Microbiotica drug trial for melanoma treatment begins
The first patient has been dosed in Microbiotica’s advanced melanoma (MELODY-1) trial - an international trial taking place at clinical centres in the UK, France, Italy and Spain with up to 40 patients.
The drug being assessed, MB097, is a once daily, orally administered live biotherapeutic product (LBP) consisting of a defined consortium of nine strains of commensal bacteria designed to enhance the efficacy of immune checkpoint inhibitors (ICIs).
The MELODY-1 study will investigate the safety, tolerability, and initial signals of efficacy of MB097 in advanced (metastatic) melanoma, in combination with KEYTRUDA (pembrolizumab), MSD's (Merck)) anti-PD-1 therapy, in patients with cutaneous melanoma who have failed to respond to immunotherapies. MSD will supply KEYTRUDA.
This is a Phase 1b, first-in-human, randomised open-label clinical trial with all patients receiving MB097 and pembrolizumab for up to six months.
Half of the participants will also receive the antibiotic vancomycin before starting the co-therapy. This aims to reduce the resident bacterial in the gut prior to treatment to determine how significant the gut microbiome is in helping the bacterial strains in MB097 to embed and grow in the gut efficiently. Initial data readouts are expected by the end of 2025.
Ron Carter, Microbiotica’s chief medical officer, said: “The gut microbiome, the community of bacteria in the gut, plays a crucial role in digesting food and protecting people from infections, but it also interacts very closely with the immune system. In cancer patients, the bacteria in MB097 appear to be associated with better response rates to immune checkpoint inhibitor therapies, such as anti PD-1 drugs.
“MB097, with its precisely selected microbes based on data from responsive patients, in combination with ICIs, could therefore activate a therapeutic benefit for non-responding patients with advanced melanoma. Moreover, as the MB097 bacteria are found in healthy subjects as well as in patients who responded to ICIs, we anticipate a favourable safety profile.”
Participants benefiting from the treatment at the end of the initial six-month period may continue to receive pembrolizumab for up to an additional 18 months (approximately 24 months total). There will be up to 18 sites taking part in the study across the four countries.
Professor Paolo Ascierto, director of the Unit of Melanoma, Cancer Immunotherapy and Development Therapeutics, National Tumor Institute Fondazione G Pascale, Naples, Italy - where the first patient has been dosed - said: “Combining beneficial microbes with immune checkpoint inhibitors to increase the number of patients who could benefit from these life-saving therapies is a cutting-edge modality that could change the medical paradigm for advanced melanoma patients.
“With more than half of patients with melanoma being treated with anti PD-1 drugs either not responding or relapsing, I have great hope that the addition of a MB097 precision microbiome therapy to the treatment regime can improve the outcome for many more patients.”
Pippa Corrie, affiliated associate professor of medical oncology, University of Cambridge, leading the UK arm of the study, said: “Our MELRESIST study has been fundamental in identifying precisely those gut bacteria that are associated with positive outcomes for melanoma patients on ICIs.
“The microbial signature comprising a small group of bacteria that were consistently raised in abundance in responding patients across multiple independent cohorts, which gives confidence that MB097 has real potential to increase the number of patients who can benefit from these ICI treatments by optimising the patient’s gut microbiome.”
Details of the study, and who can take part, are available here.
