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Open Orphan #ORPH – Journal for Clinical Studies article publication

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 an article has been written and published in the Journal for Clinical Studies (“JCS”). The article, entitled “Hot Topics – Vaccine Solutions for Tropical Diseases” is written by Adrian Wildfire, Director of Scientific and Business Strategy and Bruno Speder, VP of Regulatory Affairs and Consultancy Services at hVIVO, a subsidiary of Open Orphan plc.

The article explores the issue of vaccine development for tropical diseases for low and middle income countries and the barriers to effective treatments. In the article, hVIVO discuss how challenge study models can be used in the development of vaccines for tropical diseases. They further discuss the importance of Chemistry, Manufacturing & Control (CMC) development in relation to storage conditions, stress tests for tropical regions and the importance of non-clinical development.

The full article can be found here https://hvivo.com/hot-topics-vaccine-solutions-for-tropical-diseases/

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  (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 – 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 – Option to Acquire CHIMagents Limited

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 it has signed an option to acquire (the “Option”) CHIMagents Limited (“CHIMagents”) for a nominal sum.

CHIMagents was recently established to assist in the design, manufacture and testing of challenge agents for use in challenge studies. CHIMagents was established by an experienced team and have made great progress across a number of workstreams which will be highly valuable as part of the broader Open Orphan Group. CHIMagent’s Adrian Wildfire has over 20 years of industry experience and will join hVIVO as Director, Scientific and Business Strategy.

Under the terms of the Option, Open Orphan will have three months to exercise its option to acquire CHIMagents. Upon execution, CHIMagents will be a standalone company within Open Orphan.

CHIMagents will support hVIVO with the design, manufacture and testing of both new challenge agents and hVIVO’s industry leading portfolio of 8 existing challenge study agents. CHIMagents will also support hVIVO’s growing pipeline of challenge study clinical trials and help in accelerating the development of hVIVO’s Covid-19 challenge study clinical trials.

hVIVO’s pipeline of challenge studies is expected to grow further given the increasing importance and focus on developing vaccines and anti-virals globally. Therefore, the Option is an important strategic step for Open Orphan as it brings additional, experienced resources to the Group and will ensure that Open Orphan can meet the increased demand for its services as the world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials.

Cathal Friel, Executive Chairman of Open Orphan, said:

“We look forward to working with Adrian Wildfire and the CHIMagents team going forward and this Option is an important strategic step for the business as we rapidly grow our pipeline of challenge studies. The work CHIMagents is undertaking in relation to COVID-19 challenge agents also complements our own work and we look forward to updating all shareholders on that workstream in due course. We have real momentum across the Group and this Option further cements our position as one of the leading service providers to the developers of vaccines and anti-virals globally.”

 

For further information please contact

Open Orphan plc

+353 (0)1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

+44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

 

Notes to Editors – Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. Which 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.    In June 2020  hVIVO COVID Clear Test  was launched, the most accurate antibody test available to UK employers, helping them to get their people back to work.

Open Orphan comprises of two commercial specialist CRO services businesses ( hVIVO  and  Venn ) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn, as an integrated drug development consultancy, offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.

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