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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:
Open Orphan plc |
+44 (0) 20 7756 1300 |
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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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#POLB Poolbeg Pharma – Confirmation of vaccine platform licence execution
31 January, 2022 – Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) a clinical stage infectious disease pharmaceutical company with a capital light clinical model, confirms that it has signed the licence to AnaBio Technologies’ (‘AnaBio’) microencapsulation and nanoencapsulation technologies to develop an oral vaccine delivery platform.
This follows the binding term sheet announced on 16 December 2021. This licence provides Poolbeg with exclusive access to AnaBio’s microencapsulation and nanoencapsulation technologies for use in the development and commercialisation of vaccines. Combined with the Company’s expertise in infectious diseases and vaccine development, Poolbeg will use this technology as a platform to complement its existing and growing pipeline of assets by developing oral vaccines for multiple disease indications.
Oral vaccines have been used successfully, but in a limited way, for decades, such as in the prevention of polio and typhoid. Broadening the range of diseases with oral vaccines available is beneficial as they can provide enhanced benefits by delivering antigens to specific areas of the gut, triggering the development of ‘mucosal immunity’ which prevents pathogens from infecting the body. The COVID-19 pandemic has accelerated demand for innovation in the development of vaccines, and oral vaccines offer many advantages having improved vaccine stability profiles, easier global distribution and administration as well as tackling the issue of needle-phobia.
This is the latest in several licence agreements that Poolbeg has completed since its IPO in July 2021, demonstrating delivery against commitments made at the time of listing. The Company’s pipeline of assets continues to expand and is increasing in diversity with the addition of this innovative oral vaccine delivery platform. This latest licencing agreement follows swiftly on the back of a series of other recently announced potentially ground-breaking infectious disease asset deals. This includes the first-in-class, intranasally administered, RNA-based immunotherapy for respiratory virus infections announced on 17 January 2022 (POLB 002). In December 2021 the Company announced that it had successful signed an option agreement to licence an intramuscular Melioidosis vaccine (POLB 003). Melioidosis is a disease which presents a dangerous and underappreciated threat to human health which currently has no approved vaccine and a very high mortality rate and in addition, concerns are growing around global warming contributing to the spread of the disease to traditionally non-tropical areas. These new assets are in addition to the Company’s lead programme, POLB 001, a treatment for severe influenza. Post-pandemic the global community recognises the importance of vaccines and treatments against infectious disease and governments are hugely increasing their investment into influenza pandemic preparedness.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:
“Vaccine uptake is a critical factor in the effectiveness of combating communicable infectious diseases, something that the COVID-19 pandemic has shown in recent months. Oral vaccines bring significant benefits both in terms of the logistics required to distribute and administer them, but also in how the body responds through creating mucosal immunity in the gut and acting as a barrier to the infection.
“This licencing deal with AnaBio and the access to its advanced micro- and nano-encapsulation technologies will enable Poolbeg to develop an oral vaccine delivery platform from which to complement an already diverse pipeline of treatments and vaccines against infectious diseases.”
Aidan Fitzsimons, PhD, CEO of, AnaBio Technologies, said:
“This is a really exciting opportunity to apply AnaBio’s patented micro-encapsulation technology, which has been shown to facilitate absorption of Active Pharmaceutical Ingredients (API’s) through the gut, in the development of an oral vaccine. Micro-encapsulation is a process which involves coating microscopic particles of an API with a protective layer enabling the API to travel safely through the digestive system, and be absorbed across the gut in a bioavailable form. Combining AnaBio’s proven micro-encapsulation technology and Poolbeg’s vaccine and immunology expertise puts us both in a great position to deliver a genuine breakthrough innovation in oral vaccine development.”
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