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#ORPH Open Orphan plc – Positive in vitro results for FLU-v published
Open Orphan plc (AIM: ORPH), (to be renamed hVIVO plc (AIM: HVO) effective 26 October 2022), 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 positive data from a peer-reviewed study evaluating the in vitro efficacy of FLU-v, Imutex Limited’s (“Imutex”) broad spectrum influenza
vaccine, has been published in the scientific journal Vaccines.1
Previous clinical studies have demonstrated that FLU-v induced increased antibody and cellular responses in vivo. This placebo-controlled study evaluated the ability of FLU-v to induce cellular effector functions and cross-reactivity (both measures of the immune response, with cross-reactivity being particularly important for protection against multiple viral strains) of immune cells extracted from participants, following exposure to five different influenza strains.
The study found that measurements of IFN-γ and granzyme B production in stimulated immune cells from participants that had been previously vaccinated with either FLU-v or placebo, were significantly higher in the FLU-v group both when stimulated with vaccine antigen and also with antigens from a panel of seasonal and pandemic inactivated influenza A and B strains. These results further support the continued development of FLU-v as a broad-spectrum influenza vaccine.
FLU-v is owned by Imutex, a joint venture between hVIVO and PepTcell Limited (the legal name of SEEK Group), to develop vaccines against influenza and mosquito borne diseases such as Zika virus, malaria and other flaviviruses.
Seasonal influenza causes significant morbidity and mortality each year and a pandemic influenza continues to pose a worldwide threat. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 – 650,000 deaths per year.
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “It is encouraging to see further positive data for FLU-v, supporting its continued development as a broad-spectrum influenza vaccine. There is a large unmet need for a broad-spectrum vaccine to help battle emerging seasonal and pandemic influenza A and B viruses. Although FLU-v had already produced successful Phase II clinical data, this in vitro study is particularly important as it showed the ability of the candidate to induce an immune response against a diverse variety of influenza A and B strains.”
1. Oftung, F.; Næss, L.M.; Laake, I.; Stoloff, G.; Pleguezuelos, O. FLU-v, a Broad-Spectrum Influenza Vaccine, Induces Cross-Reactive Cellular Immune Responses in Humans Measured by Dual IFN-γ and Granzyme B ELISpot Assay. Vaccines 2022, 10, 1528. https://doi.org/10.3390/vaccines10091528
For further information please contact:
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Open Orphan plc |
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Yamin Khan, Chief Executive Officer |
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Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Phillip Marriage / |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
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#ORPH Open Orphan – £10.4m contract with existing Big Pharma client
hVIVO to develop new influenza challenge strain to test oral antiviral 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 thathVIVO, a subsidiary of Open Orphan, has signed a £10.4m contract with an existing top 5 global pharmaceutical client to manufacture a new batch of H1N1 influenza challenge virus, leveraging off an existing in-house generated challenge model, and to conduct a human challenge trial to test the client’s antiviral product.
hVIVO has world-leading expertise in challenge agent manufacture, with the ability to manufacture specific subtypes of viruses, as well as unrivalled experience in conducting challenge studies. Since the COVID-19 pandemic, the Company has seen an increase in the number of clients looking to test their vaccines and antivirals against specific subtypes of viruses that are circulating in the population or that have the potential to be widely spread. As a result, there is a greater interest in end-to-end human challenge contracts such as this, that include a novel challenge agent manufacture and a challenge study.
The study will evaluate the efficacy profile of the antiviral against the specific influenza subtype, generating data quickly and efficiently. This is the third human challenge contract signed with this client, highlighting the Company’s world leading expertise and the clear benefits of human challenge trials to Big Pharma’s drug development process.
Good Manufacturing Practice (“GMP”) compliant virus manufacturing activities will commence immediately and are expected to complete by Q2 2023. Once completed, hVIVO will conduct a Phase 2a double-blinded placebo-controlled human challenge study which is expected to be completed by Q4 2023. hVIVO will recruit healthy volunteers via the Company’s dedicated volunteer recruitment arm, FluCamp.The majority of revenue from the contract is expected to be recognised during 2023.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said : “We’re delighted to be working again with this top 5 global pharmaceutical company to test its antiviral, using a new influenza strain developed by our highly experienced team. This contract is the third challenge study with this client, and our second end-to-end full-service contract overall. Our one-stop shop service offerings from manufacturing bespoke challenge agents to conducting full challenge studies is unique in the market. I am confident, that with our highly qualified teams and their clinical development expertise, we are well placed to address the growing infectious disease and respiratory research markets.
“Influenza poses a serious global health threat, causing an estimated 290,000 – 650,000 deaths per year with significant pandemic potential, and as such, the development of new vaccines and antivirals to fight flu remains vitally important.”
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “This contract is a strong example of where human challenge studies can provide significant value. These studies can quickly and cost-effectively generate efficacy data for our clients in specific viral subtypes. As illustrated with this contract, our world-class manufacturing capabilities can produce a challenge agent for subtypes that pose a particular global health risk or are already circulating in the population. The resulting data can then indicate whether the candidate is viable for Phase II/III studies, providing substantial time and financial savings compared to traditional field-based studies.”
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.
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:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Yamin Khan, Chief Executive Officer |
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Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
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Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson / Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Phillip Marriage / |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
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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:
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Open Orphan plc |
+44 (0) 20 7756 1300 |
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Yamin Khan, Chief Executive Officer |
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Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
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Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson / Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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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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#ORPH Open Orphan – Vaccine field study contract
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, has been awarded a new study with an existing Big Pharma client to act as a vaccination site for a Phase II field study of the client’s respiratory syncytial virus (RSV) vaccine candidate.
As part of the study, hVIVO will recruit 60 healthy volunteers to the Company’s new site clinic at Plumbers Row, where they will then be inoculated with either the RSV vaccine candidate or a placebo. As opposed to a human challenge study, where volunteers would then be challenged and quarantined within hVIVO’s FluCamp facilities, these participants will then be free to leave the facilities. Participants will then be monitored for RSV symptoms over the following months, with regular clinical check-ups at Plumbers Row, to assess the efficacy of the vaccine candidate and its ability to prevent illness through RSV. The study is expected to begin in Q3 2022 with the majority of revenue from the contract recognised in 2023.
This is the first vaccine field study the Company has been awarded since it announced the expansion of its facilities on 8 March 2022 . In addition to the core human challenge studies the expansion has enabled Open Orphan to provide a larger service offering including non-first in human Phase I trials such as PK (pharmacokinetics) studies, bridging studies and Phase II trials in patients and healthy volunteers.
The volunteers for the study will be recruited through the Company’s specialist volunteer recruitment arm, FluCamp . FluCamp has decades of experience attracting suitable healthy subjects to meet recruitment requirements, primarily sourcing subjects for hVIVO trials to date. FluCamp’s large database, tech-enabled platform and recently improved screening capabilities will mean that hVIVO is able to efficiently recruit and assess potential volunteers for its client’s field studies in a timely and cost-effective manner.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said : “This is a significant award for Open Orphan as it is our first study as a site. To date we have mainly acted as a Contract Research Organisation to provide either challenge studies, laboratory or consulting services. Although we have acted as a site as part of the challenge studies, we have not provided stand-alone site services. We expanded our facilities at Plumbers Row in March of this year with the aim to provide site services. It is a great testament to the team that they have been able to fulfil site activity work in such a short timeframe. There are a great number of synergies between our core challenge study activities and new the site services, this will help us to conduct the new work in an efficient manner.”
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.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com .
For further information please contact:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman Yamin Khan, Chief Executive Officer |
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Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
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Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson / Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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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 / |
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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
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+44 (0) 207 183 1499 |
| finnCap Ltd (Nominated Adviser & Joint Broker)
Geoff Nash, James Thompson, Charlie Beeson
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+44 (0) 207 220 0500 |
| Arden Partners PLC (Joint Broker)
John Llewellyn-Lloyd, Louisa Waddell
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+44 (0) 207 614 5900 |
| J&E Davy (Joint Broker)
Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
| Instinctif Partners
Melanie Toyne Sewell, Rozi Morris, Tim Field |
+44 (0) 20 7457 2020
poolbeg@instinctif.com |
#ORPH Open Orphan – £5m RSV human challenge study contract win
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, has signed a £5m respiratory syncytial virus (“RSV”) human challenge study contract with a European biotechnology company (“European biotech”) to test its intravenous antiviral candidate, using the hVIVO RSV Human Challenge Study Model.
The study is expected to commence this year and will test and assess the efficacy of the client’s antiviral candidate in a cohort of healthy young adult volunteers. This contract builds on Open Orphan’s existing relationship with this European biotech, following previous early clinical work completed by the Venn Breda team, highlighting the Company’s ability to maintain relationships with its clients over time and to cross sell services between brands. The Company expects the revenues from the contract to be recognised across 2022 and 2023.
The study will be conducted by hVIVO’s highly trained team of medics at its state-of-the-art quarantine facilities in London which was recently expanded in a cost-efficient manner from 43 to 62 beds, an increase of c. 45%. The Company’s specialised virology laboratories, hLAB, will provide qPCR (quantitative polymerase chain reaction), infectivity and serology data for the study.
Healthy volunteers for the study will be recruited through the Company’s volunteer recruitment arm, FluCamp. The FluCamp volunteer recruitment capacity was also recently expanded across its screening facilities in London and Manchester to enable larger cohorts to be recruited more quickly than before. The new screening facilities opened in Manchester expands the Company’s reach to facilitate the increasing demand for human challenge studies and allows the Company to recruit volunteers beyond the greater London area.
RSV is the main cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems, such as COPD. Globally it affects an estimated 50-million people annually, leading to 4 million hospitalisations and up to 75,000 in-hospital deaths in children under the age of 5 years. There is a lack of understanding and insight into RSV disease, especially in adult groups, despite its considerable impact on society and its high degree of infectivity.
hVIVO has a long history of challenge studies with its roots dating back to 1947 with the establishment of the UK Common Cold Clinic in Salisbury, which conducted some of the first influenza human challenge studies. Since its establishment, the Company has been conducting human challenge studies for a range of industry, governmental and academic clients, and has the most frequently used commercial challenge models on the market. hVIVO has expertise in conducting challenge studies in its highly controlled clinical environment, across a range of infectious and respiratory diseases, including influenza, RSV, human rhinovirus (HRV – common cold virus), malaria, SARS-CoV-2, asthma, COPD, and cough, and is continuing to expand its offering.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to announce this £5m contract to test our client’s antiviral candidate using the hVIVO RSV Human Challenge Study Model. RSV is a significant threat to public health, and we are delighted to support this European biotech in the development of its antiviral candidate.
“Following the recent expansion of our FluCamp facilities, which boosts our volunteer and patient recruitment capabilities as well as increasing our bed capacity by c.45%, we are now even better equipped to identify volunteers and to complete our growing pipeline of studies in a time efficient manner.
“Leveraging my extensive CRO experience, I look forward to continuing to drive further contract wins across our portfolio of infectious and respiratory disease challenge models.”
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “This contract is a further demonstration of the significant value of human challenge studies. Efficacy data provided by the Company following the completion of the study can lead to entry into Phase II as well as optimisation of a Phase III programme. For Big Pharma as well as smaller biotechs, the substantial time and financial savings compared to typical field-based studies is increasingly making human challenge the trial design of choice for achieving early proof of concept data.”
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.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.
For further information please contact:
| Open Orphan plc | +353 (0) 1 644 0007 | ||
| Cathal Friel, Executive Chairman | |||
| Yamin Khan, Chief Executive Officer | |||
| 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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#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
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson, Richard Chambers , Sunila de Silva (ECM)
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+44 (0) 20 7220 0500 |
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Arden Partners PLC (Joint Broker) John Lewellyn-Lloyd, Louisa Waddell
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+44 (0) 207 614 5900 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field
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+44 (0) 20 7457 2020 |
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Little Dog Communications for OneThree Jessica Yingling, Ph.D.
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+1 (858) 344-8091 |
#ORPH Open Orphan – Launch of STRiVE project
Respiratory viral strains suitable for challenge agents being collected from consenting volunteers
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 plc, has recently launched the STRiVE project (Seasonal Transmissible Respiratory Virus SurvEy) to collect respiratory viral strains suitable for challenge agents from consenting hVIVO employees. Collection of new respiratory viral strains circulating in the community will allow hVIVO to continually update and broaden its world leading portfolio of human challenge study models.
As part of STRiVE, volunteers with cold or flu like symptoms can send nasal swabs to hVIVO for analysis. Since starting the project, hVIVO has identified over 180 promising virus candidates that could be used in the manufacture of novel challenge agents for its human challenge trials. Viruses isolated include several strains of coronavirus, adenovirus, human metapneumovirus (HMPV), human rhinovirus (HRV), parainfluenza virus (PIV), influenza, and respiratory syncytial virus (RSV).
STRiVE ensures hVIVO can regularly update its challenge agent portfolio with relevant strains as viruses mutate over time. Manufacturing antigenically relevant strains on demand broadens hVIVO’s repository of viral pathogens and could help extend the range of human challenge models it currently offers.
The average UK adult has an estimated 2-4 respiratory infections each year, resulting in billions of pounds of lost output due to illness. Despite familiarity with the negative impacts of cold and flu viruses, remarkably little is understood about the hundreds of viruses responsible that cause illness, including transmission and markers of protective immunity. Using human challenge modelling to better understand such issues could enable future public health benefits and savings.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious diseases, including various strains of influenza, RSV, human rhinovirus (HRV – common cold virus), malaria, and asthma. This portfolio has also expanded to include the SARS-CoV-2 virus.
Cathal Friel, Executive Chairman of Open Orphan, said: “Despite only commencing recently, STRIVE has already been a remarkable success, with over 180 viruses identified and 12 different strains, with potential to be used as challenge agents in hVIVO human challenge trials. I would like to thank all hVIVO employees who have thus far participated and encourage more to do so in order to continue to build up this important repository for cold and flu research.
“Importantly, the STRIVE clinical research project will play a significant role in the Company’s efforts to broaden its world leading portfolio of human challenge models.”
Adrian Wildfire, Director of Scientific and Business Strategy at hVIVO, commented: “Access to viable strains of circulating respiratory pathogens is extremely limited and this often presents a significant obstacle to anyone seeking to grow a new viral challenge agent. To grow a new viral strain a virus must be collected from a human host, processed and stored in an adequate manner to keep the virus alive.
“STRIVE will allow the Company to use its expertise to monitor the viral strains of cold and flu that are circulating in the community, and potentially lead to the discovery of new, wild type challenge agents and the development of new human challenge models with unparalleled translation into the field.”
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.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.
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) | +44 (0)20 7933 8780 or openorphan@walbrookpr.com | |||
| Paul McManus/ Sam Allen / Louis Ashe-Jepson | +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 | |||
#ORPH Open Orphan – New Malaria Human Challenge Model Launched
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials announces that further to the announcement on 9 August 2021, hVIVO, a subsidiary of Open Orphan, has inoculated the first cohort of volunteers with a GMP-manufactured malaria challenge agent as part of its first controlled human malaria infection (CHMI) challenge study. This study will assess CHMI using existing standard of care antimalarial drugs against Plasmodium malaria.
The study, which is taking place at hVIVO’s state-of-the-art facilities in London, is expected to complete in Q1 2022 with results in Q2 2022. For the study, hVIVO has leveraged its extensive experience in clinical trial recruitment, via its clinical trial recruitment arm FluCamp, to identify and screen volunteers to rapidly enrol the study cohort. Following the successful completion of the study, hVIVO will be able to sign malaria human challenge study contracts to assess the efficacy of novel antimalarial drugs and vaccines as well as correlates of immunity using a Plasmodium challenge agent.
hVIVO’s Direct Venous Inoculation (“DVI”) clinical trial protocol was reviewed by all necessary UK regulatory bodies and fully approved prior to the start of the study. Expert diagnostic services from the London School of Hygiene and Tropical Medicine have been contracted to monitor the welfare of subjects and provide essential correlates relating to drug and vaccine efficacy. Additionally, comprehensive training programmes have been completed by staff and senior professional oversight put in place for the review of scientific and safety data.
This malaria challenge model consists of inoculating volunteers with purified, infectious P. falciparum (Pf) sporozoites, harvested from the salivary glands of Anopheles stephensi mosquitoes. This type of malaria challenge model has been safely used in multiple clinical trials in the United States, Europe and Africa.
Conducting malaria modelling with Plasmodium in antimalarial drug and vaccine trials has several potential advantages over traditional methods of P. falciparum infected mosquito challenge, including superior predictability, a cleaner safety profile and improved control over levels of infection.
Learn more about hVIVO’s Malaria human challenge model here www.hvivo.com/clinical-development-services/hvivo-challenge-models/malaria/ or if you are interested in participating in a Malaria human challenge study or any other human challenge study visit www.flucamp.com
Adrian Wildfire, Director of Scientific & Business Strategy at hVIVO, said: “Malaria is a disease of significant unmet need around the world, with 241 million cases and 627,000 deaths caused in 2020. Its prevention and cure is a designated World Health Organization target. As such, we are pleased to have commenced this study to allow our clinical teams to better acquaint themselves with the recently established Controlled Human Malaria Infection model, ahead of using human challenge studies to test our clients’ malaria products. Data resulting from such studies translates well into the field and malaria human challenge studies have been pivotal to the development of many of the novel drugs now entering late phase trials.”
Cathal Friel, Executive Chairman of Open Orphan, said: “We are delighted to have inoculated the first cohort of volunteers for the Malaria study at our QMB facility in London. hVIVO is fully committed to growing the malaria model’s capabilities and capacity over the coming years to meet the challenge of accelerating the introduction of novel, safe and effective drugs and vaccines to the market.
“This study also ensures that Open Orphan is both strengthening and further diversifying the Company’s world leading portfolio of viral challenge models. We look forward to updating the market in due course.”
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.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.
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) | +44 (0)20 7933 8780 or openorphan@walbrookpr.com | |||
| Paul McManus / Sam Allen / Louis Ashe-Jepson | +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 | |||