A clinical trial follow-up featuring patients with end-stage liver cirrhosis shows increased survival rates and fewer liver transplants in those treated with macrophage cell therapy.
The results, from biopharmaceutical company Resolution Therapeutics and the University of Edinburgh, will be presented today at the European Association for the Study of the Liver (EASL) conference in Milan.
After 18 months of extended follow-up (30 months post-randomisation) the macrophage infusion group had significantly improved outcomes when analysing either patient survival (Chi-square=4.35; p=0.037), or transplant free survival (Chi-square=7.07; p=0.0078).
There were 2 deaths, 0 liver transplants, 0 patients listed for transplant and 1 malignancy (HCC) in the macrophage infusion group compared to 7 deaths, 2 liver transplants, 1 patient listed for transplant, and 3 malignancies (0 HCC) in the control group.
The MATCH 2 data provides clear clinical proof of concept for macrophage cell therapy as an effective and durable treatment for advanced liver cirrhosis.
The new treatment, invented by Professor Stuart Forbes of the University of Edinburgh and supported by Edinburgh Innovations (EI), involves scientists taking immune cells from the patients’ blood and turning them into mature macrophages which are then re-injected back into the patient to stimulate liver regeneration and repair.
An initial smaller, Phase 1 study led by Professor Forbes in 2019, called MATCH, successfully proved its safety.
In 2020, Professor Forbes co-founded Resolution Therapeutics, a biotech company focused on engineering macrophage cell therapies. Resolution has also developed a platform to engineer and cryopreserve autologous macrophages with a pro-regenerative phenotype for the treatment of patients with ESLD.
Professor Forbes said:
We are greatly encouraged by the data from the MATCH Phase 2 study and this long term follow up study. We will continue monitoring patients with the aim of reporting further data at the American Association for the Study of Liver Disease (AASLD) meeting in November 2024. The macrophage production and engineering platform that has been created at Resolution is the next step in tackling this severely underserved condition. We are looking forward to seeing further platform progress and publications in the coming months. ”
Resolution’s upcoming Phase 1/2 EMERALD study will investigate the safety and efficacy of engineered macrophage cell therapy, RTX001, in patients with decompensated liver cirrhosis following hospitalisation due to a recent decompensation event.
Dr Lara Campana, Scientific Co-Founder and Vice President of Research Operations of Resolution Therapeutics, added:
The data from Professor Forbes’ group has shown that autologous macrophages are a safe and effective treatment for patients with advanced liver cirrhosis. Our advanced macrophage engineering and production platform aims to maximise the transformative potential of macrophages, increasing their pro-regenerative properties, potentially leading to fewer liver transplants being needed and a longer life expectancy for those with ESLD. ”
Dr Susan Bodie, EI’s Head of Business Development for the College of Medicine and Veterinary Medicine, said:
The Resolution TX cell technology is a fantastic translation of academic research into a biotech environment where it can begin to make a difference.
“Strong results like these show real promise of a treatment for patients who currently can only hope for a liver transplant and a life on immunosuppressants. We will continue to follow it with excitement. ”
