faecalibacterium prausnitzii EXL01-strain (EXL01)
/ Exeliom Biosciences
- LARVOL DELTA
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July 09, 2025
FAECALIBACTERIUM PRAUSNITZII - EXL01 IN CROHN'S DISEASE: FROM PRECLINICAL DISCOVERY TO FIRST-IN-HUMAN CLINICAL TRIAL IN PATIENTS WITH MILD TO MODERATE CROHN'S DISEASE
(UEGW 2025)
- "EXL01, administered during and after CS tapering, was safe and well tolerated for up to 24 weeks in patients with CD. Though limited by small sample size, the study supports the biological activity of EXL01, notably through its impact on ileal gene expression. A phase 2 randomized controlled trial is ongoing to further assess efficacy."
First-in-human • P1 data • Preclinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease
July 09, 2025
FAECALIBACTERIUM PRAUSNITZII EXL01 EXHIBITS A SPECIFIC PEPTIDOGLYCAN THAT IS INVOLVED IN ITS ANTI-INFLAMMATORY EFFECT IN A NOD2-DEPENDENT WAY
(UEGW 2025)
- P1 | "Our study showed that Faecalibacterium and its PG activate NOD2, and therefore the production of IL-10, in a different way than other Gram-positive bacteria. These results provide new insight into the molecular pathways underlying the immunomodulatory effects of F. prausnitzii, and highlight NOD engagement as a key immunological feature. Identification of PG as a molecule responsible for the therapeutic effects paves the way for the next generation of Faecalibacterium-based drugs, whether whole-cell or component-driven, in inflammatory diseases such as CD."
Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Inflammation • Inflammatory Bowel Disease • CD14 • GLI2 • IL10 • TNFA
September 23, 2025
BIG: First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer
(clinicaltrials.gov)
- P2 | N=120 | Recruiting | Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group | Trial completion date: Dec 2029 ➔ Apr 2029 | Trial primary completion date: Apr 2027 ➔ Sep 2027
Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor • PD-L1
August 20, 2025
Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer
(clinicaltrials.gov)
- P1 | N=33 | Not yet recruiting | Sponsor: City of Hope Medical Center
New P1 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor
July 26, 2025
MOTHER: Microbiota Modification for Immuno-oncology in Hepatocellular Carcinoma
(clinicaltrials.gov)
- P2 | N=34 | Recruiting | Sponsor: Center Eugene Marquis | Trial primary completion date: Nov 2025 ➔ Mar 2026
Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor
June 17, 2025
BIG: First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer
(clinicaltrials.gov)
- P2 | N=120 | Recruiting | Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group | Trial completion date: Mar 2029 ➔ Dec 2029 | Trial primary completion date: Mar 2026 ➔ Apr 2027
Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor • PD-L1
April 15, 2025
MAINTAIN-POP: Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
(clinicaltrials.gov)
- P2 | N=80 | Recruiting | Sponsor: Madeleine Bezault
New P2 trial • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease
March 04, 2025
MOTHER: Microbiota Modification for Immuno-oncology in Hepatocellular Carcinoma
(clinicaltrials.gov)
- P2 | N=34 | Recruiting | Sponsor: Center Eugene Marquis | Not yet recruiting ➔ Recruiting
Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor
January 12, 2025
Faecalibacterium prausnitzii induces an anti-inflammatory response and a metabolic reprogramming in human monocytes
(ECCO-IBD 2025)
- P1 | "These results provide new insight into the mechanisms underlying the anti-inflammatory effects of F. prausnitzii and are crucial for a better understanding of its potential use in the treatment of IBD. The well-characterised F. prausnitzii EXL01 is already in clinical development in Crohn's disease (NCT05542355), and the results of the first phase 1/2A study involving 8 patients will be available in early 2025."
Crohn's disease • Inflammation • Inflammatory Bowel Disease • CD14 • IL10
December 03, 2024
EXLIBRIS: EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy.
(clinicaltrials.gov)
- P1/2 | N=21 | Recruiting | Sponsor: University Hospital, Lille | Not yet recruiting ➔ Recruiting
Combination therapy • Enrollment open • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
October 10, 2024
MAINTAIN: EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease
(clinicaltrials.gov)
- P1 | N=8 | Terminated | Sponsor: Exeliom Biosciences | Active, not recruiting ➔ Terminated; Due to low recruitment
Trial termination • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease
August 13, 2024
MOTHER: Microbiota Modification for Immuno-oncology in Hepatocellular Carcinoma
(clinicaltrials.gov)
- P2 | N=34 | Not yet recruiting | Sponsor: Center Eugene Marquis
Immuno-oncology • New P2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor
July 25, 2024
BIG: First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer
(clinicaltrials.gov)
- P2 | N=120 | Recruiting | Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2024 ➔ Jul 2024
Combination therapy • Enrollment open • Metastases • Trial initiation date • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1
July 03, 2024
Faecalibaterium prausnitzii strain EXL01 boosts efficacy of immune checkpoint inhibitors.
(PubMed, Oncoimmunology)
- "F. prausnitzii strain EXL01 will be evaluated as an adjuvant to ICI in multiple cancers in the near future."
Checkpoint inhibition • Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor
June 28, 2024
MAINTAIN: EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease
(clinicaltrials.gov)
- P1 | N=8 | Active, not recruiting | Sponsor: Exeliom Biosciences | Recruiting ➔ Active, not recruiting | N=67 ➔ 8 | Trial completion date: Oct 2025 ➔ Oct 2024 | Trial primary completion date: Oct 2025 ➔ Oct 2024
Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease
June 07, 2024
EXLIBRIS: EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy.
(clinicaltrials.gov)
- P1/2 | N=21 | Not yet recruiting | Sponsor: University Hospital, Lille
Combination therapy • Metastases • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
May 15, 2024
LIVEDIFF: Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
(clinicaltrials.gov)
- P1/2 | N=56 | Recruiting | Sponsor: Hospices Civils de Lyon | Not yet recruiting ➔ Recruiting
Enrollment open • Infectious Disease
March 12, 2024
LIVEDIFF: Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
(clinicaltrials.gov)
- P1/2 | N=56 | Not yet recruiting | Sponsor: Hospices Civils de Lyon
New P1/2 trial • Infectious Disease
February 16, 2024
BIG: First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer
(clinicaltrials.gov)
- P2 | N=120 | Not yet recruiting | Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Combination therapy • Metastases • New P2 trial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1
January 01, 2024
MAINTAIN: EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease
(clinicaltrials.gov)
- P1 | N=67 | Recruiting | Sponsor: Exeliom Biosciences
Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease
March 22, 2023
MAINTAIN: EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease
(clinicaltrials.gov)
- P1 | N=67 | Recruiting | Sponsor: Exeliom Biosciences | Initiation date: Sep 2022 ➔ Mar 2023
Trial initiation date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • CRP
October 05, 2022
MAINTAIN: EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease
(clinicaltrials.gov)
- P1 | N=67 | Recruiting | Sponsor: Exeliom Biosciences | Not yet recruiting ➔ Recruiting
Enrollment open • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • CRP
September 15, 2022
MAINTAIN: EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease
(clinicaltrials.gov)
- P1 | N=67 | Not yet recruiting | Sponsor: Exeliom Biosciences
New P1 trial • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • CRP
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