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Merck Gaining Gut Microbe Technology for Vaccines

Microbiome graphic

(Tony Webster, Flickr)

8 Oct. 2019. Drug maker Merck & Co. is partnering with a developer of treatments for disease derived from microbes in the gut, for discovery of up to three vaccines. The deal could bring 4D Pharma in Leeds, U.K. more than $350 million in milestone payments and an equity stake if Merck & Co. goes through with licensing the technologies, and all parts of the agreement are fulfilled.

4D Pharma discovers and develops what it calls live biotherapeutics, biological therapies for disease originating with live gut bacteria from healthy human donors. The company says its discovery process, called MicroRX, identifies therapeutic properties of specific gut bacteria strains from genomic sequencing of the microbes. The results are then analyzed with tools from microbiology and immunology, as well as bioinformatics, to isolate bacterial strains that can affect humans and disease pathways influencing those effects on humans. 4D Pharma’s development and manufacturing processes result in freeze-dried bacterial therapies administered as oral drugs.

The 4D Pharma pipeline includes treatments for intestinal disorders, irritable bowel syndrome and Crohn’s disease, in mid- and early-stage clinical trials. But the company is also developing live biotherapeutics for solid tumor cancers in early-stage trials, as well as other treatments and immunotherapies for cancer as supplemental drugs in preclinical development. 4D Pharma also has a treatment for asthma in an early-stage trial and neurodegenerative therapies in preclinical stages.

The new agreement calls for Merck in Kenilworth, New Jersey, and 4D Pharma to collaborate on discovery and development of up to three vaccines with the MicroRx process, although the specific disease targets are not disclosed. Merck will have an option to exclusively license 4D Pharma’s technology for each of the three vaccines, and be responsible for their development, manufacturing, and commercialization.

Under the deal, 4D Pharma will receive undisclosed initial payments for each option, and be eligible for up to $347.5 million in licensing, development, and regulatory milestone payments, as well as royalties on sales of products from the agreement. In addition, Merck — known as MSD outside North America — has under certain conditions, the opportunity to purchase $5 million in 4D Pharma shares in the first year of the collaboration.

“This research collaboration agreement brings together 4D’s innovation in the microbiome space and MSD’s track record of developing cutting-edge vaccines,” says Duncan Peyton, 4D Pharma’s CEO, in a company statement. “MSD and 4D have worked closely combining world leading science to develop a workplan to advance the understanding of this field, with the aim of generating a new class of vaccines in areas of high unmet need.”

Daria Hazuda, Merck’s vice president of infectious diseases and vaccines discovery research, adds “By applying 4D’s MicroRx technology we hope to gain meaningful insights into the role for the host microbiome in modulating the immune response and ultimately protection conferred by vaccines.”

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