Poolbeg Pharma Regulatory News (POLB)

Poolbeg Pharma plc

Confirmation that the licence to develop oral vaccine delivery platform has been executed

31 January, 2022 - Poolbeg Pharma (AIM: POLB, 'Poolbeg' or the 'Company') a clinical stage infectious disease pharmaceutical company with a capital light clinical model, confirms that it has signed the licence to AnaBio Technologies' ('AnaBio') microencapsulation and nanoencapsulation technologies to develop an oral vaccine delivery platform.

This follows the binding term sheet announced on 16 December 2021. This licence provides Poolbeg with exclusive access to AnaBio's microencapsulation and nanoencapsulation technologies for use in the development and commercialisation of vaccines. Combined with the Company's expertise in infectious diseases and vaccine development, Poolbeg will use this technology as a platform to complement its existing and growing pipeline of assets by developing oral vaccines for multiple disease indications.

Oral vaccines have been used successfully, but in a limited way, for decades, such as in the prevention of polio and typhoid. Broadening the range of diseases with oral vaccines available is beneficial as they can provide enhanced benefits by delivering antigens to specific areas of the gut, triggering the development of 'mucosal immunity' which prevents pathogens from infecting the body. The COVID-19 pandemic has accelerated demand for innovation in the development of vaccines, and oral vaccines offer many advantages having improved vaccine stability profiles, easier global distribution and administration as well as tackling the issue of needle-phobia.

This is the latest in several licence agreements that Poolbeg has completed since its IPO in July 2021, demonstrating delivery against commitments made at the time of listing. The Company's pipeline of assets continues to expand and is increasing in diversity with the addition of this innovative oral vaccine delivery platform. This latest licencing agreement follows swiftly on the back of a series of other recently announced potentially ground-breaking infectious disease asset deals. This includes the first-in-class, intranasally administered, RNA-based immunotherapy for respiratory virus infections announced on 17 January 2022 (POLB 002). In December 2021 the Company announced that it had successful signed an option agreement to licence an intramuscular Melioidosis vaccine (POLB 003). Melioidosis is a disease which presents a dangerous and underappreciated threat to human health which currently has no approved vaccine and a very high mortality rate and in addition, concerns are growing around global warming contributing to the spread of the disease to traditionally non-tropical areas. These new assets are in addition to the Company's lead programme, POLB 001, a treatment for severe influenza. Post-pandemic the global community recognises the importance of vaccines and treatments against infectious disease and governments are hugely increasing their investment into influenza pandemic preparedness.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:

"Vaccine uptake is a critical factor in the effectiveness of combating communicable infectious diseases, something that the COVID-19 pandemic has shown in recent months. Oral vaccines bring significant benefits both in terms of the logistics required to distribute and administer them, but also in how the body responds through creating mucosal immunity in the gut and acting as a barrier to the infection.

"This licencing deal with AnaBio and the access to its advanced micro- and nano-encapsulation technologies will enable Poolbeg to develop an oral vaccine delivery platform from which to complement an already diverse pipeline of treatments and vaccines against infectious diseases."

Aidan Fitzsimons, PhD, CEO of, AnaBio Technologies, said:

"This is a really exciting opportunity to apply AnaBio's patented micro-encapsulation technology, which has been shown to facilitate absorption of Active Pharmaceutical Ingredients (API's) through the gut, in the development of an oral vaccine. Micro-encapsulation is a process which involves coating microscopic particles of an API with a protective layer enabling the API to travel safely through the digestive system, and be absorbed across the gut in a bioavailable form. Combining AnaBio's proven micro-encapsulation technology and Poolbeg's vaccine and immunology expertise puts us both in a great position to deliver a genuine breakthrough innovation in oral vaccine development."

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Enquiries

About Poolbeg Pharma

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a "one-stop shop" for Big Pharma seeking mid-stage products to licence 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. It already has a Phase II ready repositioned small molecule immunomodulator for severe influenza and a portfolio of other exciting assets. The Company plans to broaden this portfolio further going forward and is in active discussions with AI data analysis platforms to help accelerate the power of its human challenge model data and biobank.

For more information, please go to www.poolbegpharma.com or follow us @PoolbegPharma

About AnaBio Technologies

AnaBio Technologies is a specialist microencapsulation company, focussed on improving health and performance through micro-encapsulation of sensitive bioactive ingredients for food, beverage and pharmaceutical applications. Founded in 2011 by Dr Sinead Bleiel, and based in Carrigtwohill Co Cork, AnaBio has developed into a global leader in the field of micro encapsulation with 15 patent families and clients across N America, Asia, and EU.

Bioactives and APIs clearly bestow health benefits, but are vulnerable to being inactivated by environmental stresses encountered during processing, storage and digestion. This can result in limited quantities of intact active bioactives reaching the site of action in the body, and no health benefit.

Microencapsulation represents a sophisticated delivery system designed to overcome this problem. A protective coat is created at microscopic level around the bioactive or API which protects the ingredient from a wide range of environmental conditions, enables its release at the appropriate site within the body, and thereby ensures that the potential health benefits of the bioactive are fully realised.

AnaBio Technologies offers its clients a range of services including contract research to develop bespoke microencapsulation solutions, commercial scale manufacture and supply of microencapsulated ingredients and licencing of its patented microencapsulated technology

For further information visit www.anabio.ie or email aidan.fitzsimons@anabio.ie.