Microbiotica has dosed the first subject in the Phase Ib MELODY-1 clinical trial of MB097, a precision microbiome co-therapy targeting advanced melanoma.
A once-daily oral live biotherapeutic product (LBP), MB097 is composed of nine specific strains of commensal bacteria, designed to boost immune checkpoint inhibitors’ (ICIs) efficacy.
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The randomised, open-label, first-in-human, global study aims to enrol up to 40 subjects at up to 18 clinical sites in the UK, Italy, France and Spain. It will assess the safety, tolerability and initial efficacy of MB097 plus MSD’s (Merck & Co.) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with cutaneous melanoma who have not responded to prior immunotherapies.
MSD will provide KEYTRUDA for the MELODY-1 trial.
In the study, trial subjects will receive MB097 plus pembrolizumab over six months.
Half of the participants will also receive vancomycin before starting the co-therapy to evaluate its role in enhancing the colonisation of MB097 strains in the gut.
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By GlobalDataPatients showing positive responses after the initial six months may continue pembrolizumab for up to an additional 18 months, for a total treatment period of around 24 months, the company noted.
In addition to safety and tolerability, efficacy will be assessed using standard oncology metrics including imaging-based tumour response.
The trial will also evaluate the engraftment of the bacterial strains and monitor changes in immune biomarkers.
Microbiotica expects to report the initial data from the trial by the end of next year.
Microbiotica chief medical officer Ron Carter said: “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.”
