Therapy Areas: Inflammatory Diseases
Bacthera, Seres Therapeutics Collaborate for Commercial Manufacturing of SER-109, a Potential Treatment Against Recurrent C. difficile Infection
12 November 2021 - - Switzerland-based contract development and manufacturing organization Bacthera and US-based microbiome therapeutics company Seres Therapeutics (NASDAQ: MCRB) have forged a collaboration to manufacture SER-109, Seres' lead product candidate for recurrent Clostridioides difficile infection, the companies said.

Under the terms of the agreement, Bacthera is establishing a dedicated facility for commercial manufacturing in its new Microbiome Center of Excellence, a manufacturing site dedicated to the production of LBPs located on Lonza's Ibex campus in Visp, Switzerland.

CDI, causing severe diarrhea and colitis, an inflammation of the colon, has been classified as one of the greatest microbial threats to human health by the Centers for Disease Control and Prevention.

It is the leading cause of hospital-acquired infections in the United States and is responsible for 170,000 hospitalizations and the deaths of more than 20,000 Americans each year.

SER-109 is a potentially first-in-class investigational microbiome-based therapeutic consisting of bacterial spores from healthy human donors.

This consortium of human microbiota from the gastrointestinal tract is designed to prevent further recurrences of C. difficile infections.

The agreement between Bacthera and Seres Therapeutics aims to expand upon Seres' initial commercial manufacturing supply chain. In addition to Seres' existing manufacturing infrastructure, the collaboration with Bacthera will expand the commercial production capacities of SER-109 and provide supply support.

SER-109 has the potential to be the first product within the entire live biotherapeutic industry to be produced commercially.

To support the commercial manufacturing needs of SER-109 and other LBPs, Bacthera is establishing a new Microbiome Center of Excellence dedicated to LBP Manufacturing at Lonza's site in Visp, Switzerland.

The new Microbiome Center of Excellence will be based on Lonza's proven Ibex Solutions concept for manufacturing, providing capacity for early commercial launches and production.

The new Microbiome Center of Excellence will occupy an overall footprint of approximately 12'000 m2 with three manufacturing floors, including capacity for commercial production. One of the three manufacturing floors will be dedicated to the manufacturing of SER-109.

Under the terms of the agreement, Bacthera will provide GMP drug substance manufacturing and filling of the final drug product formulation into capsules.

The capsules will leverage Lonza's Capsugel hypromellose plant-based capsule portfolio combined with encapsulation technologies that are scientifically designed to improve the stability of the product by ensuring protection from humidity, gastric acid, and other environmental factors.

SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicutes spores, which normally live in the healthy microbiome.

SER-109 is designed to prevent further recurrences of CDI in patients with a history of multiple infections by modulating the disrupted microbiome to a state that resists C. difficile colonization and growth.

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.

LBPs for short or more popularly known as bugs-as-drugs, are a new therapeutic modality being developed by a range of biotech and pharma companies across the world.

LBPs are unique because their active substance is a living organism, most commonly a bacterium, that has been identified as showing promise in treating one or sometimes several diseases. LBPs are diverse and can consist of e.g., a single organism, a genetically modified organism, or a consortium of organisms.

Bacthera was founded in 2019 as a 50: 50 joint venture of Chr. Hansen A/S and a Lonza Group Affiliate to specifically serve the needs of the emerging LBP industry.

Bacthera's expertise and the capabilities of production of bacteria for pharmaceutical purposes were transferred by both parent companies to Bacthera right from the beginning.

Bacthera offers a compelling set of services across the LBP life cycle and process chain, from technical R and D development right through to GMP manufacture and QC testing of drug substance and drug product.

Bacthera operates from its Headquarters and Center of Excellence for drug product process development and manufacturing, and QC analytical testing in Basel, CH, and its Center of Excellence for drug substance process development, analytical development, and manufacturing in Hørsholm, DK.

Seres Therapeutics, Inc. (NASDAQ: MCRB) is a microbiome therapeutics company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease.

Seres' SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA.

The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.

Seres is evaluating SER-301 in a Phase 1b study in patients with ulcerative colitis and SER-155 in a Phase 1b study to address gastrointestinal infections, bacteremia, and graft-versus-host disease.

Seres entered into an agreement with Nestlé Health Science in July 2021 to jointly commercialize SER-109 in the US and Canada.

Under the terms of the agreement, Nestlé Health Science will utilize its global pharmaceutical business, Aimmune Therapeutics, which has a strong presence in the field of gastroenterology, allowing it to lead the commercialization of SER-109 while providing Seres the ability to retain a strategic role and actively participate in the launch.

Lonza is the preferred global partner to the pharmaceutical, biotech, and nutrition markets.
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