MB310 / Microbiotica, Roche - LARVOL DELTA

ORGANOID MODELS DEMONSTRATE THERAPEUTIC POTENTIAL OF MB310, A CONSORTIUM OF GUT COMMENSAL BACTERIA LINKED TO CLINICAL BENEFIT IN ULCERATIVE COLITIS (UEGW 2025) - "The accumulated data suggest that MB310 interacts with the host epithelial barrier leading to improvement of its integrity, repair after damage and reduction of leakiness. Moreover, transcriptomic analysis demonstrated the ability of MB310 to rewire epithelial cells to an anti-inflammatory programme, under inflammatory conditions. COMPOSER-1 is an ongoing phase 1b trial testing MB310 in UC patients."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IFNG • TNFA

COMPOSER-1: A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis (clinicaltrials.gov) - P1 | N=29 | Active, not recruiting | Sponsor: Microbiotica Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Microbiotica Announces Completion of Recruitment in its Phase 1b Trial (COMPOSER-1) of MB310, a Precision Microbiome Medicine, in Ulcerative Colitis Patients (GlobeNewswire) - "Microbiotica...announces that patient recruitment is complete in its Phase 1b First-in-Human trial, COMPOSER-1, of MB310 in ulcerative colitis (UC) patients. This international trial has recruited 29 adult patients at clinical centres in the UK, Austria, Bulgaria, Poland and Spain. Initial results are expected by the end of 2025."

Enrollment closed • P1 data • Ulcerative Colitis

GUT COMMENSAL BACTERIA, ASSOCIATED WITH CLINICAL REMISSION IN ULCERATIVE COLITIS, PROTECT AND HEAL GUT EPITHELIAL BARRIER THROUGH THREE NOVEL PATHWAYS (DDW 2025) - "Therefore, this data, together with the immunomodulatory effects of the strains, suggest MB310 has therapeutic potential for a wide spectrum of UC patients. COMPOSER-1 is an ongoing phase 1b trial testing MB310 in mild-to-moderate UC patients."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Ulcerative Colitis • CLDN1 • CLDN2 • OCLN

Microbiotica unveils multiple mechanisms by which MB310, in clinical development for the treatment of ulcerative colitis, protects the intestinal barrier (GlobeNewswire) - "Microbiotica...has presented new data on the mechanism of action of MB310, its product in development as a treatment for ulcerative colitis (UC), at Digestive Disease Week (DDW) 3rd – 6th May in San Diego....Data from new preclinical studies presented at DDW demonstrated that three bacterial strains in MB310 enhance the epithelial barrier integrity by three distinct mechanisms: release of nicotinic acid; polyamine production; and expression of a novel protein IZOR (Internalin-like ZO1 Regulator)."

Preclinical • Ulcerative Colitis

Microbiotica unveils data on the mechanism of action of MB310, a clinical-stage drug candidate in development for the treatment of ulcerative colitis (GlobeNewswire) - "Microbiotica...has presented new data on the mechanism of action of MB310, its product in development as a treatment for ulcerative colitis (UC), at the Keystone Symposia ‘Human Microbiome: Diversity, Selection and Adaptation’ held February 18-21 in Banff, Canada and at the European Crohn’s and Colitis Organisation (ECCO) meeting held February 19-22 in Berlin....Data from new preclinical studies presented at the congresses demonstrated that MB310 acts via at least three independent mechanisms of action (MOA) 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....MB310 is in a Phase 1 study COMPOSER-1, with data readout expected by the end of 2025."

P1 data • Preclinical • Immunology • Ulcerative Colitis

Mechanistic understanding of MB310: a consortium of gut commensal bacteria for the treatment of Ulcerative Colitis (ECCO-IBD 2025) - "This highlights that multifaceted effects of MB310 that can circumvent the challenge of UC disease heterogeneity, proposing it as a potential therapeutic for a wide spectrum of UC patients. COMPOSER-1 is an ongoing phase 1b trial testing MB310 in UC patients."

Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CD4 • FOXP3 • IL10 • TNFA

COMPOSER-1: A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Microbiotica Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

COMPOSER-1: A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Microbiotica Ltd

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Microbiotica’s Microbiome Medicines in Melanoma and Ulcerative Colitis Gain Regulatory Approvals in EU and UK for Phase 1b Studies (GlobeNewswire) - "Microbiotica...announce that it has received regulatory approvals to initiate clinical studies for its first two programmes in...ulcerative colitis (COMPOSER-1) in selected EU countries and the UK. Both studies are due to start shortly, with initial data readouts expected by the end of 2025."

New P1 trial • P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

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

MB310: From Clinical FMT to a Phase 1 Study with a Defined, Orally Administered Live Bacterial Therapeutic for Mild Moderate Ulcerative Colitis (ECCO-IBD 2024) - "Costello, et al. (2019) Jama 321.2: 156-164."

Clinical • P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CD4

Microbiotica Raises £50m ($67m) to Advance Pipeline of Microbiome-based Therapeutics (Businesswire) - "Microbiotica...announced the completion of a £50 million ($67 million) Series B financing round – the largest microbiome-related financing in Europe to date....The proceeds will be used to progress Microbiotica’s two lead oral Live Bacterial Therapeutics (LBTs), MB097 and MB310 to Phase 1b clinical studies."

Financing • Inflammatory Bowel Disease • Ulcerative Colitis

[VIRTUAL] MULTI-FUNCTIONAL LIVE BACTERIAL THERAPEUTIC FOR ULCERATIVE COLITIS DERIVED FROM PRECISION METAGENOMIC ANALYSIS OF CLINICAL FMT STUDY (DDW 2021) - "The bacteria also have an anti-inflammatory effect of when incubated with different primary immune cells in vitro.In summary, we have identified a consortium of bacteria using patient-first discovery in a successful FMT study that is being developed as an LBT for the treatment of UC. The LBT has been validated in an in vivo disease model, protects from epithelial barrier damage, and is anti-inflammatory."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Transplantation • Ulcerative Colitis

[VIRTUAL] Patient-first discovery of bacterial biomarkers and live bacterial therapeutics for cancer immunotherapy (Bio Europe Fall 2020) - "New best-in-class study into how the gut microbiome impacts response to immune checkpoint inhibitors in advanced melanoma  Precision mapping of this study using Microbiotica’s platform has identified a pre-treatment microbiome signature highly predictive of response to anti-PD1 therapy across 4 independent melanoma studies  A live bacterial therapeutic is being developed based on a consortium of strains associated with response to enhance the efficacy of anti-PD1 therapy in melanoma  Analysis indicates microbiome associated with response varies between indications"

Biomarker • Clinical • IO Biomarker • Immune Modulation • Inflammation • Melanoma • Oncology • Solid Tumor