London startup to trial drug to prevent cancer therapy side-effect ‘cytokine storm’ | Pharmaceuticals industry
A London-based startup is about to trial a drug that could prevent people receiving cancer immunotherapy from experiencing life-threatening side effects in six NHS hospitals.
Poolbeg Pharma said its oral drug POLB 001 could prevent blood cancer, making treatment safer. cytokine release syndrome (CRS)When the immune system goes into overdrive and attacks the body, it causes organ damage.
The drug could also save the NHS and other healthcare systems millions of pounds because those receiving treatment do not need to be monitored at central specialist cancer centers if they succumb to the cytokine storm.
Instead, care can be provided in public hospitals, thus reducing the cost per patient and allowing more patients to be treated.
The drug is to be tested on 30 people who will be treated with Johnson & Johnson’s blood cancer drug teclistamab (sold as Tecvayli) at six hospitals in England in a trial led by the University of Manchester and Christie NHS Foundation Trust.
Jeremy Skillington, Poolbeg’s chief executive, said cancer immunotherapies such as CAR T cell and bispecific antibody treatments “work wonders, but they all have problems with this cytokine storm, so patients need to receive these treatments in a specialist cancer hospital.”
“If someone lives in the countryside of the UK, they will need to come to London or go to a big city… because CRS is potentially fatal. There is no diagnosis; you can’t predict who will develop it.”
About 70% of people receiving cancer immunotherapy from J&J, Gilead, Novartis, AstraZeneca and other companies develop CRS, which begins with fever and increased heart rate and may require intensive care. There is currently no approved treatment for the prevention of CRS.
In the interim clinical trial, patients will begin taking the drug Poolbeg at home before starting cancer treatment, “just to keep the immune system in check … and so you don’t develop CRS,” Skillington said.
The drug, from Palau Pharma in Spain and originally developed for chronic inflammation, works by blocking a specific cell signaling pathway. Poolbeg expects to have provisional data from the trial by the end of the summer.
Poolbeg estimates that nearly half a million people have been diagnosed with blood cancers, multiple myeloma and diffuse large B-cell lymphoma. By 2031, immunotherapy will be available in the United States and the five largest countries in Europe. They normally need to stay in hospital for two to three weeks if they develop CRS.
Based on the POLB 001 drug’s potential price of $20,000 (£15,000), the market could be worth $10 billion, according to Skillington, a former research scientist at the University of California, Berkeley, who also worked at US biotech Genentech, part of Roche. Cancer immunotherapies cost approximately $300,000 to $400,000 for one course of treatment.
Poolbeg is also developing a GLP-1 weight loss pill with Irish microencapsulation company AnaBio Technologies and will test it in 20 healthy volunteers with a body mass index over 30 in an early-stage trial later this year. The trial will be led by Dr Carel Le Roux, professor of metabolic medicine at the University of Ulster.
The company, named after the Poolbeg peninsula in Dublin by its co-founder, Irish entrepreneur Cathal Friel, split from clinical research organization hVIVO in July 2021.
It listed on the London Stock Exchange’s Aim market and raised £25 million to develop the drug. hVIVO, also headquartered in Canary Wharf, traces its roots to Retroscreen Virology, developed in 1989 by Prof John Oxford from Queen Mary University of London.
Skillington said the NHS was “imploding” due to cost and demand pressures. “If you can reduce that burden, that’s your ultimate goal,” he said.
