GI Biome starts clinical trial of colorectal cancer treatment candidate 'GB-X01'

By Kim Joo-heon Posted : June 2, 2023, 16:53 Updated : June 3, 2023, 12:16

[Courtesy of GI Biome]

SEOUL -- GI Biome, a microbiome-based drug developer in South Korea, has started administering GB-X01, an anti-colorectal cancer candidate, to patients in the first clinical trial in South Korea. Through the test, the company aims to confirm the safety, drug tolerance, and composition variation of intestinal microorganisms before and after administration.
The microbiome is a cluster of all types of microscopic organisms that co-exist with humans such as bacteria, fungi, protozoa, and viruses. Many of them live inside human bodies and beneficial types are used as ingredients for healthy foods or medicines.
GI Biome said in a statement on June 1 that the result for GB-X01 would be secured in the second half of 2023. GB-X01 is an oral medication mainly composed of a strain from adult women. The pharmaceutical firm said anti-tumor effects have been confirmed when the treatment was used alone and with other drugs.  
Through preclinical study, GI Biome also found that the new candidate is also effective in alleviating chemotherapy-induced diarrhea, which frequently happens as a side effect during cancer treatment. After completing the phase 1 process, the company plans to develop GB-X01 as a treatment for gastrointestinal (GI) side effects caused toxicity of chemical anti-cancer drugs. GI side effects include nausea, vomiting, and loss of appetite.
GI Biome is affiliated with pharmaceutical company GI Innovation. The company known for its immunotherapy agents including GI-101 and GI 102 was listed on KOSDAQ, the South Korean version of the U.S stock market NASDAQ, in March 2023. GI Innovation had 27 registered patents and completed 138 patent applications as of March 2023.

South Korea is nurturing its microbiome sector with government support to build an industrial microbiome ecosystem. In August 2021, the Ministry of Agriculture, Food and Rural Affairs revealed its plan to build a microbiome resource center in Sunchang some 244 kilometers (152 miles) south of Seoul to create a database of microorganisms. The resource center is set to begin its operation in the second half of 2023. 
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