On Jume 1, 2023 GI Biome, an affiliate of GI Innovation and a microbiome drug development company, reported that it has started administering GB-X01 to the first patient in the domestic phase 1 clinical trial for colorectal cancer microbiome treatment (Press release, GI Biome, JUN 1, 2023, View Source [SID1234633251]).
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This clinical trial will be conducted at Samsung Seoul Hospital for patients who have completed standard treatment after radical resection of colorectal cancer. It is planned to evaluate the safety and tolerability of GB-X01 and to confirm changes in the composition of the intestinal microflora before and after administration. It is expected to secure phase 1 results in the second half of this year, including a 4-week dosing period for a total of 9 patients (up to 18) and a 4-week follow-up period thereafter. GB-X01
, obtained through GI Biome’s platform, has a single strain isolated from an adult female as its main component. As an oral drug, the antitumor effect was confirmed in monotherapy and combination therapy. It was said that ‘5-FU’, the most commonly used chemical anticancer drug for the treatment of colorectal cancer, showed a synergistic effect in combination with target anticancer drugs such as bevacizumab and natural killer (NK) cells under development by GI Cell . Based on these preclinical results, we applied for domestic and international patents on materials and uses. The company also confirmed through preclinical studies that it relieves anticancer drug-induced diarrhea ( CID ), which is a typical side effect of anticancer treatment, leading to treatment delay, dose reduction, and treatment discontinuation. A phase 2 plan for mitigating gastrointestinal side effects caused by the toxicity of chemical anticancer drugs is also taking shape.
When phase 1 is completed in the second half of this year, the goal is to apply for phase 2 in Korea early next year. In phase 2, it plans to evaluate the anticancer efficacy through the improvement of side effects caused by chemotherapy and the combination therapy of immune cell therapy.