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Open Orphan #ORPH – Quotient Limited & hVIVO Partnership to Support Wide-Spread COVID-19 Antibody Testing in the UK

Open Orphan plc (ORPH) the rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is the world leader in the testing of vaccines and antivirals using human challenge study models, is pleased to announce that Quotient has entered into an exclusive contract with hVIVO to support COVID-19 antibody testing in the UK.

The MosaiQ™ by Quotient system and MosaiQ COVID-19 Antibody Microarray will be used by hVIVO to screen for SARS-CoV-2 antibodies (COVID-19). The MosaiQ COVID-19 Antibody Microarray was CE marked (certified to meet EU requirements) as of 01 May 2020 based on testing that demonstrated 100% sensitivity (ability to detect COVID-19 antibodies) and 99.8% specificity (ability to rule out the presence of COVID-19 antibodies). The test is designed as a serological disease screen specific to COVID-19. It detects the IgG and IgM antibodies that humans develop when infected by SARS-CoV-2.

Quotient is a Nasdaq listed, commercial-stage diagnostics company delivering diagnostic solutions. MosaiQ is Quotient’s proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities.

Cathal Friel, Executive Chairman of Open Orphan, said:

“We are delighted to exclusively partner with Quotient Limited to bring fast and accurate COVID-19 antibody testing to the UK. Open Orphan plc, via our subsidiary hVIVO, has industry leading scientific and laboratory capability and the MosaiQ™ system’s best in class COVID-19 antibody testing performance makes the system a natural addition to our state-of-the-art virology laboratory in London. There is a clear demand for COVID-19 antibody testing and we will be making testing available both as a standalone offering and will also utilize the testing capability to screen volunteers for our industry leading range of human challenge studies to ensure no disruption to our clients.”

Franz Walt, Chief Executive Officer of Quotient, said:

“This collaboration marks a major milestone for our company, and we are proud to collaborate with an industry leader like hVIVO. Quotient has developed what we believe is a gold standard antibody microarray to help combat the COVID-19 pandemic. This collaboration is uniquely positioned to leverage our combined expertise, and helps address the large need for antibody testing in the U.K. and beyond.” said Franz Walt, Chief Executive Officer of Quotient.”

Separately, Open Orphan plc (AIM: ORPH) announces the appointment of finnCap Ltd as its joint broker with immediate effect.

ENDS

For further information please contact

Open Orphan plc

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 / Benjamin Cryer

finnCap Ltd (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

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Notes to Editors – Open Orphan:

Open Orphan is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London. hVIVO supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of Covid-19 in 2020. The Company also 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 Coronavirus challenge study model and expects to be very active with many companies in the development of a Covid-19 vaccine. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. 

Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) 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.

Notes to Editors – Quotient Limited:

Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial-stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced. MosaiQ, Quotient’s proprietary multiplex microarray technology, offers the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ is designed to be a game-changing solution, which Quotient believes will increase efficiencies, improve clinical practice, deliver significant workflow improvements, and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania.

The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.

Open Orphan Chairman Cathal Friel speaks to BRR Media re the new contract, other developments and the CEO’s departure

Open Orphan PLC’s (LON:ORPH) Cathal Friel speaks to Rosie Riall at BRR Media after signing a new deal with a US biotech for the provision of a respiratory syncytial virus human challenge study. Cathal also covers the channel pipeline, the hVIVO quarantine centre, flu and malaria vaccines and the planned departure of CEO Trevor Phillips.

Open Orphan #ORPH & Cadence Minerals #KDNC on the Vox Markets podcast

  

Cathal Friel, Executive Chairman of Open Orphan (ORPH) talks about the major new contract they’ve signed with a US biotechnology company.

Kiran Morzaria CEO of Cadence Minerals (KDNC) provides an update on operations at their Amapá project. Interview starts at 24 minutes 40 seconds.

Link here to listen

Open Orphan #ORPH Exec Chairman Cathal Friel speaks to Proactive’s Andrew Scott about the new US biotech deal

Open Orphan PLC’s (LON:ORPH) Cathal Friel speaks to Proactive London’s Andrew Scott after signing a new deal with a US biotech for the provision of a respiratory syncytial virus human challenge study.

Open Orphan #ORPH – Major New Contract Signed With US Biotech Company for RSV Human Study & CEO Trevor Phillips to Step Down.

Open Orphan plc (ORPH) the rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is the world leader in the testing of vaccines and antivirals using human challenge study models, is pleased to announce the signing of a new contract with a US biotechnology Company for the provision of a respiratory syncytial virus (RSV) human challenge study.

Highlights:

  • Challenge study projected to deliver £3.5 million in revenue in 2020
  • Utilising complementary in-house Clinical Research Organisation (“CRO”) services of hVIVO and Venn Life Sciences (“Venn”) following completion of merger with hVIVO
  • Trevor Phillips to stand down as CEO. Strong management team in place with Cathal Friel, continuing as Executive Chairman and running the business alongside a leadership team focused on delivering growth at a very exciting time for the Company

Major New Contract with US Biotechnology Company

The company has signed a contract with a US Biotech company for the provision of an RSV human challenge study with work to deliver the study expected to commence shortly. The contract is projected to deliver £3.5 million in revenue all of which is expected to be recognised in 2020. The signing of this new contract follows the signing in March of this year of another RSV human challenge contract, now underway, for an initial £3.2 million.

This contract represents continued conversion of Open Orphan’s substantial pipeline, generation of significant cash flow and further validates its position as world leader in the provision of viral challenge studies, vaccine and viral laboratory services, supporting product development for customers developing antivirals, vaccines and respiratory therapeutics. These services are particularly relevant and topical in environment of heightened awareness of virology following the onset of Covid-19.

This study will commence in hVIVO’s unique London-based quarantine unit in the third quarter of 2020, which is Europe’s only commercial 24-bed quarantine clinic with on-site virology laboratory. hVIVO is the only company globally with the capability to run an RSV human challenge study.

This agreement utilises what is now a broader and complementary in-house service offering. All aspects of the study will be conducted within Open Orphan, with data management, biostats and medical writing being provided by our Venn Life Sciences colleagues leading to the elimination of sub-contractor costs and retention of more contracted revenue. We look forward to delivering the work for this US Biotech Company and further developing our relationship.

Directorate Change

Trevor Phillips is standing down as CEO and, to ensure an orderly transition, he will remain in his role until the end of June but leaves the Board with immediate effect. Trevor was brought into hVIVO in 2017 at a critical time for the business and successfully completed the restructuring and repositioning the business and its strategy. Recently, Trevor led the hVIVO team during its successful completion of the merger with Open Orphan plc, expanding the specialist CRO provision and positioning the Company for profitability.

Cathal Friel, Executive Chairman, will continue to lead the Company alongside a refreshed, focused management team and Board. The Company has also recently formed an advisory board chaired by Professor John Oxford, Professor at Queen Mary’s University London and one of the world’s leading experts on global diseases such as influenza, including bird flu, SARS, MERS and Coronavirus,  to help support customers’ product development and the Company’s response to Covid-19.

Cathal Friel, Executive Chairman of Open Orphan, said:

“Firstly, I would like to thank Trevor for his help merging Open Orphan and hVIVO. Trevor had previously successfully right sized and focused hVIVO and our refreshed management team is now focused on delivering growth at a very exciting time for the Company.

“The signing of this new £3.5 million contract with a US Biotechnology Company is further evidence of this exciting time as we successfully convert Open Orphan’s pipeline of prospects into formal customer contracts. Open Orphan will be utilising its complementary in-house CRO services of hVIVO and Venn to deliver this contract. This contract demonstrates the Open Orphan and hVivo group’s focus on building long term contracts with recurring revenues to deliver future profitability while ensuring rationalising the business and reduce costs.”

Trevor Phillips, CEO of Open Orphan, said:

“This is an exciting time for Open Orphan, I wish the company well. It was an honour to have led hVIVO and its staff through the business turnaround and with the merger completed I leave the Company in a stronger position as it enters its next phase of growth.”

ENDS

For further information please contact

Open Orphan plc

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 / Benjamin Cryer

 

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 is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London. hVIVO supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of Covid-19 in 2020. The Company also 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 Coronavirus challenge study model and expects to be very active with many companies in the development of a Covid-19 vaccine. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. 

Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) 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.

Irish Independent – Open Orphan subsidiary starts testing drug for treating Covid-19

by Ellie Donnelly

A subsidiary of Open Orphan has started testing a drug that could potentially treat Covid-19.

Open Orphan is a Europe- focused pharma services company specialising in rare disease and so-called orphan drugs.

The tests are being carried out by its London-based subsidiary Hvivo on behalf of its client Nearmedic International.

The drug being tested has both potential anti-viral and anti-inflammatory activity, and therefore could reduce both virus infectivity and disease severity respectively, a statement from Open Orphan said.

Hvivo will be testing its utility against a panel of viruses that include influenza virus, “normal”, circulating betacoronavirus and ultimately SARS-CoV2 (Covid-19).

Cathal Friel, chairman of Open Orphan, said: “We are very happy to be assisting in the battle against Covid-19 and are delighted to be working with Nearmedic International.”

“Hvivo is a world leading provider of services to global vaccine and antiviral development companies and our scientists have considerable knowledge from previous anti-viral trials which gives us confidence in our testing,” he added

Link here for original article

Irish Times – Open Orphan to test Covid-19 drug through London subsidiary

Pharma company steps up fight against virus that has infected more than 2.6m worldwide

by Ciara O’Brien

Photograph: iStock

Dublin-listed pharma services company Open Orphan has begun testing an anti-viral treatment for Covid-19 through its London-based subsidiary Hvivo.

The testing is being carried out on behalf of Nearmedic International, a specialist pharmaceutical, biotechnological and medical company headquartered in Moscow.

The drug being tested is potentially anti-viral and anti-inflammatory, and could reduce both virus infectivity and disease severity. It will be tested against a panel of viruses including the influenza virus, circulating betacoronavirus and Covid-19.

“Hvivo is a world leading provider of services to global vaccine and antiviral development companiesand our scientists have considerable knowledge from previous anti-viral trials which gives us confidence in our testing,” said Cathal Friel, executive chairman of Open Orphan.

Open Orphan agreed to merge with UK-based Hvivo last year in a £30 million tie-up that classified as a reverse takeover. Hvivo is a clinical trial business that can accelerate drug and vaccine development.

The company previously said it would restart a project whereby humans will be deliberately infected with a coronavirus as part of efforts to develop a vaccine to Covid-19.The project was originally suspended by Hvivo after concerns there was insufficient market demand for the product.

 Read the original Irish Times article here

Open Orphan #ORPH – Testing of anti-viral for treating COVID-19 underway

Open Orphan plc (ORPH) the rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services, is pleased to announce that its London-based subsidiary hVIVO has commenced the testing of an anti-viral for treating COVID-19 on behalf of its client Nearmedic International Ltd.

hVIVO has initiated work on this contract with Nearmedic International Ltd, a specialist pharmaceutical, biotechnological and medical business headquartered in Moscow, to test using hVIVO’s virology expertise and laboratory capability an anti-viral drug with potential utility for treating SARS-CoV2 (COVID-19) infections. This drug has both potential anti-viral and anti-inflammatory activity and as such could reduce both virus infectivity and disease severity respectively.

hVIVO will be testing its utility against a panel of viruses to include influenza virus, “normal”, circulating betacoronavirus and ultimately SARS-CoV2 (COVID-19).

Cathal Friel, Executive Chairman of Open Orphan, commented:

“We are very happy to be assisting in the battle against Covid-19 and are delighted to be working with Nearmedic International Ltd. hVIVO is a world leading provider of services to global vaccine and antiviral development companiesand our scientists have considerable knowledge from previous anti-viral trials which gives us confidence in our testing. We look forward to updating the market on a regular basis in the weeks and months ahead.”

  For further information please contact:

 

Open Orphan plc

Cathal Friel, Executive Chairman

+353 (0)1 644 0007

Trevor Phillips, Chief Executive Officer

+44 (0)20 7347 5350

Arden Partners plc (Nominated Adviser and Joint Broker)

+44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer

 

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

 

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Daniel Sherwen

 

Notes to Editors:

Open Orphan  is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services  and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London. hVIVO supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of Covid-19 in 2020. The Company also 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 Coronavirus challenge study model and expects to be very active with many companies in the development of a Covid-19 vaccine.  No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.  

Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) 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 (c hemistry, 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: Flu vaccine data showcased in peer reviewed article – Proactive Investors

by Ian Lyall. 

FLU-v has been developed by Imutex, 49%-owned by Open Orphan unit hVIVO

The results of a successful phase IIb trial of a potential flu vaccine being developed by an Open Orphan PLC  (LON:ORPH) joint-venture have been written up in a peer-reviewed article carried by a scientific journal.

The data from FLU-v 004 challenge study underlined its ability to reduce mild-to-moderate symptoms of the illness.

FLU-v has been developed by Imutex, 49%-owned by Open Orphan unit hVIVO, as the first ‘universal’, broad-spectrum influenza vaccine.

The publication of the results in the periodical ‘npj Vaccines’ follows hard on the heels of results from a separate field assessment of the drug, which revealed “cellular and humoral immunogenicity” from a single dose of adjuvanted FLU-v.

In other words, the jab immediately provoked an immune response.

Imutex, meanwhile, is scheduling meetings with regulators on both sides of the Atlantic ahead of further trials.

“Progression to larger phase III studies with FLU-v can further describe the cellular immune response and evaluate how the vaccine interacts with influenza disease,” said Open Orphan chief executive Trevor Phillips.

Chairman Cathal Friel added: “The need for better, more broadly protective vaccines against influenza is a high priority worldwide, and few new vaccines have demonstrated efficacy in humans as seen in the results of the challenge study for FLU-v 004. 

“This is the first universal influenza vaccine that has shown this protection from influenza and reduction of symptoms in late-stage studies and together with the highly statistical immune results reported in a peer review article earlier this week means that the risk of failure in a phase III setting is greatly reduced compared with entering into phase III studies with no efficacy data.”

Link here to view the original Proactive article

A view from the hVivo / Open Orphan #ORPH Laboratory – Professor John Oxford

With Marie’s help and encouragement from the scientific group and Cathal Friel, I am re starting “My View” Series which will be as before, a mixture of Science and with a personal view. Marie is very important, not least since she can read my writing after a 5-year absence. I am pleased to be back. I am Chairing the Scientific Advisory Group (SAG), and I am of drawing up a list of the good and famous! We (SAG) will meet once per year.

Actually during today so far there are two initiatives which pleased me. Firstly, I can see the initiative in the 2000 bed Nightingale Hospital in East London. In the Great Pandemic of 1918, which killed 250,000 young people in the UK a Prize possession was not a doctor but a nurse. Quiet nursing saved many lives at home where otherwise most people died. There were more beds in 1919 than today around 180,000 but most were occupied by wounded soldiers. There were no antibiotics, but oxygen and masks were used for intensive patients. On my next round Robin, I will discuss antivirals/vaccines.

In 1918 a group of pathologists began to make a vaccine against the microbe pneumococcus which caused half the deaths by super infection, but the war ended suddenly, and the work stopped. There were plans for civilian versions, which did work but these were never used on a large scale. After the second wave in 1919 everyone began to forget Spanish Influenza and the interest was not restarted until 1933. That year a group of scientists at St Bart’s Hospital isolated a true influenza virus. By 1948 workers in the Soviet Union and the USA made killed vaccines which more or less we have today! The Russians and Americans also started to work with live influenza vaccines which we have today.

But a second piece of good news is that the Chinese are lifting their social distancing and the country is slowly getting back to normal. At the same time, an Australian Mathematical model paper is published which clearly predicts that compliance with “social distancing” must be 80 or 90% otherwise it will not work. My friend Peter Doherty in Australia has reminded everyone that the positive effects of this intervention similar to which we are trying to do here) will take 2 weeks to filter through to fewer deaths etc, so do not expect instant results! Incidentally Peter has ‘form’ because of his Nobel Prize! There must be 80-90% compliance.

More young people are showing serious clinical problems during infections particularly if diabetic and overweight. So, the problems are not confined to the grandparents who seem to be behaving themselves at least as regards social distancing! Incidentally we now have 10 grandchildren including Juliette’s latest a couple of weeks ago. Some of you may remember that Juliette worked for a while with Anthony and the medical team at the hotel quarantine in East London probably 10 years ago.

Personally, I would say the best advice is to spend less time watching TV news which is sensational and not very good. Personally, I view this Covid outbreak as akin to a bad winter influenza epidemic. In this case we have had 8000 deaths this last year in the ‘at risk’ groups viz over 65% people with heart disease etc. I do not feel this current Covid will exceed this number. We are suffering from a media epidemic!

Finally, I am pleased that hVivo/Open Orphan is out there looking for good contracts with COVID, RSV and Influenza. In the long term all 3 viruses are important and the quarantine and laboratory expertise is key to the future. COVID will probably settle down or as a yearly disease like flu.

All regards from my sunny North London garden and Science museum on the top floor!

Professor John Oxford

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