Poolbeg Pharma (POLB) has appointed Professor Daniel Hoft to its Scientific Advisory Board. 

The London-listed clinical stage infectious disease pharmaceutical company, which is a spin-out of Open Orphan, said Hoft, who has published over 140 peer reviewed scientific publications, has been working in immunology and infectious diseases for a total of 32 years.

Following his appointment, Hoft will join the Scientific Advisory Board alongside Dr Elaine Sullivan and Prof Luke O’Neill and will guide Poolbeg on its asset development programmes 'with an extensive background in infectious disease, immunology, and vaccinology.'

He will also work with Poolbeg to scout for prospective in-licencing opportunities, the group told investors.

Poolbeg said Hoft is ‘heavily involved’ in vaccine development research, especially for pandemic influenza and tuberculosis which has seen him undertake pioneering work in T-cell targeting vaccines which is particularly relevant to the Company’s Vaccine Discovery Platform.

He is Principal Investigator of the SLU’s Vaccine & Treatment Evaluation Unit, one of ten US National Institutes of Health centers, placing it among an elite group of top academic centers conducting clinical trials of novel vaccines for global protection against future pandemics.

‘Since the SARS-CoV-2 pandemic the SLU VTEU led by Prof Hoft has featured prominently in the urgent COVID-19 vaccine development and Prof Hoft is the VTEU protocol chair for a first-in-human phase I trial of a novel COVID-19 vaccine,’ the company told investors.

To date, Hoft has received numerous awards from NIH, US Department of Defense, and the Bill & Melinda Gates Foundation and is a regular advisor to the World Health Organisation.

Dr Jeremy Skillington, Chief Executive Officer of Poolbeg Pharma, commented: “Prof Hoft is a great addition to the Poolbeg Scientific Advisory Board, joining Dr Elaine Sullivan and Prof Luke O’Neill. His expertise in infectious disease, particularly with severe influenza and vaccine development will be invaluable as we develop Poolbeg’s pipeline of assets.”

Hoft will work with Poolbeg “to scout for prospective assets to in-licence and develop.”

Prof Daniel Hoft, M.D., Ph.D., commented: “Poolbeg has an interesting portfolio of assets within infectious disease with an exciting lead asset, POLB 001. Coupled with its unique access to 20 years’ of human viral challenge study data, means its approach has real potential in this space. I look forward to helping support the business as it develops.”

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Last week, Poolbeg said it would 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 had 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 advance of the Phase Ib study commencing next year, Poolbeg has completed the manufacturing of a non-GMP (Good Manufacturing Practice) batch of POLB 001 which is ‘on hand for any non-clinical (not administered to humans) requirements’, such as formulation. 

The company said this is also “an important step” in validating the manufacturing process.

On this basis, manufacturing can now be scaled up as required as the clinical development phase progresses, and Poolbeg will move towards manufacturing GMP* grade POLB 001 material needed for the LPS challenge study and has similarly selected a vendor for this work.

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