VastBiome Announces Extensive Exploratory Prospective Data Collection to Understand Basic Microbiome Science and Immune Checkpoint Inhibitor Therapy
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–VastBiome announces sponsorship of an observational clinical study designed to collect data to understand the molecular associations between immune checkpoint inhibitor (ICI) therapy and the gut microbiome (the collection of bacteria and other insects living in the gastrointestinal tract). This study, named PARADIGM (Pursuit to Analyze and Reveal Associated Drivers of Immunotherapy results through the Gut Microbiome) is listed on ClinicalTrials.gov (NCT05037825) and is actively recruiting patients.
PARADIGM will monitor the immune system and microbiome of patients over multiple cycles of ICI therapy and its findings may offer new insights into the role of the microbiome 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 examine blood, stool, imaging and medical record information describing cancer diagnosis, treatment, comorbidities and concomitant medications. This rich scientific information can inform the development of improved ICI therapies for future patients.
VastBiome Co-Founder and CEO Kareem Barghouti said, “The links between the gut microbiome and ICI therapy have been highlighted in a number of high profile publications, and there remains a great opportunity to build on these studies with larger, more cohesive patients. data sets. These data are needed to understand useful mechanisms and identify potential therapies. PARADIGM will provide this data by profiling the microbiome and host at an unprecedented depth. We are grateful to our clinical partners and, more importantly, our patients who make PARADIGM and a future for better treatments possible.
The microbiome space has evolved rapidly over the past few years with multiple live biotherapies, engineered strains, pre- and probiotics making their way into clinical trials. Through PARADIGM, VastBiome aims to improve therapeutic development by understanding the activity of particular natural products produced by gut microbes, combining the chemical depth of the gut ecosystem with modern drug development processes.
VastBiome is a drug discovery company that harnesses the gut microbiome in search of 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 exclusive active ingredients allow the development of advanced drugs, taking advantage of the chemical richness of the microbial ecosystem of the intestine.