We are advancing a pipeline of programmes in immuno-oncology and inflammatory bowel disease. Several of our programmes are being progressed with the support of strategic collaborators.
Clinical stage programmes
MB097 – co-therapy with immune checkpoint inhibitor
| Pre-clinical | Phase 1 | Phase 2 | Phase 3 | Collaborator |
|---|
Therapeutic area
Immuno-oncology
Specific indication
Melanoma
Live biotherapeutic product (LBP)
MB097 – co-therapy with immune checkpoint inhibitor
Milestone
Phase 1b data in 2025
Learn more about MB097 programme
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.
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.
MELODY-1 - UK/EU Phase 1b study in advanced melanoma - now recruiting
Phase 1b study: To investigate the safety, tolerability, and initial signals of efficacy of MB097 in advanced melanoma, in combination with KEYTRUDA® (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, in patients with cutaneous melanoma who have failed to respond to immunotherapies. MSD will supply KEYTRUDA.
Study design: Randomised open label clinical trial with all patients receiving MB097 (once daily, orally administered LBP capsule consisting of a defined consortium of nine bacterial strains) and pembrolizumab for up to six months.
Half of the participants will also receive vancomycin before starting the combined treatment to determine whether it helps the bacterial strains in MB097 engraft and grow in the gut more efficiently.
Participants benefiting from the treatment at the end of the initial six-month period may continue to receive pembrolizumab alone for up to approximately 18 months.
Endpoints: The study will assess the safety and tolerability of the co-therapy and investigate efficacy including impact on tumour growth. In addition, it will measure the engraftment of the strains being dosed, and changes in several immune biomarkers. Data readout expected by the end of 2025.
Study centres: There will be up to 18 clinical trial sites across the four countries: UK, France, Italy and Spain
Study identifiers: NCT06540391; MSD KEYNOTE-E75; 023-507377-17.
MB310 – monotherapy
| Pre-clinical | Phase 1 | Phase 2 | Phase 3 | Collaborator |
|---|
Therapeutic area
Inflammatory bowel disease
Specific indication
Ulcerative colitis (UC)
Live biotherapeutic product (LBP)
MB310 – monotherapy
Milestone
Phase 1b data in 2025
Learn more about MB310 programme
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.
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.
COMPOSER-1 - UK/EU Phase 1b study in ulcerative colitis - now recruiting
Phase 1b study: To investigate the safety, tolerability and initial signals of efficacy of a once daily oral dose of MB310 as a monotherapy for the treatment of ulcerative colitis (UC), an inflammatory bowel disease.
Study design: Randomised, placebo-controlled, double-blind, clinical trial recruiting up to 30 adult patients with active, mild-to-moderate UC.
The patients will take two capsules of study medication (active or matched placebo) once a day for 12 weeks in addition to their standard of care medication, with a 12-week follow-up period.
Endpoints: The study will assess the safety and tolerability of MB310 and measure the degree to which the bacteria within MB310 successfully engraft into patients’ intestinal microbial community.
Data readouts are expected by the end of 2025.
Study centres: There will be up to 23 clinical trial sites across five countries: UK, Austria, Bulgaria, Poland and Spain.
Study identifiers: NCT06582264; 2023-507376-50
Discovery programme
Immuno-oncology
Collecting and analysing clinical data from MITRE study to inform product development
Milestone
Interim analysis 2024
Collaborator
Learn more about our discovery programme
MITRE: An ongoing observational immuno-oncology clinical study
Our collaboration with Cancer Research UK, and Cambridge University Hospitals is conducting a large observational study, ‘MITRE’ (Microbiome Immunotherapy Response Evaluation), with up to 1,800 cancer patients receiving immune checkpoint inhibitors, in 12 UK centres.
MITRE is investigating the association between the gut microbiome and treatment outcome – both efficacy and toxicities – in a range of tumour types including Non-small Cell Lung Cancer (NSCLC) and Renal Cell Carcinoma (RCC). The study utilises Microbiotica’s Discovery Platform to identify bacteria signatures that will inform the composition of live bacterial products for co-therapy to enable therapeutic manipulation of the microbiome for improved patient outcomes. Furthermore, the clinical data generated will inform patient selection for immune checkpoint drugs.
