Leading companies in developing new PO microbiome drugs

Genome & Company, Lactococcus lactis

KoBioLabs, Lactobacillus Gasseri

Enterobiome, Akkermansia muciniphila, preparation for metabolic disease IND

The next-generation microbiome, Akkermansia muciniphila, was observed under an electron microscope (photo by Enterobiome)

Recently, the world's first oral microbiome treatment obtained approval from the US Food and Drug Administration (FDA).

 

VOWST from Seres Therapeutics in the U.S.

 

is a drug that prevents re-infection after antibacterial treatment for CDI bacteria for people over 18 years of age.

 

As a new microbiome drug, it is the second after Rebyota of Ferring Pharmaceuticals of Switzerland, but if the treatment was an anal-administered drug, VOWST is significant in that it is the first oral formulation treatment of a related drug.

 

As microbiome new drugs are approved one after another, domestic microbiome companies are also accelerating the development of new drugs for various indications based on each company's microbial strain pipeline.

 

The microbiome is a combination of microbe and biome and refers to various microorganisms living in the human body and their genes.

 

Microbiome treatment is one of the fields that many biopharmaceutical companies are challenging because it is based on microorganisms and has the advantage of higher safety than other treatments.

 

Genome & Company's GEN-001 is a microbiome-based immuno-anticancer drug made in an oral formulation by improving a single strain of Lactococcus lactis isolated from the intestine of a healthy person and has currently obtained a domestic patent.

 

GEN-001 acts as a mechanism to activate the body's immunity and is currently conducting phase 2 clinical trials for gastric cancer in combination with Bavencio, an immuno-oncology drug from Merck and Pfizer.

 

In the case of MSD's phase 2 clinical trial of Keytruda, an anticancer drug for biliary tract cancer, it is currently applying for approval to change its IND (clinical trial plan) to the Ministry of Food and Drug Safety, and patients are scheduled to be administered in the second half of this year.

 

KoBioLabs' KBL697 is a Lactobacillus gasseri monostrain substance with an anti-inflammatory immunomodulatory mechanism and is currently patented in the US.

 

The strain is undergoing global phase 2 clinical trials in the US and Australia, targeting psoriasis (KBLP-001) and ulcerative colitis (KBLP-007) caused by an excessive immune response.

 

KBLP-007 recently received IND approval from the Ministry of Food and Drug Safety, which includes Korea for phase 2 clinical trials and is about to proceed with domestic clinical trials.

 

Some companies are developing microbiome treatments using new strains that have not been registered with the Ministry of Food and Drug Safety in Korea.

 

Enterobiome's EB-AMDK19 is Akkermansia muciniphila, a non-notified strain of Akkermansia muciniphila that is non-cultivable and extremely anaerobic that lives in the intestinal mucosa of the body and shows efficacy in diseases such as metabolic and immune diseases.

 

Akkermansia muciniphila, also known as next-generation probiotics, is an extremely anaerobic bacterium that is extremely sensitive to oxygen and requires advanced culture technology because it is difficult to isolate, identify, and culture.

 

Enterobiome has completed the registration of a 'patent for high-yield cultivation technology of anaerobic bacteria' in the United States, Australia, India, and Canada, starting with Korea, and holds six patents related to the EB-AMDK19 strain.

 

The strain has completed the GLP non-clinical toxicity test and is currently scheduled to apply for an IND targeting atopic skin disease in the first half of next year.