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#POLB Poolbeg Pharma PLC – Poolbeg identifies novel RSV drug candidates
Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a leading infectious disease focused biopharmaceutical company, announces that it has successfully identified potential new drug candidates from its Respiratory Syncytial Virus (‘RSV’) artificial intelligence (‘AI’) Programme with OneThree Biotech, Inc.
Since initiating the collaboration in February 2022, Poolbeg’s scientific team has worked closely with OneThree to build a tailored AI approach that leverages Poolbeg’s unique RSV human challenge trial data in order to identify disease-relevant biological pathways and potential drug targets. Based on those newly discovered drug targets, the collaboration has now identified a number of promising drug candidates to rapidly bring forward to lab-based validation to determine the full potential of these assets.
The Company has prioritised compounds with existing Phase I clinical data and which could, if successfully validated, be repositioned as novel treatments for RSV infection. Candidates with solid safety and pharmacodynamic data in humans are well positioned to rapidly enter a clinical trial to generate early human efficacy data for RSV. This is in line with Poolbeg’s efficient, capital light clinical development strategy that is at the core of its ambitious growth model.
RSV, which inflames the smallest airways of the lungs, usually sends an average of 58,000-80,000 children under the age of 5 to hospital each year in the US alone, according to the US Centers for Disease Control and Prevention (CDC). RSV can also be dangerous for adults over the age of 65, resulting in around 177,000 hospitalisations per year in the United States alone. The current cold and flu season commenced about two months earlier than anticipated and already rivals some of the worst seasons on record with RSV hospitalising young children in the United States and Europe at an alarming rate. Public health officials have been warning for weeks that a “tripledemic” of SARS-CoV-2, influenza and RSV would strain an already weary healthcare system. RSV has made so many young children ill this fall that weekly paediatric hospitalisations in the US are the highest recorded.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: “In the past few months, RSV has been sending children to hospital at alarming rates in the United States and Europe. As paediatric units fill beyond capacity, and our healthcare systems contend with a ‘tripledemic’ of RSV, influenza and SARS-CoV-2, the need for better treatments has never been so urgent.
We’re impressed with the quality of work executed so far with OneThree leveraging their AI expertise to present new drug potential candidates from our unique human challenge trial data which Poolbeg will now optimise for further development in RSV, the only one of the three main respiratory illnesses for which there are not yet any approved vaccines and where treatment options are limited.”
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Neel S. Madhukar, PhD, co-founder and CEO of OneThree Biotech, said: “We are very pleased to be working with Poolbeg and to have the opportunity to deploy the ATLANTIS platform to complete the first ever AI-driven analysis of RSV disease progression data. I am delighted that Poolbeg’s unique dataset combined with OneThree’s externally validated platform have now delivered new actionable insights surrounding disease biology and drug discovery that can bring much needed treatment options for both the young and the elderly; the most vulnerable to RSV infection.”
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Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)
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+44 (0) 207 220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 207 496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Optimum Strategic Communications Mary Clark, Nick Bastin, Manel Mateus, Vici Rabbetts
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+44 (0) 208 078 4357 |
About Poolbeg Pharma
Poolbeg Pharma specialises in the development of innovative medicines to address the unmet need in prevalent and emerging infectious diseases. Poolbeg has a disciplined portfolio approach to mitigate risk, accelerate drug development and enhance investor returns. The Company simultaneously advances multiple programmes in cost-effective clinical trials, rapidly generating early human safety and efficacy data to enable early partnering / out-licensing, with the funds generated reinvested in the pipeline. Poolbeg also uses AI to interrogate human challenge trial data sets to quickly identify new targets and drugs, and in-license near or in the clinic medicines, leading to faster development and greater commercial appeal.
The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.
With its initial assets from hVIVO plc (formerly Open Orphan plc), an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza (POLB 001) which has completed its LPS human challenge trial with full data read-out expected in Q2 2023; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also developing two Oral Delivery Programmes and is progressing two Artificial Intelligence (AI) Programmes to add promising new assets to its pipeline.
For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.
About OneThree Biotech
OneThree Biotech is a private, clinically validated, biology-driven artificial intelligence (AI) company focused on using its proprietary ATLANTIS AI platform in combination with systems biology to understand the mechanisms that drive drug-target-disease relationships. This approach has been used not only to generate a pipeline of first-in-class programs, but also in partnerships with other biopharmaceutical companies. OneThree Biotech’s proven technology platform integrates chemical, biological, and clinical data with cutting-edge computational tools to answer complex questions surrounding disease biology and drug discovery. The company’s AI platform has shown success in identifying new targets for the treatment of various cancers and optimizing early-stage drug discovery and development by quickly and accurately generating new, testable insights and hypotheses. The OneThree platform has been validated across early-stage drug discovery through multiple partnerships, clinical trials, and more than 20 peer-reviewed publications. OneThree Biotech is based in New York City.
For more information, please go to https://onethree.bio/
Twitter: @onethreebiotech
#POLB Poolbeg Pharma PLC – Metabolic diseases oral delivery licence signed
Clinical trial to demonstrate technology can safely deliver GLP-1 to commence in H1 2023
Prof Brendan Buckley joins Poolbeg’s Scientific Advisory Board to guide clinical development of technology
Licence expands Poolbeg’s existing exclusive licence to AnaBio’s oral vaccine delivery technology
Investor Meet Company presentation on 14 December 2022 at 5:30pm
Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a leading infectious disease focused biopharmaceutical company, announces that it has acquired an exclusive licence from InsuCaps Limited (“InsuCaps”), a sister company of AnaBio Technologies (“AnaBio”), to use InsuCaps’ patented microencapsulation and nanoencapsulation oral delivery technologies in metabolic syndrome related diseases including obesity, pre-diabetes and diabetes. Obesity alone costs the US healthcare system c. $173bn a year.
Following the licence, in H1 2023 Poolbeg will rapidly commence a proof-of-technology clinical trial to determine that a Glucagon-like Peptide 1 receptor (GLP-1) agonist can be safely delivered orally in humans. GLP-1 agonists, which are used to treat diabetes and obesity, represent an extremely large, fast-growing opportunity estimated to grow to c.$22bn per annum by 2025. At present, all but one GLP-1 products are injectables, which are more onerous for patients than oral delivery.
The upcoming trial is designed to provide data confirming that the patented microencapsulation and nanoencapsulation technologies can safely deliver GLP-1 orally, with results expected to be announced later next year. In line with its rapid-partnering model, Poolbeg then intends to licence the technology to pharma and biotech for use in obesity and / or diabetes, as well as other active molecules in metabolic syndrome related diseases.
This oral GLP-1clinical trial rapidly follows the completion of Poolbeg’s LPS challenge trial for POLB 001 and, like the LPS challenge study, is in line with Poolbeg’s efficient, capital light approach to clinical development at the core of the Poolbeg model.
This exclusive licence is in addition to Poolbeg’s exclusive license to AnaBio’s microencapsulation and nanoencapsulation technologies which underpins Poolbeg’s Oral Vaccine Platform. As recently announced, a Poolbeg-led consortium was awarded €2.3m in non-dilutive funding by the Irish Government’s Disruptive Technologies Innovation Fund to progress the Oral Vaccine Platform.
Addition to Poolbeg’s Scientific Advisory Board
Poolbeg has also added Prof Brendan Buckley to its Scientific Advisory Board. He is the former Chief Medical Officer at ICON plc, a medical graduate of University College Cork and a doctoral graduate in Biochemistry in the Faculty of Medicine at Oxford University. Prof Buckley has advised Poolbeg since inception and has deep experience in metabolic diseases including over 40 years’ experience in clinical practice as a Consultant Physician in endocrinology, diabetes and in academic clinical pharmacology. In addition, Brendan has sat on the European Medical Agency (EMA)’s Scientific Advisory Group for Diabetes and Endocrinology. He has published over 150 scientific papers, mainly on metabolic disease, as well as the recent key opinion-leading book ‘Re-Engineering Clinical Trials’.
Investor Meet Company presentation – 14 December 2022 at 5:30pm
Jeremy Skillington, PhD, Chief Executive Officer, and Professor Brendan Buckley will provide a live presentation via the Investor Meet Company platform on 14 December 2022 at 5:30pm. Click here to register.
The presentation is open to all existing and potential shareholders. Investors can sign up to Investor Meet Company for free and add to meet Poolbeg Pharma plc here. The presentation and recording will be available on the Company’s website after the event here.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: “Poolbeg saw the potential for microencapsulation and nanoencapsulation oral delivery technologies in vaccines, and this has been further validated by the grant from the Irish Government’s Disruptive Technologies Innovation Fund. Drawing on our growing understanding of this technology from our Oral Vaccine Platform, we believe that there is significant opportunity in other adjacent areas, such as metabolic diseases. Diabetes and obesity are extremely fast growing markets and the ability to administer drugs orally, rather than through injection, will improve access and quality of life for millions of patients. We are really excited to be moving swiftly to a proof-of-concept trial in H1 2023 to test the oral delivery of GLP-1 in humans, with the results to be announced later in the year.”
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Dr Sinéad Bleiel, Founder & Chief Scientific Officer of InsuCaps said: “We are excited to be expanding our working relationship with Poolbeg and believe that the trial commencing in H1 2023 will deliver meaningful data showing our ability to orally deliver GLP-1 safely and efficiently. As the world is beginning to realise, GLP-1 and similar metabolic peptides have life changing effects for diabetics and are becoming the obesity management drug of choice for the years ahead. We believe that our microencapsulation and nanoencapsulation oral delivery technologies can potentially deliver significant quality of life benefits to patients suffering from these long-term metabolic syndrome conditions.”
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Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)
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+44 (0) 207 220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 207 496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Optimum Strategic Communications Mary Clark, Nick Bastin, Manel Mateus, Vici Rabbetts
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+44 (0) 208 078 4357 |
#POLB Poolbeg Pharma Plc- Capital Markets Day
17 November 2022 – Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, announces that it will be holding a Capital Markets Day for analysts and institutional investors on Wednesday 30 November between 10am – 12:45pm.
The event, which will be chaired by Jeremy Skillington, Chief Executive Officer, will provide insights into a number of the Company’s growing pipeline of infectious disease vaccines and treatments and one of its innovative artificial intelligence programmes which is unlocking the power of human challenge trial data. In addition, attendees will gain a greater understanding of how Poolbeg’s unique model and business development strategy can drive growth from the infectious disease market. A networking lunch will follow at the end of the session.
There will be an opportunity for attendees to take part in a Q&A with Poolbeg’s management team including Ian O’Connell, Chief Financial Officer and David English, VP of Business Development as well as a number of guest speakers:
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Dr Tal Almog of CytoReason, one of Poolbeg’s artificial intelligence partners; a world leader in AI which to date has worked with five of the world’s top ten pharma companies |
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Derek Gilroy, Head of the Centre for Clinical Pharmacology and Professor of Immunology at University College London and has pioneered research examining the molecular and biochemical pathways that regulates the resolution of acute immune reactions |
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Professor Brendan Buckley, co-founder of Minerva Medical, acquired by IQVIA and Firecrest Clinical, acquired by ICON plc where he held the position of Chief Medical Officer. Brendan has over thirty years of experience in clinical research and has published over 150 scientific papers |
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Further speakers will be announced in advance of the event |
Analysts, institutional investors and media are welcome to attend the event in the City of London. Due to restrictions on numbers, it will not be possible for all interested parties to attend in-person. However, a live webcast will be available for retail investors and others to view the presentations here.
To register your interest to attend the in-person event, please RSVP to poolbeg@instinctif.com.
A recording of the presentation will be made available on the Company’s website after the event here.
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson
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+44 (0) 207 220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 207 496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field
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+44 (0) 20 7457 2020 |
About Poolbeg Pharma
Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a “one-stop shop” for Big Pharma seeking mid-stage products to license or acquire.
The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.
With its initial assets from hVIVO plc (formerly named Open Orphan plc), an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza (POLB 001) which has commenced its LPS human challenge trial with initial results expected by year end 2022; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) programmes to accelerate the power of its human challenge model data and biobank, with outputs from the first programme expected by year end 2022.
#POLB Poolbeg Pharma PLC – Upcoming Events
21 October 2022 – Poolbeg Pharma (AIM: POLB, OTCQB: POLBF), a clinical stage infectious disease pharmaceutical company with a capital light clinical model, announces that its management and business development team will be attending and presenting at a number upcoming partnering and investor events from October 2022 to January 2023.
Partnering events
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BIO-Europe from 24-26 October 2022 at Leipzig Messe, Leipzig, Germany 04356 |
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Jefferies London Healthcare Conference from 15-17 November 2022 in London |
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JP Morgan 41st Annual Healthcare Conference from 9-12 January 2023 at the Westin St. Francis Hotel, San Francisco, CA |
Investor events
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London South East Webinar (virtual) on 8 November 2022. Register here |
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LSX Inv€$tival ShowcaseTM on 14 November 2022 at Old Billingsgate, London EC3R 6DX. Poolbeg CEO, Jeremy Skillington, will present at 14:15 on Stage 4: Biotech Late Growth. Register here |
Event details may be subject to change – further information and updates are available on the Poolbeg Pharma website here.
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Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 20 7183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson Nigel Birks, Harriet Ward (ECM)
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+44 (0) 20 7220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 20 7496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field
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+44 (0) 20 7457 2020
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About Poolbeg Pharma
Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a unique capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a “one-stop shop” for pharma and biotech seeking mid-stage products to license or acquire.
The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.
With its initial assets from Open Orphan plc, an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza (POLB 001) which has commenced its LPS human challenge trial with initial results expected by year end 2022; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) programmes to accelerate the power of its human challenge model data and biobank, with results from the first programme expected by year end 2022.
#ORPH Open Orphan Plc – Capital Markets Day
Open Orphan plc (AIM: ORPH), (to be renamed hVIVO plc (AIM: HVO) effective 26 October 2022), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces it will be holding a Capital Markets Day for analysts, institutional investors and media on Wednesday 2 November 2022 at 9.30 am – 12.00 pm (GMT).
The event, which will be chaired by CEO Yamin ‘Mo’ Khan, will provide a deeper insight into the Company’s end-to-end early clinical development services business, the human challenge trial market, and the benefits of human challenge to the Company’s clients. There will also be an opportunity for attendees to take part in a Q&A with the Company’s management team including its new CFO, Stephen Pinkerton, and guest speakers which include Peter Openshaw, Professor of Experimental Medicine at Imperial College London.
Analysts, institutional investors and media are welcome to attend the event in the City of London. Due to restrictions on numbers, it will not be possible for all interested parties to attend in-person, however, a live webcast will be available on the Company’s website for retail investors and others to view the presentations here.
To register your interest for the webcast, please contact Walbrook PR on +44 20 7933 8780 or email
openorphan@walbrookpr.com.
A recording of the presentation will be made available on the Company’s website after the event.
For further information please contact:
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Open Orphan plc |
+44 (0) 20 7756 1300 |
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Yamin ‘Mo’ Khan, Chief Executive Officer |
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Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
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Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
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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) Stephanie Cuthbert / Phillip Marriage / |
+44 (0) 20 7933 8780 or openorphan@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
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#ORPH Open Orphan – £10.4m contract with existing Big Pharma client
hVIVO to develop new influenza challenge strain to test oral antiviral candidate
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces thathVIVO, a subsidiary of Open Orphan, has signed a £10.4m contract with an existing top 5 global pharmaceutical client to manufacture a new batch of H1N1 influenza challenge virus, leveraging off an existing in-house generated challenge model, and to conduct a human challenge trial to test the client’s antiviral product.
hVIVO has world-leading expertise in challenge agent manufacture, with the ability to manufacture specific subtypes of viruses, as well as unrivalled experience in conducting challenge studies. Since the COVID-19 pandemic, the Company has seen an increase in the number of clients looking to test their vaccines and antivirals against specific subtypes of viruses that are circulating in the population or that have the potential to be widely spread. As a result, there is a greater interest in end-to-end human challenge contracts such as this, that include a novel challenge agent manufacture and a challenge study.
The study will evaluate the efficacy profile of the antiviral against the specific influenza subtype, generating data quickly and efficiently. This is the third human challenge contract signed with this client, highlighting the Company’s world leading expertise and the clear benefits of human challenge trials to Big Pharma’s drug development process.
Good Manufacturing Practice (“GMP”) compliant virus manufacturing activities will commence immediately and are expected to complete by Q2 2023. Once completed, hVIVO will conduct a Phase 2a double-blinded placebo-controlled human challenge study which is expected to be completed by Q4 2023. hVIVO will recruit healthy volunteers via the Company’s dedicated volunteer recruitment arm, FluCamp.The majority of revenue from the contract is expected to be recognised during 2023.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said : “We’re delighted to be working again with this top 5 global pharmaceutical company to test its antiviral, using a new influenza strain developed by our highly experienced team. This contract is the third challenge study with this client, and our second end-to-end full-service contract overall. Our one-stop shop service offerings from manufacturing bespoke challenge agents to conducting full challenge studies is unique in the market. I am confident, that with our highly qualified teams and their clinical development expertise, we are well placed to address the growing infectious disease and respiratory research markets.
“Influenza poses a serious global health threat, causing an estimated 290,000 – 650,000 deaths per year with significant pandemic potential, and as such, the development of new vaccines and antivirals to fight flu remains vitally important.”
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “This contract is a strong example of where human challenge studies can provide significant value. These studies can quickly and cost-effectively generate efficacy data for our clients in specific viral subtypes. As illustrated with this contract, our world-class manufacturing capabilities can produce a challenge agent for subtypes that pose a particular global health risk or are already circulating in the population. The resulting data can then indicate whether the candidate is viable for Phase II/III studies, providing substantial time and financial savings compared to traditional field-based studies.”
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.
For further information please contact:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Yamin Khan, Chief Executive Officer |
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Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
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Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
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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) Stephanie Cuthbert / Phillip Marriage / |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
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Alan Green discusses #WTB Whitbread, #POLB Poolbeg Pharma & #FCM First Class Metals on the Vox Market Podcast
Alan Green discusses #WTB Whitbread, #POLB Poolbeg Pharma & #FCM First Class Metals on the Vox Market Podcast
Listen here
#ORPH Open Orphan – Omicron human challenge model
Vaxart becomes the first client of the programme to test its oral COVID-19 vaccine candidate
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO , a subsidiary of Open Orphan, is developing the world’s first Omicron human challenge model. hVIVO has signed an agreement with Vaxart Inc. (“Vaxart”), (NASDAQ: VXRT) to develop the model with the intent to conduct a subsequent Omicron human challenge study in 2023 to test the efficacy of Vaxart’s oral vaccine candidate, VXA-CoV2-1.
To develop the model, hVIVO will manufacture a new SARS-CoV-2 (COVID-19) challenge agent based on the Omicron variant. The Good Manufacturing Practice (“GMP”) compliant virus manufacturing activities will commence immediately and are expected to complete by Q4 2022. Following manufacture of the challenge agent, the Company intends to conduct a characterisation study. Subject to the successful completion of the characterisation study and receipt of relevant regulatory approvals, hVIVO expects to conduct Omicron human challenge studies in 2023.
The characterisation study will establish a dose of the Omicron challenge agent that will cause a safe and reliable infection in healthy volunteers. The study will enrol healthy male and female volunteers who have previously been vaccinated against or infected with SARS-CoV-2, with no known risk factors for severe COVID-19 and low levels of serum neutralising antibodies (and therefore still likely to become infected following inoculation).
hVIVO has two decades of experience and expertise in challenge agent manufacture and clinical characterisation across a range of respiratory viruses including various strains of influenza, respiratory syncytial virus (RSV), human rhinovirus (hRV – common cold virus), as well as the initial circulating SARS-CoV-2 virus and variants which have since emerged. hVIVO leads the Challenge Agent Manufacture Consortium, which has developed international standards that pertain to challenge agent manufacture and storage, to ensure safety, quality and consistency.
Yamin Khan, Chief Executive Officer of Open Orphan, said: “With our leading end-to-end human challenge expertise, we are delighted to be developing the world’s first Omicron human challenge model and to welcome Vaxart as the first client of this programme.
“hVIVO’s fight against the pandemic continues with the development of this new challenge agent. The benefits to Vaxart are immense, and we have already been contacted by a number of biopharma companies looking to test the efficacy of their products using this challenge virus. I have no doubt that the successful completion of the world’s first COVID-19 characterisation, which was published in Nature Medicine earlier this year, has given our customers the confidence to move forward with the less severe yet more infective Omicron challenge model.”
Dr. James Cummings, Chief Medical Officer of Vaxart, said: “A human challenge study of our oral tablet COVID-19 vaccine candidate against the Omicron variant of SARS-CoV-2 is the most rapid and direct way to assess the efficacy of this candidate against a highly prevalent viral strain.
“hVIVO has pioneered COVID-19 characterization and the Omicron human challenge model, and the use of this model in our planned Phase II human challenge trial will rapidly generate robust, controlled data on the ability of our COVID-19 vaccine candidate to prevent infection and the development of symptomatic disease, as well as its effect on viral shedding, which plays a critical role in the spread of infection from one person to another. The results of this study will inform the next steps in the development of our COVID-19 vaccine candidate, which has the potential to transform personal and public health approaches to controlling the global pandemic.”
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “The team and I at hVIVO are excited to begin work to manufacture an Omicron challenge agent, the follow-on characterisation, and future human challenge trials. We have unparalleled expertise in SARS-CoV-2 challenge agent manufacturing, having completed work on both the original Wuhan strain and the subsequent Delta variant, in addition to our prior experience in successfully conducting the world’s first COVID-19 characterisation study, and our decades of experience in conducting human challenge trials. We are delighted to be working with Vaxart on this programme and look forward to the opportunity to subsequently test the efficacy of their exciting novel vaccine.”
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.
For further information please contact:
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Open Orphan plc |
+44 (0) 20 7756 1300 |
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Yamin Khan, Chief Executive Officer |
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Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
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Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
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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) Paul McManus / Sam Allen / Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0)7747 515393 |
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#ORPH Open Orphan – Board appointment
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces the appointment of Martin Gouldstone as an Independent Non-Executive Director of the Company with effect from 8 June 2022.Martin will also Chair the Audit & Risk Committee and will be a member of the Nominations Committee and the Remuneration Committee.
Martin brings 30 years of corporate development experience in the CRO, healthcare and pharmaceutical sectors, holding a number of senior roles at healthcare AI businesses. Martin has expertise in executing multi-billion dollar deals across Europe and the US, architecting end-to-end portfolio out-sourcing deals, and negotiating multi-year research partnerships.
Martin is currently Global SVP, Business Development at Owkin, a French-American start-up using artificial intelligence to discover and develop better treatments for unmet medical needs. Previously, Martin has held the roles of Chief Business Officer at both BenevolentAI and Sensyne Health and was a Partner at Results Healthcare, an international M&A advisory firm, where he co-led the company’s healthcare practice. Prior to this, Martin was Head of Life Sciences for BDO UK LLP, Senior Director responsible for M&A and joint venture opportunities in Europe for Quintiles (now IQVIA), and Business Development and Licensing Lead at Confirmant Ltd, Pharmacopeia Inc, Sareum Ltd.
Martin holds a BSc in Genetics and has completed a range of post graduate management courses.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to welcome Martin to the Board of Open Orphan. Martin has extensive corporate development experience in the CRO, healthcare and pharmaceutical sectors and held a number of senior roles in healthcare AI businesses. I look forward to working closely with Martin as we drive further growth across the business.”
Martin Gouldstone, Non-Executive Director, said: “I am delighted to join the Board of Open Orphan at what is an exciting time for the Company and the infectious disease market as it continues to grow significantly post pandemic. I am delighted to bring my previous three decades of experience in the CRO, healthcare and pharmaceutical industry to the Company as it continues to build and expand on partnerships with leading global biopharma companies.”
Regulatory Disclosures
Save for the information set out above and below, there are no further disclosures to be made in accordance with Rule 17, Schedule Two (g) of the AIM Rules for Companies in respect of the appointment of Mr Martin John Gouldstone, aged 55, Martin does not hold an interest in the Company’s share capital.
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Current Directorships |
Past Directorships |
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Novara Therapeutics Limited |
n.a. |
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Orthopaedic Research UK |
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Sempiternum Ltd |
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For further information please contact:
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Open Orphan plc |
+44 20 7756 1300 |
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Yamin ‘Mo’ Khan, Chief Executive Officer |
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Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
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Ben Cryer / Edward Mansfield / Phil Walker / Will King |
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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) Paul McManus / Sam Allen / Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / +44 (0) 7502 558 258 / |
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#ORPH Open Orphan – Challenge virus manufacturing contract
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO , a subsidiary of Open Orphan, has signed a substantial contract with an existing top 5 global pharmaceutical client to manufacture a virus for use in human challenge studies.
Virus manufacturing activities have commenced and are expected to be completed by end of Q3 2022. The Company is optimistic that a characterisation study and a substantial human challenge study would follow the completion of the GMP-compliant manufacturing process. The aim of a characterisation study is to establish the right dose of the virus that causes a safe and reliable infection in healthy volunteers. The revenue for the manufacturing process will be recognised in 2022.
The manufacture of new challenge viruses ensures that hVIVO has contemporary challenge agents available to meet the needs of the global pharmaceutical industry as they continue to fight the battle against infectious disease. Furthermore, this ensures the Company continues to enhance and expand its offering of human challenge studies, especially among infectious diseases where variants continually emerge and are often poorly understood.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said : “We are delighted to have secured this challenge virus manufacturing contract, from an existing Big Pharma client. This contract is testament to our world-class capabilities in the entire challenge trial process, beginning with virus manufacture, through to characterisation study and challenge study execution. This contract illustrates our ability to leverage this to build deep, long-lasting relationships with our clients over significant periods of time.
“This contract is also a further example of the Company’s ability to secure repeat contracts from its existing base of Big Pharma clients, who have great confidence in our decades of world leading clinical trial experience. With this experience coupled with our expanded offering following the facilities expansion, I look forward to providing further clinical services support to the significantly enlarged and growing infectious and respiratory disease market.”
The Company also confirms that it has no plans to delist and is working with Liberum to complete their due diligence following their appointment as Nominated Adviser to the Company. It looks forward to confirming the completion of the required due diligence in due course.
The wording included in the announcement dated 28 April 2022 announcing the appointment of Liberum as Nominated Adviser was standard wording for all former clients of Arden Partners given the relatively short notice provided to the Company to appoint and complete take-on of a new Nominated Adviser following the recommended takeover of Arden Partners by The Ince Group plc.
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:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman Yamin Khan, Chief Executive Officer |
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Liberum Capital (Nominated Adviser and Joint Broker) |
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Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
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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) Paul McManus / Sam Allen / Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / +44 (0) 7502 558 258 / |
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