Genome and Company, a leading global microbiome anti-cancer drug development company in Korea, has entered into a first Clinical Trial Collaboration and Supply Agreement (CTCSA) with MSD (a tradename of Merck & Co., Inc.).

Upon the execution of the agreement, Genome and Company will conduct a phase 2 clinical trial to evaluate the safety and efficacy of its immuno-oncology microbiome therapeutic, 'GEN-001', in combination with MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with biliary tract cancer. Genome and Company will be the sponsor of the clinical trial and MSD will supply KEYTRUDA.

'GEN-001' is an orally administered immuno-oncology microbiome therapeutic candidate consisting of Lactococcus lactis (L. lactis), a single live bacterial strain isolated from a healthy human.

Biliary tract cancer is one of the carcinomas associated with a poor prognosis after diagnosis, limited treatment options and five-year survival rate of only 5 to 15%. According to the findings in the MDPI Cancers 2021, an SCI academic journal, the infiltrations of immune cells around cancer cells were observed in 70% of biliary tract cancer patients, also confirming the relationship between the immune cells and biliary tract cancer cells.