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Open Orphan #ORPH – Launch of Disease in Motion platform

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO , a subsidiary of Open Orphan, has officially launched its Disease in Motion® platform. This unique data-focused platform includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has multiple infectious disease applications that are applicable to a wide variety of end users including big tech, wearables, pharma and biotech companies.  

hVIVO has been at the forefront of running human challenge studies for more than 20 years and has built up one of the most comprehensive, multi-parametric bio and databanks ever created for infectious diseases. This dataset from the Disease in Motion platform is continuously gathered throughout the onset, progression and resolution of an infection which is enabled by hVIVO’s challenge study model. The Company is committed to volunteer patient data privacy and data is only collected from fully consented volunteers in accordance with all relevant privacy guidelines.

For more information on the platform, please visit www.hvivo.com/DiseaseInMotion  

Cathal Friel, Executive Chairman said: The Disease in Motion platform includes data from cutting edge wearables that are applicable to a wide variety of end users including big tech, wearables, pharma and biotech companies. As volunteers remain under close observation prior to viral challenge, during disease progression and until resolution, data is captured across the full time-course of the infection, yielding possible insights into the body’s response to infection. The Disease in Motion platform currently spans several conditions with plans to expand this going forward.  

As a recognised global leader in supporting the development of therapeutics and vaccines, hVIVO and our team of virological, clinical and regulatory experts are actively in discussion with potential partners to help address the next set of challenges facing humanity.” 

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 #ORPH – COVID-19 Human Challenge Programme update

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces an update in the world’s first COVID-19 characterisation study. Following Research Ethics Committee approval on 17 February 2021, hVIVO, a subsidiary of Open Orphan, began the study at the Royal Free London NHS Foundation Trust earlier this month.

The first three volunteers have now successfully completed the quarantine phase of their study participation with no safety concerns presented and have been discharged from the unit. The study will now progress to the next group of volunteers. The first three volunteers will continue their study participation with follow up visits and monitoring for a period of up to one year. As is normal practice during any clinical trial, none of the partners in the study will be identifying any of the volunteers.

The virus characterisation study will inoculate up to 90 volunteers, between the ages of 18 and 30 years old, to enable identification of the most appropriate dose of the virus needed to cause COVID-19 (SARS-CoV-2) infection in a safe and controlled environment. The study is funded by the UK Government and Imperial College London is the clinical study sponsor. The study is conducted by hVIVO at the Royal Free Hospital, under the scrutiny of highly trained scientists and medics. The virus being used in the characterisation study has been 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.

Individuals interested in taking part in this research can visit www.UKCovidChallenge.com to learn more.

Chief Scientific Officer at hVIVO, Dr Andrew Catchpole, said : “We are pleased to announce that the first three volunteers in this world’s first study have now successfully completed the quarantine phase, these volunteers will continue to be monitored post-study for up to 1 year. Throughout their stay at the Royal Free Hospital in London, the volunteers are closely monitored by our highly trained team of clinicians.

“We would like to thank these volunteers for their participation in this important study and look forward to welcoming the following cohorts. We expect that this study will greatly assist our understanding of this disease and provide insights into its progression, natural immune response, and transmission. We look forward to publishing the study’s results in due course and moving forward with vaccine challenge studies later this year.”

Dr Chris Chiu,  Chief Investigator and Reader in Infectious Disease at Imperial College London said: “We’re pleased to confirm the first group of three healthy volunteers has now successfully completed the first stage of the trial, with no unexpected issues. The volunteers are in good health. It would be premature to discuss further details at this early stage.”  

Group Chief Executive at the Royal Free London, Caroline Clarke, said:We are incredibly proud to be working with our partners from hVIVO, Imperial College London and the government’s Vaccine Taskforce on this important research. We’re delighted that the first stage of the study has been completed successfully and we look forward to continuing our close collaboration as this research moves forward.”

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 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

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893 

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, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge 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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

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 – Ethics approval – COVID-19 Human Challenge Study

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces the world’s first COVID-19 characterisation study has received approval from a specially convened Research Ethics Committee (“REC”). This news follows the announcement on 20 October 2020 of Open Orphan subsidiary hVIVO’s contract with the UK Government to develop a COVID-19 human challenge study model.  

The initial virus characterisation study will inoculate up to 90 volunteers, between the ages of 18 and 30 years old, to enable identification of the most appropriate dose of the virus needed to cause COVID-19 (SARS-CoV-2)infection in a safe and controlled environment. The study is set to commence shortly and is funded by the UK Government. Imperial College London is the clinical study sponsor and the study will be conducted by hVIVO at the Royal Free London NHS Foundation Trust’s specialist clinical research unit, under the scrutiny of highly trained scientists and medics. The virus being used in the characterisation study has been 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 REC approval completes all the independent external body approvals required before the study can commence.   

Individuals interested in taking part in this research can visit  www.UKCovidChallenge.com to learn more. 

Chief Scientific Officer, hVIVO, Dr Andrew Catchpole, said: “Ethical review of the research plan is a crucial part of conducting clinical studies and approval from the Ethics Committee represents a very important milestone in the development of the COVID-19 challenge model. COVID-19 Human Challenge studies have the potential to play an important role in providing data and information that will help continue to develop vaccines to control the pandemic. 

“This study is a key enabling study to establish the COVID-19 challenge model and determine the lowest possible dose of virus required.  Data from this study will immediately facilitate the challenge model to be used for vaccine efficacy testing as well as to answer a wide range of fundamental scientific questions that are not feasible with traditional field trials, such as exactly what type of immunological response is required to confer protection from re-infection.” 

Dr Chris Chiu, Clinical Reader, Honorary Consultant and Chief Investigator of this study said: “The recent worsening of the pandemic and urgent need to vaccinate people quickly and effectively have raised new questions about COVID-19 and how to best protect ourselves against it. This study will immediately tell us about mild and asymptomatic infection, which is a major driver of continuing transmission. While the first wave of vaccines are being rolled out, human challenge studies could also be pivotal in helping to shape the timings and doses of existing vaccines, finding out how long one dose is protective for, and if they are effective against new variants of the virus.”

“The Research Ethics Committee has provided detailed independent scrutiny. Their favourable opinion is a crucial step towards getting this study open and running, and greatly helps us in our efforts to minimise risks and enhance the quality of the research.”

Cathal Friel will be presenting at a Mello event on Monday, 22 February. To register for this, please follow the link: https://melloevents.com/mellomonday-22nd-february-2021/

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 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

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893 

 

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, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge 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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

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.

Health Research Authority (HRA)

Before commencing a clinical study, researchers must submit an application for Health Research Authority (HRA) approval which brings together the assessment of governance and legal compliance, with the independent Research Ethics Committee (REC) opinion to confirm whether a research study has all the necessary approvals in place from the relevant bodies to proceed. The HRA, as the body responsible for running the UK Research Ethics Service, brought together a group of experienced REC members from around the UK to review the COVID-19 challenge study. The specially convened committee was made up of 12 members, a mixture of lay people and experts as required by law and has been recognised by UKECA (The United Kingdom Ethics Committee Authority).

Open Orphan #ORPH – New challenge study quarantine clinic at Whitechapel

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services contract research organization (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, part of Open Orphan plc, has opened a new quarantine clinic in East London. The new site is based in Whitechapel, directly opposite the Queen Mary BioEnterprise Innovation Centre (“QMB”) which houses hVIVO’s 24 bedroom unique state-of-the-art FluCamp site and the recently opened new street-level volunteer screening centre.  The Whitechapel Clinic will act as an extension of hVIVO`s current QMB site.

The converted 26-bedroom former boutique hotel, which will be known as the Whitechapel Clinic, has the capacity for up to 19 quarantine rooms and will be used as an additional unit for human challenge trials and volunteer recruitment screening. The quarantine rooms are located across three floors of the former hotel, with each level fully converted  to include a nurses station on each floor.

The new site, like QMB, will follow the highest safety standards to deliver each clinical study and volunteer screening visit. Of the 19 rooms, 8 rooms on a single floor are flexible use clinic rooms, meaning they can be used as either quarantine bedrooms for challenge studies or for volunteer screening visits. Each room at the facility has been fully repurposed to the highest standard, with all volunteer rooms equipped with an en-suite bathroom, TV, wardrobe, and tea & coffee making facilities. This will provide a comfortable space for volunteers during studies. The Whitechapel Clinic, like QMB, is also equipped with a 24-hour security presence and a working hour reception desk.

Cathal Friel, Exexcutive Chairman of Open Orphan plc commented: “Our newest quarantine unit greatly increases our capacity to facilitate hVIVO’s pipeline of upcoming studies. Our QMB clinic is now close to full capacity until December 2021, and as such, the newly renovated, state of the art Whitechapel Clinic will allow us to increase our study capacity substantially in the year ahead.

“We have leased the entire former Whitechapel Hotel and managed to convert the space on a very cost efficient basis which is now almost fully booked to capacity for H1 2021. This new facility will be run at the same high standard as our QMB site, and volunteers will be expertly supervised by our highly trained nurses and doctors in a safe and controlled clinical environment.”

Interested in becoming a volunteer?

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 .

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

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 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

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893 

 

About Open Orphan ( www.openorphan.com )

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 volunteers 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. 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 – Article Published in Drug Discovery Today

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organization (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces an article submission has been published in Drug Discovery Today, a print and online trade magazine with an emphasis on the science which underpins drug discovery and development. The published editorial is titled “Modelling the World – can deliberately infecting healthy volunteers really tell us much about what happens outside the clinic during an epidemic or pandemic?”

The article was written by Adrian Wildfire, Director of Scientific and Business Strategy at hVIVO, part of Open Orphan plc. Adrian is a specialist in the fields of virology, medical microbiology and parasitology.

The article explores what can be learned from using the method of human challenge trials to support vaccine development, and focuses on the role hVIVO plays in this, in particular in relation to COVID-19. hVIVO has a long history of successfully delivering human challenge studies at their state-of-the-art quarantine facility in East London.

To view the article, please follow the link: https://bit.ly/3nLct9Q

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 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 .

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 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

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893 

 

About Open Orphan ( www.openorphan.com )

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 volunteers 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. 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 – First volunteer dosed in intranasal COVID-19 vaccine clinical trial

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces that the first volunteer has been dosed with the Codagenix Inc. (“Codagenix”) needle free, intranasal COVID-19 vaccine, COVI-VAC. Conducted by hVIVO, part of Open Orphan plc, the Phase I clinical trial of COVI-VAC is being carried out at their facility in the UK. COVI-VAC is a single-dose, intranasal, live attenuated (the entire virus in a weakened form) vaccine against SARS-CoV-2, the virus that causes COVID-19.

Further to the Company’s announcement on 28 July 2020, hVIVO is working in collaboration with US biotech Codagenix to conduct a Phase I study of COVI-VAC. This is a randomised, double-blinded, placebo-controlled dose-escalation study, and will evaluate the safety and tolerability of the single-dose intranasal vaccine candidate in 48 healthy young adult volunteers at hVIVO’s state-of-the-art Quarantine Facility in Whitechapel, London.

The study will also evaluate the vaccine’s ability to provoke an immune response – measuring neutralising antibodies, mucosal immunity in the airway and cellular immunity. COVI-VAC has the potential to address several key logistical challenges to immunisation against SARS-CoV-2 at a global scale. As a single-dose, intranasally-delivered vaccine, COVI-VAC will not require a needle and syringe to be administered, nor ultra-low temperature freezers for storage. COVI-VAC can be manufactured on a large scale and supports ease of administration in a mass vaccination campaign. Codagenix expects to report initial data from the study by mid-2021.

Cathal Friel, Executive Chairman, Open Orphan, commented: “We are delighted to have been chosen by the New York based Codagenix to run this very important COVID-19 vaccine study in our quarantine clinic in London. This vaccine is one of the first of the next generation COVID-19 vaccines, it is a single dose, needle free, intranasal, live attenuated COVID-19 virus vaccine. Thus, in our opinion, because it is a live attenuated virus vaccine, COVI-VAC has the potential to give much longer-lasting cellular immunity against COVID-19 than many of the first-generation vaccines.

“Codagenix sought an inpatient facility for the first in human evaluation of COVI-VAC to allow for thorough evaluation of product safety and real-time volunteer monitoring, and our unique state-of-the-art quarantine facility in East London is one of the few facilities in the world suitable to conduct this trial safely and successfully. hVIVO are providing a full-service trial as part of this contract with Codagenix and the team at FluCamp have been responsible for all aspects of trial recruitment for this study through www.FluCamp.com .

“hVIVO is world-recognised for its expertise in evaluation of live viruses in human volunteers and we look forward to a positive outcome.”

Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said: “Dosing of the first patients in the Phase 1 clinical trial of COVI-VAC, our single-dose, intranasal, live attenuated vaccine against COVID-19, is an important milestone for Codagenix and the hVIVO team.   As a live attenuated vaccine, COVI-VAC has the potential to provide a broader immune response in comparison to other COVID-19 vaccines that target only a portion of the virus, which could prove critical as new variants of SARS-CoV-2 have begun to emerge.  Additionally, we believe COVI-VAC can address potential gaps in supplying the global immunization effort against COVID-19, especially in developing countries .”

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 .

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 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

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893 

 

About Open Orphan ( www.openorphan.com )

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 volunteers 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. 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 Chairman Cathal Friel talks to Ian King, Sky News about the Codagenix nasal Covid-19 vaccine phase I study

Open Orphan #ORPH Chairman Cathal Friel talks to Ian King, Sky News about the Codagenix nasal Covid-19 vaccine phase I study, which has received regulatory approval. Tests start at the hVIVO Whitechapel facility in the new year. Cathal explains the simplicity, ease of application of the nasal application, and looks at the history of hVIVO’s East London facility.

BRR Media – Open Orphan #ORPH secure MHRA approval to start Codagenix COVID-19 phase 1 vaccine trial

Open Orphan #ORPH – MHRA approval for nasal COVID-19 vaccine clinical trial

First in human trials for vaccine candidate with the potential to confer long-term immunity

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials, announces the first in human (Phase I) study of Codagenix intranasal SARS-CoV-2 (COVID-19) vaccine candidate has received approval from the UK’s independent Medicines and Healthcare Products Regulatory Agency (MHRA).

Further to the Company’s announcement on 28 July 2020, hVIVO, part of Open Orphan plc, is working in collaboration with US biotech Codagenix Inc. (“Codagenix”) to conduct this Phase I study of COVI-VAC, Codagenix’s intranasal SARS-CoV-2 (COVID-19) vaccine candidate. The study will evaluate safety and immunogenicity of a single-dose nasal vaccine candidate in 48 healthy young adult volunteers at hVIVO’s state-of-the-art Quarantine Facility in Whitechapel, London.

COVI-VAC is one of the few vaccines that uses the live-attenuated virus (i.e. the entire virus in a weakened form), unlike most other vaccines which only contain the viral spike. This vaccine, therefore, has the potential to induce broad antibody, cellular and mucosal immunity with a single intranasal dose and could be one of the first vaccines to provide long-term immunity from COVID-19.

hVIVO expects the study to commence in January 2021, the initial data expected in early Q2 2020. The Company has already begun enrolling volunteers for this study in its unique East London, 24-bedroom quarantine clinic through hVIVO’s dedicated volunteer recruitment website: www.flucamp.com

Cathal Friel, Executive Chairman of Open Orphan, said:

“We are delighted to have MHRA approval to begin recruiting volunteers for this much needed clinical trial. The volunteers who attend our unique quarantine facility in East London are expertly supervised in a safe, controlled clinical environment and could be contributing to the development of a new breakthrough vaccine candidate that has the potential to confer immunity to individuals over a much longer timescale.

“We hope to demonstrate safety and immunogenicity through this trial, which will then allow us to support Codagenix as they move into a larger Phase II / Phase III programme.”

Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said:

“We are very excited to be moving forward with our collaboration with hVIVO for this first-in-human study of COVI-VAC, our live attenuated vaccine against COVID-19. The initial safety and immunogenicity data from healthy adults will position us well to move into larger studies in 2021 with our partners at Serum Institute of India. We believe COVI-VAC, a needle-free, single dose vaccine, is well-suited to address potential gaps in supplying the global community, as there is likely to be significant unmet need even after the initial roll-out of first generation COVID-19 vaccines.”

Dr. Rajeev Dhere, Executive Director, Serum Institute of India, said:

“We at the Serum Institute of India are pleased with the MHRA approval for initiating the first-in-human clinical trial for the novel intranasal product against COVID-19, developed by Codagenix in collaboration with SII. We are happy to have hVIVO conducting the clinical trial of this unique Intranasal vaccine.”

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
Walbrook PR (Financial PR & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus / Alice Woodings +44 (0)7980 541 893 / +44 (0)7407 804 654

About Open Orphan (www.openorphan.com)

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.

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.

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