As a startup, it can sometimes be difficult to think too far into the future. However, with a major manufacturing partnership announced on Wednesday, CTO Carole Schwintner and her team at MaaT Pharma are taking the first steps toward establishing a long-term game plan for the seven-year-old company.
French biotech and CDMO Skyepharma are partnering to build the largest dedicated manufacturing facility for microbiome-based therapies. The plant will help MaaT increase its production tenfold by 2030, with the aim of producing several thousand enemas of lead candidate MaaT-013, to treat graft-versus-host disease (GvHD), which occurs during Donated bone marrow or stem cells regard the recipient’s body as foreign, and the donated cells and bone marrow attack the body. It will also produce “several hundred thousand capsules” of MaaT-033, for patients who receive an allogeneic stem cell transplant.
Through this partnership, the two companies will build a 1,500 square meter manufacturing site in France, with the potential to double in size if needed to increase manufacturing capacity. The letter of intent was signed in September 2021, the companies were disclosed in a press release and the financial terms are still under wraps. The site will be operational by 2023 and will house MaaT Pharma’s team and equipment. Skyepharma, meanwhile, will bring its expertise in product quality, regulatory affairs and large-scale production to MaaT. MaaT will also benefit from Skyepharma’s expertise in delayed release formulation. While MaaT could have focused on its own manufacturing plans, the new agreement allows MaaT to focus on what it knows best: its pipeline.
“(Skyepharma has) already many years of experience. Their sites have already been inspected by the French, the Americans and several other inspectors,” Schwintner said in an interview with Terminal news. “It’s important for us to have something really solid, and they bring that extra bit of expertise…Rather than trying to build something entirely new, they already have something that has been challenged and validated.”
Last month, MaaT completed its phase II/III trials early, and data from four of five planned cohorts showed satisfactory safety and “good microbiome engraftment” determined by the presence of specific gut bacteria.
Through this agreement, MaaT will accelerate MaaT-03X, which uses microbiome ecosystem co-fermentation technology, and recently received two public grants.
MaaT has moved candidates into six different clinical trials over its seven-year history and is expected to enroll its first participant in the MaaT-013 Phase III trial any day now. Its candidate uses microbiome-based therapies to eliminate good gut bacteria in a patient’s system through an enema formulation. The company prides itself on the accuracy of its donor screening, quality control and the diversity of bacteria in its product. Which is formulated from excrement of healthy donors.
The company landed €18m in its Series B funding round in February 2020.