San Diego-based biotechnology company Persephone Biosciences announced the launch of the ARGONAUT clinical study that will examine the role played by the gut microbiome in the immune system and the efficacy of cancer treatments.
Persephone said in a press release announcing the launch of the clinical study that it will seek to enroll up to 4,000 patients, which it said is “the largest ever clinical study to map the cancer gut microbiome immune axis in the U.S.”
ARGONAUT is a longitudinal, prospective, observational study that will enroll advanced-stage cancer patients of diverse racial backgrounds to collect data to both inform the development of precision microbiome medicines and to identify needed companion diagnostics to guide treatments. The study will focus on four types of: non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC), and pancreatic cancer.
“I believe this study will provide important new insights into how the microbiome can inform the treatment of patients with cancer,” says Sandip Patel, M.D., associate professor, UC San Diego Moore’s Cancer Center in the release. “This work could help improve patients’ response to existing and future treatments through the use of more personalized treatment regimens.”
A key component of ARGONAUT is developing data from patient of a range of socioeconomic and racial backgrounds to better understand the nuances of developing precision therapies for different patient populations.
“Significant cancer health disparities currently exist, but with this nationwide study that include tumor types, like TNBC, that are more prevalent in at-risk demographics, we believe we can address these disparities and develop equitable precision medicine, thereby potentially increasing survival rates and quality of life,” Patel adds.
The official title of the ARGONAUT study is: “Development and Analysis of a Blood and Stool Sample Bank for Cancer Patients, Enabling the Systematic Study of the Effect of Blood and Gut Microbiomes on Response to Treatment.” More information can be found at clinicaltrials.gov using the identifier NCT04638751. Patients enrolled in the trial will provide 2 samples each of blood and stool over a 6-month period, and will be followed for up to two years.
“The ARGONAUT study will provide us with more data than ever before on the importance of gut microbiome in patients’ response to oncology treatment,” notes Stephanie Culler, CEO or Persephone in a prepared statement. “With this data, Persephone Biosciences will be the partner of choice for oncology companies wishing to improve the therapeutic benefit of existing drugs, as well as develop effective new therapies targeting microbiome optimization.”