Poolbeg Pharma (POLB ) has signed an option agreement with the University College Dublin, a public research university, to licence a vaccine candidate for Melioidosis. Melioidosis, also called Whitmore’s disease, is an infectious disease that can infect humans or animals.
Poolbeg says it is interested in melioidosis due to its rising incidence around the world and because there is currently no approved vaccine available. In particular, it said concerns are growing about global warming contributing to the spread of the disease to non-tropical areas.
Melioidosis is caused by the bacterium Burkholderia pseudomallei, commonly found in the soil and surface groundwater of many tropical and subtropical regions, with diverse clinical presentations including pneumonia and severe sepsis with multiple organ abscesses.
The incidence of the disease is widespread in South-East Asia, Northern Australia and India, with climate change having a substantial impact on the spread of the disease to new areas such as Brazil.
Currently, there are an estimated 165,000 cases of melioidosis each year, of which as many as 89,000 (54%) are estimated to be fatal, the Company detailed to investors.
The clinical stage infectious disease pharmaceutical firm, which is a spin-out of London-listed Open Orphan, said it will continue its due diligence on the vaccinate known as MelioVac.
Under the agreement, Poolbeg will aid the development of MelioVac as well as five other potential vaccine candidates discovered by the inventor, Associate Professor Siobhán McClean and her team, for the duration of the deal, prior to signing a licence agreement.
The other potential vaccine candidates include those for Klebsiella pneumoniae, Escherichia coli, Burkholderia cepacia complex, Pseudomonas aeruginosa and Acinetobacter baumannii.
Following her research on lung infections, Dr McClean, an Associate Professor and Head of Biochemistry at the UCD School of Biomolecular and Biomedical Science, has now developed a platform technology to identify proteins that bacteria use to attach to human cells - proteins that have so far proven to be ‘excellent vaccine candidates,’ the company told shareholders.
Commenting, Dr Jeremy Skillington, CEO of Poolbeg Pharma, said: “Melioidosis offers Poolbeg an opportunity to expand our portfolio of infectious disease assets, as promised at IPO. This 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.”
He added: “If we can take MelioVac through clinical development to Phase II ready, it has the potential to generate significant returns for investors in the short-term while contributing to the global response to the threat of infectious diseases with an unmet medical need.”
Siobhán McClean, Associate Professor at the UCD School of Biomolecular and Biomedical Science and inventor of MelioVac, said: “We are passionate about developing a vaccine against Melioidosis. Poolbeg Pharma is a great potential partner to work with, bringing its experience of vaccine development and industry connections to our innovative science.
If a licence is taken, McClean said the development of MelioVac and other candidates would therefore contribute “significantly to the world’s renewed fight against infectious diseases.”
Last month, Poolbeg said it is to start a Phase Ib human challenge study of its lead asset POLB 001 next year in June 2022 which will be “a key step” in the molecule’s development.
The infectious disease pharmaceutical firm, a spin-out of Open Orphan, said it has signed a letter of Intent to retain the Centre for Human Drug Research (CHDR) to run the study.
It has also signed an agreement with SEDA Pharmaceutical Development Services for drug formulation services. A vendor has also been selected for GMP* manufacturing of POLB 001.
In this study, clinical researchers from CHDR will stimulate a healthy volunteer’s immune system with bacterial lipopolysaccharide (LPS) in a safe and controlled clinical environment.
The study is expected to provide key human data on the efficacy of the POLB 001 asset in dampening the immune response in otherwise healthy volunteers. It will use LPS to simulate the effects of treating severe influenza in the volunteers without the virus itself being present.
’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’s mode of action is to reduce this hyper-immune response,’ the company explained to investors this morning.
The design of the study (the study protocol) is expected to be finalised by the end of 1Q22.
In October 2021, Poolbeg also submitted further patent applications for PredictViral™, its disease severity platform which the company has described as a ‘transformative product’.
The latest patent aims to predict whether an individual exposed to a respiratory virus (such as Influenza, RSV) will have a higher severity of disease and / or be more likely to be contagious.
Addressing investors at the time, Poolbeg said it believes that PredictViral™ will offer diagnostic companies ‘a transformative product that will enhance clinical decision-making while differentiating their platforms at a time of intense competition in this market.’
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