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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

#POLB Poolbeg Pharma – GMP manufacturing contract signed

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 an update on its lead asset, POLB 001, a small molecule immunomodulator which aims to address a significant unmet need in severe influenza. The Company has signed a contract for GMP manufacturing, ensuring ample supply of GMP grade POLB 001 for use in its upcoming LPS human challenge clinical trial, due to commence in June 2022, and for use in investigating POLB 001 as a treatment for other disease indications.

 

POLB 001 has potential therapeutic applications beyond severe influenza, due to its mode of action of reducing hyperinflammation which is linked with many diseases. This is when harmful inflammation occurs in different areas of the body, such as the heart and lungs, causing organ damage.  POLB 001 can block this from happening. The Company holds the worldwide rights to POLB 001 for all uses in humans and as such, is in a position to expand its IP around this asset to cover new disease areas which greatly increases the value of the program for partnering purposes. Following receipt of the results from the upcoming bacterial lipopolysaccharide (LPS) human challenge trial, the Company aims to rapidly monetise POLB 001 by partnering or out licensing the product to pharma / biotech for further development and commercialization.

 

The GMP manufacturing of the product began in late 2021 to ensure that sufficient grade and quantities of the product is available for use in the forthcoming human challenge trial which is due to commence in June 2022, with first results expected before the end of the year. The Company now has a validated manufacturing process for the development of the product for use in its clinical development for multiple disease areas.

 

The Company signed the Clinical Trial Agreement with the Centre for Human Drug Research (CHDR) in March 2022 for the upcoming LPS human challenge study. As part of the study, which is being completed in line with the Company’s capital light approach, researchers will stimulate healthy volunteers’ immune systems with LPS which triggers a robust immune response acting as a simulant for the hyperinflammatory effects associated with severe influenza infections, as well as other diseases. The study will provide 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: “Preparations for the upcoming clinical trial of our lead asset, POLB 001, are progressing well and we are delighted to have executed a GMP manufacturing contract ensuring ample supply of POLB 001 for use in its clinical development for severe influenza and beyond.

 

With a mode of action which reduces the body’s hyperinflammatory response, POLB 001 has the potential to address several disease indications beyond severe influenza, and with our exclusive license for all human uses this could provide Poolbeg with the opportunity to greatly increase the value of the program for partnering and monetisation of POLB 001 to pharma or biotech companies.”

 

Note: 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.

– 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

#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

 

#POLB Poolbeg Pharma – Final Results

Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) announces its audited results for the period ended 31 December 2021. These results follow the Company’s spin-out from Open Orphan plc and the subsequent listing on the AIM market of the London Stock Exchange in July 2021.

 

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company with a capital light model which is looking to develop multiple products faster and more cost effectively than the conventional biotech model. Poolbeg is targeting the growing infectious disease market and, in the wake of the COVID-19 pandemic, infectious disease is becoming one of the fastest growing markets with an expected value of c. $250 billion by 2025.

 

The Company aims to bring innovative infectious disease products through to a value inflection point by generating early human efficacy data before rapidly monetising through partnerships and licensing deals with pharma and biotech. Poolbeg’s model aims to significantly reduce spend and risk compared to the conventional biotech model and allows multiple opportunities for monetisation through its broad portfolio. The model also enhances investor returns as the out-licensing revenues will be reinvested into the pipeline of additional assets which in turn, can be further monetised rapidly and as such, substantially extending the runway from the original £25m raised at IPO. 

 

Operational Highlights since IPO – significant strategic and operational progress

– POLB 001, a treatment for severe Influenza, remains on track to commence its bacterial lipopolysaccharide (LPS) human challenge trial in June 2022. Human data is expected before year end, at which point the Company aims to monetise by partnering or out licensing the product to pharma / biotech

–  Continued expansion and diversification of the portfolio, reducing risk due to having multiple shots on goal;

o  POLB 002 – in-licensed first-in-class, intranasally administered, RNA-based immunotherapy for respiratory virus infections

o  Option to licence and evaluate an intramuscular vaccine to prevent Melioidosis (POLB 003), a disease predominately found in tropical and sub-tropical regions, and five additional bacterial vaccine candidates

o  Oral Vaccine Delivery Platform – licensed access to use micro- and nanoencapsulation technology to develop oral vaccines for multiple disease indications

– In February 2022 the Company signed its first Artificial Intelligence (AI) deal with OneThree Biotech Inc. to identify new treatments for Respiratory Syncytial Virus (‘RSV’) through analysis of Poolbeg’s unique human challenge trial data and OneThree’s clinically validated biology driven platform

 

Financial & Corporate Highlights

–  Well capitalised with a strong cash balance of £20.9m at period end, following the IPO fundraise of £23.2m (after expenses)

–  Loss for the period amounted to £2.3m including the initial non-recurring costs of establishing the Group

– The Company has significant financial resources and will maintain its capital light approach to support its pipeline expansion and development

– Scientific Advisory Board strengthened with the appointment of Professor Daniel Hoft joining Professor Luke O’Neill and Dr Elaine Sullivan

 

2022 Pipeline

–  Intention to dual-list on the OTC market in the US in Q2 2022 to provide additional liquidity in the stock

–  Evaluating opportunities for non-dilutive grant funding to support the further development of existing pipeline

– Upon receipt of human data from POLB 001 study in H2 2022, the Company will look to commence monetisation to pharma and biotech companies via licensing or partnership agreements

–  Generation of value through advancement of portfolio assets POLB 002, POLB 003, and Oral Vaccine Delivery Platform

–  Preliminary outputs from the RSV Artificial Intelligence Discovery Programme are expected in H2 2022

–  Continuous engagement and discussion with pharma and biotech companies around the Company’s portfolio including out-licensing and product rights deals

– Continue to identify and conduct diligence on numerous new innovative infectious disease products to add to the pipeline, leveraging the expertise and network of our management team and scientific advisory board. In addition, we continue to evaluate further AI partnerships

– Continue to position the Company firmly at the cutting edge of global R&D as the infectious disease market grows to c. $250bn by 2025

 

 

Investor presentation

 

Poolbeg’s Chairman, Cathal Friel and CEO, Jeremy Skillington will provide a live presentation via the Investor Meet Company platform on 3 March 2022 at 6:00pm.

 

The presentation is open to all existing and potential shareholders. Investors can sign up to Investor Meet Company for free and add to meet Poolbeg Pharma plc via: www.investormeetcompany.com/poolbeg-pharma-plc/register-investor

 

 

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:

“This has been a period of great progress at Poolbeg. In less than six months we have grown and diversified our portfolio of products and platforms targeting a range of infectious diseases. POLB  001 is on track to commence its LPS human challenge trial, we have in-licensed an intranasal RNA-based immunotherapy POLB 002, as well as partnering to develop an oral vaccine delivery platform and agreeing an option to licence a late pre-clinical Melioidosis vaccine, POLB 003.

 

“In addition, we are now using cutting edge Artificial Intelligence technology to exploit our unique human challenge data, having signed up leading AI drug development experts OneThree Biotech to analyse and interrogate our RSV data to identify new drug targets and treatments. This is the first time that AI is being used to analyse RSV human challenge study data and initial results are expected in H2 2022.

 

“As well as growing our operational team since July, we’ve also added invaluable international academic expertise to our Scientific Advisory Board. Our capital-light business model is working well, leaving us with significant financial resources to invest in growing our pipeline further and developing our offering to pharma, without any need for further investment.”

 

 

Cathal Friel, Chairman of Poolbeg Pharma said:

“As the single largest shareholder of the Company, I will make it my duty to ensure that the share price starts performing again. I want to make it clear that none of us are happy with where the share price is currently given the drop since IPO. Market conditions have been and remain extremely challenging however, I want to reassure you that we are actively working on creating demonstrable value as we drive the business forward.

 

My personal belief is that one of the biggest reasons for the pressure on the share price is the perceived overhang from the forthcoming end to the lock-in of the shares received as part of the spin-out, by Open Orphan shareholders. Many shareholders are concerned that the release of these shares may damage the share price. I personally feel that this perception is wrong and that we won’t see a large sell-off of these dividend in specie shares. However, I would like to reassure shareholders that we are looking to put in place a series of actions that will reduce or eliminate the potential for these shares to impact the market. In addition to these specific actions, Poolbeg is also at an advanced stage of dual listing on the OTC market in the USA with plans to complete this within Q2. This should help provide additional liquidity in the Company.

 

Furthermore, the distribution in specie shares issued to shareholders as part of the demerger from Open Orphan are treated as a distribution for UK tax purposes, which could be taxable as dividend income. However, as advance clearance for a statutory demerger was obtained from HMRC, the distribution is exempt for UK income tax purposes, and hence there should be no UK income tax liabilities for UK resident shareholders. The only time that UK resident shareholder will be subject to tax on these dividend in specie shares, will be in the event that they sell them, and in that event there will be a capital gains tax payment due. This is a further reason why I don’t see shareholders looking to sell these dividend in specie shares immediately upon the end of the lock in.

 

In summary, I am very optimistic that in the months ahead our share price will perform and more importantly, that we will continue to progress our business model as outlined at IPO while we rapidly grow Poolbeg into a unique publicly listed company which will be a ‘one-stop-shop’ for pharma and biotechs seeking a range of infectious disease assets to develop in the months and years ahead.”

 

 

The Company’s Annual Report and Accounts for the period ended 31 December 2021 will be posted to shareholders in due course together with the notice of the 2022 Annual General Meeting, and will be available on the Company’s website: www.poolbegpharma.com/investors/documents/  

 

Footnote: c. $250bn infectious disease market made up of the: Diagnostics Market ( link ), Therapeutics Market ( link ), and Vaccines Market ( link ).

 

– 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

#POLB Poolbeg Pharma – Artificial Intelligence deal with OneThree Biotech

Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) a clinical stage infectious disease pharmaceutical company with a capital light clinical model, has signed an agreement with OneThree Biotech, Inc . a biology-driven artificial intelligence (‘AI’) company, to identify new drug targets and treatments for Respiratory Syncytial Virus (‘RSV’).

 

Under the terms of the transaction and as aligned with Poolbeg’s strategy, OneThree Biotech’s state-of-the-art AI analysis tools will identify drug assets which target immune-response pathways, have a higher probability of clinical success and have the potential to prevent and / or treat infectious diseases. The analysis will prioritise drugs with existing Phase I safety data, reducing spend and risk, which can feed into Poolbeg’s rapid, capital light clinical development strategy and its expanding pipeline of assets. The analysis is expected to commence in Q1 2022 with preliminary outputs from this work expected in H2 2022.

 

OneThree Biotech is a clinically validated AI company with a proven technology platform which integrates chemical, biological, and clinical data with cutting-edge computational tools to answer complex questions surrounding disease biology and drug discovery. The team at OneThree will work closely with Poolbeg’s scientific team to build a tailored AI analysis model which can leverage the unique insights of human challenge trial data to identify disease-relevant cell signalling pathways which could lead to novel drug targets. OneThree will receive milestone payments based on candidate development and royalties on the sale of products derived from this partnership.

 

The Company believe that this partnership with OneThree Biotech is the first time that AI analysis has been undertaken on RSV human challenge trial data and samples to identify new drug targets. The unique nature of human challenge trials to produce disease progression data with high precision is expected to revolutionise the insights generated from this analysis. Poolbeg’s lead asset POLB 001, which is progressing towards its first human challenge trial in June 2022, was identified using such disease progression data. However, by utilising AI the Company aims to identify more targets, quicker and more cost efficiently than previously possible without this technology. 

 

Poolbeg entered a partnership with Eurofins Genomics in October 2021 to complete RNA sequencing of Poolbeg’s RSV disease progression samples from human challenge trials. This work was a key step in Poolbeg advancing its AI analysis programme. This RSV discovery dataset has been specifically designed for incorporation into OneThree’s AI platform. The data sets within this project will leverage up to 140Gb of biological data per subject spread over baseline healthy measurements and the course of infection which is expected to unveil unprecedented insights.

 

RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat affecting an estimated 50-million people annually, leading to 4 million global hospitalisations and up to 74,500 in-hospital deaths in children under the age of 5 years. An estimated 45% of these cases and deaths occur in new-born infants under the age of 6 months.

 

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

“OneThree Biotech’s AI analysis tools will allow us to break new ground in data-driven drug discovery, by allowing us to evaluate and interrogate human challenge trial data like never before. This is a key part of our growth strategy, as we’ll be able to identify and develop drugs in a more time and cost effective manner, compared with the traditional biotech model. It will enable us to identify potential new treatments which have a higher probability of clinical success and which can feed into our rapidly expanding pipeline in-line with our capital light model.

 

This will be the first time that AI tools will be used to analyse RSV human challenge trial disease progression data, which illustrates the significance of this deal as well as Poolbeg’s innovative model. We look forward to updating the market on the outputs from this cutting-edge AI analysis in due course.”

 

Neel S. Madhukar, PhD, co-founder and CEO of OneThree Biotech , said:

“At OneThree our mission has always been to unlock new therapeutic opportunities by understanding biology on a deeper level. The ability to combine our AI platform with the data and expertise from Poolbeg Pharma will enable just that, and create an opportunity to make meaningful progress in the treatment of infectious diseases.”

 

Brad Pryde, co-founder and COO of OneThree Biotech , concluded:

 

“We have been impressed with Poolbeg Pharma’s clear dedication towards using technology and data to create efficiencies in drug discovery and development. We’re excited to demonstrate the strength of this partnership as future developments arise.”

 

Footnote: During a human challenge study, a number of healthy volunteers are exposed to an infectious agent in a safe and controlled quarantine setting to assess the efficacy of vaccines or treatments. Human challenge trial data is unique in the depth of longitudinal virology, health, biomarker and symptom data collected during the course of disease from pre-infection, onset, progression and resolution of an infection .

– Ends –

  Enquiries

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

  +44 207 183 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 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

Little Dog Communications for OneThree   

Jessica Yingling, Ph.D.

 

+1 (858) 344-8091

jessica@litldog.com

#ORPH Open Orphan – Imutex Vaccine Phase I Study Results

AGS-v PLUS mosquito vaccine candidate shows favourable safety, tolerability, and immunogenicity results

Results to be presented at the American Society of Tropical Medicine and Hygiene Annual Meeting

 

Open Orphan plc (AIM: ORPH) announces that data from the first-in-human Phase I clinical study evaluating the safety, immunogenicity, and in vitro efficacy of AGS-v PLUS,  Imutex Limited’s (“Imutex’) mosquito saliva vaccine candidate against arboviral diseases, as well as data on the candidate’s effect on the reproductive capacity of mosquitoes that fed on vaccinated subjects will be presented on the 20th and 21st of November 2021. Imutex Limited (“Imutex”) is a joint venture with PepTcell Limited (“PepTcell”) (the legal name of SEEK Group) in which Open Orphan has a 49% shareholding.

 

The results will be presented in two virtual sessions at the American Society of Tropical Medicine and Hygiene (“ASTMH”) Annual Meeting, held from 17-21 November 2021. The titles and details of the two presentations are as follows:

 

·    “Blood feeding on humans vaccinated with AGS-v PLUS, a mosquito salivary peptide vaccine, impairs the reproductive capacity of female Aedes albopictus mosquitoes” – Scientific Session 91: Mosquitoes-Vector Biology Epidemiology I, at 8.00 am (ET) on 20 November 2021. To be presented by Joshua Lacsina, M.D., Ph.D. of the Laboratory of Malaria and Vector Research at the National Institute of Allergy and Infectious Diseases.

·    Safety and immunogenicity of AGS-v PLUS, a mosquito saliva peptide vaccine against arboviral diseases” – Scientific Session 126: Clinical Tropical Medicine: Vector borne Disease, at 8.00 am (ET) on 21 November 2021. To be presented by DeAnna J. Friedman-Klabanoff, M.D. of the University of Maryland School of Medicine.

 

Following the presentations, Imutex expect to publish the results from the study in a scientific peer-reviewed journal.

 

Imutex was funded by the Department of Health and Social Care as part of the UK Vaccine Network (UKVN), a UK Aid programme to develop vaccines for diseases with epidemic potential in low and middle-income countries (LMICs) to carry out this study. 

 

Data from this study, which was performed at the University of Maryland School of Medicine (Baltimore, Maryland, U.S.) and is related to a collaboration between PepTCell and The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), demonstrated that AGS-v PLUS was well tolerated with no serious adverse events experienced, and that it generated a strong immune response in participants. AGS-v PLUS showed a more robust immune response compared to AGS-v, a first-generation vaccine candidate developed by Imutex. The study evaluating the effect of AGS-v PLUS on the reproductive capacity of mosquitoes that fed on vaccinated subjects found that a regimen of the vaccine in combination with an adjuvant resulted in fewer eggs laid and adult progeny in the species Aedes albopictus.

 

Imutex’s AGS-v and AGS-v PLUS vaccine candidates are mosquito-borne disease vaccines with a novel proposed dual action mechanism of preventing infection in humans whilst controlling the mosquito population. AGS-v is composed of four synthetic peptides isolated from mosquito salivary glands. The AGS-v PLUS vaccine contains the same four peptides as AGS-v but adds a fifth synthetic peptide found in the saliva of many mosquitoes, increasing the potential breadth of protection.

 

Mosquito-borne diseases include Zika virus, West Nile virus, chikungunya virus, dengue, yellow fever, and malaria. There are around ~360 million cases of and more than 600,000 deaths from mosquito-borne diseases annually, although the true burden is likely underestimated. A vaccine efficacious against multiple mosquito-borne diseases could significantly impact public health.

 

Imutex is focused on developing broad-spectrum vaccines against influenza (flu) and mosquito borne diseases. To find out more about the product developments, both in influenza vaccine development (FLU-v) and in Zika vaccine development (AGS-v), please visit the Imutex website: www.imutex.com

 

Cathal Friel, Executive Chairman of Open Orphan, said“The Company has been eagerly anticipating the results from Imutex’s first-in-human Phase 1 clinical trial for its AGS-v PLUS mosquito vaccine candidate, and we now look forward to the data being presented at the upcoming ASTMH Annual Meeting.

“The positive data for the AGS-v PLUS mosquito vaccine candidate is encouraging; data showed AGS-v PLUS was well tolerated and generated a strong immune response in participants against mosquito-borne diseases, with an increased immune response compared to the four peptide AGS-v candidate. Imutex’s AGS-v and AGS-v PLUS vaccine candidates both employ a novel proposed dual action mechanism that prevents infection in humans whilst controlling mosquito population by limiting transmission.

“There are more than 600,000 deaths worldwide per year from mosquito borne diseases, as such, if these positive Phase I results translate into clinical efficacy, the potential number of lives saved will be significant.”

Dr Olga Pleguezuelos, Chief Science Officer at PepTcell, commented: “We are very excited about the study results. AGS-v PLUS was demonstrated to be safe and immunogenic, and not only impacted the pathogenicity of the Zika virus as seen in an in vitro assay, but also reduced the number of eggs and adult progeny of mosquitoes that fed on vaccinated subjects. The next step is to evaluate clinical efficacy in a controlled human challenge study or in a study in endemic areas. Many mosquito-borne diseases lack effective preventative and therapeutic treatments, so AGS-v PLUS could potentially save many lives.”

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.

 

 

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 / 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 515393 

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