All Microbiomes articles
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NewsNew collaboration to boost access to innovative microbiome therapies
The new agreement, focused on improving regulation and drug development within the microbiome therapeutic sector, will harness cross-sector cooperation to ensure these medicines become available to more patients.
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ArticleDeveloping the EU’s first intestinal microbiota-based biologic
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 ...
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NewsLBP-immunotherapy could benefit oncology patients
New data for a microbiome-based therapeutic together with an immune checkpoint inhibitor has shown “encouraging clinical benefits” in advanced cancers.
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ArticlePioneering the next wave of LBP-based therapeutics
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.
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NewsLong-term data indicates “significant” potential of aGvHD microbiome treatment
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.
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ArticleAdvancing microbiome innovation
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.
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ArticleLive biotherapeutic products: bridging innovations and challenges in manufacturing
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.
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ArticleNavigating the unique CMC challenges of oral anaerobic live biotherapeutics
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.
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ArticleMicrobiome innovation: have we forgotten the basics?
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.
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NewsASH 2023: microbiome-based therapy shows potential in graft-versus-host disease
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).
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ArticleKey developments in pharmaceutical manufacturing - September 2023
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.
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NewsNew acquisition to accelerate microbiome therapeutics manufacture
Clinical development and manufacture of microbiome-based therapeutics is set to be accelerated through Kanvas Biosciences’ new acquisition of key assets from Federation Bio.
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NewsWill novel antibiotic become front-line for C. difficile?
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.
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NewsMicrobiome therapy manufacturing facility completed
Europe’s largest microbiome ecosystem therapies manufacturing facility is set to begin production by the end of Q3 2023.
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NewsSafety analysis published for C. diff biotherapeutic
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).
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NewsCould faecal transplants improve melanoma immunotherapy?
In the first clinical trial of its kind, faecal microbiota transplants (FMT) were shown to improve immunotherapy response in advanced melanoma.
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ArticleMicrobiome therapies: a maturing movement
On World Microbiome Day 2023, Hervé Affagard, CEO and co-founder of MaaT Pharma and Jeffrey Silber, Chief Medical Officer of Vedanta Biosciences delve into the current innovative landscape of microbiome-based therapeutics.
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NewsGut microbiome linked to cancer CAR T therapy response
For patients with B cell lymphomas, the gut microbiome may modulate the efficacy of CAR-T immunotherapy, research has found.
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ArticlePharmaceutical microbiology: key developments 2022
Here, microbiology experts Tim Sandle, Tony Cundell and AstraZeneca’s Miriam Guest reflect on key developments in pharmaceutical microbiology during 2022.
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NewsGut microbiome key in Parkinson’s, suggests study
A large metagenomics study determined that gut microbiome is at the centre of Parkinson’s disease pathogenesis.