The move is in response to the French National Agency for the Safety of Medicines & Health Products’ (ANSM) decision in March that prevented faecal microbiota product collection and use during the pandemic.
As long as the revised guidelines are met, the firm can now continue faecal microbiota collection for bulk and hospital compounding as well as medicine production.
Raw and manufactured material will now be placed under quarantine until additional protection measures are communicated, which may trigger retrospective screening before release.
Improving outcomes
“Our goal is to provide the most appropriate microbiome-based biotherapies to patients to improve treatment outcomes in oncology and our ongoing dialogue with regulators worldwide is of the utmost importance to ensure both the safety and quality of our products,” says Hervé Affagard, co-founder and CEO of MaaT Pharma.
Pre-pandemic, the Lyon-based firm received €18m in Series B financing back in February as it looked to continue development of its microbiome-based biotherapeutics pipeline to tackle this relatively rare form of cancer.
Its lead product candidate MaaT013 is based on the company’s MaaT Microbiome Restoration Biotherapeutics (MMRB) platform and contains bacteria protected within a formulation, derived from pooling the intestinal ecosystems of donors.
“There remains a significant medical need for new drug modalities in patients with severe conditions and resuming our sample collection and manufacturing activities enables us to continue to develop our microbiome biotherapeutics for these patients,” adds Affagard.
“The French private and public microbiome ecosystem benefits from the global leadership position ANSM has established, since 2014, in developing a regulatory framework for live biotherapeutic products.”
Cancer and the gut
The microbiome’s role in cancer has seen a recent upsurge in interest with scientists now suggesting tumours have their own microbiome that could form a basis for new treatments or research directions.
In addition, greater gut microbial diversity in patients appear to increase chances of recovery from certain cancers with studies linking this diversity with a stronger response to immunotherapy for solid tumours.
NutraIngredients recently reported on DuPont’s Human Microbiome Venture (HMV) forming a research collaboration with Rutgers University.
The two-year agreement will focus on the microbiome’s role in chemotherapy, specifically its influence on its effectiveness and how response rates can be improved by decreasing gut inflammation.
Last year, US-based Vedanta Biosciences, isolated 11 bacterial strains from healthy human donor faeces in order to investigate their ability to enhance antimicrobial or antitumour immunity in mouse models.
Meanwhile, UK-based 4D Pharma and its live biotherapeutic MRx0518 is currently undergoing trials investigating its anti-cancer and immune system modulating effects in patients, who have undergone the removal of solid tumours.
Other firms active in this research area include Israeli-based BiomX, which is developing both natural and engineered phage therapies that target bacteria naturally present in tumours.
The aim is to convert these ‘cold’ tumours to ‘hot’ by releasing an immunostimulatory ‘payload’ and eradicate bacteria such as Fusobacterium nucleatum that appear to protect the tumour.