Announced yesterday, the deal will expand Seres’ manufacturing capabilities for SER-109, an oral microbiome therapeutic containing Firmicutes spores, which normally live in the healthy microbiome.
SER-109 is designed to prevent rCDI by modulating the disrupted microbiome to resist C. difficile colonisation and growth.
Further terms will see Bacthera, a Basel-based contract development and manufacturing firm, provide drug substance manufacturing and filling of the final product formulation into Lonza’s Capsugel hypromellose plant-based capsule range.
“This collaboration truly exemplifies Bacthera's leading offering for LBP manufacturing as a strategic partner on the path to commercialsation,” explains Jean-Christophe Hyvert, President, Biologics and Cell and Gene, Lonza.
“Bacthera will utilise a facility inspired by the Ibex Solutions to offer an assured supply, enabling its customers to mark a significant milestone in the advance of microbiome-targeting therapies."
Hyvert, who joined Lonza in 2017, is referring to the new LBP Manufacturing facility located at Lonza's site in Visp, Switzerland.
The 12’000 m2 Microbiome Center of Excellence covers three manufacturing floors, including capacity for commercial production. One of the floors will be dedicated to the manufacturing of SER-109.
“We are proud to be part of bringing an entirely new class of medicines to people who have a profound need for it,” adds Lukas Schüpbach, CEO, Bacthera.
“With our new Microbiome Center of Excellence in Visp, we are looking forward to supporting the manufacturing of potentially life-saving microbiome-based treatments, such as SER-109."
There are few options for the treatment of recurrent CDI. These include vancomycin pulse taper regimens but have shown modest efficacy because they do not address the disrupted microbiome.
Seres entered into an agreement with Nestlé Health Science in July 2021 to jointly commercialise SER-109 in the US and Canada.
Under the terms of the agreement, Nestlé Health Science will call on its global pharmaceutical business, Aimmune Therapeutics, to lead SER-109's commercialisation, providing Seres the ability to retain a strategic role and actively participate in the launch.
SER-109 is designed to modulate microbiome functions such as the production of antimicrobial compounds, pathogen growth inhibition, and improve gut lining integrity.
The SER-109 manufacturing purification process is designed to remove unwanted microbes, thereby reducing the risk of pathogen transmission beyond donor screening alone.
The US FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the treatment of rCDI.
“We are pleased with the progress we have made to prepare for an expected biologics license application submission in mid-2022,” says Eric Shaff, CEO of Seres.
“We look forward to partnering with Bacthera to expand upon our existing production capacity to meet demand growth beyond the initial phase of launch and help ensure eligible patients worldwide can receive this potential new treatment option.”
In a 50/50 joint venture between Chr. Hansen and Lonza, Bacthera was created in April 2019, specialising in live biotherapeutic (LBP) products to address gastrointestinal and cardiovascular conditions.
The two multinationals agreed to develop and manufacture these products in a phased investment approach that committed around €90m shared between the partners over three years.
"With Bacthera, we are on a mission to pioneer the future of medicine based on good bacteria,” adds Christian Barker, Executive Vice President Health & Nutrition at Chr. Hansen.
“While Bacthera has already been successful in winning and executing several projects for customers based in Europe, the US, and Asia, we consider this first commercial manufacturing agreement a breakthrough in our microbiome lighthouse.
“This will support Bacthera in becoming a world-leading contract development and manufacturing organisation (CDMO) in the emerging Live Biotherapeutic Product industry."