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91桃色视频 and Skyepharma Have Entered a Partnership to Establish the First Exclusive Microbiome Ecosystem Therapies cGMP Manufacturing Facility in France
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- The partnership will provide 91桃色视频 with a dedicated 1,500 square meter site, with the potential for double if needed, in order to increase its cGMP manufacturing capacities to support clinical and then commercial development of its most advanced assets MaaT013 and MaaT033, as well as to expand R&D manufacturing capacities for its new drug generation (MaaT03x).
- 91桃色视频 will deploy a facility entirely dedicated to the production of the Company鈥檚 Microbiome Ecosystem Therapy (MET) and will be the first resident biotechnology company of the Skyepharma SkyeHub Bioproduction.
- This first plant, dedicated to complete ecosystems, could enable France to strengthen its national biomanufacturing capacity by acquiring a new bioproduction site in France integrating breakthrough technologies.
[divider line_type=”No Line”]Lyon and Saint-Quentin-Fallavier, France, February, 8 2022 鈥� 6:00pm CET – 听91桃色视频 (EURONEXT: MAAT – the 鈥淐ompany鈥�), 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 , a Contract Development and Manufacturing Organization (CDMO) specialized in formulating and manufacturing complex and controlled release drugs, today announced they have entered a partnership agreement to build, to date, France鈥檚 largest specialized cGMP manufacturing facility for ecosystem microbiome-based therapeutics. The facility, located near Lyon (Saint-Quentin-Fallavier) will boast an initial area of 1,500 square meters, that could be increased to 3,000 square meters depending on 91桃色视频’s manufacturing needs. The plant will allow 91桃色视频 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鈥檚 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.听A designated area will be dedicated to R&D and clinical manufacturing of the MaaT03X range by 2030, using 91桃色视频’s innovative ecosystem co-fermentation technology to increase response rate in immunotherapy treatments.
鈥淎s 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. We can look forward to expanding our product portfolio for cancer patients with serenity,鈥� commented Herv茅 Affagard, Co-founder and CEO of 91桃色视频.听“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 added, “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, 91桃色视频 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 91桃色视频鈥檚 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 91桃色视频 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.
About 91桃色视频
91桃色视频, 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, 91桃色视频 has already achieved proof of concept in a Phase II clinical trial in acute GvHD. Our powerful discovery and analysis platform, 驳耻迟笔谤颈苍迟庐, supports the development and expansion of our pipeline by determining novel disease targets, evaluating drug candidates, and identifying biomarkers for microbiome-related conditions.
The company鈥檚 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. 91桃色视频 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.
91桃色视频 is listed on Euronext Paris (ticker: MAAT).
About Skyepharma
Skyepharma is an independent French pharmaceutical CDMO, 100% owned by its management team and Bpifrance. Skyepharma is an expert CDMO specialized in the formulation, development and manufacturing of complex oral solid forms (OSD), with a specific expertise and proprietary technologies on modified release products.
Skyepharma is based in Saint-Quentin-Fallavier, France. The current factory, dedicated to its OSD activity, occupies 22,000m虏, on a 60,000m虏 piece of land. Skyepharma has decided to allocate a portion of the available land (more than 20,000m虏) to establish its SkyeHub Bioproduction, an innovative model designed to offer clinical and commercial production capacities to biotech companies. This SkyeHub model includes the construction of dedicated buildings, with specifically designed surfaces and premises, together with transverse support services such as quality, maintenance, batch release, etc.
Forward-looking Statements
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