A London startup, Poolbeg Pharma, is set to trial an oral drug, POLB 001, to prevent cytokine release syndrome in cancer immunotherapy patients. The trial will take place at six NHS hospitals and could reduce treatment costs significantly.
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A London-based startup is about to trial a drug at six NHS hospitals that could stop people on cancer immunotherapy getting a life-threatening side-effect.
Poolbeg Pharma said its oral drug POLB 001 could make treatment for blood cancer safer by preventing cytokine release syndrome (CRS), when the immune system goes into overdrive and attacks the body, leading to organ damage.
The drug could also save the NHS and other health systems millions of pounds because those being treated do not have to be supervised in centralised specialist cancer centres in case they succumb to a cytokine storm.
Instead, care can take place in community hospitals, reducing the cost per patient and allowing more patients to be treated.
The drug is about to be tested on 30 people who will be treated with Johnson & Johnson’s blood cancer medication teclistamab (sold as Tecvayli), at six hospitals in Britain, in a trial led by the University of Manchester and the Christie NHS Foundation Trust.
Jeremy Skillington, Poolbeg’s chief executive, said cancer immunotherapies such as CAR T-cell and bispecific antibody treatments “are working wonders, but they all have issues with this cytokine storm. So patients have to take these therapies in a dedicated cancer hospital.
“If somebody’s living in rural UK, they’re going to have to come up to London or go to a big city … because CRS is potentially fatal. There’s no diagnostic – you can’t predict who will develop it.”
About 70% of people who receive cancer immunotherapies from J&J, Gilead, Novartis, AstraZeneca and others develop CRS, which begins with fever and increased heart rate and can require intensive care. There is no approved therapy for CRS prevention at the moment.
In the intermediate clinical trial, patients will start taking Poolbeg’s drug at home before they begin cancer treatment “just to keep the immune system under control … and you won’t develop CRS”, Skillington said.
The drug, which was acquired from Spain’s Palau Pharma and was originally developed for chronic inflammation, works by blocking a particular cell signalling pathway. Poolbeg expects to have interim data from the trial by the end of the summer.
Poolbeg estimates that about half a million people diagnosed with the blood cancers multiple myeloma and diffuse large B-cell lymphomawill receive immunotherapy by 2031 in the US and the five biggest European countries. Normally they have to stay in hospital for two to three weeks in case they develop CRS.
Cytokine release syndrome (CRS) is a life-threatening side effect where the immune system overreacts, potentially causing organ damage.
POLB 001 could lower costs by allowing treatment in community hospitals instead of centralized cancer centers, reducing the need for constant supervision.
The trials for POLB 001 will occur at six NHS hospitals across Britain, led by the University of Manchester and the Christie NHS Foundation Trust.
The trial will involve 30 patients who will be treated with Johnson & Johnson’s blood cancer medication teclistamab.
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Based on a potential price of $20,000 (£15,000) a treatment with the POLB 001 drug, the market could be worth $10bn, according to Skillington, a former research scientist at the University of California who also worked at the US biotech Genentech, part of Roche. The cancer immunotherapies cost about $300,000 to $400,000 for a course of treatment.
Poolbeg is also developing a GLP-1 weight loss pill with the Irish microencapsulation company AnaBio Technologies, and will test it in 20 healthy volunteers with a body mass index of more than 30 in an early-stage trial later this year. The trial will be led by Dr Carel Le Roux, professor of metabolic medicine at Ulster University.
The company, named after the Poolbeg peninsula in Dublin by its co-founder, the Irish entrepreneur Cathal Friel, was spun out of the clinical research organisation hVIVO in July 2021.
It listed on the London Stock Exchange’s Aim market, raising £25m to develop medicines. hVIVO, also based in Canary Wharf, traces its roots back to Retroscreen Virology, which was spun out of Queen Mary University of London in 1989 by Prof John Oxford.
Skillington said the NHS was “bursting at the seams” under cost and demand pressures. “If you can reduce that burden, that’s the ultimate goal,” he said.