GI Biome said on Monday that it received approval from the Ministry of Food and Drug Safety (MFDS) for its phase 1 investigational new drug (IND) submission for GB104, a microbiome candidate for colorectal cancer.

This trial will evaluate the safety of GB104 in patients with left-sided colorectal cancer, sigmoid colon cancer, and rectal cancer who have completed the planned standard of treatment. It will also analyze immune responses and microbiome-related biomarkers in colorectal cancer patients, and measure improvements in cancer patients' quality of life.

In particular, the study will evaluate the improvement of low anterior resection syndrome (LARS) which refers to the symptoms of difficulty defecating due to this surgical method. 

Various immunotherapies are being developed, but these anticancer immune cells do not sufficiently penetrate solid tumor tissues. In non-clinical trials, the microbiome candidate GB104 effectively penetrated natural killer (NK) cells and T cells into tumor tissue with monotherapy and showed a strong anticancer effect, the company said.

Lee Woo-yong, the principal investigator who is also the director of Samsung Medical Center's Comprehensive Cancer Center, will lead the GB104 clinical trials.

Phase 1 clinical trials are expected to be completed in the first half of the year. 

Subsequently, GI Biome plans to cooperate with GI Cell in the second half of the year to enter the world's first phase 2 clinical trials combining NK cells and microbiomes, GI Biome said.

"In the next few years, microbiome therapies are expected to show great effects in anticancer treatment, with enhanced response compared to immunotherapies," said Moon Han-lim, a hemato-oncology specialist who heads clinical development company MediRama. "The non-clinical trials of GB104 presented a positive outlook for the clinical trials ahead and are looking forward to excellent outcomes.”