World-first Australian cancer trial targets common immunotherapy side effects

Biotech News: In advancing cancer immunotherapy treatment, St Vincent’s Hospital Sydney has embarked on the world’s first randomised controlled trial utilising capsule Faecal Microbiota Transplantation (FMT) specifically tailored for patients with colitis or diarrhoea due to their cancer immunotherapy.

Immunotherapy, a transformative approach in the fight against various cancers, has significantly improved treatment outcomes, even for those diagnosed with advanced stages of the disease. However, the therapeutic journey is not without its challenges. A substantial proportion of patients on these medicines, nearly 40%, grapple with adverse effects such as diarrhoea and colitis, resulting in a diminished quality of life, increased hospitalisation rates, and in some instances, a forced cessation of their life-saving immunotherapy.

Leading this world-first trial is Dr Craig Haifer, Chief Investigator and gastroenterologist, who underscores the importance of exploring novel therapies. He envisions the trial as a means to demonstrate that a short regimen of orally administered FMT capsules could induce remission, curtail hospitalisations, and facilitate an early resumption of the vital cancer immunotherapy.

Dr Haifer enthusiastically noted, “Capsule FMT is the next step forward in the quest for feasible and acceptable microbial based therapy and I’m grateful to collaborate with gastroenterologist Dr Sam Costello Co-founder and CEO at BiomeBank on this study.

“This accomplishment is a testament to our multi-faceted team of clinicians and scientists whose combined aim is to advance the frontier of medical science whilst developing novel and innovative treatments.”

The stage for this trial was set in November 2022 when the Therapeutic Goods Administration (TGA) granted approval for BiomeBank’s FMT product, Biomictra, marking a significant milestone in gut microbiota restoration for the treatment of recurrent Clostridioides difficile (C-diff) infection. BiomeBank was the first company to secure regulatory approval for a donor derived microbiome drug product worldwide.

The ambitious FMT trial for immunotherapy-associated colitis has garnered support from St Vincent’s Health Network Sydney, The Kinghorn Cancer Centre, St Vincent’s Clinic Research Foundation, GESA, UNSW, NSW Health, and the Cancer Research Institute (CRI). This collective support underscores the criticality of enhancing the lives of cancer patients navigating the challenges of immunotherapy.

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