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Open Orphan #ORPH – First volunteer dosed in intranasal COVID-19 vaccine clinical trial
Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces that the first volunteer has been dosed with the Codagenix Inc. (“Codagenix”) needle free, intranasal COVID-19 vaccine, COVI-VAC. Conducted by hVIVO, part of Open Orphan plc, the Phase I clinical trial of COVI-VAC is being carried out at their facility in the UK. COVI-VAC is a single-dose, intranasal, live attenuated (the entire virus in a weakened form) vaccine against SARS-CoV-2, the virus that causes COVID-19.
Further to the Company’s announcement on 28 July 2020, hVIVO is working in collaboration with US biotech Codagenix to conduct a Phase I study of COVI-VAC. This is a randomised, double-blinded, placebo-controlled dose-escalation study, and will evaluate the safety and tolerability of the single-dose intranasal vaccine candidate in 48 healthy young adult volunteers at hVIVO’s state-of-the-art Quarantine Facility in Whitechapel, London.
The study will also evaluate the vaccine’s ability to provoke an immune response – measuring neutralising antibodies, mucosal immunity in the airway and cellular immunity. COVI-VAC has the potential to address several key logistical challenges to immunisation against SARS-CoV-2 at a global scale. As a single-dose, intranasally-delivered vaccine, COVI-VAC will not require a needle and syringe to be administered, nor ultra-low temperature freezers for storage. COVI-VAC can be manufactured on a large scale and supports ease of administration in a mass vaccination campaign. Codagenix expects to report initial data from the study by mid-2021.
Cathal Friel, Executive Chairman, Open Orphan, commented: “We are delighted to have been chosen by the New York based Codagenix to run this very important COVID-19 vaccine study in our quarantine clinic in London. This vaccine is one of the first of the next generation COVID-19 vaccines, it is a single dose, needle free, intranasal, live attenuated COVID-19 virus vaccine. Thus, in our opinion, because it is a live attenuated virus vaccine, COVI-VAC has the potential to give much longer-lasting cellular immunity against COVID-19 than many of the first-generation vaccines.
“Codagenix sought an inpatient facility for the first in human evaluation of COVI-VAC to allow for thorough evaluation of product safety and real-time volunteer monitoring, and our unique state-of-the-art quarantine facility in East London is one of the few facilities in the world suitable to conduct this trial safely and successfully. hVIVO are providing a full-service trial as part of this contract with Codagenix and the team at FluCamp have been responsible for all aspects of trial recruitment for this study through www.FluCamp.com .
“hVIVO is world-recognised for its expertise in evaluation of live viruses in human volunteers and we look forward to a positive outcome.”
Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said: “Dosing of the first patients in the Phase 1 clinical trial of COVI-VAC, our single-dose, intranasal, live attenuated vaccine against COVID-19, is an important milestone for Codagenix and the hVIVO team. As a live attenuated vaccine, COVI-VAC has the potential to provide a broader immune response in comparison to other COVID-19 vaccines that target only a portion of the virus, which could prove critical as new variants of SARS-CoV-2 have begun to emerge. Additionally, we believe COVI-VAC can address potential gaps in supplying the global immunization effort against COVID-19, especially in developing countries .”
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com . hVIVO welcomes volunteers to take part in our clinical trials under expertly supervised conditions, to further medical research, and help us to take the understanding of respiratory illnesses to a new level. Volunteers are central to the work that we do; our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.
Further details on all aspects of our volunteer programs including testimonials from previous volunteers can be found at www.flucamp.com .
If you are interested in being contacted and provided with details about future COVID-19 human challenge study research, please leave your contact details at www.UKCovidChallenge.com .
For further information please contact:
Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com |
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Anna Dunphy / Paul McManus |
+44 (0)7876 741 001 / +44 (0)7980 541 893 |
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About Open Orphan ( www.openorphan.com )
Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com . The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.
The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering.
Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO and Venn Life Sciences and is also building out a valuable data platform business. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteers via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn is an integrated drug development consultancy firm which offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.
Open Orphan #ORPH Chairman Cathal Friel talks to Ian King, Sky News about the Codagenix nasal Covid-19 vaccine phase I study
Open Orphan #ORPH Chairman Cathal Friel talks to Ian King, Sky News about the Codagenix nasal Covid-19 vaccine phase I study, which has received regulatory approval. Tests start at the hVIVO Whitechapel facility in the new year. Cathal explains the simplicity, ease of application of the nasal application, and looks at the history of hVIVO’s East London facility.
BRR Media – Open Orphan #ORPH secure MHRA approval to start Codagenix COVID-19 phase 1 vaccine trial
Open Orphan #ORPH – MHRA approval for nasal COVID-19 vaccine clinical trial
Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials, announces the first in human (Phase I) study of Codagenix intranasal SARS-CoV-2 (COVID-19) vaccine candidate has received approval from the UK’s independent Medicines and Healthcare Products Regulatory Agency (MHRA).
Further to the Company’s announcement on 28 July 2020, hVIVO, part of Open Orphan plc, is working in collaboration with US biotech Codagenix Inc. (“Codagenix”) to conduct this Phase I study of COVI-VAC, Codagenix’s intranasal SARS-CoV-2 (COVID-19) vaccine candidate. The study will evaluate safety and immunogenicity of a single-dose nasal vaccine candidate in 48 healthy young adult volunteers at hVIVO’s state-of-the-art Quarantine Facility in Whitechapel, London.
COVI-VAC is one of the few vaccines that uses the live-attenuated virus (i.e. the entire virus in a weakened form), unlike most other vaccines which only contain the viral spike. This vaccine, therefore, has the potential to induce broad antibody, cellular and mucosal immunity with a single intranasal dose and could be one of the first vaccines to provide long-term immunity from COVID-19.
hVIVO expects the study to commence in January 2021, the initial data expected in early Q2 2020. The Company has already begun enrolling volunteers for this study in its unique East London, 24-bedroom quarantine clinic through hVIVO’s dedicated volunteer recruitment website: www.flucamp.com
Cathal Friel, Executive Chairman of Open Orphan, said:
“We are delighted to have MHRA approval to begin recruiting volunteers for this much needed clinical trial. The volunteers who attend our unique quarantine facility in East London are expertly supervised in a safe, controlled clinical environment and could be contributing to the development of a new breakthrough vaccine candidate that has the potential to confer immunity to individuals over a much longer timescale.
“We hope to demonstrate safety and immunogenicity through this trial, which will then allow us to support Codagenix as they move into a larger Phase II / Phase III programme.”
Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said:
“We are very excited to be moving forward with our collaboration with hVIVO for this first-in-human study of COVI-VAC, our live attenuated vaccine against COVID-19. The initial safety and immunogenicity data from healthy adults will position us well to move into larger studies in 2021 with our partners at Serum Institute of India. We believe COVI-VAC, a needle-free, single dose vaccine, is well-suited to address potential gaps in supplying the global community, as there is likely to be significant unmet need even after the initial roll-out of first generation COVID-19 vaccines.”
Dr. Rajeev Dhere, Executive Director, Serum Institute of India, said:
“We at the Serum Institute of India are pleased with the MHRA approval for initiating the first-in-human clinical trial for the novel intranasal product against COVID-19, developed by Codagenix in collaboration with SII. We are happy to have hVIVO conducting the clinical trial of this unique Intranasal vaccine.”
For further information please contact
Open Orphan plc | +353 (0)1 644 0007 | |
Cathal Friel, Executive Chairman | ||
Arden Partners plc (Nominated Adviser and Joint Broker) | +44 (0)20 7614 5900 | |
John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons | ||
finnCap plc (Joint Broker) | +44 (0) 20 7220 500 | |
Geoff Nash / James Thompson/ Richard Chambers | ||
Davy (Euronext Growth Adviser and Joint Broker) | +353 (0)1 679 6363 | |
Anthony Farrell | ||
Walbrook PR (Financial PR & IR) | +44 (0)20 7933 8780 or openorphan@walbrookpr.com | |
Paul McManus / Alice Woodings | +44 (0)7980 541 893 / +44 (0)7407 804 654 | |
About Open Orphan (www.openorphan.com)
Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com. The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.
The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering.
Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO and Venn Life Sciences and is also building out a valuable data platform business. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc in January 2020. Venn is an integrated drug development consultancy firm which offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.
Open Orphan #ORPH – Interim Results for 6 months ended 30 June, will be operationally profitable in Q4
Open Orphan Plc, a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical studies is pleased to announce its interim results for the six months ended 30 June 2020. The interim results include the first six months of hVIVO group (“hVIVO”) following its acquisition by Open Orphan Plc on the 17 January 2020.
Operational Highlights:
· Completed the acquisition of hVIVO plc for an aggregate consideration of approximately GBP£13 million in equity on 17 January 2020
· Implemented a major restructuring and integration of our operations to drive efficiency and competitiveness which is now substantially completed
· Successfully secured a number of RSV human challenge studies in the period including:
– £3.4m contract with a major European biotech company, with anticipated £7m follow-on study
– £3.7m contract with a US biotechnology company
· Driving growth of Dutch early clinical development services while refocussing French operations towards biometry services
· Large contract signed with a global leader in vaccine development
· Launch of COVID-19 Antibody testing partnership with Quotient Ltd
· Appointment of Leo Toole as Group Chief Financial Officer enhancing the executive management team
Financial Highlights:
· Cash and cash equivalents at half year end of GBP £14.7m following two successful placings:
– Executed a fundraise on 31 January 2020 raising GBP £5.3 million at 6.1p per share (before expenses)
– Executed a fundraise on 22 May 2020 raising GBP £12.6 million at 11p per share (before expenses)
· Reported Interim Results
o Revenue of GBP £7.1 m for H1 2020 – continued focus on delivering larger contracts
o EBITDA loss of GBP £4.1m for H1 2020
o Operating Loss of GBP £5.0m for H1 2020
· Pro-forma Interim Results
o Revenue of GBP £7.4m (H1 2019 Revenue of GBP £11.6m)
o EBITDA Loss of GBP £4.7m (H1 2019 EBITDA loss of GBP £4.7m)
o Operating Loss of GBP £5.6m (H1 2019 Operating Loss of GBP £6.3m)
· Post completion of Merger, reduction in overheads on target to deliver annualized cost efficiencies of GBP £10.1m by end of 2020
Post Period End:
· Acquired the CHIMagents team in July, reinforcing hVIVO’s position as the world leading services company in the testing of vaccines and antivirals through human challenge study clinical trials.
· Integrated hVIVO’s unparalleled database of infectious diseases progression data into the Open Orphan data platform – expecting potential commercialisation in Q4, with some of the world’s largest wearable companies for this disease progression data.
· Progressing as planned to monetise two of our non-core assets, the 49% stake in Imutex and the 62.6% stake in PrEP.
· The Company continues to provide testing to large commercial employers in the UK and Ireland as part of a combined COVID-19 antibody and COVID-19 PCR (swab) testing offering.
· Contracts signed post period end include:
– Laboratory services contracts signed with a number of parties – a key strategic growth area for Open Orphan taking advantage of our laboratory expertise.
– Contract signed with Codagenix Inc. for a first-in-human Phase I COVID-19 vaccine study, demonstrating that hVIVO’s quarantine facility is uniquely suited to conducting Phase I studies for infectious disease vaccines such as this.
– Further RSV human challenge study contract for £4m signed with a Top 3 global pharma company with hVIVO acting as sponsor for this study.
– First-in-human clinical pharmacology trial signed with Carna BioSciences.
– Contract signed with a major European pharmaceutical company for data management, statistics and medical writing to support a 750 subject oncology study.
– Contract signed for a further £4.3m human challenge study with a top 10 global vaccine company.
Outlook:
· The Group has a strong pipeline of contracted work and new projects at an advanced stage of negotiation and is targeting growth with strong operating cash flow in the second half of 2020 and is on target to be operationally profitable in Q4.
· As of September 2020, we are close to having the hVIVO quarantine clinic block booked with conventional challenge studies until December 2021. Quarantine clinic block expected to shortly be booked out for the next 18 months to two years with conventional challenge study contracts.
· Further to its announcements of 9 March 2020 and 22 May 2020, the Company is well progressed in developing the world’s first Coronavirus human challenge study model to test a range of COVID-19 vaccines, complementing existing human challenge study models. We are in advanced discussions and negotiations with a range of potential customers, including the UK Government to test COVID-19 vaccines.
Cathal Friel, Executive Chairman of Open Orphan, said:
“Since we acquired hVIVO in January 2020, we have achieved what we set out to do. We have created a leaner more efficient businesses, removed excess costs and we are now a truly unique clinical research organisation (CRO) that is the world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. We have secured larger, more profitable contracts with both large pharma and the leading vaccine developers globally. We have delivered upon our aim of improving revenue streams through the delivery of several new revenue lines including the provision of laboratory services to third parties. We have reinvigorated both the Venn Life Sciences business and the hVIVO business during the first half of 2020 and have created a strong foundation for future growth.
Looking ahead, I am extremely excited by the potential for this business, we have entered a decade of significant spending on vaccines and antivirals by both governments and pharma companies around the world. The Open Orphan Group including hVIVO and Venn Life Sciences is ideally positioned to capitalise on this increase in vaccine development expenditure. Earlier this year we set ourselves the target of being profitable in the second half of 2020 and I am delighted to confirm that, despite profitability taking a few months longer than expected, we are on target to be operationally profitable in Q4 2020.
None of the above would have been possible without the exceptional effort, dedication and professionalism shown by all hVIVO, Venn and Open Orphan team members. They have worked diligently through the past 6 months, despite the added difficulty of the pandemic, to ensure that we have delivered an excellent performance. The teams are really well positioned to thrive as the world leaders in the testing of vaccines and antivirals for the decade ahead.”
Conference call for sell-side analysts and investors
The Company will hold a conference call for sell-side analysts and investors at 10:30 today.
Details for the conference call can be found at: https://www.speakservecloud.com/register-for-call/254ba4b5-e780-48fb-9142-c5762f4ef8ef
A corporate presentation is available to shareholders on the Group’s website at: https://www.openorphan.com/investors/reports-and-presentations/year/2020
Enquiries:
Open Orphan Plc Tel: +353 (0)1 644 0007
Cathal Friel, Executive Chairman
Arden Partners (Nominated Adviser and Joint Broker) Tel: +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) Tel: +353 (0)1 679 6363
Anthony Farrell (Corporate Finance)
Camarco (Financial PR)Tel: +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. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com. The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.
The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering.
Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO and Venn Life Sciences and is also building out a valuable data platform business. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc in January 2020. Venn is an integrated drug development consultancy firm which offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.
Executive Chairman’s Statement
Dear Shareholder,
As Executive Chairman, I am very happy to report the first set of combined results since Open Orphan plc’s (formerly Venn Life Sciences Holdings plc) acquisition of hVIVO plc (now hVIVO Limited) in January 2020.
Summary
The 6 months to the end June 2020 have been a period of significant change initially focussed on progressing our strategy to sign contracts for our world leading human challenge studies clinical trials which are used to test vaccines and anti-virals. We are also signing new contracts for biometry services from our Paris office and early clinical development services from our Breda, Netherlands office while at the same time developing further new revenue streams such as laboratory services to complement our existing London business. This has all been done while at the same time we implemented a major restructuring and integration of our operations to drive efficiency and competitiveness which is now substantially completed.
Also, in this period, the Company addressed the rapidly evolving COVID-19 pandemic event by enabling a safe and efficient working environment for our staff at home and in our clinic and laboratory facilities. We have worked proactively with our clients to manage project timetables to minimize the impact of Covid-19 on our revenues streams while continuing to build new relationships to expand our confirmed project pipeline well into 2021 and beyond.
Other highlights include the completion of a placing of £12.6m (before expenses) at 11p per share in May 2020 allowing us to invest to accelerate the development of a world-first coronavirus challenge study model to test COVID-19 vaccines and antivirals. This was all done while also expanding our laboratory service offerings to offer enhanced external laboratory services and to develop testing services to support the nascent testing environment for Covid-19.
Interim Results
Reported results for Open Orphan plc are summarized below and are covered by the schedules and notes from pages 6 to 14 of these Interim Financial Statements (and in particular reflect reverse merger accounting treatment under IFRS 3 and IFRS 10 of the combination of Venn Life Sciences Holdings plc and Open Orphan DAC as of 28 June 2019). We also share for reference the results for hVIVO plc (now hVIVO Limited), Open Orphan plc (formerly Venn Life Sciences Holdings plc) and Open Orphan DAC on a stand-alone basis.
Open Orphan plc(As reported) | hVIVO plc(Proforma results on standalone basis) | Open Orphan plc(formerly Venn Life Sciences Holdings plc -proforma resultson a stand-alone basis) | Open Orphan DAC (proforma resultson a stand-alone basis) | Open Orphan plc(proforma results on a combined basis and including the impact of the 28 June 2019 and 17 January 2020 combinations) | ||||||
Unaudited6 months ended30 June2020£’000 | Unaudited6 months ended30 June2019£’000 | Unaudited6 months ended30 June2020£’000 | Unaudited6 months ended30 June2019£’000 | Unaudited6 months ended30 June2020£’000 | Unaudited6 months ended30 June2019£’000 | Unaudited6 months ended30 June2020£’000 | Unaudited6 months ended30 June2019£’000 | Unaudited6 months ended30 June2020£’000 | Unaudited6 months ended30 June2019£’000 | |
Revenue (incl. Other income) | 7,078 | – | 3,379 | 6,409 | 4,062 | 5,179 | – | – | 7,441 | 11,588 |
Operating (Loss) | (5,005) | (156) | (3,067) | (4,224) | (2,128) | (1,965) | (447) | (159) | (5,642) | (6,348) |
EBITDA before exceptional items | (4,145) | (156) | (2,478) | (3,192) | (1,811) | (1,340) | (445) | (159) | (4,734) | (4,691) |
Loss for the period | (6,490) | (1,070) | (2,934) | (3,833) | (2,408) | (1,809) | (458) | (1,091) | (7,136) | (6,733) |
As at 30 June 2020€’000 | As at 30 June 2019€’000 | |||||||||
Non-current assets | 17,721 | 5,250 | ||||||||
Current assets (excl. cash) | 3,602 | 5,714 | ||||||||
Cash | 14,651 | 4,540 | ||||||||
Total Assets | 35,974 | 15,504 | ||||||||
Equity attributable to owners | 26,994 | 7,576 | ||||||||
Non-current liabilities | 2,271 | 3,304 | ||||||||
Current liabilities | 6,709 | 4,624 | ||||||||
Total equity and liabilities | 35,974 | 15,504 |
Governance
The Board continues to recognise the importance of the high standards of corporate governance and considers that the Group’s success is enhanced by the imposition of a strong corporate governance framework. I am grateful for the contributions of the new Board formed after the acquisition in January 2020 and want to acknowledge the important service of Trevor Philips during his tenure on the Boards of hVIVO plc (now hVIVO Limited) and Open Orphan plc until he stepped down in May 2020.
Outlook
Our business outlook has never been stronger. Demand and interest to complete Challenge studies in our 24-bed quarantine facilities in the UK is translating into a steady flow of signed new contracts and new customer engagement. As a result of the fundraise at the end of May, Open Orphan now has a large, healthy cash balance and, as such, is very well capitalised and we are ideally placed to be providing such services to governments and pharma companies around the world who seek to address the current pandemic and mitigate the risk of future such events. We are progressing a number of encouraging avenues to rapidly develop a human challenge model specific to SARS CoV-2 to fast track the identification of efficacious vaccines and treatments for Covid-19.
Our early clinical development business based out of Breda in the Netherlands is showing strong year on year growth while our biometry services based out of our Paris office, now focussing on data management, biostatistics, medical writing and randomisation, are contributing strongly to generate synergies for our viral challenge studies and expand their pipelines.
Across the second half of 2020, we will see the impact of the major efforts undertaken across the Group to divest from underperforming businesses, reduce overheads, deliver merger integration savings and right-size the management team including combining senior roles in both Venn and hVIVO leading to operational profitability in Q4. Our renewed focus on reducing hierarchy has increased the speed of decision making while empowering our teams to deliver our ambitious goals.
In addition, data is an important upstream area of development for the Group where we believe there will be an important convergence of hVIVO’s global infectious disease progression data with the digitization of other vital signs and biomarkers available through our challenge studies, all with the goal of creating a ground-breaking Open Orphan Health Data platform that can be monetized with major pharma players.
I am very encouraged for the remainder of 2020 and our prospects in 2021. We have a world leading team, focused on ground-breaking work which will create sustainable value for all our stakeholders.
Cathal Friel
Executive Chairman
30 September 2020
Full results announcement with financial statements here
The Times – Trial to infect British volunteers with modified coronavirus at hVIVO Quarantine Centre
Scientists are planning to infect British volunteers with a weakened, computer-designed form of the coronavirus, which researchers believe could work as a vaccine.
The early-stage trial will take place in a special 24-bed quarantine clinic in Whitechapel, east London. The US biotech company behind it, Codagenix, is in talks with UK regulators and expects to begin before the end of the year.
The vaccine consists of an enfeebled version of the coronavirus, designed using special software and built in a laboratory. The aim is produce a cheap inoculation that would be administered as a nose drop.
Link here to view the full Times article.
Open Orphan #ORPH Awarded Contract From Codagenix Inc For COVID-19 Vaccine Trial
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 a new contract with Codagenix Inc. (“Codagenix”) to conduct a first in human (Phase I) trial evaluating safety and immunogenicity of a single-dose, intranasal SARS-CoV-2 (COVID-19) vaccine candidate in 48 healthy young adult volunteers.
Highlights:
- First in human (Phase I) study of CodaVax-COVID, a codon deoptimized SARS-CoV-2 (COVID-19) single-dose, intranasal vaccine candidate
- Vaccine being trialled at hVIVO’s state-of-the-art Quarantine Facility in Whitechapel in London
- Phase I study to start in early Autumn with initial data expected by the end of 2020
- Study will include second dose as surrogate viral challenge at Day 28
hVIVO, part of Open Orphan, will conduct the COVID-19 vaccine trial for Codagenix at its state-of-the-art Quarantine Facility. CodaVax-COVID is a live-attenuated vaccine that replicates very slowly, but contains all SARS-CoV-2 proteins, unlike most other vaccines that only contain the viral spike. This vaccine has the potential to induce broad antibody, cellular and mucosal immunity with a single intranasal dose. hVIVO is currently kicking off the initial steps of this exciting study and are expected to start the trial in the quarantine unit this autumn.
This contract reinforces Open Orphan’s position as the world leader in the testing of vaccines and antivirals.
Cathal Friel, Executive Chairman, Open Orphan, said:
“We are proud to be conducting this Phase I study for Codagenix, a leader in their field, as it will help bring a promising vaccine candidate to the public to help combat the COVID-19 pandemic as quickly as possible.
hVIVO, with its unique quarantine facility, is one of the few organisations in the world that has now publicly stated that it is working on testing COVID-19 vaccines for efficacy using human challenge model clinical trials.
Today’s announcement also shows that hVIVO’s quarantine facility is uniquely suited to conducting Phase I studies for infectious disease vaccines such as this.
Codagenix’s expertise in viral design technology, combined with hVIVO’s Phase I trial capability, gives us confidence that this trial will be successful and a step forward for the world as it seeks to develop a COVID-19 vaccine to bring the pandemic to a close.”
Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said:
“We are very excited to be collaborating with hVIVO for the first-in-human study of CodaVax-COVID. hVIVO is world-recognized for expertise in evaluation of live viruses in human volunteers. Based on our animal data we expect this vaccine to be effective with a single dose, but will also evaluate a repeat dose to assess potential for boosting and as a model for protection from wildtype challenge.
We plan to move quickly from this initial demonstration of safety and immunogenicity in a controlled inpatient setting to larger Phase 2/3 program in conjunction with our partners at Serum Institute of India who are currently scaling up manufacturing to support rapid acceleration of our joint development program.”
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.
Notes to Editors – Codagenix Inc.
Codagenix is a clinical-stage synthetic biology company that uses software to recode the genomes of viruses, constructing live-attenuated vaccines or viruses to prevent viral infections or treat solid tumours. Codagenix’s recoded vaccine candidates are a perfect antigenic match to the target virus and induce a robust immune response to all viral antigens. For cancer, our nimble platform allows us to turn a virus into a potential oncolytic immuno-oncology therapy. Both programs rely on scalable, low-cost manufacturing. Codagenix Inc. spun out of the laboratory of National Academy of Science Member Eckard Wimmer at Stony Brook University in 2012 and is located at the Broad Hollow Bioscience Research Park in Farmingdale, N.Y. Our programs are supported by Adjuvant Capital, TopSpin Partners, Euclidean Capital, and government agencies such as the USDA, NIH/NIAID and the Department of Defense.