FMT_XBI302 / Xbiome - LARVOL DELTA

Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of Anti- PD-1 (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Peking University | Active, not recruiting ➔ Completed

Trial completion • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Transplantation

Fecal microbiota transplantation promotes immunotherapy sensitivity in refractory gastrointestinal cancer patients: open label, single-arm, single center, phase 1 study (medRxiv) - P1 | N=10 | NCT04130763 | "The combination of FMT and anti-PD1 treatment was well tolerated with no serious adverse reactions observed among all 10 patients. The objective response rate was 20% and the disease control rate was 40%. The progression-free survival of these two responders were 15 and more than 19 months respectively. Clinical benefits were associated with colonization of donor-derived immunogenic microbes, and an activated immune status reflected by peripheral immune cell populations. Responder-enriched microbes interacted closely as a butyrate-functional guild, while non-responder-enriched microbes interacted sparsely and had higher fraction of oral-originated microbes. Donor-specific microbial traits that influence clinical efficacy of FMT were validated in an independent cohort."

P1 data • Gastrointestinal Cancer • Oncology • Solid Tumor

Human-derived fecal microbiota transplantation alleviates social deficits of the BTBR mouse model of autism through a potential mechanism involving vitamin B6 metabolism. (PubMed, mSystems) - "The analysis linked the amelioration of social deficits following FMT treatment to the restoration of mitochondrial function and the modulation of vitamin B6 metabolism. Bacterial species and compounds with beneficial roles in vitamin B6 metabolism and mitochondrial function may further contribute to improving FMT products and designing novel therapies for ASD treatment."

Journal • Preclinical • Autism Spectrum Disorder • Genetic Disorders • Transplantation

Unknown FMT drug XBI-302 has received feedback from the US FDA and can enter the second phase of clinical trials [Google translation] (leiphone.com) - "...Shishijun announced that its EOP1 application for enterobacterial transplantation (hereinafter referred to as FMT) drug code-named XBI-302 has received feedback from the US FDA and can officially enter the clinical phase II trial stage for the treatment of acute graft-versus-host disease (aGvHD)."

New P2 trial • Acute Graft versus Host Disease

Metagenomic and metabolomic analyses reveal synergistic effects of fecal microbiota transplantation and anti-PD-1 therapy on treating colorectal cancer. (PubMed, Front Immunol) - "Furthermore, metabolomic analysis upon mouse plasma revealed several potential metabolites that upregulated after FMT, including punicic acid and aspirin, might promote the response to anti-PD-1 therapy via their immunomodulatory functions. This work broadens our understanding of the mechanism by which FMT improves the efficacy of anti-PD-1 therapy, which may contribute to the development of novel microbiota-based anti-cancer therapies."

IO biomarker • Journal • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • Transplantation

Safety and Tolerability of FMT Capsules in Healthy Volunteers (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Shenzhen Xbiome Biotech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

Safety and Tolerability of FMT Capsules in Healthy Volunteers (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Shenzhen Xbiome Biotech Co., Ltd.

New P1 trial • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology