Delivering immune stimulating antigens to specific areas of the gut, using proprietary encapsulation technologies, with the objective of activating protective ‘mucosal immunity’

By delivering vaccines to the gut, oral vaccines can trigger ‘mucosal immunity’ which prevents pathogens infecting the body by producing a protective response in the areas of the body where there is a high level of infectious threat, such as the gut and respiratory system, and prevents the transmission and growth of pathogens that cause disease.

In comparison to intramuscular injections which generate systemic immunity (individuals become infected before blood-borne immunity can take effect), the oral vaccine approach prevents infections from taking hold in the body by counteracting them at the point of entry.

In January 2022, we acquired an exclusive license to AnaBio’s encapsulation technology for oral vaccine delivery.

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Benefits of Oral Vaccines

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EncOVac, a consortium led by Poolbeg Pharma, was awarded €2.3 million in grant funding under the Irish Government’s Disruptive Technologies Innovation Fund (‘DTIF’) to develop a Phase I clinical trial ready oral vaccine candidate.

This three-year collaboration between Poolbeg Pharma, University College DublinTrinity College Dublin and AnaBio Technologies will result in a technology which will serve as a platform for additional oral vaccine candidates for a wide range of pathogens, initially targeting bacterial infections.

Validation of the encapsulation process is progressing well and once this has been successfully validated, the consortium will proceed to encapsulate vaccine antigen candidates developed by Associate Professor Siobhán McClean at University College Dublin together with adjuvants identified by Professor Ed Lavelle at Trinity College Dublin. This oral vaccine candidate will then complete all required non-clinical testing in preparation for a Phase I clinical trial.

“Oral vaccines are currently only available to treat a small number of pathogens and a more comprehensive approach to vaccine development is needed to design new, safe, and effective oral vaccines. Such a system would revolutionise our approach to protecting people from infectious diseases, unleashing their full potential.”

Prof Luke O’Neill, Non-Executive Director, Scientific Advisory Board and Project Advisory Board Chair

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First-in-class broad spectrum RNA-based immunotherapy for respiratory virus infections

Respiratory Virus Infections in Numbers

Seasonal

5-20%

of global population infected by seasonal outbreaks

Worldwide Deaths

3M+

annual deaths worldwide

5 30

Top 5

global cause of death

Respiratory virus infections are considered a top five global cause of death, resulting in more than three million annual deaths worldwide. Current treatments, vaccines and antiviral drugs are typically created for specific pathogens making resistance over time a major concern. By triggering nasal cells we can help protect against and treat the virus as well as preventing it from spreading within the body. This reduces both the amount of virus affecting a person and the symptoms of the disease.

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First-in-class broad spectrum RNA-based immunotherapy

Poolbeg Pharma has secured an exclusive licence to this dual antiviral prophylactic and therapeutic candidate, which is at a late-pre-clinical development stage. In vivo data confirms that this immunotherapy asset targets pan-respiratory virus infections, which could include influenza, respiratory syncytial virus (RSV), SARS-CoV-2 and others.

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The candidate was developed at the University of Warwick and derived from twenty years of research by world class virologists, Professor Andrew Easton and Professor Nigel Dimmock.

Administered intra-nasally, this RNA-based immunotherapy works by triggering nasal cells into an antiviral state to protect against the infecting virus. Simultaneously, it blocks the cells from making more virus by directly preventing its replication. Both modes of actions combined can reduce infectious viral loads and improve disease symptoms. 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).

Melioidosis – the Disease

  • Burkholderia pseudomallei causes severe disease in humans & animals
  • Infection routes: inhalation, percutaneous inoculation (through an open wound), & ingestion (food or water)
  • Treatment: lengthy antibiotic treatment for up to 6 months
  • Antibiotic resistant
  • Significant underreporting of cases
  • CDC designated biothreath – stockpiling potential
  • Global warming expected to change disease epidemiology
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165,000

estimated cases per annum

Ribbon

54%

of cases are fatal

No Syringe

0

vaccines available

Late pre-clinical stage Melioidosis Vaccine Candidate

A new approach

Through an extensive characterisation of the protein structures present on the bacteria’s surface, the team at University College Dublin identified a homologue of the common OmpW bacterial antigen specific to this strain, called BpOmpW. Preclinical studies using this antigen showed significant survival benefit when challenged with the bacteria. Similarly, so-called correlates of protection, which provide an indication of the protection status of a subject, were much improved including increased IFN-γ production and an enhanced T-Cell response profile, both of which have a proven role in protection against Melioidosis.

Poolbeg in-licensed the product in September 2022.

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Efficacy data

  • 75% survival rate of immunized mice over 81 days
  • Subsequent characterisation of immune responses confirmed T-cell (CD25 and CD44 activation) and B-Cell responses required for an effective vaccine
  • As diabetes is a substantial comorbidity, a standalone insulin resistance mouse model was created that demonstrated activation markers and cytokine production associated with immunoreactivity, giving confidence of translation to this vital patient sub-population
Burkholderia Pseudomallei

Burkholderia pseudomallei

Safety data

  • No safety signals in GLP toxicology study 
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Poolbeg Pharma has a unique biomarker platform in development which may be used to identify those at risk of developing severe disease.

Human challenge trials were conducted with front loaded sample collection time points to interrogate the earliest signs of disease following infection. Poolbeg Pharma has identified a set of biomarkers that can predict the severity of disease a patient will suffer before the onset of symptoms. 

Current antiviral treatments can be given prophylactically to at-risk populations exposed to an infected individual. These treatments can cause adverse effects and are often layered on top of existing medications in these treatment groups. The ability to reliably predict disease severity may be used to triage existing patient groups in addition to use in the general population following exposure to individuals known or suspected to be infected with highly pathogenic viral strains.

ViralPredict™ will provide valuable information for assessing the best course of treatment for viral disease. It has the potential to help early interventions when needed and to reduce the spread of disease, even amongst those who are unaware they are infected – the importance of which has become very clear during the COVID-19 global pandemic.” Dr Jeremy Skillington, CEO

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The Vaccine Discovery Platform is a patent-protected challenge model-derived discovery platform to identify new vaccine candidates by isolating protective elements of the naturally occurring immune response associated with recovery.

Epitopes are the molecular elements of an antigen that the adaptive immune system identifies and responds to during an infection. The human immune system can recognise an endless variety of epitopes via diverse antibody and T cell receptors. In contrast to antibodies which recognise antigens exposed on the surface of a pathogen in their natural state, T cells recognise epitopes which are presented by major histocompatibility complex class I (MHC I) protein. To be presented on an MHC I protein, a pathogen must be engulfed by an immune cell and broken down in small fragments by chemical means, consequently it can be difficult to identify or predict the correlates of T cell immunity. 

The human challenge trial offers an ideal setting to isolate pathogen-specific cells which can be used to identify reactive epitopes.  Traditional vaccine design has focused predominantly on stimulating B cell antibody-mediated immunity. We and others have shown that T cell immunity is critical for immunity to viral infections and the Vaccine Discovery Platform is set to reveal effective correlates of immunity following natural infection. 

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