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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.”
-Ends-
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
#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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#POLB Poolbeg Pharma PLC – HC Wainwright Global Investment Conference
12 September 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 the Company’s Chairman, Cathal Friel, will be attending the HC Wainwright Global Investment Conference, which is taking place from 12-14 September at the Lotte New York Palace Hotel in New York City, NY, USA.
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, Richard Chambers, Sunila de Silva (ECM), Nigel Birks
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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.
For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.
#POLB Poolbeg Pharma – US patents granted for POLB 001 and POLB 002
26 May 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, has been granted patents by the US Patent and Trademark Office (USPTO) for POLB 001, a small molecule immunomodulator for the treatment of severe influenza and POLB 002, a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections.
POLB 001
The USPTO granted a patent for the majority of Poolbeg’s claims around the use of certain p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment or prevention of severe influenza and the hypercytokinaemia (or “cytokine storm”) it causes through modulation of the immune response (reducing the body’s hyperinflammatory response to the virus). To further strengthen its position, Poolbeg will pursue a continuation patent application to augment the protection offered by this patent family.
Poolbeg holds the worldwide rights to POLB 001 for all uses in humans and as such, is exploring the opportunity to expand its IP around this asset to cover new disease areas which would maximise the value of the asset for partnering purposes.
POLB 002
The USPTO granted a patent for the identification of defective interfering (DI) RNA-based influenza viruses for use against infection by influenza, that provides a drug candidate with both antiviral prophylactic and therapeutic applications. By having a dual mechanism of action POLB 002 (which was identified using this method) directly interferes with influenza virus replication blocking disease progression and also triggers nasal cells into an antiviral state . In this way, POLB 002 could provide pan-viral protection from respiratory virus infections including influenza, respiratory syncytial virus (RSV), SARS-CoV-2 and others.
The Company is continuing working with its patent advisors to broaden and expand the POLB 001 and POLB 002 patent families.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:
“The additional US patent protection of POLB 001 and POLB 002 is an important step in the commercialisation of these novel infectious disease products. Enhancing the IP protection of these assets across key markets such as the US increases the overall value of these products to potential partners, particularly as we move closer to the commencement of our POLB 001 LPS human challenge trial next month with data expected by year end and monetisation to commence thereafter.”
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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, James Thompson, Charlie Beeson
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+44 (0) 207 220 0500 |
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Arden Partners PLC (Joint Broker) John Llewellyn-Lloyd, Louisa Waddell
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+44 (0) 207 614 5900 |
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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 poolbeg@instinctif.com |
#ORPH Open Orphan – Completion of Nominated Adviser due diligence
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 further to the appointment of Liberum Capital Limited (“Liberum”) as its Nominated Adviser and Joint Broker on 28 April 2022, Liberum has confirmed that is has completed its due diligence .
For further information please contact:
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Open Orphan plc |
+44 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 / |
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#POLB Poolbeg Pharma – GMP manufacturing contract signed
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 an update on its lead asset, POLB 001, a small molecule immunomodulator which aims to address a significant unmet need in severe influenza. The Company has signed a contract for GMP manufacturing, ensuring ample supply of GMP grade POLB 001 for use in its upcoming LPS human challenge clinical trial, due to commence in June 2022, and for use in investigating POLB 001 as a treatment for other disease indications.
POLB 001 has potential therapeutic applications beyond severe influenza, due to its mode of action of reducing hyperinflammation which is linked with many diseases. This is when harmful inflammation occurs in different areas of the body, such as the heart and lungs, causing organ damage. POLB 001 can block this from happening. The Company holds the worldwide rights to POLB 001 for all uses in humans and as such, is in a position to expand its IP around this asset to cover new disease areas which greatly increases the value of the program for partnering purposes. Following receipt of the results from the upcoming bacterial lipopolysaccharide (LPS) human challenge trial, the Company aims to rapidly monetise POLB 001 by partnering or out licensing the product to pharma / biotech for further development and commercialization.
The GMP manufacturing of the product began in late 2021 to ensure that sufficient grade and quantities of the product is available for use in the forthcoming human challenge trial which is due to commence in June 2022, with first results expected before the end of the year. The Company now has a validated manufacturing process for the development of the product for use in its clinical development for multiple disease areas.
The Company signed the Clinical Trial Agreement with the Centre for Human Drug Research (CHDR) in March 2022 for the upcoming LPS human challenge study. As part of the study, which is being completed in line with the Company’s capital light approach, researchers will stimulate healthy volunteers’ immune systems with LPS which triggers a robust immune response acting as a simulant for the hyperinflammatory effects associated with severe influenza infections, as well as other diseases. The study will provide key human data on the efficacy of POLB 001 in dampening the immune response in otherwise healthy volunteers.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: “Preparations for the upcoming clinical trial of our lead asset, POLB 001, are progressing well and we are delighted to have executed a GMP manufacturing contract ensuring ample supply of POLB 001 for use in its clinical development for severe influenza and beyond.
With a mode of action which reduces the body’s hyperinflammatory response, POLB 001 has the potential to address several disease indications beyond severe influenza, and with our exclusive license for all human uses this could provide Poolbeg with the opportunity to greatly increase the value of the program for partnering and monetisation of POLB 001 to pharma or biotech companies.”
Note: Good Manufacturing Practice (GMP) is the regulatory code of standards that a medicine’s manufacturer must meet in its production processes to enable administration to humans.
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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, James Thompson, Charlie Beeson
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+44 (0) 207 220 0500 |
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Arden Partners PLC (Joint Broker) John Llewellyn-Lloyd, Louisa Waddell
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+44 (0) 207 614 5900 |
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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 poolbeg@instinctif.com |
#ORPH Open Orphan – Vaccine field study 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 been awarded a new study with an existing Big Pharma client to act as a vaccination site for a Phase II field study of the client’s respiratory syncytial virus (RSV) vaccine candidate.
As part of the study, hVIVO will recruit 60 healthy volunteers to the Company’s new site clinic at Plumbers Row, where they will then be inoculated with either the RSV vaccine candidate or a placebo. As opposed to a human challenge study, where volunteers would then be challenged and quarantined within hVIVO’s FluCamp facilities, these participants will then be free to leave the facilities. Participants will then be monitored for RSV symptoms over the following months, with regular clinical check-ups at Plumbers Row, to assess the efficacy of the vaccine candidate and its ability to prevent illness through RSV. The study is expected to begin in Q3 2022 with the majority of revenue from the contract recognised in 2023.
This is the first vaccine field study the Company has been awarded since it announced the expansion of its facilities on 8 March 2022 . In addition to the core human challenge studies the expansion has enabled Open Orphan to provide a larger service offering including non-first in human Phase I trials such as PK (pharmacokinetics) studies, bridging studies and Phase II trials in patients and healthy volunteers.
The volunteers for the study will be recruited through the Company’s specialist volunteer recruitment arm, FluCamp . FluCamp has decades of experience attracting suitable healthy subjects to meet recruitment requirements, primarily sourcing subjects for hVIVO trials to date. FluCamp’s large database, tech-enabled platform and recently improved screening capabilities will mean that hVIVO is able to efficiently recruit and assess potential volunteers for its client’s field studies in a timely and cost-effective manner.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said : “This is a significant award for Open Orphan as it is our first study as a site. To date we have mainly acted as a Contract Research Organisation to provide either challenge studies, laboratory or consulting services. Although we have acted as a site as part of the challenge studies, we have not provided stand-alone site services. We expanded our facilities at Plumbers Row in March of this year with the aim to provide site services. It is a great testament to the team that they have been able to fulfil site activity work in such a short timeframe. There are a great number of synergies between our core challenge study activities and new the site services, this will help us to conduct the new work in an efficient manner.”
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) |
+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 – Launch of STRiVE project
Respiratory viral strains suitable for challenge agents being collected from consenting volunteers
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 plc, has recently launched the STRiVE project (Seasonal Transmissible Respiratory Virus SurvEy) to collect respiratory viral strains suitable for challenge agents from consenting hVIVO employees. Collection of new respiratory viral strains circulating in the community will allow hVIVO to continually update and broaden its world leading portfolio of human challenge study models.
As part of STRiVE, volunteers with cold or flu like symptoms can send nasal swabs to hVIVO for analysis. Since starting the project, hVIVO has identified over 180 promising virus candidates that could be used in the manufacture of novel challenge agents for its human challenge trials. Viruses isolated include several strains of coronavirus, adenovirus, human metapneumovirus (HMPV), human rhinovirus (HRV), parainfluenza virus (PIV), influenza, and respiratory syncytial virus (RSV).
STRiVE ensures hVIVO can regularly update its challenge agent portfolio with relevant strains as viruses mutate over time. Manufacturing antigenically relevant strains on demand broadens hVIVO’s repository of viral pathogens and could help extend the range of human challenge models it currently offers.
The average UK adult has an estimated 2-4 respiratory infections each year, resulting in billions of pounds of lost output due to illness. Despite familiarity with the negative impacts of cold and flu viruses, remarkably little is understood about the hundreds of viruses responsible that cause illness, including transmission and markers of protective immunity. Using human challenge modelling to better understand such issues could enable future public health benefits and savings.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious diseases, including various strains of influenza, RSV, human rhinovirus (HRV – common cold virus), malaria, and asthma. This portfolio has also expanded to include the SARS-CoV-2 virus.
Cathal Friel, Executive Chairman of Open Orphan, said: “Despite only commencing recently, STRIVE has already been a remarkable success, with over 180 viruses identified and 12 different strains, with potential to be used as challenge agents in hVIVO human challenge trials. I would like to thank all hVIVO employees who have thus far participated and encourage more to do so in order to continue to build up this important repository for cold and flu research.
“Importantly, the STRIVE clinical research project will play a significant role in the Company’s efforts to broaden its world leading portfolio of human challenge models.”
Adrian Wildfire, Director of Scientific and Business Strategy at hVIVO, commented: “Access to viable strains of circulating respiratory pathogens is extremely limited and this often presents a significant obstacle to anyone seeking to grow a new viral challenge agent. To grow a new viral strain a virus must be collected from a human host, processed and stored in an adequate manner to keep the virus alive.
“STRIVE will allow the Company to use its expertise to monitor the viral strains of cold and flu that are circulating in the community, and potentially lead to the discovery of new, wild type challenge agents and the development of new human challenge models with unparalleled translation into the field.”
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.
For further information please contact:
| Open Orphan plc | +353 (0) 1 644 0007 | |||
| Cathal Friel, Executive Chairman | ||||
| Arden Partners plc (Nominated Adviser and Joint Broker) | +44 (0) 20 7614 5900 | |||
| John Llewellyn-Lloyd / Louisa Waddell | ||||
| finnCap plc (Joint Broker) | +44 (0) 20 7220 0500 | |||
| Geoff Nash / James Thompson / Richard Chambers | ||||
| Davy (Euronext Growth Adviser and Joint Broker) | +353 (0) 1 679 6363 | |||
| Anthony Farrell | ||||
| Walbrook PR (Financial PR & IR) | +44 (0)20 7933 8780 or openorphan@walbrookpr.com | |||
| Paul McManus/ Sam Allen / Louis Ashe-Jepson | +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 | |||
#POLB Poolbeg Pharma – Poolbeg to develop oral vaccine delivery platform
16 December, 2021- Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) a clinical stage infectious disease pharmaceutical company with a capital light clinical model, has signed a binding term sheet, encompassing all commercial terms, with AnaBio Technologies (AnaBio), with a full licence and collaboration agreement to follow.
The partnership allows Poolbeg exclusive access to AnaBio’s microencapsulation and nanoencapsulation technologies, IP and expertise for oral vaccine applications. Poolbeg will utilise this technology in conjunction with its own expertise in infectious diseases, vaccine development and its associated technologies to develop an oral vaccine delivery platform. Poolbeg will also investigate using its proprietary Vaccine Discovery Platform in conjunction with this jointly developed oral vaccine delivery platform.
Oral vaccines for diseases such as polio have been used successfully for decades by delivering antigens to specific areas of the gut with the objective of stimulating ‘mucosal immunity’, which prevents pathogens infecting the body. Oral vaccines offer an efficient method of administration, reducing significant challenges for distribution and administration addressing the gaps in supplying the global community as well as addressing needle-phobia.
Microencapsulation is key to delivering drugs to the gut and results in prolonged absorption profiles. Microencapsulation also helps to ensure the right dose of a product is absorbed by the body. Preliminary data has shown that AnaBio’s platform may be combined with dual nanotechnology to create a two-step delivery process with enhanced uptake to specific cells. This technology platform can be used to encapsulate a wide range of drugs including molecules such as proteins, peptides, DNA and RNA. As a result of the pandemic, mRNA vaccines have been one of the standout success stories in the fight against COVID-19.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: “As we have seen in the COVID-19 pandemic, the success of global vaccination drives is dependent on the effective uptake of vaccines. Oral vaccines are highly attractive due to their improved stability profiles, ease of administration, generation of mucosal immunity and being preferable to needle-phobic patients.
“The pharma sector is increasingly recognising that oral vaccines can act as standalone regimens or as boosters to injected vaccines which can struggle to generate mucosal immunity. By working with the experts at AnaBio and accessing its advanced micro and nano encapsulation technology, this places Poolbeg in a prime position to develop products for the oral vaccine market with vaccines for enteric (gut) and respiratory pathogens.”
Aidan Fitzsimons, PhD, CEO of, AnaBio Technologies, said: “The global pandemic has led to a major acceleration in vaccine development based on a deeper understanding of how to create and maintain immunity to disease; including the importance of mucosal immunity in addition to blood immunity. We believe that our patented microencapsulation technology designed to deliver intact active pharmaceutical ingredients (APIs) to specific sites within the body, combined with Poolbeg’s innate knowledge of viruses, could enable us together to create effective oral vaccines and make a significant impact on the vaccine market.”
– Ends –
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+353 (0) 1 644 0007 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson
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+44 (0) 20 7220 0500 |
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Arden Partners PLC (Joint Broker) John Lewellyn-Lloyd, Louisa Waddell
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+44 (0) 207 614 5900 |
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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 |
+44 (0) 20 7457 2020 |
#ORPH Open Orphan – Imutex Vaccine Phase I Study Results
AGS-v PLUS mosquito vaccine candidate shows favourable safety, tolerability, and immunogenicity results
Results to be presented at the American Society of Tropical Medicine and Hygiene Annual Meeting
Open Orphan plc (AIM: ORPH) announces that data from the first-in-human Phase I clinical study evaluating the safety, immunogenicity, and in vitro efficacy of AGS-v PLUS, Imutex Limited’s (“Imutex’) mosquito saliva vaccine candidate against arboviral diseases, as well as data on the candidate’s effect on the reproductive capacity of mosquitoes that fed on vaccinated subjects will be presented on the 20th and 21st of November 2021. Imutex Limited (“Imutex”) is a joint venture with PepTcell Limited (“PepTcell”) (the legal name of SEEK Group) in which Open Orphan has a 49% shareholding.
The results will be presented in two virtual sessions at the American Society of Tropical Medicine and Hygiene (“ASTMH”) Annual Meeting, held from 17-21 November 2021. The titles and details of the two presentations are as follows:
· “Blood feeding on humans vaccinated with AGS-v PLUS, a mosquito salivary peptide vaccine, impairs the reproductive capacity of female Aedes albopictus mosquitoes” – Scientific Session 91: Mosquitoes-Vector Biology Epidemiology I, at 8.00 am (ET) on 20 November 2021. To be presented by Joshua Lacsina, M.D., Ph.D. of the Laboratory of Malaria and Vector Research at the National Institute of Allergy and Infectious Diseases.
· “Safety and immunogenicity of AGS-v PLUS, a mosquito saliva peptide vaccine against arboviral diseases” – Scientific Session 126: Clinical Tropical Medicine: Vector borne Disease, at 8.00 am (ET) on 21 November 2021. To be presented by DeAnna J. Friedman-Klabanoff, M.D. of the University of Maryland School of Medicine.
Following the presentations, Imutex expect to publish the results from the study in a scientific peer-reviewed journal.
Imutex was funded by the Department of Health and Social Care as part of the UK Vaccine Network (UKVN), a UK Aid programme to develop vaccines for diseases with epidemic potential in low and middle-income countries (LMICs) to carry out this study.
Data from this study, which was performed at the University of Maryland School of Medicine (Baltimore, Maryland, U.S.) and is related to a collaboration between PepTCell and The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), demonstrated that AGS-v PLUS was well tolerated with no serious adverse events experienced, and that it generated a strong immune response in participants. AGS-v PLUS showed a more robust immune response compared to AGS-v, a first-generation vaccine candidate developed by Imutex. The study evaluating the effect of AGS-v PLUS on the reproductive capacity of mosquitoes that fed on vaccinated subjects found that a regimen of the vaccine in combination with an adjuvant resulted in fewer eggs laid and adult progeny in the species Aedes albopictus.
Imutex’s AGS-v and AGS-v PLUS vaccine candidates are mosquito-borne disease vaccines with a novel proposed dual action mechanism of preventing infection in humans whilst controlling the mosquito population. AGS-v is composed of four synthetic peptides isolated from mosquito salivary glands. The AGS-v PLUS vaccine contains the same four peptides as AGS-v but adds a fifth synthetic peptide found in the saliva of many mosquitoes, increasing the potential breadth of protection.
Mosquito-borne diseases include Zika virus, West Nile virus, chikungunya virus, dengue, yellow fever, and malaria. There are around ~360 million cases of and more than 600,000 deaths from mosquito-borne diseases annually, although the true burden is likely underestimated. A vaccine efficacious against multiple mosquito-borne diseases could significantly impact public health.
Imutex is focused on developing broad-spectrum vaccines against influenza (flu) and mosquito borne diseases. To find out more about the product developments, both in influenza vaccine development (FLU-v) and in Zika vaccine development (AGS-v), please visit the Imutex website: www.imutex.com
Cathal Friel, Executive Chairman of Open Orphan, said: “The Company has been eagerly anticipating the results from Imutex’s first-in-human Phase 1 clinical trial for its AGS-v PLUS mosquito vaccine candidate, and we now look forward to the data being presented at the upcoming ASTMH Annual Meeting.
“The positive data for the AGS-v PLUS mosquito vaccine candidate is encouraging; data showed AGS-v PLUS was well tolerated and generated a strong immune response in participants against mosquito-borne diseases, with an increased immune response compared to the four peptide AGS-v candidate. Imutex’s AGS-v and AGS-v PLUS vaccine candidates both employ a novel proposed dual action mechanism that prevents infection in humans whilst controlling mosquito population by limiting transmission.
“There are more than 600,000 deaths worldwide per year from mosquito borne diseases, as such, if these positive Phase I results translate into clinical efficacy, the potential number of lives saved will be significant.”
Dr Olga Pleguezuelos, Chief Science Officer at PepTcell, commented: “We are very excited about the study results. AGS-v PLUS was demonstrated to be safe and immunogenic, and not only impacted the pathogenicity of the Zika virus as seen in an in vitro assay, but also reduced the number of eggs and adult progeny of mosquitoes that fed on vaccinated subjects. The next step is to evaluate clinical efficacy in a controlled human challenge study or in a study in endemic areas. Many mosquito-borne diseases lack effective preventative and therapeutic treatments, so AGS-v PLUS could potentially save many lives.”
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.
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 |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Louisa Waddell |
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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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