and vaccines using the original COVID-19 strain as well as variants of the virus.

The characterisation study results and the insights they provide into COVID-19 infection have potential implications for public health. During the study, the average incubation period was 42 hours, which is considerably shorter than existing estimates of five to six days. Results also showed that while virus was detected significantly earlier in the throat, peak levels of virus were far higher in the nose, implying a potentially higher risk of viral shedding from the nose. This underlines the importance of proper facemask use to cover both the mouth and nose. Additionally, insights into the timeline of infection, with viable virus seen after nine days and 12 days for some, support the isolation periods advocated in most guidelines.

Lateral flow tests (LFTs) were also shown to be a good indicator of whether someone was harbouring viable virus. Positive LFTs correlated well with lab-confirmed detection of virus from swabs throughout the course of infection, including in those who were asymptomatic. However, the tests were less effective in picking up lower levels of virus at the very start and end of infection.

The challenge virus used in the study was produced under hVIVO’s supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, with support from virologists at Imperial College London. The Human Challenge Programme is funded by the UK Government, who commissioned Imperial College London to act as the clinical study sponsor. The study was conducted by hVIVO at the Royal Free Hospital, under the supervision of the Company’s highly trained scientists and medics.

Cathal Friel, Executive Chairman of Open Orphan, said : “I am delighted that the world’s first COVID-19 characterisation study has completed with no serious adverse events or serious symptoms, demonstrating that a COVID-19 human challenge study is safe in healthy young adults. The results, which have been made public today, have provided invaluable insights into COVID-19 disease progression.

“Crucially, we have now successfully established a COVID-19 Human Challenge Model which could be instrumental in accelerating the development of future COVID-19 therapeutics. New variants, such as Omicron, often mean that vaccines and antivirals have to be quickly re-evaluated to ensure effectiveness. Human challenge studies could prove to be the fastest way to compare old and new vaccines and therapies.”

Dr Andrew Catchpole, Co-investigator on the study and Chief Scientific Officer of hVIVO, said : “The SARS-CoV-2 characterisation study has provided invaluable insights into the progression of COVID-19 infection in healthy young adults. Importantly the study demonstrated that SARS-CoV-2 challenge studies are safe and well tolerated by the volunteers with no serious symptoms and no Serious Adverse Events (SAEs).  The study’s results have provided useful insights which could be used to inform public health decisions on COVID-19 symptoms and virus detection going forward, including isolation periods for infectious individuals, the use of LFTs, and establishing the human challenge platform to investigate further aspects of COVID-19.

“While the characterisation study was focused on the original SARS-CoV-2 strain, and there are differences in transmissibility between it and the other variants, the same factors will be responsible for protection against it, meaning the findings remain valuable for variants such as Delta or Omicron.  These data provide a clear platform to now utilise the human challenge model to expedite product efficacy testing for new vaccines or antivirals

Professor Christopher Chiu, Professor of Infectious Diseases from the Institute of Infection at Imperial College London and Chief Investigator on the trial, said: “First and foremost, we’ve shown that our challenge infection model was safe and well tolerated in healthy young adult participants. People in this age group are believed to be major drivers of the pandemic and these studies, which are representative of mild infection, allow detailed investigation of the factors responsible for infection and pandemic spread.

“Our study reveals some very interesting clinical insights, particularly around the short incubation period of the virus, extremely high viral shedding from the nose, as well as the utility of lateral flow tests, with potential implications for public health.” 

Professor Sir Jonathan Van-Tam, Deputy Chief Medical Officer at Department of Health and Social Care, said: “Human challenge studies have been performed using other pathogens for decades, including flu and Respiratory Syncytial Virus (RSV). They need full independent ethical review and very careful planning – as has been the case this time. Every precaution is taken to minimise risk.

“Scientifically these studies offer real advantage because the timing of exposure to the virus is always known exactly, therefore things like the interval between exposure and the profile of virus shedding can be accurately described.

“This important study has provided further key data on COVID-19 and how it spreads, which is invaluable in learning more about this novel virus, so we can fine-tune our response. Challenge studies could still prove to be important in the future to speed the development of ‘next-generation’ Covid-19 vaccines and antiviral drugs.

“This data underline just how useful a tool lateral flow tests can be to pick up people when infectious and the importance of wearing a face covering in crowded, enclosed spaces.”

Dr Mariya Kalinova, Principal Investigator on the study and Medical Director of hVIVO, said: “Closely observing and examining COVID-19 infection disease progression in volunteers during the SARS-CoV-2 characterisation study has revealed several important insights which will benefit public health going forward. Results uncovered new insights into the average incubation period for COVID-19 infection as well as disparities in viral loads between the nose and mouth, which endorses proper mask wearing guidance. Most importantly, there were no serious or adverse events, which proves a SARS-CoV-2 challenge is safe and well tolerated.”

Dr Sir Michael Jacobs, consultant in infectious diseases at the Royal Free London, said: “We have vast experience of safely managing highly transmissible infections at the Royal Free Hospital and we are really pleased to have been able to play our part in this landmark study.

“The trial has already provided some fascinating new insights into SARS-CoV2 infection, but perhaps its greatest contribution is to open up a new way to study the infection and the immune responses to it in great detail and help test new vaccines and treatments.”

‘Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge’ by Killingley, B. et al. is available on the Research Square pre-print server and has been submitted for peer-review. DOI: 10.21203/rs.3.rs-1121993/v1 https://www.researchsquare.com/article/rs-1121993/v1

Interested in becoming a volunteer? 

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

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 (as implemented into English law) (“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 / Louisa Waddell

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

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

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

7747 515393 

Notes to Editors  

Virus: The challenge virus used was a pre-Alpha strain of SARS-CoV-2, from the B1 lineage, which includes the Alpha, Beta and Delta variants (first detected in England (Kent), South Africa and India, respectively). It contained the D614G mutation in the spike protein, which is believed to have increased transmissibility compared to the originally described strain. The study used virus from very early in the pandemic obtained from a hospitalized patient in the ISARIC4C study.

Viral load: Swabs were taken from participants’ nose and throat twice a day. Viral replication was detected using PCR analysis and lab cultures, enabling analysis of viral load.

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been significant growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma, and biotech companies.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing, and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

#ORPH Open Orphan – New Malaria Human Challenge Model Launched

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials announces that further to the announcement on 9 August 2021, hVIVO, a subsidiary of Open Orphan, has inoculated the first cohort of volunteers with a GMP-manufactured malaria challenge agent as part of its first controlled human malaria infection (CHMI) challenge study. This study will assess CHMI using existing standard of care antimalarial drugs against Plasmodium malaria.

 

The study, which is taking place at hVIVO’s state-of-the-art facilities in London, is expected to complete in Q1 2022 with results in Q2 2022. For the study, hVIVO has leveraged its extensive experience in clinical trial recruitment, via its clinical trial recruitment arm FluCamp, to identify and screen volunteers to rapidly enrol the study cohort. Following the successful completion of the study, hVIVO will be able to sign malaria human challenge study contracts to assess the efficacy of novel antimalarial drugs and vaccines as well as correlates of immunity using a Plasmodium challenge agent.

 

hVIVO’s Direct Venous Inoculation (“DVI”) clinical trial protocol was reviewed by all necessary UK regulatory bodies and fully approved prior to the start of the study. Expert diagnostic services from the London School of Hygiene and Tropical Medicine have been contracted to monitor the welfare of subjects and provide essential correlates relating to drug and vaccine efficacy. Additionally, comprehensive training programmes have been completed by staff and senior professional oversight put in place for the review of scientific and safety data.

 

This malaria challenge model consists of inoculating volunteers with purified, infectious P. falciparum (Pf) sporozoites, harvested from the salivary glands of Anopheles stephensi mosquitoes. This type of malaria challenge model has been safely used in multiple clinical trials in the United States, Europe and Africa.

 

Conducting malaria modelling with Plasmodium in antimalarial drug and vaccine trials has several potential advantages over traditional methods of P. falciparum infected mosquito challenge, including superior predictability, a cleaner safety profile and improved control over levels of infection.

 

Learn more about hVIVO’s Malaria human challenge model here www.hvivo.com/clinical-development-services/hvivo-challenge-models/malaria/ or if you are interested in participating in a Malaria human challenge study or any other human challenge study visit www.flucamp.com

 

Adrian Wildfire, Director of Scientific & Business Strategy at hVIVO, said: Malaria is a disease of significant unmet need around the world, with 241 million cases and 627,000 deaths caused in 2020. Its prevention and cure is a designated World Health Organization target. As such, we are pleased to have commenced this study to allow our clinical teams to better acquaint themselves with the recently established Controlled Human Malaria Infection model, ahead of using human challenge studies to test our clients’ malaria products. Data resulting from such studies translates well into the field and malaria human challenge studies have been pivotal to the development of many of the novel drugs now entering late phase trials.

 

Cathal Friel, Executive Chairman of Open Orphan, said: “We are delighted to have inoculated the first cohort of volunteers for the Malaria study at our QMB facility in London. hVIVO is fully committed to growing the malaria model’s capabilities and capacity over the coming years to meet the challenge of accelerating the introduction of novel, safe and effective drugs and vaccines to the market.

 

“This study also ensures that Open Orphan is both strengthening and further diversifying the Company’s world leading portfolio of viral challenge models. We look forward to updating the market in due course.”

 

Interested in becoming a volunteer?

 

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

 

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

 

For further information please contact:

 

Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser and Joint Broker)   +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Louisa Waddell
 
finnCap plc (Joint Broker) +44 (0) 20 7220 0500
Geoff Nash / James Thompson / Richard Chambers
 
Davy (Euronext Growth Adviser and Joint Broker) +353 (0) 1 679 6363
Anthony Farrell
 
Walbrook PR (Financial PR & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus / Sam Allen / Louis Ashe-Jepson +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393

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

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan plc, has signed a £5m influenza human challenge study contract with a biotech company developing an antiviral drug for protection against respiratory viral infections. 

The study, which is expected to commence in H2 2022, will test and assess the efficacy of a single dosing regimen of the client’s antiviral drug, with healthy adult volunteers, using the hVIVO Influenza human challenge study model.  Conducted at hVIVO’s state-of-the-art facilities in London, Open Orphan expects the majority of revenues to be recognised in 2022.

Respiratory tract infections are infections of parts of the body involved in breathing, such as the sinuses, throat, airways or lungs and are often caused by viruses such as influenza. Seasonal influenza causes significant morbidity and mortality each year and a pandemic influenza continues to pose a worldwide threat. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 – 650,000 deaths per year. Healthy volunteer human challenge studies of wild-type influenza play a major role in the development of vaccines and therapeutics against influenza.

hVIVO has been studying influenza for over 20 years and conducting influenza human challenge studies with its flu disease models for more than 15 years. hVIVO has conducted numerous flu challenge studies for a range of industry, governmental and academic clients, making its models the most well-used commercial flu disease models available on the market. hVIVO also has expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of Influenza, Respiratory Syncytial Virus (RSV) and human Rhinovirus HRV (common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.

Cathal Friel, Executive Chairman of Open Orphan, said: “We are delighted to be working with this biotech client to assess the efficacy of their antiviral product which has the potential to be an important treatment against respiratory viral infections, using the hVIVO Influenza human challenge study model.

“We have now signed contracts for 95% of our 2022 forecasted revenues. This is the fourth Influenza human challenge study that we have signed in 2021 and coupled with the contract wins that we have seen in other disease areas, this further underlines the growing interest in respiratory and infectious diseases within the pharmaceutical and biotechnology industries, which we expect to continue over the coming years.

“Additionally, the continued damaging effects of the COVID-19 pandemic have underlined the need for increased pandemic preparedness in relation to other potential pandemic infectious diseases, such as influenza. Our expertise in testing vaccines and antivirals against our portfolio of infectious disease human challenge models will be important in ensuring we are prepared for the next, potentially more dangerous pandemic disease.”

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 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

Interested in becoming a volunteer?

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

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

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

   +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

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

Paul McManus/ Sam Allen/ Louis Ashe-Jepson

+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393  

 

Notes to Editors

 

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of other models. There has been an explosion in the growth of the infectious disease pharmaceuticals market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

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