MaaT Pharma, a French clinical-stage biotech (Phase 3) and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, and Skyepharma, a contract development and manufacturing organization (CDMO) specialized in formulating and manufacturing complex and controlled release drugs, have entered a partnership agreement to build, to date, France’s largest specialized cGMP manufacturing facility for ecosystem microbiome-based therapeutics.

The facility, located near Lyon (Saint-Quentin-Fallavier) will contain an initial area of 1,500 square meters, that could be increased to 3,000 square meters depending on MaaT Pharma’s manufacturing needs. The plant will allow MaaT Pharma to increase its manufacturing capacities ten-fold in order to support clinical and commercial development by 2030. The facility will aim to annually produce several thousand enemas of the company’s lead candidate (MaaT013) dedicated to Graft-versus-Host disease and several hundreds of thousands capsules of its second drug candidate (MaaT033) designed to improve survival in patients receiving allogeneic stem cell transplantation.

A designated area will be dedicated to R&D and clinical manufacturing of the MaaT03X range by 2030, using MaaT Pharma’s innovative ecosystem co-fermentation technology to increase response rate in immunotherapy treatments.

“As we enter Phase 3 with our lead product MaaT013, the agreement with Skyepharma will allow us to scale up manufacturing to meet product demands, including commercial launch,” said Hervé Affagard, co-founder and CEO, MaaT Pharma. “We can look forward to expanding our product portfolio for cancer patients with serenity. This partnership is fully in line with France’s ambition, as stated in the 2030 innovation plan for health, to become a nation at the forefront of biotherapies and ensure health independence in biomanufacturing. The emerging microbiome industry could open up an opportunity to position France as a leader.”

David Lescuyer, managing director of Skyepharma, said, “SkyeHub will increase cGMP production capacity for microbiome-based drugs in France. Our partnership acts as a value booster as each company brings its know-how and expertise.”

Under the terms of the agreement, which follows a bilateral letter of intent signed in September 2021 and whose financial conditions remain confidential, MaaT Pharma will have a dedicated facility within SkyeHub Bioproduction and construction will be financed by Skyepharma. It is planned that the production site, expected to be operational in 2023, will host MaaT Pharma’s team and proprietary equipment. In this context, the Lyon-based biotech will retain controlling oversight of the R&D as well as clinical and commercial production of its diverse portfolio of enema and capsule drug candidates. In addition to providing the cGMP building, Skyepharma will also provide its extensive expertise in product quality standards, regulatory affairs, certification, and large-scale production.

This new plant will also allow MaaT Pharma to accelerate the development of MaaT03X, its new generation of drug candidates, using its unique proprietary microbiome ecosystem co-fermentation technology, for which the Company was recently awarded two public grants (Plan France Relance and the 4th Programme d’Investissements d’Avenir (PIA4)). This new oral class of MET products includes hundreds of species and is tailor-made based on clinical data.