Our Lead Clinic-Ready Programmes
Immuno-oncology
MB097: our lead immuno-oncology therapeutic candidate, is a co-therapy for advanced melanoma.
MB097: oral capsule comprised of a consortium of nine defined live gut commensal bacterial strains.
Rationale: MB097 is being developed as a co-therapy with an immune checkpoint inhibitor (ICI) to enhance its efficacy and enable a durable, sustained anti-tumour response in patients who have not initially responded to immunotherapy.
Discovery: The bacterial strains in MB097 were identified by analysing the microbiome of patients in multiple studies of ICIs in melanoma including the MELRESIST study carried out with our collaborators at Cancer Research UK and Cambridge University Hospitals. Microbiotica’s discovery platform enabled precise, strain-level identification of a bacterial signature associated with clinical response in all cohorts.
Mechanism of Action (MoA): Collectively the MB097 bacterial consortium modulates important features of the microbiome needed to promote an anti-tumour immune response. Our pre-clinical studies demonstrate that MB097 stimulates dendritic cells and core pathways of the immune system to drive Cytotoxic T Lymphocytes (CTLs) and Natural Killer (NK) cells to search out and kill tumour cells.
Clinical status: Entering Phase 1b clinical studies.
Collaborator: MSD
Melanoma stats: Immune checkpoint inhibitors (ICI) have transformed the management of several cancers including melanoma by increasing long-term survival rates. For melanoma patients, the increased survival rate is relatively high, but still only 40 to 50% of patients benefit. Microbiotica is developing a co-therapy with the aim of further improving long-term survival rates by increasing the number of responding patients.
Inflammatory Bowel Disease
MB310: our lead inflammatory bowel disease therapeutic candidate for ulcerative colitis, an inflammatory bowel disease.
MB310: oral capsule comprised of a consortium of eight specific live gut commensal bacterial strains..
Rationale: MB310 is designed to be a best-in-class therapy that is given as a once-daily dose to deliver long-term remission to ulcerative colitis patients, without immunosuppression or unwanted side effects.
Discovery: The bacterial strains in MB310 were identified by analysing clinical and microbiome data from a faecal microbiota transplantation (FMT) study of ulcerative colitis patients carried out with collaborators at the University of Adelaide. The results demonstrated the ability of a microbiome- therapy to induce remission in ulcerative colitis, without significant side-effects. These data provided compelling evidence for a novel therapeutic approach based on administering commensal bacterial strains associated with response. Microbiotica‘s analysis identified the engrafting bacteria associated with clinical remission, leading to the development of MB310 as a LBP.
Mechanism of action (MoA): Our pre-clinical studies demonstrated that MB310 acts via at least three independent mechanisms that are central to the pathology of UC: promoting the healing of the damaged gut epithelial barrier, regulating the balance of cytokines that are inflammatory (TNF) and immune-modulatory (IL-10); and inducing a regulatory T-cell response.
Collaborator: University of Adelaide
Ulcerative colitis stats: Ulcerative colitis, the most common form of Inflammatory Bowel Disease (IBD), is a major debilitating disease that affects over 1.4m people globally.