SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--VastBiome is announcing sponsorship of an observational clinical study designed to collect data to understand molecular associations between immune checkpoint inhibitor (ICI) therapy and the gut microbiome (the collection of bacteria and other bugs living in the gastrointestinal tract). This study, named PARADIGM (Pursuit to Analyze and Reveal Associated Drivers of Immunotherapy outcomes through the Gut Microbiome) is listed on ClinicalTrials.gov (NCT05037825) and actively enrolling patients.
PARADIGM will monitor patients’ immune system and microbiome across multiple cycles of ICI therapy and its findings may offer new insights into the microbiome’s role in cancer and its effects on the host immune system. PARADIGM will recruit a large cohort of patients with non-small cell lung cancer, malignant melanoma, renal cell carcinoma, and triple-negative breast cancer and will examine blood, stool, imaging and medical record information describing cancer diagnosis, treatment, comorbidities, and concurrent medications. This rich scientific information may inform development of improved ICI therapies for future patients.
VastBiome’s Co-Founder and CEO, Kareem Barghouti, said, “Links between the gut microbiome and ICI therapy have been made evident in a number of high-profile publications, and there remains great opportunity to build on these studies with larger and more cohesive patient datasets. Such data is necessary to understand useful mechanisms and identify potential therapies. PARADIGM will provide these data by profiling the microbiome and host at unprecedented depth. We are grateful to our clinical partners and most importantly, our patients who make PARADIGM—and a future for better treatments—possible.”
The microbiome space has evolved rapidly over the past several years with multiple live biotherapies, engineered strains, pre- and probiotics making their way into clinical testing. Through PARADIGM, VastBiome aims to enhance therapeutic development by understanding the activity of particular natural products produced by gut microbes, bringing together the chemical depth of the gut ecosystem with modern drug development processes.
VastBiome, is a drug discovery company mining the gut microbiome for small molecules to treat immunological disorders and advance immunotherapy. Using artificial intelligence and synthetic biology, VastBiome indexes the microbiome for molecules with therapeutic properties. These proprietary assets enable development of best-in-class medicines, leveraging the chemical richness of the gut microbial ecosystem.