Hervé Affagard
CEO – Co-Founder of MaaT Pharma
Engineer, Executive MBA, Certificate “Exploring your Microbiome”
1/ What is your professional background?
I lead the MaaT Pharma project since its inception phase in December 2013. Previously I worked as an entrepreneur in residence for venture capital firms with regards to their investments in the Healthcare field. In parallel, I also used to work as a consultant for biotechnology companies where he led transformation program. I was previously an executive director leading a multidisciplinary team at Biomnis. Combined with my previous experience at Bio-Rad which serves life science research and clinical diagnostics customers. Today I work with a team of 20+ passionate individuals developing drugs to fight iatrogenic symbiosis.
2/ Why are you interested in Human Microbiome Therapeutics? What is the historical context of your work in Human Microbiome Therapeutics? Why is it important for your projects?
There’s growing evidence that the microorganisms living in our gut play an important role in our health. Many biotech companies, are trying to exploit that link to develop therapies for a wide range of diseases. The French VC Seventure Partners sees promise in the field and has created the world’s first microbiome investment fund. I Co-founded MaaT Pharma in 2014 with Dr Joël Doré, Dr Pierre Bélichard, Pr Mohamad Mohty, Dr Pierre Rimbaudand, the support of Seventure Partners which invested immediately after the company incorporation.
Back in 2013, I met with Pierre Belichard who initiated me to the Microbiome world and its perspective. I found it very interesting as an entrepreneurial adventure but mostly from a personal perspective, because my family has a history of intestinal disorders. For me, it meant giving a new angle to analyze diseases where drugs showed limited effects. I was, in 2013, this will lead to a new generation of microbiome-drugs considering man-microbes as a whole and therefore bring new solutions.
MaaT Pharma’s core business focuses on the restoration of the man-microbes symbiosis. The microbiotech[1] is one of the few companies in clinical phase II development in the field of Gut Microbiota, offering a selective approach by leveraging intestinal homeostasis to improve the recovery and treatment of patients with life-threatening conditions.
MaaT Pharma has a unique positioning on an emerging market: the microbiotech has built and clinically validated a platform to develop FMT-based treatment. MaaT Pharma developed 4 patents and 2 trademarks and we recently announced the CE marking of a stool collection device. This device marks the first step in the MaaT Pharma value chain, gΛt RePrint ™, which begins with stool collection and ends with medication delivery.
MaaT Pharma is also the first in Europe to enter in the clinics for complex ecosystem based drugs. We noticed an emerging need for which no solution existed in the market to treat the consequences of heavy treatments such as chemotherapy, antibiotics and infectious diseases. Our goal is to become one of the leaders in development of drugs aiming at preventing and treating dysbiosis-related diseases by using the clinical promise of Fecal Microbiota Transfert (both autologous and allogenic). MaaT Pharma is currently partnering with Biocodex on the industrialization and development of an oral formulation of FMT, the microbiotech anticipates its first marketing authorization for 2023.
3/ According to you, what are the biggest challenges in Human Microbiome Therapeutics (regulatory, scientific insight…)? ‘what is your business strategic positioning on Human Microbiome Therapeutics (pipelines…)? How do you see the evolution of Human Microbiome Therapeutics market?
The nascence of the Microbiome industry could be set at 2008, when academics such as INRA, in France, generated major breakthrough in basic science. Since then, many startups emerged throughout the world and are setting the rules regarding regulatory which is probably one of the biggest challenge for those startups developing living micro-organisms-based therapeutics. Coming back to Fecal Microbiota Transfer, France is ahead of the curve as the French Agency set a working group no later than 2013 to support, first hospital physicians and now the entire industry. The highest level of qualification was decided in France as FMT is regulated as a drug, as it is in the USA, UK or even Germany. However, there is lack of harmonization as few countries are considering it as an issue.
Therefore, the FMT is an investigational drug since 2013 and has been already recognized as an important therapeutic option for Clostridium difficile infection, where it has shown 90% efficacy (more than the double of the the standard of care: antibiotics). Knowing the fact that 25% of the population shows abnormality in man-microbe dialogue. We have built and clinically validated a platform to develop FMT-based treatments based on a safe, patented, GMP end-to-end process designed to restore unbalanced intestinal microbiota following medical treatment. Thereby eradicate multidrug resistance bacterial infections and improve Gastro Intestinal functions. MaaT Pharma’s business model consists in outlicensing its technology to small and medium and pharmas, while retaining its proprietary assets (bioprocess; diluent for preservation of raw matter; medical devices; culture; bioinformatics pipelines, preclinical models…), enabling continued product creation. We are deciding a niche strategic positioning to start with by establishing a Human Proof of Concept in immune-compromised patients: Leukemia.
Multiple pharmaceutical forms (oral form with crude, cultured or enriched microbiota) will facilitate product line extensions in numerous other indications which are to be assessed: Autism, IBD and Metabolic Disorders… Our product has been demonstrated to be safe. New clinical programs are to be launched in additional fields of Immuno-oncology and infectious diseases. Our goals are to reduce infections co-mortality in Leukemia patients, reduce re-hospitalization rate and improve response to anti-cancer treatments. We are targeting initial markets of €1.83bn in a nascent market. We want to secure, industrialized, simplify the process and ensure the reproducibly of the FMT addressing various pathologies in onco-hematology but also infectious diseases. By providing a safer and easier process thanks to MaaT Pharma’s technologies, we believe that will help medical professionals to perform this procedure and enables universal access to FMT-based drugs. The development of an oral form thanks to a partnership with Biocodex will enable universal access to FMT and will have a positive impact on the community. In its oral form the product facilitates global spread of the Company’s FMT solution and will maximize benefits for the community. In this form access to FMT products can also be expanded to other indications.
In this period of exponential growth, a Series B private placement of €26 million was opened in June 2017 to new investors in parallel with Seventure (the worldwide leading investor in microbiota since 2013), CM-CIC and Biocodex. MaaT Pharma was awarded Phase 3 of the World Innovation Competition and a fund of € 150 million was set up as part of the Investments for the Future, which is reserved for the winners of Phase 3. We position ourselves with our historical shareholders, with the W.I.C. and other investors we are launching a fund raising of a significant amount of €26M.
4/ At which stage of therapeutical product development do you think it is important to provide a microbiome study?
In our case, we do Microbiome study from Day1 as our products are all microbiome-based! In all our studies, we do biological safety control, metagenomics, clinical outcome measurement…
Basically, scientists know that a symbiotic microbiome has beneficial health effects and are seeking to understand what specific players make you healthy. Understanding the details might help MaaT Pharma create better treatments for a wide range of conditions. To do so, the company is partnered with top researchers in academia. “We are working with several organizations; INRA, the Gustave Roussy Institute, APHP physicians, HCL physisciansand Bioaster.”
MaaT Pharma is notably strongly collaborating with Joel Doré’s and the INRA teams, Europe’s top player in Microbiome Research, For example, MaaT Pharma “created a new cryoprotectant method to preserve the bacteria that makes it possible to rebuild 80% of the original ecosystem at the gene level. In November 2016, we opened the first European GMP platform procedure for microbiota transfer.”
The company seems to work well with academics. “We have a clear distinction between what the scientists are good at and what we’re good at, at MaaT Pharma. We do clinical development, taking product ideas from academics. We challenge them on their own science. They see us as a facilitator to bring to the market what they’ve worked on during years. I think that’s part of the recipe for success, we’re always throwing something new at them when we collaborate.“
There are 3 clinical trials in the pipeline: Odyssee, Ulysse and Osiris.
– Odyssee: Prevention of dysbiosis complications with autologous FMT in patients with Acute Myeloid Leukemia and has for objective to restore the diversity of gut microbial and to eradicate MDRB.
– Ulysse: Epidemiological study to assess clinical consequences of dysbiosis in patients with Acute Myeloid Leukemia and has for objective to characterize the microbiota.
– Osiris: A prospective clinical study aiming to assess the potential of gut microbiotherapy in patients with Bone and Joint Infections undergoing long term antibiotherapy.
We are expected intermediary results by September 2017.
What differentiates MaaT Pharma from others biotech is that the transplant can be autologous. “For example, patients suffering from leukemia are treated with chemo and antibiotics, and we’ll collect the microbiota before the treatment and will return it afterward. That’s gonna be their own microbiota.” (ODYSSEE – ULYSSE)
[1] microbiotech or MicrobioT/Tech : gut microbiota biotech specialist