CJRB-102 / CJ Biosci 
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  • ||||||||||  CJRB-102 / CJ Biosci
    Trial completion date, Trial termination, Trial primary completion date:  A Study of Live Biotherapeutic Product MRx0518 With Hypofractionated Radiation Therapy in Resectable Pancreatic Cancer (clinicaltrials.gov) -  Jun 2, 2023   
    P1,  N=13, Terminated, 
    Further analysis of immune cell infiltrates within recected tumors will help reveal further associations to changes in the local microbiome. Trial completion date: Oct 2023 --> May 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2023 --> May 2023; Sponsor insolvency
  • ||||||||||  CJRB-102 / CJ Biosci
    Enrollment change, Trial completion date, Trial termination, Combination therapy, Metastases:  KEYNOTE-823: Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors (clinicaltrials.gov) -  Jun 1, 2023   
    P1/2,  N=63, Terminated, 
    Trial completion date: Oct 2023 --> May 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2023 --> May 2023; Sponsor insolvency N=132 --> 63 | Trial completion date: Mar 2024 --> May 2023 | Active, not recruiting --> Terminated; Sponsor insolvency
  • ||||||||||  MRx0518 / 4D Pharma
    Immune modulation and the oral live biotherapeutic product, MRx0518, in treatment-na (On Demand | Hall A; Poster Bd # 343) -  Apr 26, 2023 - Abstract #ASCO2023ASCO_1846;    
    P1, P2
    N=132 --> 63 | Trial completion date: Mar 2024 --> May 2023 | Active, not recruiting --> Terminated; Sponsor insolvency This study demonstrates the long-term safety profile of MRx0518 therapy in treatment-na
  • ||||||||||  CJRB-102 / CJ Biosci
    Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, Metastases:  AVENU: Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma (clinicaltrials.gov) -  Apr 18, 2023   
    P2,  N=0, Withdrawn, 
    This study demonstrates the long-term safety profile of MRx0518 therapy in treatment-na N=30 --> 0 | Trial completion date: Jan 2024 --> Apr 2023 | Active, not recruiting --> Withdrawn | Trial primary completion date: Oct 2023 --> Apr 2023
  • ||||||||||  MRx0518 / 4D Pharma
    Combination MRx0518 and anti-PD-1 overcomes checkpoint inhibitor resistance via myeloid modulation (Hall C) -  Oct 6, 2022 - Abstract #SITC2022SITC_1150;    
    Conclusions Immune activation was recovered in R patients with MRx0518 and anti-PD-1 combination therapy. Immune changes associated with improved outcome include: 1) increased expression of HLA-DR and decreased PD-L1 expression on myeloid cells and 2) increased CD8+ T-cell frequencies in circulation.
  • ||||||||||  CJRB-102 / CJ Biosci
    Enrollment closed, Trial completion date, Trial primary completion date:  MICROBIOME: MRx0518 in Patients With Solid Tumours Waiting Surgical Removal of the Tumour (clinicaltrials.gov) -  Aug 11, 2022   
    P1,  N=120, Active, not recruiting, 
    Trial Registration NCT03934827 Unknown status --> Active, not recruiting | Trial completion date: Feb 2022 --> Dec 2022 | Trial primary completion date: Aug 2021 --> Dec 2022
  • ||||||||||  CJRB-102 / CJ Biosci
    Enrollment closed, Metastases:  AVENU: Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma (clinicaltrials.gov) -  Jul 6, 2022   
    P2,  N=30, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Jul 2021 --> Oct 2023 | Trial primary completion date: Jul 2021 --> Jan 2023 Recruiting --> Active, not recruiting
  • ||||||||||  MRx518 / 4D Pharma
    [VIRTUAL] Linking immunity and cancer to human microbiome () -  Oct 21, 2020 - Abstract #BioEuropeFall2020BIO_EUROPE_43;    
    Part B will focus on investigating efficacy in a further 100 treatment naïve patients with a placebo-controlled arm. How can cancer patients improve their outcomes with microbiome-based therapeutics? Oncology (MRx0518)
  • ||||||||||  MRx518 / 4d Pharma
    Live biotherapeutic MRx0518 as a modulator of immune responses in intestinal tissue and breast tumor microenvironment (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_1243;    
    Our preclinical studies demonstrate that the ability of oral MRx0518 to reduce tumor growth in the EMT-6 syngeneic model of breast cancer is mainly related to changes in innate (increase in NK cells, upregulation of tumour TLR5 expression) and adaptive (increase of ratio CD8+ T cells/FoxP3+ regulatory T cells) immune responses locally in the gut but also in the distal tumour microenvironment. In this context, MRx0518 monotherapy and combination with immune checkpoint inhibitors is a promising therapeutic approach for enhancing antitumor immune responses.
  • ||||||||||  CJRB-102 / CJ Biosci
    Enrollment open, Trial completion date, Trial primary completion date, Combination therapy, Metastases:  KEYNOTE-823: Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors (clinicaltrials.gov) -  Jan 14, 2019   
    P1,  N=132, Recruiting, 
    Phase classification: P1 --> P1/2 Not yet recruiting --> Recruiting | Trial completion date: Jun 2022 --> Mar 2024 | Trial primary completion date: May 2021 --> Mar 2023