BPR: Can you introduce yourself and tell us a little bit about your professional background?
I am the CEO and co-founder of MaaT Pharma. Prior to MaaT Pharma, I started in the IT field in different missions and joined Bio-Rad Laboratories in 2006 as global IT Director and a member of the M&A Europe team, before joining Biomnis Laboratories as executive director as part of the LBO.
I’m also president of the Alliance Promotion Microbiote (APM) association, an independent, non-profit organization created in 2022 dedicated to support the European microbiome industry - I am also a scientific board member of Biofortis Mérieux NutriSciences.
I co-founded MaaT Pharma in 2014 with Dr. Joël Doré, INRAE research director, scientific director of Métagénopolis, author of nearly 500 publications, and one of the world's most cited authors in the microbiome sphere today. In 2016 I was awarded “entrepreneur of the year in healthcare” by France Biotech, in recognition of MaaT Pharma’s fast development.
BPR: Could you tell us about MaaT Pharma?
MaaT Pharma is a patient-centric, oncology-focused microbiome company with 2 full-ecosystem microbiome therapies programs in clinical development, and 1 in preclinical development – with around 300 patients treated to date across 3 indications. We are the most advanced company developing microbiome-therapy in oncology, with ongoing phase 3 for MaaT013 in hemato-oncology, a phase 2 in immuno-oncology, and a phase 2b for MaaT033 in hemato-oncology.
We are focused on providing innovative therapies to patients with high unmet medical needs. As of today, we have a team of 60 people and have inaugurated a GMP manufacturing facility in partnership with Skyepharma in November 2023 to support the increase of our clinical production, our R&D, and tomorrow our commercial production.
BPR: Could you tell us more about your lead product, MaaT013?
MaaT013 is a pooled-donor standardized microbiome ecosystem therapy for acute hospital use in patients with gastrointestinal acute graft-versus-host Disease (GI-aGvHD). The treatment protocol of MaaT013 entails 3 doses over 2 weeks via an enema bag for direct delivery into the colon. Our lead product is currently being evaluated in ongoing phase 3 for patients with GI-aGvHD who haven’t been responding to previous standard lines of treatment (corticoid and ruxolitinib). We announced, in October 2023, a positive outcome for the trial following the review of a Data Safety Monitoring Board, an independent experts committee. It concluded that the benefit/risk ratio with 'high efficacy and low toxicity' was favourable in this patient population and stated that the trial continues without modifications.
We recently presented positive results from the Early Access Program (EAP) for MaaT013 at the 2023 American Society of Hematology (ASH) Annual Meeting, paving the way for advancing the treatment landscape for aGvHD, with microbiome-based innovations.
Overall, we have been delighted to recently report significant progress in the development of therapeutic solutions for patients battling severe acute GvHD. Modulation of the microbiota is increasingly proving to be a breakthrough in the oncology field.
BPR: What’s next for MaaT013?
Our latest results add to the growing research highlighting higher gut microbiome diversity is associated with better outcomes in oncology - it reinforces our approach based on restoring patients’ immune systems through gut microbiome ecosystem therapies. The efficacy and safety results underscore the strong favourable benefit-risk profile for MaaT013, and we look forward to continuing the investigation of MaaT013, with the aim of having it accessible globally for patients in need as soon as possible.
MaaT013 is also being evaluated in phase 2, an investigator-sponsored trial currently enrolling up to 60 patients with metastatic melanoma. The trial is a randomized, placebo-controlled study with the primary and secondary endpoints being, respectively, safety and MaaT013’s potential to improve the response to ICI therapies, because of MaaT013’s impact on the patient’s gut microbiome. Immune checkpoint inhibitor (ICI) therapies have become the standard of care for treating solid tumors.
However, only around 25% to 35% of patients respond to the treatment. Simultaneously, numerous studies have indicated that immune homeostasis and the diversity and richness of gut microbiota could improve the response to ICI treatment. This research opens promising new possibilities for enhancing cancer treatment and this ongoing phase 2 with MaaT013 is being used as a proof-of-concept for the next generation of the company’s candidates based on co-culturing microbiome to be used to boost immunotherapies.
Success in at least one of the indications above will open the door of the entire oncology field allowing for a dramatic portfolio expansion.
BPR: Can you tell us a bit about MaaT033, your second candidate presented at ASH?
Following phase 1b positive results presented at ASH 2022, we presented this year our ongoing phase 2b trial design for MaaT033. This is the Company’s second drug candidate and it has been developed as an adjunctive therapy to enhance overall survival in HSCT (hematopoietic stem cell transplantation) and cellular therapy recipients; it targets optimal microbiota function for a broader patient population in a chronic setting and allowing for ambulatory treatment.
This international, multi-center trial is the largest randomized controlled study to date of a microbiome-based therapy in oncology, spanning up to 56 sites and enrolling 387 patients.