Korean companies set high expectations for microbiome industry

Korea has already cemented its position as a leader in Asia with its fast-growing microbiome therapeutics focused on live biotherapeutic products (LBPs). 

However, domestic microbiome producers are striving to go a step further to develop first-in-class microbiome drugs in niche areas such as autism spectrum disorder (ASD), colorectal cancer, and inflammatory bowel diseases.

These were discussed at Microbiome Connect Asia in Seoul on Thursday.

Genome&Company CEO Pae Ji-soo admitted that as a doctor of psychiatry, the SB-121 drug candidate for ASD that they are currently developing with Scioto Biosciences is of particular interest to him.

Pae highlighted the issues with current drugs for ASD, stating, “The half-life is too short and exits the body in less than 30 minutes.”

He also raised the point of the drug delivery issue of oxytocin which cannot be delivered effectively to the brain.

In comparison, SB-121 is a biofilm of Lactobacillus reuteri with dextran microparticles and maltose which is being developed based on Scioto Biosciences’ activated bacterial therapeutics (ABT) delivery platform technology. The drug has already been proven to increase plasma oxytocin levels, improve cognitive function and recover histological damage of brain tissues in early phase studies, he said.

“When the drug is consumed, it reaches the brain and stimulates the vagus nerve, sending electrical signals to your brain which helps address the half-life and drug delivery issues,” he added, explaining the drug's mechanism of action.

Pae also mentioned that the drug targets the symptoms of ASD, diverging from the approach of multinational pharmaceutical firms in the psychiatric field which have primarily focused on the etiology of the disease without significant success.

In a separate press release issued on the same day, Genome&Company also revealed positive preliminary phase 2 results for its leading microbiome drug candidate, GEN-001, which is indicated for gastric cancer in combination with Bavencio (ingredient: avenumulab) from Merck and Pfizer. 

As the objective response rate (ORR) exceeded the target value, the company expects GEN-001 will soon be established as a new third-line standard treatment.

Meanwhile, ImmunoBiome CEO Im Sin-hyeog presented the IMB002 drug candidate which submitted its phase 1 clinical trial IND for treating inflammatory bowel disease (IBD) at the beginning of the year and is expected to be completed by the second quarter of this year.

The same drug indicated for rheumatoid arthritis is also expected to submit the IND plan for phases 1b and 2a in the third and fourth quarters of this year.

He outlined the mechanism of action explaining, “IMB002 works by inducing regulatory T cells and suppressing inflammatory response by targeting cell-surface polysaccharides (CSSG) to reduce inflammatory responses.”

Particularly, he highlighted his company’s Avatiome platform which is an Avatar system of Human Immuno-Microbiome that mimics the human body's immune system and microbiome to develop novel therapeutics targeting neuronal, systemic inflammatory diseases, and cancer.

GI Biome CEO Kim Young-suk also presented his clinical development plan for GB-X01 to commercialize the world’s first single-strain microbiome drug for colorectal cancer by 2028.

The company has already started patient recruitment for phase 1 studies at Samsung Medical Center (SMC) and expects to initiate phase 2 studies in the first half of 2024.

Kim presented a two-pronged approach to reduce GI-related side effects such as chemotherapy-induced diarrhea and low anterior resection syndrome (LARS) by modulating the gut microbiome. The drug is also targeted towards enhancing the efficacy of standard of care to potentially be used in combination with NK cell therapies and antibody-drug conjugates.

“We tested the microbiome treatment on other cancer types like breast and lung cancer but got the most favorable results with colorectal cancer and chose to prioritize this indication,” said Kim.

Other domestic companies like LISCure Bioscience, Health Biome, and BioMe also presented their novel microbiome drug candidates for the treatment of non-alcoholic steatohepatitis (NASH), Alzheimer’s disease, and cardiovascular disease respectively.