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Trial Underway Assessing Gut Microbiome-Cancer Links

Gut microbes

Gut microbes cultured in an artistic design (Nicola Fawcett, Wikimedia Commons)

21 Sept. 2022. A clinical trial began collecting stool and blood samples to find connections between microbial communities in the gut and four types of solid-tumor cancer. The study, conducted by Persephone Biosciences Inc. in San Diego, aims to better understand links between the make-up of a person’s gut microbiome and immune health among cancer patients, for creating new diagnostics and treatments.

Persephone Bio develops engineered biologics addressing disorders in the microbiome, collections of bacteria and other microbes living in the gut. The microbiome is an emerging area for health researchers, with more recent discoveries pointing to links between conditions of microbes in the gut and disorders elsewhere in the body, including those not often associated with the gut.

The five year-old company is currently conducting large-scale observational studies to produce data that connect details of people’s gut microbes with their genomic profiles and health status. Participants provide stool and other samples, as well as permission to access to their health records. Persephone Bio then associates gut microbe compositions with genomic and metabolic conditions, to guide development of therapies, including probiotics and synthetic live biologics that work in the gut. In August, Science & Enterprise reported on the start of a clinical trial collecting infants’ stool samples to produce data on characteristics of healthy microbial communities in young children.

Also collecting data on chemo- and immunotherapies

Persephone Bio says it enrolled the first of 4,000 participants in a study to connect the state and composition of gut microbial communities with four types of solid tumor cancer: colorectal cancer, pancreatic cancer, non-small cell lung cancer, and triple negative breast cancer. Non-small cell lung cancer makes up 80 to 85 percent of all lung cancer cases in the U.S., and triple-negative breast cancer cells have no or few receptors for estrogen, progesterone, nor HER2 proteins, making the cells non-responsive to many hormonal treatments.

Participants in the clinical trial called Argonaut are patients with one of the four types of cancer who give two stool and blood samples within six months, and are then tracked at 12, 18, and 24 months for tumor scans and related health data. At each of the follow-up points, the study team also collects data on cancer medications taken by participants, either chemo- or immunotherapies. The company then plans to apply its computational tools, including machine-learning algorithms, to find associations between gut microbe profiles and immune system biomarkers or molecular indicators of these solid tumor cancers.

“As the largest study ever of its kind in the U.S.,” says Stephanie Culler, CEO and co-founder of Persephone Biosciences, in a company statement released through Globe Newswire, “Argonaut will utilize large-scale, high-throughput data collection coupled with machine learning.”

Persephone Bio says the study plans to enroll a highly diverse group of participants since colorectal cancer affects Black Americans to a greater extent than other racial or ethnic groups. For the colorectal cancer part of the trial, the company is working with Janssen Research & Development, a division of Johnson & Johnson, to also enroll a group of healthy participants but still with a high cancer risk. The microbiome-cancer connections are expected to help develop precision microbiome treatments and companion diagnostics.

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Disclosure: The author owns shares in Johnson & Johnson.

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