Home » Posts tagged 'hVIVO'

Tag Archives: hVIVO

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 – Exercise of Investor Warrants by Investors, Issue of Shares and TVR

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 , has received notice of exercise of warrants by investors who participated in the Venn loan note financing in December 2018 over 1,349,349 ordinary shares of  0.1 pence each in the capital of the Company (“Ordinary Shares”) at a price of 0.1 pence per share for 477,703 Ordinary Shares and at a price of 2.2 pence per share for 871,646 Ordinary Shares. The gross proceeds of this exercise received by the Company amounts to £19,653.91.

Following this exercise the warrants issued in connection with the 2018 Venn loan note have been substantially exercised with 1,062,111 warrants outstanding. In addition, the 2018 Venn loan note has now been fully repaid, and as such, the current outstanding debt and loans owed by the Company is £319,000.

The total outstanding warrants over Ordinary Shares are as follows:

Number of Ordinary Shares

Exercise Price per share

Date awarded

Expiry Date

Beneficiary

166,666

30 pence

7 June 2011

6 June 2021

An advisor

376,008

0.1 pence

11 December 2018

10 December 2023

Venn loan note investors

686,083

2.2 pence

11 December 2018

10 December 2023

Venn loan note investors

1,607,142

5.6 pence

28 June 2019

27 June 2024

An advisor


The Company has made application for 1,349,349 new Ordinary Shares, to be issued and allotted as a result of the warrant exercise set out above, to be admitted to trading on AIM and Euronext Growth. Admission is expected to occur at 8.00 a.m. on 8 February 2021.

Total Voting Rights

Following the admission of 1,349,349 new Ordinary Shares, the Company’s total issued ordinary share capital will consist of 669,401,610 Ordinary Shares. This figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

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.

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 – 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.

Bidstats confirmation of hVIVO contract award as announced by Open Orphan #ORPH in October 2020

Bidstats, the website that displays HM Govt procurement notices, tenders and awards, and contract information is now displaying the £46m contract award to Open Orphan #ORPH subsidiary hVIVO.

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 – Expansion of volunteer recruitment centres for human challenge trials

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and the world leader in vaccine and antiviral testing using human challenge clinical trials, has opened two new volunteer recruitment centres to screen potential trial volunteers, the first in East London and a second in central Manchester. These new locations are part of the Company’s expansion of its human challenge study trials launching in 2021.

The first new site is a repurposed former coffee shop at the street level of Queen Mary BioEnterprise Innovation Centre (“QMB”), which houses hVIVO’s current 24-bedroom state-of-the-art quarantine clinic in Whitechapel, East London. This is the first time a branded volunteer recruitment centre  has been situated at street level whereby volunteers can walk straight in for screening. The large, multi-use space has the capacity to provide substantially more volunteer medical screening and processing with dedicated private physical exam and consenting rooms, ample hot-desking space and a refreshment area, as well as a dedicated reception area. Importantly, this means the facility can now offer 520 volunteer recruitment visit slots per week, with the intention that this will increase over time. This new centre has processed its first volunteers in recent weeks. Learn more about the screening process at www.flucamp.com/what-is-screening/.

The Company has opened another similar volunteer recruitment facility in central Manchester, broadening its reach and reducing travel time required by potential volunteers to attend the initial visit at our London clinic. It will have an initial capacity for more than 100 visits per week, but this will increase substantially in the weeks that follow. The clinic is due to process its first volunteers on 27 January.

Cathal Friel, Executive Chairman of Open Orphan plc commented: “We are delighted to have had the opportunity to get access to these new volunteer recruitment screening centres and to have them fully operational so quickly. The current pandemic has forced many businesses to close and we are able to provide another use for these spaces not currently in use. These spaces presented an opportunity for us to open street level volunteer recruitment centres quickly and efficiently. The number of volunteers required by hVIVO is increasing rapidly in line with the number of studies the company is running, and these two additional centres will allow us to increase our capacity substantially in the year ahead. Given our extensive pipeline of upcoming contracted studies, we are also continuing to explore additional quarantine facilities.  

We are proud of our hard working and dedicated team for transforming both of these sites in record time into volunteer recruitment screening centres where we can efficiently process more volunteers than ever before.”

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 – 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.

Daily Mail – The volunteers who are DELIBERATELY catching Covid: 2,500 Britons will take part in the world’s first ‘human challenge trials’ run by Imperial College next month in bid to accelerate research on pandemic

by Faith Ridler

The volunteers who are DELIBERATELY catching Covid: 2,500 Britons will take part in the world’s first ‘human challenge trials’ run by Imperial College next month in bid to accelerate research on pandemic

  • Alex Greer, 20, will take part in the human challenge trials in London next month 
  • Those in the study will receive a vaccine before being exposed to coronavirus 
  • Volunteers, aged 18 to 30, will be paid up to £4,000 for two-to-three week stay 

Around 2,500 Britons will deliberately be infected with coronavirus in the world’s first ‘human challenge trials’ which will begin next month in a bid to accelerate research on the pandemic.

Alex Greer, 20, is among those who have volunteered to take part in the research, which is due to begin at the Royal Free Hospital in London in January.

In the initial study, announced by the Government in October, around 90 volunteers under the age of 30 will receive a dose of an experimental nasal vaccine before being deliberately infected with Covid-19.

Professor Openshaw previously told BBC Radio 4’s Today programme the trials could give a ‘really firm idea’ of whether a vaccine will work and how it will work….

The Government has put £33.6million behind the challenge trials.

Imperial College London will sponsor the first part of the study, where volunteers are infected with Covid-19, before moving on to the second stage where vaccinated volunteers will be exposed to the virus.

The study is being designed by hVIVO, a subsidiary of Dublin-based pharmaceutical company Open Orphan, which today announced it had secured funding from the Government.

Link here to read the full Daily Mail article

Open Orphan #ORPH – Successful completion of PrEP Biopharm Toxicology study for respiratory ‘viral mimic’

Phase IIb study to validate efficacy of PrEP-001 against circulating respiratory viruses such as COVID-19, flu and the common cold

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 that drug development company PrEP Biopharm Limited (“PrEP Biopharm”), which is 62.6% owned by Open Orphan, has successfully completed a 12-week toxicology study for its novel pan-viral prophylactic asset, PrEP-001.

The animal model study provides safety data needed to move PrEP-001 into longer duration dosing in clinical studies. PrEP Biopharm intends to move forward with a real-world, field trial intended to validate the efficacy of its PrEP-001 against all circulating respiratory viruses, including COVID-19, influenza and the common cold.

PrEP-001 is neither a vaccine nor an antiviral. Rather, it is a synthetic RNA ‘viral mimic’ that stimulates the body’s pan-viral innate immune response locally in the upper respiratory tract. Administered via a once daily nasal spray it leverages the innate immune system to create an antiviral environment to stop invading respiratory viruses. As such, it is possible that PrEP-001 could be used as a stand-alone pan-viral prophylaxis or as an adjuvant for live and inactivated or peptide intranasal vaccines targeting specific respiratory viruses. Previous studies in animals have demonstrated that intranasal administration of poly IC shortly after vaccination with live attenuated, inactivated and haemagglutinin antigen preparations of influenza virus enhanced respiratory dendritic cell function, CD8 T cell formation, and production of neutralising antibodies.

When Open Orphan acquired hVIVO in January 2020, in addition to acquiring the world leader in the testing of vaccines and antivirals using human challenge studies, hVIVO also came with a number of non-core assets including a 62.6% stake in PrEP Biopharm. The previous hVIVO Board had used shareholders’ funds to invest in these non-core assets. The Open Orphan Board and management team are primarily focussed upon cementing its position as a unique CRO and is committed to directing all resources to further improving the quality of earnings in both Venn Life Sciences and hVIVO and with shareholder funds only being used to support the profitable CRO services business. In recent months, Open Orphan has made it clear that it intends to monetise these non-core assets, however, as part of monetising these non-core assets, Open Orphan does not intend to invest any of the Open Orphan shareholders’ funds but will continue to work with the PrEP Biopharm management team to secure other sources of funding outside of the Open Orphan group while maximising the potential of these non-core assets.

Cathal Friel, Executive Chairman of Open Orphan, said: “It is very encouraging to note PrEP Biopharm’s progress towards the ultimate goal of validating the effectiveness of their one dosage nasal spray for key respiratory viruses like COVID-19, flu and the common cold. This safety data allows them to move into Phase 2b field studies and we are very excited that PrEP-001 could play a meaningful role in the current COVID-19 pandemic and future potential pandemics caused by new respiratory viruses.”   

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 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 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.

I would like to receive Brand Communications updates and news...
Free Stock Updates & News
I agree to have my personal information transfered to MailChimp ( more information )
Join over 3.000 visitors who are receiving our newsletter and learn how to optimize your blog for search engines, find free traffic, and monetize your website.
We hate spam. Your email address will not be sold or shared with anyone else.