GI Biome, Anticancer Microbiome Phase 1 Clinical Trial Approved

[Photo by GI Biome]

[Asia Economy Reporter Chunhee Lee] GI Biome, a microbiome new drug development company, announced on the 6th that it received approval from the Ministry of Food and Drug Safety on the 2nd for the clinical phase 1 trial plan (IND) of the anticancer candidate substance 'GB-104'.

This clinical trial will be conducted to evaluate the safety and dosage of GB-104 in colorectal cancer patients. It will target patients with left-sided colorectal cancer, specifically sigmoid colon cancer and rectal cancer, who have completed the planned standard treatment, and in addition to safety, it will also assess immune responses in colorectal cancer patients, microbiome-related biomarker analysis, and improvement in cancer patients' quality of life. In particular, the evaluation will include whether there is improvement in 'Low Anterior Resection Syndrome (LARS)', a defecation disorder symptom caused by the surgical method called 'low anterior resection'. The company explained that this is a strategy to secure "early clinical results with a 'two-track' approach that not only develops GB-104 as an anticancer agent but also as a drug approved for improving the quality of life of cancer patients." The principal investigator (PI) of the clinical trial is Woo Yong Lee, director of the Cancer Hospital at Samsung Seoul Hospital, an authority in colon and rectal cancer.

GI Biome explained that GB-104 showed strong anticancer effects in animal models transplanted with colorectal cancer by effectively infiltrating NK cells and T cells, which are important for anticancer activity, into tumor tissues as a monotherapy in non-clinical trials. Sujin Kim, head of clinical division at GI Biome, said, “Since GB-104, a live biotherapeutic product produced by the French company Bios, demonstrated excellent therapeutic efficacy both as a monotherapy and in combination with anticancer drugs in non-clinical efficacy tests using various colorectal cancer models, we expect successful clinical results,” adding, “We plan to firmly establish the competitive edge of the microbiome through strategic clinical development.”

Hanlim Moon, CEO of Medirama (specialist in hematology-oncology), also evaluated, “The activation state of immune cells has been enhanced and responses to immune checkpoint inhibitors have improved, and over the past few years, the microbiome has been expected to have a significant effect on anticancer treatment,” adding, “Considering the results of non-clinical trials and clinical development plans, GB-104 is expected to open a new chapter in anticancer therapy.”

GI Biome plans to complete the phase 1 clinical trial in the first half of this year and enter the world’s first phase 2 clinical trial combining NK cells and microbiome in collaboration with GI Cell in the second half.