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#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:

 

Open Orphan plc

+44 (0) 20 7756 1300

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

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)

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

#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.

Current Directorships

Past Directorships

Novara Therapeutics Limited

n.a.

Orthopaedic Research UK

Sempiternum Ltd

For further information please contact:

 

Open Orphan plc

+44 20 7756 1300

Yamin ‘Mo’ Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer / Edward Mansfield / Phil Walker / Will King

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)

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 

#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.”

 

– Ends –

Enquiries

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

 

+44 (0) 207 183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson
Richard Chambers, Sunila de Silva (ECM)

 

 

+44 (0) 207 220 0500

Arden Partners PLC (Joint Broker)

John Llewellyn-Lloyd, Louisa Waddell

 

 

+44 (0) 207 614 5900

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

 

+44 (0) 20 7457 2020

poolbeg@instinctif.com

#ORPH Open Orphan – Wellcome publication

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, notes a key considerations document for developing and manufacturing challenge agents published in the Wellcome Open Research Journal co-authored by Alex Mann, Senior Director of Clinical Research of hVIVOand the project lead, a subsidiary of Open Orphan plc, titled ‘Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents For Use In Human Infection Models’.

The project was funded by the Wellcome Trust and HIC-Vac, an international network of researchers who are developing human infection challenge (HIC) studies to accelerate the development of vaccines, based at Imperial College London. The considerations document was prepared by an hVIVO led consortium, involving engagement with global experts in the human challenge field and manufacturing. It outlines the key aspects of the development, characterisation and manufacture of infectious challenge agents. The aim of the document is to promote volunteer safety whilst maximising access to challenge agents and challenge models in low-income or middle-income countries (LMICs) and academic institutions globally.

It is hoped that these considerations will be used across high-, middle- and low-income countries for the safe production of challenge agents by trained personnel with appropriate facilities, quality control measures and other best practices.

The increase in human challenge studies being established in LMICs and the need for challenge agents to reflect naturally occurring and epidemiologically relevant pathogen strains means there is an increased likelihood that they will be manufactured in conditions where full Good Manufacturing Practice (“GMP”) is not possible. This document fills the previous gap of clear guidance on the minimum requirements for high-quality and safe manufacture outside of GMP facilities.

Challenge agents are the viruses, parasites, bacteria used in human challenge trials that volunteers are purposely challenged with. Depending on the design of the trial, the volunteers may or may not be administered a trial drug candidate before or after being exposed to the challenge agent to provide early proof of concept, allowing the candidate to progress more quickly to phase II or phase III trials.

Wellcome Open Research provides all Wellcome researchers with a place to rapidly publish any results they think are worth sharing. All articles benefit from rapid publication, transparent peer review and editorial guidance on making all source data openly available.

Yamin Khan, Chief Executive Officer of Open Orphan, said:  “As the world leader in conducting human challenge studies I am delighted that Open Orphan continues to play a key role in democratising access to human challenge trials. This latest document provides clear considerations for challenge agent manufacturing, where previously a gap existed regarding the minimum requirements for high-quality safe manufacture outside of GMP facilities. Human challenge trials have clear advantages over traditional clinical field trials, and their global adoption will be vital to progressing the development of vaccines and anti-infectives around the world.”

 

Alex Mann, Project leader and Senior Director, Clinical Science at hVIVO, said: “I was pleased to co-author the considerations document and the associated summary publication in collaboration with the Wellcome Trust and HIC-Vac, that recommends key aspects for researchers to consider for challenge agent development and manufacturing. In recent years, there has been an increase in human challenge studies in low- or middle-income countries where GMP facilities are not readily available. This document will support the development, characterisation and manufacture of challenge agents in these settings, while also maximising volunteer safety and access to challenge agents and challenge models.”

 

Shobana Balasingam, Research Lead in Infectious Disease Prevention at Wellcome, said: “The guidance to manufacture safe and effective challenge agents under GMP conditions differs globally and is not always feasible, which can slow down vital research, particularly in low- and middle-income countries where this research is often most-needed. However, guidelines for manufacturing outside of GMP facilities are not currently available.

 

“As funders of global infectious disease research, Wellcome are please to support this clear and practical document for developing challenge agents where GMP is not possible. This guidance can ensure the full potential of human infection studies around the world, which provide crucial insight into infectious diseases, helping to rapidly accelerate the development of vaccines.”

 

An editorial will be published alongside the report: ‘Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents For Use In Human Infection Models’ by Shobana Balasingam, Sarah Meillon, Cecilia Chui, Alex Mann, Carine La, Charlie Weller, Debbie King and Emma Smith. Available in Wellcome Open Research. DOI: https://doi.org/10.12688/wellcomeopenres.17869.1

 

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:

 

Open Orphan plc

+353 (0) 1 644 0007

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

 

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)

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

#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:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

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)

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  

#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:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

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)

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  

#ORPH Open Orphan – Appointment of Nominated Adviser and Joint Broker

Open Orphan

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 announcements by Arden Partners Plc on 11 and 14 April 2022 regarding the loss of its Nominated Adviser status upon the completion of its recommended takeover, the Company has appointed Liberum Capital Limited (“Liberum”) as its Nominated Adviser and Joint Broker. Given the timing of the completion of the recommended takeover of Arden Partners Plc, the Exchange has agreed that subject to initial due diligence being undertaken, Liberum has until 5pm on 27 July 2022 to complete its full due diligence.

There can be no guarantee on the outcome of the full due diligence and its impact on Liberum’s decision to continue to act as Nominated Adviser. Accordingly, in such circumstances there is a risk that if the Liberum does not continue to act as Nominated Adviser following completion of its full due diligence and the Company has not found an alternative Nominated Adviser, the Company’s AIM securities may be suspended pursuant to AIM Rule 1. If within one month of that suspension, the Company has failed to appoint a replacement Nominated Adviser, the admission of its AIM securities will be cancelled.

Notwithstanding the extension of time provided in respect of completing full due diligence obligations at engagement, Liberum will continue to be subject to all the ongoing Nominated Adviser responsibilities under the AIM Rules for Nominated Advisers.

finnCap plc and Davy will continue to act as the Company’s Joint Brokers.

Yamin ‘Mo’ Khan, Chief Executive Officer at Open Orphan, said: As the market is aware, Arden Partners can no longer act as Nomad for listed companies from 29 April 2022 and as such, we thank them for their support over the past number of years. We are delighted to now be working with such a prestigious investment bank as Liberum.”

 

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

  +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

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)

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  

#POLB Poolbeg Pharma – Key POLB 002 European Patent Granted

Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, provides an update on the strengthening of its intellectual property (IP) for its asset POLB 002, a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections.

 

In January this year, Poolbeg secured an exclusive licence for the dual antiviral prophylactic and therapeutic candidate, which is being developed as POLB 002. Data suggests it could provide pan-viral protection from respiratory virus infections including influenza, respiratory syncytial virus (RSV), SARS-CoV-2 and others. As a nasally administered and rapidly effective prophylactic antiviral candidate, it could potentially provide an effective solution for protecting at risk patient populations (e.g. the elderly, COPD patients, and asthmatics).

 

The European Patent Office has granted this important patent in the POLB 002 patent family, which protects the use of a defective interfering (DI) influenza virus against infection by influenza. POLB 002 works by triggering nasal cells into an antiviral state using DI influenza that resembles the infectious influenza virus but doesn’t have the ability to replicate and therefore can provoke an appropriate immune response but does not cause an infection. The Company will continue working with its patent advisors to broaden and expand this patent family, including the method by which defective interfering antiviral agents can be identified. Discussions with patent authorities in other jurisdictions, including the US, are continuing with further positive announcements expected following a recent ‘Notice of Allowance’ communication from the US patent authorities.

 

The development of POLB 002 and these patent updates come at a critical time with a global focus on respiratory virus infections and when such viruses are considered a top five global killer, resulting in more than three million annual deaths worldwide. The pandemic potential of influenza continues to be monitored closely by the global health authorities, while the World Health Organization (WHO) and infectious hazard experts have guided that there is statistical certainty that a future influenza pandemic can be expected. The CDC has advised that early action and effective preparedness are absolutely essential to mitigating risk, hence highlighting the importance of developing vaccines, prophylactics and antiviral treatments against viruses; with pan-viral products offering an important solution.

 

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: “The granting of this patent marks an important step in our development and protection of this important respiratory virus disease treatment. Data for POLB 002 shows it is able to both prevent viral infections and rapidly reduce viral loads where infection has occurred, improving disease symptoms and aiding recovery. This makes it an attractive candidate in a market where a significant unmet need for the treatment of most respiratory virus infections still exists.

 

“Our patent portfolio in Europe, US and elsewhere for POLB 002 are growing as part of our overall strategy to enhance the protection of Poolbeg’s assets and we look forward to updating shareholders on future patent grants.”

 

– Ends –

Enquiries

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

+44 (0) 207 183 1499
finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson
Richard Chambers, Sunila de Silva (ECM)

 

+44 (0) 207 220 0500
Arden Partners PLC (Joint Broker)

John Llewellyn-Lloyd, Louisa Waddell

 

+44 (0) 207 614 5900
J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363
Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

+44 (0) 20 7457 2020

poolbeg@instinctif.com

 

Open Orphan #ORPH – Presentation at World Vaccine Congress

open orphan

Presentation at World Vaccine Congress 

hVIVO presents on the outcomes from the world’s first COVID-19 characterisation study

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 Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, a subsidiary of Open Orphan plc, will be delivering a presentation at the World Vaccine Congress, Washington D.C., United States, titled ‘Outcome of the world’s first SARS-CoV-2 viral challenge and its utility for vaccine testing’. 

Dr Catchpole will be presenting the results from the world’s first COVID-19 characterisation study, which was a partnership between hVIVO, Imperial College London, the Vaccine Taskforce and Department of Health and Social Care (DHSC), and the Royal Free London NHS Foundation Trust. The landmark study, published in Nature Medicine on 31 March 2022, found that a SARS-CoV-2 human challenge is safe in healthy young adults and provided detailed insights into the course of COVID-19 infection with potential positive public health implications, which will also be outlined in Dr Catchpole’s presentation. 

Full details of the presentation are included below: 

Title

Outcome of the world’s first SARS-CoV-2 viral challenge and its utility for vaccine testing

Date/Time

Wednesday 20 April 2022, 09.40 am (ET)

The World Vaccine Congress will take place at the Marriott Marquis in Washington DC between 18-21 April 2022. hVIVO will be at booth 410 during the congress for potential partnering discussions. 

The World Vaccine Congress is the largest and most established meeting dedicated to vaccines and has run for 21 years. In that period, it has evolved and grown into the leading vaccines congress globally, with hundreds of speakers and thousands of attendees from leading global vaccines developers, academia and policymakers. 

More information about the event, including attendance, can be found here . 

Yamin ‘Mo’ Khan, Chief Executive Officer at Open Orphan, said: “I am delighted that Andrew will be presenting at the largest vaccine event of the year, highlighting the pivotal role hVIVO played in the world’s first COVID-19 characterisation study.”  

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: 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman
Yamin ‘Mo’ Khan, Chief Executive Officer

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)

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 515 393

#POLB Poolbeg Pharma – Proposal to Purchase Shares from Distribution in Specie Shareholders

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 a number of new investors (“New Investors”) have expressed interest in acquiring up to £1.6m of Poolbeg Pharma plc shares which are currently locked-up and held in trust by Croft Nominees Limited (“Croft”) as a result of the distribution in specie from Open Orphan plc (“Open Orphan”) on 18 June 2021.

 

As part of these proposals, the New Investors have committed to purchase up to £1.6m of the distribution in specie shares on or around 26 April 2022 at a price of 5.9 pence per share, the closing market price on Friday 8 April 2022. There is strong demand from these New Investors in acquiring shares in the Company, with the largest individual investor being an experienced life science investor. The New Investors have shown great interest in the Poolbeg story, its significant progress since IPO in July 2021, and its capabilities in developing novel products utilising its unique cost-effective model in the fast-growing infectious disease market which is expected to be worth in excess of $250bn by 2025. This is a clear vote of confidence in the Company’s prospects as it enters an extremely exciting phase of its development with its first human challenge clinical trial due to commence in June 2022 with multiple value inflection points expected in 2022 and beyond.

 

This process will allow the locked-up distribution in specie shareholders in Poolbeg the opportunity to sell part or all of their shareholding, should they wish to do so, prior to receiving the shares once the lock-up period ends on 20 April 2022. Poolbeg ended 2021 well capitalised with a strong cash balance of £20.9m so it is important to note that the Company is not raising any new funds as part of this process and, as such, there will be no dilution of existing shareholders.

 

The distribution in specie shareholders will receive a letter setting out the New Investors’ proposal and a Form of Election informing them how to participate should they wish to sell some or all of their shares prior to the lock-up ending on 20 April 2022. These proposals are open to all distribution in specie shareholders but participation is at each distribution in specie shareholder’s discretion, and the Company recognises that many distribution in specie shareholders are committed to holding their shares long term. For those shareholders who do not participate, the title to their distribution in specie shares will be transferred to them on or around 26 April 2022. If more than £1.6m is offered by way of valid Forms of Election, then the distribution in specie shareholders will be scaled back on a pro-rata basis. A copy of the letter to distribution in specie shareholders can be found on the Company’s website here and an FAQ is available here.

 

The Directors are delighted by the clear vote of confidence being given by these New Investors in the Company and are confident that many of the existing distribution in specie shareholders will remain invested in the Company going forward based on the multiple value inflection points expected in 2022 and beyond combined with the positive developments and significant progress on its strategy since its IPO in July 2021 including:

 

  • Progressing the clinical development of its POLB 001 programme for severe influenza which is due to commence in June 2022 with first data from its forthcoming LPS human challenge clinical trial expected before the end of 2022 at which point the Company aims to rapidly monetise by partnering or out licensing the asset to pharma / biotech for further development;
  • Delivering on its plans to leverage its proprietary databank of human challenge study derived disease progression data to identify new pharmaceutical assets using artificial intelligence (AI), by signing deals with two leading AI firms. Preliminary outputs from the RSV Artificial Intelligence Discovery Programme are expected in H2 2022;
  • Obtained licensed access to use micro- and nanoencapsulation technology to develop oral vaccines for multiple disease indications;
  • In-licenced a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002) to its portfolio;
  • Signed an option to licence a vaccine against the tropical and subtropical disease Melioidosis (POLB 003), while also evaluating a further 5 bacterial vaccine candidates; and
  • Successfully commenced trading on the OTCQB market in the US in March 2022, a first step towards its ambition and strategy to dual-list on a national securities exchange in the US, such as Nasdaq, subject to meeting their listing requirements.

 

Cathal Friel, Chairman at Poolbeg Pharma said: We are delighted to see this significant interest from new investors in committing to purchase up to £1.6m of the distribution in specie shares at the market price the day before this announcement, Friday 8 April 2022, which was 5.9 pence. Coming mainly from high-net-worth family offices, our new investors have shown great interest in the Poolbeg story, our significant progress since IPO, and our capabilities in developing novel infectious disease products utilising our unique cost-effective model. The Company is well capitalised with c. £20.9m at year end 2021, and given its capital light business model is therefore well funded with a long cash runway.”

 

“This arrangement has followed significant efforts from the Poolbeg team to help widen our investor base, increase future liquidity, and maximise shareholder value over the long-term. Due to the nature of the lock-up period, which was designed to allow for an orderly market following our admission to AIM, prospective investors looking to build more substantial stakes were unable to do so. These proposals ensure that any potential shares sold will be going to quality, long-term holders, whilst giving distribution in specie shareholders the option to sell shares prior to the end of the lock-up period, if they choose to do so. In addition, there will be substantially greater liquidity in our shares once the distribution in specie shares have been distributed after 26 April 2022 and we believe this will certainly help us to attract in even more new shareholders.”

 

“As outlined previously, we have started to put in place a number of strategic initiatives so as to widen our investor base, help drive future liquidity and build shareholder value for the long term. These include todays proposal to locked-up distribution in specie shareholders following strong demand from new investors, our recent commencement to trading on OTCQB market in the US. We also received permission at the annual general meeting on 4 April 2022 for potential future buybacks using the Company’s funds should it be in the best interest of all shareholders.”

 

“We have made excellent progress post IPO and I am confident that the Company has a very bright future.”

 

 

Footnote

The distribution in specie shares were issued to all Open Orphan shareholders on the share register at close of business on 17 June 2021, following this, Poolbeg successfully listed on the London Stock Exchange AIM market on 19 July 2021. While the underlying shareholders retain the beneficial ownership of the shares, the distribution in specie shares are currently held in trust by Croft during a lock-up period of nine calendar months from Poolbeg’s admission to AIM, to contribute to the creation of an orderly market. This lock-up period will end on 20 April 2022 and on or around 26 April 2022, shareholders will be sent a share certificate for the distribution in specie shares. Shareholders will then have the option to dematerialise and hold the shares via CREST. If any Open Orphan shares that gave rise to the entitlement to the distribution in specie shares are held in a nominee account, the share certificate will be sent to the shareholders’ broker.

 

The New Investors’ proposals are not open for participation by persons interested in shares who are residents or citizens of or who have an address in, or who otherwise appear to the Company or SLC Registrars to be connected to, the United States (or any of its territories or possessions), Canada, Australia, Japan, Belarus or Russia.

 

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.

 

– Ends –

Enquiries

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

+44 (0) 207 183 1499
finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson
Richard Chambers, Sunila de Silva (ECM)

 

+44 (0) 20 7220 0500
Arden Partners PLC (Joint Broker)

John Llewellyn-Lloyd, Louisa Waddell

 

+44 (0) 207 614 5900
J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

+353 (0) 1 679 6363
Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

+44 (0) 20 7457 2020

poolbeg@instinctif.com

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