INRAE and MaaT Pharma Build on the Success of their Long-Standing Partnership with the Entry of Drug-Candidate MaaT013 into Phase 3 Clinical Trial

LYON, France--(BUSINESS WIRE)-- MaaT Pharma (EURONEXT: MAAT – the “Company”), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, announced on March 28^th, 2022, the inclusion of the first patient in a pivotal Phase 3 clinical trial, potentially the last step of clinical development before marketing authorization, evaluating MaaT013 for the treatment of acute gastrointestinal Graft-versus-Host Disease (aGvHD), a serious complication following stem cell transplantation. Every year, more than 10,000 people are diagnosed in Europe and in the United States of America¹, and the prognosis for the patients with the most advanced form is poor with a mortality rate of up to 80%² in the first year. This new milestone for MaaT Pharma, the first Euronext-listed company developing microbiome-based therapies, builds on the success story of its founding partnership with INRAE initiated in 2014, in particular via the scientific support agreement³ between MaaT Pharma, INRAE and 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.

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At the end of 2014, following a project development period as an entrepreneur-in-residence with Seventure Partners, Hervé Affagard, currently CEO, founded MaaT Pharma alongside Dr. Joël Doré, now MaaT Pharma’s Scientific Advisor. As early as 2015, MaaT Pharma and INRAE co-filed three patents, for which the Company now holds exclusive exploitation rights. These patents are also at the root of the development of the Company’s native products, MaaT013 and MaaT033, both currently in clinical trials.

“Microbiome science has been at the heart of my research for more than 30 years. INRAE has established itself first as a pioneer, then as an international center of excellence in the field. In 2021, for example, INRAE was the 5^th largest academic player in the world in terms of microbiome-related patents. In my opinion, the rapid growth of MaaT Pharma, which has entered a Phase 3 clinical trial, perfectly illustrates the efficient and successful transition from pioneering science to innovative therapeutic development for the benefit of patients. Through my research, I hope to contribute to the fast emergence of a new medicinal modality, that takes into account the symbiotic relationship between human health and the microbiome,” said Dr. Doré.

Following the advent of metagenomics⁴, the research produced at INRAE on the gut microbiome has led to unprecedented results disrupting our understanding of the digestive ecosystem, and opening novel avenues for improving the health of millions of patients worldwide suffering from cancers, metabolic diseases, or inflammatory diseases to name just a few of the potential indications.

MaaT Pharma has developed a portfolio of three products since its creation including two currently in clinical phases. The Company has initiated five Phase 1 and Phase 2 clinical trials, consolidated its patent portfolio (including 13 international patent families), and raised a total of €83 million. The Company currently employs 45 people and MaaT013 has been administered to more than 100 people with aGvHD in a Phase 2 clinical trial and in an ongoing compassionate access program⁵ in France.

Hervé Affagard, CEO and co-founder of MaaT Pharma commented, “Since our foundation, we have been looking to develop the microbiome ecosystem in France and have forged partnerships with medical and scientific centers of excellence as well as with renowned industrial players to develop the Company. In 2016, we launched our first clinical trial just 18 months after the company’s creation, and we have since strengthened our position as a pioneer in microbiome-based therapies in oncology. Our translational expertise allows us to rapidly transform science into groundbreaking and safe drug candidates, with the support of our scientific partners, to improve survival outcome for cancer patients.”

The collaboration between these two pioneers continues to move forward with the formation of industry structures and the growth of national expertise in the microbiome space in Europe with the Alliance Promotion Microbiote (APM), of which both organizations are among the co-founders. APM is an association under the French law of 1901 and includes 25 private and public players (companies, clusters, research institutes, investment funds), of which Hervé Affagard was elected president in January 2022. APM aims to contribute to making France, a pioneering nation in microbiome research and engineering, into a European leader to meet the current and future challenges of this sector recognized in 2021 as a priority in the “Health Innovation Plan 2030 ".

About INRAE

Created on January 1, 2020, the French National Research Institute for Agriculture, Food, and Environment (INRAE) is a major player in research and innovation. INRAE carries out targeted research and resulted from the merger of INRA and IRSTEA. It is a community of 12,000 people with 273 research, experimental research, and support units located in 18 regional centres throughout France. Internationally, INRAE is among the top research organisations in the agricultural and food sciences, plant and animal sciences, as well as in ecology and environmental science. It is the world’s leading research organisation specialising in agriculture, food and the environment. INRAE’s goal is to be a key player in the transitions necessary to address major global challenges. Faced with a growing world population, climate change, resource scarcity, and declining biodiversity, the institute is developing solutions that involve multiperformance agriculture, high-quality food, and the sustainable management of resources and ecosystems.

About MaaT Pharma

MaaT Pharma, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, MaaT Pharma has launched, in March 2022, a Phase 3 clinical trial for patients with acute GvHD, following the achievement of its proof of concept in a Phase 2 trial. Its powerful discovery and analysis platform, gutPrint^®, supports the development and expansion of its pipeline by determining novel disease targets, evaluating drug candidates, and identifying biomarkers for microbiome-related conditions.

The company’s Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice.

MaaT Pharma is listed on Euronext Paris (ticker: MAAT).

Forward-looking Statements

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

Contacts

¹ Source: Global Data GVHD Epidemiology Report, Jan 2020.

² Source: Essai REACH1

³ Article L 531-8 and 9 of the French Research Code allowing the participation of research personnel in the creation of companies or in the activities of a company and the promotion of their work

⁴ metagenomics: a method used to study the microbiome - Qin, J., Li, R., Raes, J. et al. A human gut microbial gene catalogue established by metagenomic sequencing. Nature 464, 59–65 (2010)

⁵ Compassionate use programs allow the use of investigational drugs before they are authorized for marketing for patients with no treatment-options.

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