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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

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

 +44 (0) 20 7183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson,

Richard Chambers, Sunila de Silva (ECM), Nigel Birks

 

+44 (0) 20 7220 0500

Singer Capital Markets (Joint Broker)

Phil Davies, Sam Butcher

 

+44 (0) 20 7496 3000

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

 

 

 

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.

#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

Open Orphan #ORPH – Controlled Human Infection Studies Report following March Webinar

Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.

 

Report follows March Webinar run by hVIVO with HIC VAC, Wellcome Trust and IABS

Highlights:

  • Applicable local, national and regional guidelines on manufacture and use of challenge agents must be considered.
  • As challenge agents are biological products, ICH guidelines should be followed.
  • GMP contributes to the right execution of a process duly designed, developed and declared in the CMC documentation.
  • Good documentation practice is critical, for adherence to procedures and regulatory requirements and process reconstruction.
  • For challenge agents, a case-by-case approach should determine the extent of quality data (CMC and GMP) to be applied.

Full article here: https://www.sciencedirect.com/science/article/pii/S1045105621000737

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