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#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

 

Poolbeg Pharma #POLB – POLB 001 Clinical Development – Clinical Trial Agreement Signed

31 March, 2022Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’) announces that it has signed a Clinical Trial Agreement with the Centre for Human Drug Research (CHDR) in the Netherlands for the completion of a bacterial lipopolysaccharide (‘LPS’) human challenge study of POLB 001, which is due to commence in June 2022. First results are 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.

As part of this study, which is being completed in line with the Company’s capital light approach, researchers will stimulate the immune systems of healthy volunteers with LPS in a safe and controlled clinical environment. LPS emulates a robust immune response acting as a simulant for the hyperinflamPOmatory effects associated with severe influenza infections which CHDR will use to measure the efficacy of POLB 001 as its mode of action is to block this hyper-immune response. This differs from existing treatments because it targets the host immune response rather than the virus itself and is therefore unaffected by viral variance. Poolbeg has defined and formulated the oral administration of POLB 001 and already has sufficient grade and quantities of the drug to utilise immediately in the forthcoming human challenge study.

In the study the LPS will be administered both intradermally (a shallow injection) and intravenously (an injection of a vein). By administering the LPS intradermally, the Company can gather data around the localised response of the body to POLB 001. By then administering the LPS intravenously, data can be gathered around the full body systemic response to POLB 001. By using both methods within one study, the Company will efficiently and cost effectively collect both local and systemic efficacy data, increasing the value of the data package which will be attractive to potential partners. Overall, the study will generate 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:

“We are moving forward at a strong pace to enable the upcoming human challenge clinical trial of POLB 001 to commence as planned. This study will provide invaluable early human data on the efficacy of this asset in dampening the immune response after being stimulated, thereby limiting the damage it can otherwise cause in a setting such as severe influenza.

We will continue to provide updates as we progress towards commencing the study in June 2022 with results due before the end of the year. We are looking forward to receiving the broad spectrum of data from this study, given that it will be completed both intradermally and intravenously, thus maximizing the data package that can be shared with any potential pharma or biotech licensing partner.”

More Information on influenza and POLB 001

The threat of influenza is significant, with cases at their highest globally since the COVID-19 pandemic. Influenza affects 1 in 8 of the global population and causes 500,000 deaths each year. In cases of severe influenza, the body produces an over-heightened immune response that can cause more damage to the body than the virus itself.

POLB 001 was identified using the unique disease progression data available from human challenge trials. Data from human challenge studies are unique in that they track a healthy subject through disease to recovery in carefully controlled and monitored isolation units, collecting samples throughout the course of disease, and vitally collecting matched baseline and follow-up samples before and after infection. By mapping the entire biological process of disease, it provides a platform to help identify promising disease relevant pathways in the pursuit of novel drug targets. The Company is now progressing two artificial intelligence programmes to complete analysis of influenza and Respiratory Syncytial Virus (RSV) data faster and more cost effectively than previously possible.

*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.

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) 207 220 0500

Arden Partners PLC (Joint Broker)

John Lewellyn-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

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 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); a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) drug discovery programmes to accelerate the power of its human challenge model data and biobank.

For more information, visit www.poolbegpharma.com or follow us @PoolbegPharma

Poolbeg Pharma #POLB – Licenses RNA-based immunotherapy asset

Broadcast Event Detail

Open Orphan #ORPH – Positive Phase 1 study results published in The Lancet

Monday 15th June, 2020

Positive results from the Phase I study of the AGS-v vaccine developed by an Open Orphan joint venture, Imutex Limited, have been published in the peer reviewed journal The Lancet

AGS-v is a first-in-class mosquito saliva, standalone, vaccine candidate designed to protect against mosquito-borne diseases carried in the saliva such as Zika, Malaria, Dengue Fever and West Nile Virus

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge study models is pleased to announce that the results of a randomised, placebo-controlled, double-blind, phase 1 trial of AGS-v have been published in The Lancet. AGS-v has been developed by Imutex Limited, in which Open Orphan owns a 49% stake in conjunction with the SEEK Group.

Highlights:

·    The first trial of AGS-v, a first-in-class “mosquito saliva vaccine” in humans

·    The trial indicated that the vaccine is safe and induces a strong immune response in healthy volunteers

·    These positive findings suggest that AGS-v is now ready to advance to Phase II

Numerous studies have shown that protection from diseases carried in saliva is possible if you alter the immune response to saliva. Using natural saliva to achieve this not viable. AGS-v is designed as a transformational vaccine, the first ever mosquito synthetic saliva vaccine designed in to protect against mosquito-borne diseases carried in the saliva such as Zika, Malaria, Dengue Fever, West Nile Virus etc. AGS-v is designed to provoke an immune response against mosquito saliva, rather than any specific parasites, viruses, or bacteria the mosquito might transmit making it an important tool in the fight against mosquito-borne diseases.

In the new study published in The Lancet, NIAID scientists describe the results of the Phase 1 trial of the vaccine as “encouraging and worthy of further study”.

The Trial Results

The double-blind study, which began in 2017 at the NIH Clinical Center in Bethesda, Maryland, was the first trial of this so-called “mosquito saliva vaccine” in humans.

The volunteers’ blood tests showed that the vaccine in combination with the adjuvant produced a significant immune response to mosquito salivary peptides. Further, this immune response was not accompanied by a worse reaction to mosquito bites.

The study’s results are promising and suggest that further research to test the vaccine’s efficacy against individual pathogens, followed by larger field studies, would be worthwhile.  A widely available “universal” vaccine could provide protection against emerging and re-emerging mosquito-borne diseases as they arise, allowing public health officials to quickly respond to new outbreaks and epidemics without waiting for new treatments or vaccines to be developed.

Cathal Friel, Executive Chairman of Open Orphan, said:

“We are delighted with the results of this very important and successful trial of Imutex’s universal vaccine for mosquito-borne diseases. This further confirms and reinforces our belief that our 49% shareholding in Imutex has a lot of unrealised potential value and we look forward to working closely with Gregory Stoloff and his team in SEEK to see how we can commercialise and monetise the true value of Imutex over the coming months.”

Gregory Stoloff, Chief Executive Office, Imutex Ltd, said:

“We all know too well today the cost of pandemics to society and mosquitoes have been causing these problems for many countries for too long. It has been known for some time that injecting saliva in a particular way from an insect provides protection from the disease carried in that saliva. Harvesting natural saliva however, was not practical. We are very excited that our synthetic made saliva produced an immune response and was safe in humans. This makes a vaccine that can protect people against  so many diseases that plague the world, a step closer to reality. We are excited that we now are a step closer to making a vaccine that could deal with these issues.”

 

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 / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Experts seek approval for COVID-19 trials – China Daily

By ANGUS McNEICE in London

Medical community divided on issue of exposing humans to deadly virus

A laboratory in the United Kingdom is hoping to become the first in the world to intentionally infect volunteers with novel coronavirus in order to test the efficacy of COVID-19 vaccines.

Half of the participants in these so-called human challenge trials would be given a candidate vaccine for COVID-19, the other half would get a placebo, and all of them would then be exposed to novel coronavirus via a nasal spray.

The volunteers, aged 18 to 30, would then spend weeks quarantined at a private clinic, frequently checked on by researchers in hazmat suits running tests to determine if the vaccine provides protection against the disease. Those who display symptoms would be treated with antivirals or immunotherapeutics.

The human challenge model is a tried and tested way to assess vaccine efficacy. Such trials have previously been used in the study of influenza, malaria, typhoid, dengue fever, and cholera inoculations. Challenge studies have an advantage over traditional field trials when levels of a pathogen are low in the general population, as is the case with novel coronavirus during lockdown.

The method is also highly controversial, and the lab in question, London-based hVIVO, will have to navigate an ethical minefield to achieve its goal during this pandemic.

“We are the only place in the world that is well down the road to development for COVID-19 human challenge studies,” Cathal Friel, chief executive of hVIVO parent company Open Orphan, told China Daily. “We will be able to very quickly guarantee to any pharma company in the world if their vaccine works.”

Friel is currently in talks over running challenge trials for a dozen COVID-19 vaccine developers in Europe, North America, and Asia, three of which are from China. Before commencing the trials, hVIVO must gain approval from the ethics committee at the UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency.

Among a host of considerations, the committee will attempt to answer two core questions: is COVID-19 too dangerous for a challenge trial, and are existing treatments effective enough if and when volunteers fall ill.

Challenge trials generally involve around 100 volunteers and are typically used to test vaccines against non-lethal illnesses, such as the common cold, or diseases for which highly effective treatments exist, such as malaria. The trials are not considered for lethal diseases for which existing treatments are limited, such as Ebola or Marburg virus.

While severe cases of COVID-19 are rare among healthy young people, some in the medical community warn that not enough is yet known about the disease to run such trials, and doing so would be extremely risky. Others argue that this risk can be mitigated with well-designed trials, which would in turn greatly accelerate vaccine development, potentially saving hundreds of thousands of lives.

Vaccine developers are faced with a conundrum during this stage of the pandemic. Field trials involving tens of thousands of volunteers are most efficient when a pathogen is thriving in the general population. But lockdown measures in some regions have been so effective that there is not enough COVID-19 going around to challenge a vaccine’s efficacy.

Link here to the original story

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