04 March 2022 | News
Announces Clinical Trial collaboration with MSD to evaluate 'GEN-001' in combination of KEYTRUDA (pembrolizumab) in phase 2 clinical trial in biliary tract cancer patients
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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.