MB097 / Microbiotica - LARVOL DELTA

MELODY-1: A Phase 1b Trial to Evaluate Safety of MB097 in Combination With Pembrolizumab in Melanoma Patients (clinicaltrials.gov) - P1 | N=41 | Active, not recruiting | Sponsor: Microbiotica Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Melanoma • Oncology • Solid Tumor

Microbiotica Announces Completion of Recruitment in its International Phase 1b Trial (MELODY-1) of MB097, a Precision Microbiome Co-Therapy in Advanced Melanoma (The Manila Times) - "This international trial has recruited 41 patients at clinical centres in the UK, France, Italy, and Spain. Initial results are expected in the first half of 2026."

Enrollment closed • P1 data • Melanoma

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 (GlobeNewswire) - "MB097 comprises nine different species of gut commensal bacteria, all linked to positive CPI response in multiple clinical studies. Microbiotica has developed in vitro human systems using primary immune cells to investigate how gut bacteria modulate the immune response to cancer. 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."

Preclinical • Melanoma

Clinical response to immune checkpoint inhibitors in melanoma is associated with distinct gut bacterial species that promote anti-tumor immunity by different mechanisms (AACR 2025) - P1 | "These data begin to identify the different mechanisms by which gut commensal bacteria drive immunotherapy response in human systems. MELODY-1 (NCT06540391) is an ongoing interventional phase 1b study to evaluate MB097 in combination with pembrolizumab in advanced melanoma patients."

Checkpoint inhibition • Clinical • IO biomarker • Melanoma • Oncology • Solid Tumor • CD8 • GZMB • IFNG • IL10 • IL12A

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 (GlobeNewswire) - "Microbiotica...has presented new data on the mechanism of action of MB097 at the American Association for Cancer Research AACR IO meeting held in Los Angeles, February 23-26....These new data demonstrate that the bacterial strains within MB097 can interact directly with dendritic cells to potently activate cytotoxic T lymphocytes (CTL). In addition, certain MB097 bacteria also produced metabolites that enhanced the tumor cell-killing potential of CTLs. One strain released metabolites that reversed the inhibitory effects of tumor-associated macrophages....MB097 is being tested in an international Phase Ib clinical study, in combination with KEYTRUDA (pembrolizumab), MSD's anti-PD-1 therapy, in patients with cutaneous melanoma who have failed to respond to immunotherapies. Data readout expected by the end of 2025."

P1 data • Preclinical • Cutaneous Melanoma

MELODY-1: A Phase 1b Trial to Evaluate Safety of MB097 in Combination With Pembrolizumab in Melanoma Patients (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Microbiotica Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor

Microbiotica Announces First Patient Dosed in its International Phase 1b Trial, MELODY-1 of MB097 Precision Microbiome Co-Therapy in Advanced Melanoma (GlobeNewswire) - "Microbiotica...announces that the first patient has been dosed in its advanced melanoma (MELODY-1) trial. This international trial is due to recruit up to 40 patients at clinical centres in the UK, France, Italy and Spain. Initial data readouts are expected by the end of 2025....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....There will be up to 18 sites taking part in the study across the four countries."

P1 data • Trial status • Melanoma

MELODY-1: A Phase 1b Trial to Evaluate Safety of MB097 in Combination With Pembrolizumab in Melanoma Patients (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Microbiotica Ltd

Combination therapy • New P1 trial • Melanoma • Oncology • Solid Tumor

Microbiotica to Present Positive Update on Manufacturing Progress of its Live Biotherapeutic Products for Forthcoming Melanoma and Ulcerative Colitis Clinical Studies (GlobeNewswire) - "Microbiotica...announces that Adam Wilkinson, its Vice President of Pre-Clinical Development, will present an overview of the company’s successful product manufacturing campaigns ahead of its forthcoming melanoma and ulcerative colitis clinical studies at the 9th Microbiome Movement Drug Development Summit, on 11 July, in Boston, USA, together with Claire Derlot, CBO from its GMP manufacturing partner Biose Industrie. Microbiotica is a leading company developing LBPs based on the gut microbiome. Its lead programs, MB097 for advanced melanoma and MB310 for ulcerative colitis, are on track to enter clinical studies this year."

Clinical • New trial • Immunology • Inflammatory Bowel Disease • Melanoma • Oncology • Skin Cancer • Solid Tumor • Ulcerative Colitis

Microbiotica Announces Clinical Trial Collaboration with MSD to Evaluate MB097 in Combination with KEYTRUDA (pembrolizumab) in a Phase 1b Clinical Trial in Melanoma (Businesswire) - "Microbiotica...announces it has entered into a clinical trial collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA). Under the terms of the agreement, Microbiotica will conduct a phase 1b clinical trial to evaluate the safety and tolerability, and initial signs of clinical activity of its live biotherapeutic product, MB097, in combination with KEYTRUDA^® (pembrolizumab), MSD’s anti-PD-1 therapy, in melanoma patients with primary resistance to an anti-PD-1-containing immunotherapy. Microbiotica will be the study sponsor and MSD will supply KEYTRUDA^®."

Licensing / partnership • Melanoma • Oncology • Skin Cancer

Discovery and exploration of a live bacterial consortium as co-therapy to enhance immune checkpoint inhibitor response in melanoma patients (ESMO 2022) - "This consortium, MB097 is being developed as an anti-PD1 co-therapy for melanoma patients...This included 3 novel species. This IL-12 axis was less tightly linked to NK cell activation, suggesting other as yet undefined mechanisms may influence these cells."

Checkpoint inhibition • Clinical • IO biomarker • Melanoma • Oncology • Solid Tumor • CD86 • GZMB • IFNG • IL10 • IL12A