Drugs / MB097
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06540391 | Aug 2024 → Dec 2025 overdue | melanoma | Microbiotica Ltd | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-05-18 | Microbiotica Ltd | Results Microbiotica Announces Positive Results from its Phase 1b Trial (MELODY-1) of MB097, a Precision Microbiome Co-Therapy in Advanced Melanoma microbiotica.com ↗
MB097 could be administered safely in combination with KEYTRUDA with no serious adverse events (SAEs) related to MB097 |
| 2025-04-29 | Microbiotica Ltd | Results Microbiotica reveals novel mechanisms showing how the microbiome can improve immunotherapy response based on MB097, a clinical-stage drug candidate being evaluated in combination with KEYTRUDA® (pembrolizumab) in patients with advanced melanoma microbiotica.com ↗
These assays have demonstrated that three of the MB097 strains induce dendritic cells to produce high levels of IL-12, which in turn stimulates Cytotoxic T Lymphocytes and NK cells with potent tumour cell killing activity. |
| 2025-02-26 | Microbiotica Ltd | Results Microbiotica presented new data on the mechanism of action of MB097, a clinical-stage drug candidate being developed as a co-therapy in combination with KEYTRUDA® (pembrolizumab) in patients with advanced melanoma microbiotica.com ↗
These new data demonstrate that the bacterial strains within MB097 can interact directly with dendritic cells to potently activate cytotoxic T lymphocytes (CTL). |
| 2024-08-27 | Microbiotica Ltd | Regulatory Microbiotica’s Microbiome Medicines in Melanoma and Ulcerative Colitis Gain Regulatory Approvals in EU and UK for Phase 1b Studies microbiotica.com ↗
Microbiotica, a biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs), is pleased to announce that it has received regulatory approvals to initiate clinical studies for its first two programmes in advanced melanoma (MELODY-1) and ulcerative colitis (COMPOSER-1) in selected EU countries and the UK. |
All press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MB097 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06540391 ↗ |
| Modality | Other / unclassified | “Live bacterial therapeutic for oral administration” NCT06540391 ↗ |
| Route | Oral | “Live bacterial therapeutic for oral administration” NCT06540391 ↗ |