French biotech lands manufacturing deal in step toward commercialization of rare bone disease drug
As a startup, it can sometimes be tough to think too far ahead in the future. However, with a major manufacturing partnership announced 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.
The French biotech and CDMO Skyepharma will partner to build the largest specialized manufacturing facility for microbiome-based therapeutics. The plant will help MaaT increase its output by ten-fold by 2030, with the aim to produce several thousand enemas of the lead candidate MaaT-013, to treat Graft-versus-Host disease (GvHD), which happens when donated bone marrow or stem cells view the recipient’s body as foreign, and donated cells and bone marrow attack the body. It will also produce “several hundreds of thousands capsules” of MaaT-033, for patients who receive an allogeneic stem cell transplantation.
Through the 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 disclosed in a release, and financial terms are still under wraps. The site will be operational by 2023 and will host MaaT Pharma’s team and equipment. Skyepharma, meanwhile, will lend MaaT expertise in product quality, regulatory affairs and large-scale production. MaaT also will benefit from Skyepharma’s expertise on delayed-release formulation. While MaaT could have focused on its own manufacturing plans, the new deal allows MaaT to focus on what it knows best: its pipeline.
“(Skyepharma has) already many years of experience. Their sites have been already inspected by the French, Americans, and several other inspectors,” Schwintner said in an interview with Endpoints News. “It’s important for us to have something really solid, and they bring this part of expertise on top of it…Rather than trying to build an entirely new thing, they have something already its been challenged and validated.”
Last month, MaaT completed its Phase II/III trials early, and data from four out of five intended cohorts showed satisfactory safety and “good microbiome engraftment” determined by the presence of specific gut bacteria.
Through the deal, MaaT will accelerate MaaT-03X, which uses a microbiome ecosystem co-fermentation technology, and recently was awarded two public grants.
MaaT has moved candidates into six different clinical trials in its seven years of existence and should be signing up its first participant in MaaT-013’s Phase III trial any day now. Its candidate uses microbiome-based therapeutics to flush good gut bacteria into a patient’s system through an enema formulation. The company prides itself on the precision of its donor screening, quality control and diversity of bacteria in its product. That is formulated using feces from healthy donors.
The company landed €18 million in its Series B financing round in February 2020.