Merck doubles down on live biotherapeutics with 4D deal

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Dr Microbe)
(Image: Getty/Dr Microbe)

Related tags: LBPs, Merck, 4D Pharma

Merck extends its partnership with 4D Pharma to discover and develop LBP vaccines for three undisclosed indications, adding to their Keytruda partnership.

Merck, known as MSD outside of North America and Mexico, provided an undisclosed upfront payment for each potential indication, and offered $347.5m (€316m) in potential milestone payments.

The partnership will specifically look to develop live biotherapeutics (LBPs) for vaccines.

Should Merck choose to exercise its option on any program, it will be responsible for development, manufacturing and commercialization.

Daria Hazuda, CSO of Merck’s VP of infectious disease and vaccines discovery research, explained why 4D’s technology is of interest: “By applying 4D's MicroRx technology we hope to gain meaningful insights into the role of the host microbiome in modulating the immune response and ultimately protection conferred by vaccines.”

UK-headquartered, 4D Pharma specializes in LBPs and has three candidates in clinical trials, including a potential treatment for irritable bowel syndrome (IBS), oncology, and asthma.

MicroRx is 4D’s proprietary platform that is able to select bacteria that have a potential therapeutic effect in specific diseases.

Merck has already tapped into 4D’s technology through a clinical trial looking into the potential for the former’s commercial product, Keytruda (pembrolizumab), to be paired with the latter’s MRx0518 as combination treatment for solid tumors.

The ongoing Phase I/II​ will determine whether the addition of one capsule, twice daily, of MRx0518, alongside doses of Keytruda, is of benefit in patients who have progressed on PD-1 inhibitors.

MRx0518 is an LBPs product consisting of a lyophilized formulation of a proprietary strain of bacterium.

Wider than its partnership with Merck, 4D’s Blautix, a candidate for IBS, is at the Phase II clinical trial stage and in a Phase I trial, the company noted, was able to demonstrate that patients showed improvements in symptoms and an increase in microbiome diversity.

In addition, the company outlines that it holds the manufacturing capacity to produce its LBPs in-house, from preclinical to commercial scale. The company holds 4,900-square-feet of manufacturing space, with the capacity to scale up to 3,000L fermentation.

Last month​, Lonza and Chr. Hansen created a joint venture contract development and manufacturing organization that would specialize in LBPs, as the companies anticipates greater development in this therapeutic modality.

Related topics: Pipelines, Bio Developments

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