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In this final installment of EPR's Microbiome therapeutics: microscope to medicine, Dr Olaia Aurtenetxe, Head of Clinical Research at Mikrobiomik, reveals study data demonstrating why MBK-01, an investigational drug based on faecal microbiota transplantation, presents a promising alternative to the current standard of care for Clostridioides difficile infections (CDI), potentially…
New data for a microbiome-based therapeutic together with an immune checkpoint inhibitor has shown “encouraging clinical benefits” in advanced cancers.
Christopher Weidenmaier, PhD, Chief Scientific Officer, and Johannes B. Woehrstein, PhD, Chief Technology Officer at mbiomics share with EPR about the challenges and considerations of manufacturing microbiome-based therapeutics.
In third line, MaaT013 represents the highest overall survival in acute graft-versus-host disease (aGvHD) when compared to reported literature evidence, according to MaaT Pharma.
In the fourth instalment of EPR's ‘Microbiome therapeutics: microscope to medicine’ series, Emilie Plantamura, Deputy Chief Medical Officer at MaaT Pharma, examines the promising potential of microbiome therapeutics beyond Clostridium difficile infection, particularly in the onco-haematological field.
In our third instalment of EPR's exclusive ‘Microbiome therapeutics: microscope to medicine’ series, Tue Hodal, Chief Technology Officer and Lorenz Rindisbacher, Chief Quality Officer, Bacthera, explore how live biotherapeutic products (LBPs) represent a transformative shift in medicine, highlighting their unique challenges and potential.
Here, Chief Technical Officer, Mike Frodsham and Ryan Wilson, Head of Microbiome Services at SGS Quay Pharma, explore the chemistry, manufacturing, and control (CMC) challenges of developing drug products containing live anaerobic bacterial strains, used for treatments such as microbiome therapeutics.
Here, Chrysi Sergaki from the Medicines and Healthcare products Regulatory Agency (MHRA), UK, explores how innovators and regulators can navigate the challenges affecting the development and regulation of microbiome therapeutics to bring safe and efficacious therapies to patients as soon as possible.
Data presented at the 2023 American Society of Hematology (ASH) Annual Meeting suggest that the off-the-shelf microbiome therapeutic could offer a “potentially life-saving approach” in graft-versus-host disease (GvHD).
This article outlines the recent progress of several major new manufacturing facilities that will be central in supporting the production of innovative therapies in Europe.
Clinical development and manufacture of microbiome-based therapeutics is set to be accelerated through Kanvas Biosciences’ new acquisition of key assets from Federation Bio.
Based on positive Phase II data, the first-in-class antibiotic candidate ibezapolstat for C. difficile is expected to advance to Phase III trials more quickly.
Europe’s largest microbiome ecosystem therapies manufacturing facility is set to begin production by the end of Q3 2023.
The largest safety evaluation of any microbiota-based live biotherapeutic includes data for up to two years for the first approved microbiome-based treatment for recurrent Clostridioides difficile (C. diff).
In the first clinical trial of its kind, faecal microbiota transplants (FMT) were shown to improve immunotherapy response in advanced melanoma.
