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Open Orphan #ORPH – Major year-on-year revenue growth and profitable H1 2021 performance following a year of turnaround and transition in 2020

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces its unaudited interim results for the six months ended 30 June 2021. These results show a continued pattern of profitability from Q4 2020 to a firmly profitable position delivering a positive EBITDA profit of £2.1 million compared to an EBITDA loss of £4.1 million in H1 2020. We look forward to achieving record revenues in 2021 in our first full year of EBITDA profitability with recent contract wins and exceptional pipeline growth fueling revenues into 2022.

In the past 12 months, the Company has received international recognition and media attention for its excellence in delivering human challenge studies as a partner in the world’s first COVID-19 human challenge characterisation study. The Company now has a broad range of human challenge study models, focusing on leveraging the major growth opportunities presenting in infectious and respiratory disease markets, including RSV, Influenza, Asthma, hRV, COPD and Malaria.

Profitable Financial Performance in H1 2021:

  • Continuing from a profitable Q4 2020, the Company has moved the business to a firmly profitable position with losses consigned to the past
    • 242% reported revenue growth in H1 2021 (£21.9m) versus H1 2020 (£6.4m). Other income grew to £1.2m in H1 2021 from £0.7m in H1 2020
    • EBITDA profit of £2.1m (2020: EBITDA loss of £4.1m)
    • Revenue has more than tripled reflecting six active challenge studies in H1 2021 vs two active challenge studies in H1 2020 and a solid performance in Early Clinical / Biometry Services
    • In H1 2021, non-COVID-19 related work accounted for 75% of revenues
    • Gross margin has grown from 6% to 28% of revenue, reflecting that the Company is driving substantial operating leverage through cross selling, restructuring, functional integration and operational productivity
  • Cash and cash equivalents were £14.9m at 30 June 2021, primarily reflecting the operating cashflow cycle of the business with new contract prepayments expected in H2 2021
  • The Company has executed a share capital re-organisation as an important enabler to progress the monetisation of non-core assets via distribution of dividend in specie. In June, it completed the first distribution in specie back to the shareholders worth £26.2m at 16 September 2021, in relation to the demerging of certain non-core assets into Poolbeg Pharma Limited (“Poolbeg Pharma”)

 

Open Orphan Plc Group

(Results as Reported)

   
Unaudited

6 months ended

30 June 2021

Unaudited

6 months ended

30 June 2020

     
Income Statement £’000 £’000
Revenue (incl. other income) 23,166 7,078
Gross Profit 6,041 390
Operating Profit (Loss) after exceptional items 1,629 (6,340)
EBITDA before exceptional items 2,073 (4,145)

Operational highlights

  • Delivered a strong and growing pipeline of new challenge study contract wins across a broadening range of challenge studies including influenza, RSV, hRV, Asthma, etc. Strong growth from Big Pharma clients which will deliver revenues across H2 2021 and into FY 2022
  • Continued to diversify services offering and associated activities such as virus manufacturing and lab services enabled by CAP and UKAS accreditations which are progressing, as well as the development of new challenge study models (Malaria, COVID-19) as part of its broadening portfolio of challenge models
  • Leveraged its state-of-the-art facilities, including the new 19-bedroom quarantine facility (Whitechapel Clinic) beside the existing 24-bedroom Queen Mary’s BioEnterprises Centre facilities also in Whitechapel (QMB). All COVID-19 characterisation study activities conducted in the 19-bedroom quarantine facility in Royal Free Hospital in London. We have delivered a record volume of quarantine studies on an increasingly cost-efficient basis with ample capacity to further grow the business
  • Increased volunteer recruitment capacity through the opening of a new volunteer screening centre in Manchester and also a new dedicated street level screening facility in QMB increasing screening capacity to 520 visits per week
  • Disease in Motion® launched as a first step towards its spin off as a standalone company, with the intention that the value will be delivered to our shareholders via dividend in specie in the same format as was successfully completed with Poolbeg Pharma plc. This unique data-focused platform has multiple infectious disease applications for a wide variety of end users including big tech, wearables, pharma and biotech companies

Post-period end

  • Multiple high value human challenge study contracts signed – £5.7m Influenza study (September 2021), £8.1m asthma study (August 2021), significant hRV & Influenza study (July 2021)
  • Successful Phase 2a RSV human challenge studies completed for a top tier pharma company and for Bavarian Nordic highlight the value of human challenge studies, their role in mainstream clinical trial design, and hVIVO’s industry leading position
  • Successfully monetised the first non-core asset via spin-out and AIM IPO of Poolbeg Pharma plc through a dividend in specie to Open Orphan shareholders, which was non-dilutive to existing shareholdings in the Company
    • As of 16 September 2021, the Open Orphan shareholders’ value in Poolbeg Pharma plc is £26.2
    • Poolbeg Pharma raised £25m in fresh funds from new investors in an IPO in July 2021
    • Created substantial value for Open Orphan shareholders who received these dividend shares in Poolbeg Pharma with no income tax due as part of a HMRC approved statutory demerger
  • Additional 1.3m shares in Open Orphan, valued at £350,000, purchased by Company Directors (Cathal Friel and Prof. Brendan Buckley)

Outlook

  • Post-pandemic, the infectious and respiratory disease market is seeing exponential growth, with an expected global market value of $250bn by 2025. This is resulting in a vastly increased market for Open Orphan to test a new range of infectious and respiratory disease products as the world leader in the provision of human challenge studies
  • The Company is experiencing a major increase in negotiations, contract wins, and repeat contract wins with Big Pharma, while also seeing increased wins from biotech companies with major deals expected to now sign in Q4 2021 driving revenue in 2022
  • Open Orphan is expanding its focus and service offering in providing infectious and respiratory disease challenge studies
  • Full year guidance of c. £40m revenue (incl. other income) with full year EBITDA profitability for FY 2021, with non-COVID-19 work expected to represent c. 70% of FY 2021 revenue mix. While 2021 will represent record revenues for the Company and a return to full year EBITDA profitability, it is somewhat behind analyst expectations as the anticipated COVID-19 challenge studies will now likely commence in 2022 on foot of the successfully completed quarantine phase of the Human Challenge Programme characterisation study
  • Year-end cash balances expected to close in line with the half year position of £14.9m
  • Targeting revenues in the region of £50m for 2022 in non-COVID-19 work, reflecting signed contracts and contracts in advanced negotiations, ongoing momentum in the core business and ongoing market growth. COVID-19 revenue for 2022 will be in addition to this and will depend on the eventual timing of these studies
  • The Company continues to work towards the monetisation of all remaining non-core assets and to hand these back to Open Orphan shareholders via dividend in specie allowing the Company to focus on its core offering
    • These spin-offs / demergers offer an excellent opportunity for shareholders to maximise value in separate shareholdings in both exciting pharma product commercialisation companies, in addition to a profitable and world leading CRO
    • Opportunity to complete spin-off of Disease in Motion® platform along with plans to monetise the other non-core assets, namely the Company’s 62.6% stake in PrEP Biopharm, and 49% stake in Imutex Limited

Cathal Friel, Executive Chairman of Open Orphan plc commented:

Open Orphan has delivered very strong progress both operationally and financially. The Company’s H1 2021 revenues grew by 242% versus H1 2020, which continues a pattern of profitability from Q4 2020 and transitions the business to a firmly profitable position, having delivered a positive EBITDA profit of £2.1 million in H1 2021. The business is now well positioned to capitalise on the significant growth in the infectious disease market, which is expected to grow to in excess of $250bn by 2025 and we have seen our business development pipeline grow accordingly.

“I am delighted and hugely satisfied with the fantastic turnaround and team effort by everyone in the Open Orphan organisation; they have completely transformed the business following the acquisition of both hVIVO and Venn in the past two years. These two companies are now fully integrated and, in the process, we have created the world leader in the testing of vaccines, antivirals and other infectious and respiratory disease products using human challenge studies. With a broadening portfolio of human challenge studies, we are well placed to continue working with Big Pharma and biotechs alike to move their products through the clinic as the infectious disease market experiences one of the largest pharmaceutical growth cycles ever, with the market expected to grow significantly by 2025.  We look forward to further progress and a profitable H2 as the business continues to attract additional clients.

“Additionally, we will look to provide further shareholder value through the monetisation of our non-core assets, as we did post-year end with the successful spin-out, listing and distribution in specie of Poolbeg Pharma plc.”

Analyst Briefing

An online briefing for Analysts will be hosted by Cathal Friel, Executive Chairman, and Leo Toole, Group Chief Financial Officer, at 9.30am (BST) on 20 September 2021 to review the results and prospects. Analysts wishing to attend should contact Walbrook PR on openorphan@walbrookpr.com or on 020 7933 8780.

Investor presentation

OPEN ORPHAN PLC is pleased to announce that Cathal Friel and Leo Toole will also provide a live presentation relating to H1 2021 Interim Results via the Investor Meet Company platform on 20 September 2021 at 6:00pm (BST).

The presentation is open to all existing and potential shareholders.

Investors can sign up to Investor Meet Company for free and add to meet OPEN ORPHAN PLC via:

https://www.investormeetcompany.com/open-orphan-plc/register-investor

Investors who already follow OPEN ORPHAN PLC on the Investor Meet Company platform will automatically be invited.

For further information please contact:

 

Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser and Joint Broker)    +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Louisa Waddell / Oscair McGrath
finnCap plc (Joint Broker) +44 (0) 20 7220 0500
Geoff Nash / James Thompson/ Richard Chambers
Davy (Euronext Growth Adviser and Joint Broker) +353 (0) 1 679 6363
Anthony Farrell
Walbrook PR (Financial PR & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus / Louis Ashe-Jepson / Sam Allen +44 (0)7980 541 893 / 07747 515 393 / 07502 558 258

 

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

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

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

LINK HERE FOR FULL FINANCIAL STATEMENTS

Open Orphan #ORPH – £5.7m Influenza human challenge study contract win

Open Orphan (AIM: ORPH), a rapidly growing specialist 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 plc, has signed a £5.7m contract with a specialist biotechnology company developing therapeutics for respiratory viral infections, to test its antiviral product using the hVIVO Influenza human challenge study model.

The human challenge study is expected to commence in Q1 2022 and will be conducted at hVIVO’s state-of-the-art facilities in London. The Company expects the revenue from the contract to be recognised across 2021 and 2022.

The client’s influenza antiviral product has demonstrated effectiveness in animal preclinical models of respiratory viruses and has several clinical and commercial advantages with respect to convenience, resistance, durability and compatibility when compared to similar products.

The Company expects to sign more contracts in this area as attention switches to potential future Influenza outbreaks. Influenza is expected to be a major global issue due to low level population immunity caused by reduced infection rates over the last 18 months, which is the result of COVID-19 mitigation measures such as social distancing and mask wearing. After a solidly EBITDA profitable H1, this contract will help ensure the Company enters a period of sustained growth and profitability across a whole range of challenge studies.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of Influenza, Respiratory Syncytial Virus (RSV) and human Rhinovirus HRV (common cold virus), malaria, asthma. In October 2020, this expanded to include the SARS-CoV-2 virus. 

Cathal Friel, Executive Chairman of Open Orphan, said: “We are delighted to be working with this biotechnology company to test their exciting antiviral product against our Influenza human challenge study model. As a result of social distancing, hand washing and other COVID-19 mitigation measures, there has been extremely low levels of population immunity to Influenza. As such, there is an increasing concern that in the year ahead Influenza outbreaks could spike considerably and therefore this type of therapeutic could form part of an effective defence against future outbreaks of Influenza due to its compelling array of clinical and commercial advantages.

“This contract is also a further demonstration of our expertise and capabilities testing therapeutics across the infectious disease and respiratory market, which is due to grow exponentially to over $250 billion by 2025, as pharmaceutical companies around the world look to restock the medicine cabinets with novel vaccines and antivirals. With this in mind, we expect that moving into 2022, our work will continue to come from a broad range of infectious and respiratory diseases, as we see rapid growth in those spaces. 

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

Interested in becoming a volunteer? 

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

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

 

For further information please contact:

 

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

 

Notes to Editors  

Open Orphan plc

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

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

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

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

Researchers Infect Volunteers With Coronavirus, Hoping to Conquer Covid-19 – Wall Street Journal

By Jenny Strasburg Sept. 4, 2021 530 am ET

LONDON—Much of the world spent the past year taking vaccines and wearing masks to evade Covid-19. In the U.K., almost four dozen volunteers have had the virus dripped into their noses by syringe in clinical experiments.

So-called human challenge studies—which intentionally expose healthy people to viruses and other pathogens to study illness, vaccines and treatments—aren’t new. Scientists globally have used them for decades to assess how infections and drugs behave from the moment they enter the body.

But only the U.K. has pushed ahead with Covid-19 challenge trials, deliberately infecting volunteers to study a new, sometimes-deadly disease that still harbors many unknowns.

On March 8, 23-year-old Jacob Hopkins, a U.K. university student, watched researchers enter his quarantine room’s airlocked entrance at London’s Royal Free Hospital. They wheeled a cart carrying a big red box, like a picnic cooler, labeled “biohazard.”

“It’s kind of like that scene from ‘Contagion’—well, any scene from ‘Contagion,’ really—all wearing hazmat suits [with] a little ventilator thing to the side,” he said. He lay on the bed with his head tilted back. A droplet of the coronavirus was inserted into his left nostril, then his right. He stayed there, his nose clipped closed for about another 20 minutes….

….

Planning started in April 2020, led by researchers from the University of Oxford and Imperial College London, officials from the government-appointed U.K. Vaccine Taskforce, and a small London-based biotech called hVivo Services Ltd. that specializes in contract drug testing….

Link here to read the full article

WSJ – Researchers Ready Lab-Grown Covid-19 Delta Variant for Human Trials

U.K. company is growing the highly contagious variant under tight lab controls for use in challenge studies

Scientists have coaxed the Delta strain to mature, said Andrew Catchpole, chief scientiic oficer of trial partner hVivo.

PHOTO: HVIVO SERVICES LIMITED

by Jenny Strasburg – Wall Street Journal

LONDON—While the rest of the world is trying to stamp out the Covid-19 Delta variant, British researchers are making progress growing a carefully controlled batch in a lab that they hope to use to infect volunteers in studies.

The effort marks a new phase in the U.K.’s human challenge trials, the only Covid-19 studies in the world intentionally exposing participants to the virus with the goal of developing new vaccines and treatments. Other researchers are also isolating and growing Covid variant specimens for study. U.S. government-funded scientists are producing variants for research, but not for use in humans, a National Institute of Allergy and Infectious Diseases official said.

Two Covid challenge trials sponsored by Imperial College London and the University of Oxford started earlier this year in the U.K. They so far have exposed more than 40 healthy, young volunteers under isolated medical supervision to the original Wuhan strain that circulated widely in 2020.

Since then, the highly transmissible Delta variant has come to dominate infections globally, rendering vaccines less effective and boosting case numbers across the U.K., U.S. and elsewhere. Delta’s fast rise led researchers and U.K. challenge-trial partner hVivo Services Ltd. to focus on trying to grow the variant in the lab.

Full article here

Open Orphan #ORPH – £8.1m Asthma Human Challenge Study Contract Win

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan plc, has signed an £8.1m contract with a major global pharmaceutical company to test its inhaled human rhinovirus (hRV) antiviral product using the hVIVO Asthma Human Challenge Study Model, which uses a hRV challenge agent (common cold virus).

Asthma is a long-term condition that is characterised by inflammation and narrowing of the small airways of the lungs, which causes coughing, shortness of breath and chest tightness. 5.4 million people in the UK currently receive treatment for asthma. Illnesses such as the common cold, which is most commonly caused by HRV, can worsen symptoms.    

This antiviral study will be conducted by hVIVO and is expected to commence in H1 2022. The Company expects the bulk of the revenue from this contract to be recognised across 2021 and 2022. This new contract further underlines the increased international focus and investment into respiratory and infectious diseases following the outbreak of COVID-19, in areas such as the common cold, Influenza, and many other areas which were previously underserved by the pharmaceutical industry.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious disease viruses, including various strains of influenza, RSV, HRV, Asthma and Malaria, etc.

Cathal Friel, Executive Chairman of Open Orphan, said: “We are pleased to sign this contract with this top five European pharmaceutical company to test its inhaled hRV antiviral product using our Asthma Human Challenge Study Model. This contract demonstrates how our broad range of challenge study models can support our clients’ varied infectious and respiratory disease product pipelines, and adds to our exciting pipeline of RSV, hRV, Influenza, Malaria, and Asthma challenge study contracts.

“The COVID-19 pandemic has highlighted that for the past 30 years there has been very little investment into the infectious disease and respiratory products space. As such, when the pandemic arrived the world discovered that the medicine cabinet of infectious disease products to deal with COVID-19 was virtually empty. Post-pandemic, most governments across the world, all of the Big Pharma companies and many of the smaller pharma companies are now investing hugely in new infectious and respiratory disease products and as such, this market is expected to grow from $20bn in 2019 to $250bn by 2025. This restocking of the pharmaceutical industries medicine cabinet of infectious disease products around the world is now leading to an enormous expansion of investment into the infectious disease and respiratory product market and will be seen as one of the biggest growth opportunities in the history of the pharmaceutical industry.

“Having recently launched our Malaria Human Challenge Study Model, adding to our world leading portfolio of challenge study models, Open Orphan is now ideally situated to be one of the few companies in the world that can quickly and efficiently test a broad range of these new infectious and respiratory disease products in our human challenge clinical trial studies. Open Orphan is well placed to work with Big Pharma and biotechs alike to move their products through the clinic as human challenge becomes a part of mainstream clinical trial design.”

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

Interested in becoming a volunteer?

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

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

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

   +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell / Oscair McGrath

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

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

Paul McManus/ Sam Allen/ Louis Ashe-Jepson

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

 

Notes to Editors

Open Orphan plc (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 with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of other models including the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme. 

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 – Development of Controlled Human Malaria Infection Human Challenge Study

Open Orphan plc (AIM: ORPH), a rapidly growing specialist clinical research organisation (CRO) and world leader in testing vaccines and antivirals using human challenge clinical trials, announces that its subsidiary, hVIVO, has developed a Controlled Human Malaria Infection (“CHMI”) challenge model, both strengthening and further diversifying the Company’s world leading portfolio of viral challenge study models. The Malaria challenge model will assist in the advancement of antimalarial drug and vaccine candidates from November 2021. Results from CHMI modelling of drug and vaccine efficacy have previously shown good translation into the field.

Malaria is a serious and life-threatening disease prevalent across much of tropical and sub-tropical Asia, South America and Sub-Saharan Africa. Due to increasing resistance to current antimalarial regimens, new drugs are required as both stand-alone and partner therapies to address a growing unmet medical need. In addition, novel combinations of existing drugs may be required to fill the gap until pipeline candidates can be safely progressed to market. New drugs and combination therapies are required to not only reduce mortality and morbidity in susceptible, primarily paediatric populations, but also to help the move towards a greater goal of malaria elimination.

hVIVO has secured access to a unique, GMP-manufactured P. falciparum sporozoite challenge agent (“PfSPZ Challenge”) for use in its malaria challenge studies. PfSPZ Challenge has been used in multiple clinical trials in the United Kingdom, United States, Europe, Indonesia and Africa. As of June 2021, 1,204 volunteers have received 2,011 doses of PfSPZ Challenge (NF54) with no unresolved serious adverse event, sequelae, or deaths to date. Controlled Human Malaria Infection by Direct Venous Inoculation has largely replaced the traditional method of CHMI (mosquito bite), owing to its superior predictability and safety profile. Reported symptoms are mostly mild to moderate and include headache, fever, nausea and fatigue.

Cathal Friel, Executive Chairman of Open Orphan, said: “Malaria is a disease of huge unmet need around the world, with 229 million cases and 409,000 deaths caused in 2019. Its prevention and cure is a designated World Health Organization target. We are pleased to have formally announced today the latest addition to our portfolio of human challenge models namely the Malaria Human Challenge Study Model. The safety profile of PfSPZ is impressive, and we are optimistic that it will enable us to assist in the advancement of antimalarial drug and vaccine candidates from November. This also adds a new challenge model to our already world leading portfolio of viral challenge study models and continues to build on our global infectious disease expertise.”

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.

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 / Louisa Waddell / Oscair McGrath

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

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

Paul McManus / Louis Ashe-Jepson / Sam Allen

+44 (0)7980 541 893 / 07747 515 393 / 07502 558 258  

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 with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of other models including the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme.

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 – Pfizer successful Phase 2a human challenge trial

Rapid progress at Open Orphan #ORPH. In Pfizer’s recent quarterly update, CEO Albert Bourla, noted (on page 5) that one of the key highlights of Pfizer’s Q2 was the “Successful Phase 2a human challenge trial with RSV Adult vaccine candidate”.

Although Pfizer have not mentioned Open Orphan by name and we have not formally announced our involvement, hVIVO is listed as the sponsor to the study here and with hVIVO contact details noted on the Pfizer website here:

Open Orphan #ORPH – World’s first Covid-19 human challenge study to expand

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 plc, is continuing to work with the UK Government to inoculate up to 20 further volunteers as part of the world’s first COVID-19 characterisation study.

As part of the characterisation study, researchers aimed to identify a dose of COVID-19 that causes a safe and reliable infection in unvaccinated COVID-19 naïve volunteers. The UK Government has decided to expand the Human Challenge Programme to answer further questions that can help in the fight against COVID-19.

The study expansion will commence as soon as appropriate regulatory approvals and clinical preparations are complete. The study is funded by the UK Government who have commissioned Imperial College London to act as the clinical study sponsor. The study is conducted by hVIVO at the Royal Free Hospital, under the supervision of our 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 data from this study is already providing valuable insight into the biology of the virus which causes COVID-19. This knowledge will improve the ability to manage the virus and deliver a range of treatment options in the future.

The revenue from the contract is expected to be recognised in the current financial year.

Cathal Friel, Executive Chairman of Open Orphan, said: “At Open Orphan we are committed to helping the UK Government in partnership with two great institutions, Imperial College London and the Royal Free Hospital, to discover effective treatments for COVID-19. This study expansion further illustrates the effectiveness and importance of this study.”  

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “We are delighted to announce this study expansion with the UK Government. This will enable 20 furthervolunteers to participate in this next phase of the world’s first study of its kind which will help scientists better understand and treat COVID-19.   

“Open Orphan, through its subsidiary hVIVO, is proud to be working with the UK Government’s Human Challenge Programme in this initiative to help control and minimise the spread of the virus and we will look to provide updates on the study with further announcements in due course.”

Caroline Clarke, Royal Free London group chief executive, said: “We are excited to enter this next phase of this study with our partners from hVIVO, Imperial College London and the government’s Vaccine Taskforce. Ultimately, we hope this research will give us more information about vaccines, as well as its impact on infection rates, and enable us to provide better treatments in the future for patients with COVID-19.”

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

Interested in becoming a volunteer? 

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

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

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

   +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

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

Paul McManus/ Sam Allen/ Louis Ashe-Jepson

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

 

Notes to Editors

Open Orphan plc

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

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, 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 – Significant HRV & Influenza human challenge study contract win

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 plc, has signed a significant contract with AIM ImmunoTech Inc (“AIM IT”) to test its antiviral candidate, Ampligen, using both the human Rhinovirus HRV (common cold virus) and Influenza human challenge study models as part of a single study.

This antiviral study will be conducted by hVIVO. AIM IT will be the study sponsor of the Phase 2 human challenge trial, which is expected to commence in Q4 2021. The Company expects the majority of revenue from the contract to be recognised in the current financial year. The AIM IT contract demonstrates the breadth of Open Orphan’s service offering and its ability to test multiple pathogens at once in its state-of-the-art zoned unit, reinforcing its status as the world leader in its field. The Company expects to sign more contracts in this area due to the increased international focus on respiratory and infectious diseases following the outbreak of COVID-19 and as attention turns to potential future outbreaks of other viral diseases.  

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of Influenza, Respiratory Syncytial Virus (RSV) and human Rhinovirus HRV (common cold virus). In October 2020, this expanded to include the SARS-CoV-2 virus.

Cathal Friel, Executive Chairman of Open Orphan, said: “We are delighted to commence work with AIM ImmunoTech, a leading immuno-pharma company, to test their product against both HRV and Influenza human challenge study models as part of a single study. Being able to test our client’s product against multiple pathogens in a single study demonstrates our capability of our state-of-the-art London unit, our industry leading experience, and our position as the go to provider of human challenge studies for biotech and pharmaceutical companies globally. Fortunately, with our access to three challenge study clinics in London, we were able to find a small gap in our schedule later this year to slot this particular study in at short notice.

“Likewise, as previously confirmed to the market, our London facilities are comprehensively prebooked throughout this year and into next year. As such, I am also delighted to confirm that we were solidly EBITDA profitable in H1 2021 and we remain on target for a profitable and successful 2021.”

Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech Inc., said: “It is our belief that Ampligen’s mechanism of action regarding the human innate immune system gives Ampligen broad-spectrum capabilities as an antiviral prophylaxis and therapeutic. The ability to do a human challenge trial using HRV and Influenza allows us to test in humans Ampligen’s potential role as a powerful prophylaxis and therapeutic for a wide range of respiratory viruses. It is our belief that if it works in these two viruses, then it will have the potential to have a similar impact in other respiratory viruses.”

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

Interested in becoming a volunteer?

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

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

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

   +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

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

Paul McManus/ Sam Allen/ Louis Ashe-Jepson

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

 

Notes to Editors  

Open Orphan plc

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

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, 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.

AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

Open Orphan #ORPH – 2020 Annual Report and 2021 AGM Notice

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces that the following documents have been sent to shareholders: 

·      Annual Report and Accounts for the year ended 31 December 2020 (“2020 Annual Report”)

·      Notice of Annual General Meeting (“AGM”) 2021 and voting proxy form

In accordance with AIM Rule 26, these documents are also available to view on the Company’s website:

https://www.openorphan.com/investors/reports-and-presentations/year/2021.

The 2020 Annual Report, and the Notice of AGM, which includes details of voting by proxy, have been posted to shareholders who have not consented to receive electronic communications. 

The AGM is scheduled to be held at 12 noon BST on 21 July 2021 at the offices of Arden Partners plc, 125 Old Broad St, London EC2N 1AR, and will consider the resolutions set out in the Notice of AGM.

In light of the UK Government’s response to the ongoing COVID-19 outbreak, the Company and the Executive Chairman have determined that the Resolutions to be proposed at the AGM shall be voted on through a poll rather than on a show of hands; and, accordingly, shareholders are strongly encouraged to either submit their Form of Proxy or use the CREST Proxy Voting Service, rather than attend the meeting in person.  

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

www.openorphan.com

Cathal Friel, Executive Chairman

+353 (0) 1 644 0007 

Arden Partners plc (Nominated Adviser and Joint Broker)

   +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

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

Paul McManus / Sam Allen /

Lianne Cawthorne

+44 (0)7980 541 893 / +44 (0)7748 651 727 /

+44 (0)7584 391 303

 

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.

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