Genome and Company (KOSDAQ: 314130, CEO∙CTO: Jisoo Pae∙Hansoo Park), a leading global microbiome anti-cancer drug development company, announced it has entered into a first Clinical Trial Collaboration and Supply Agreement (CTCSA) with MSD (a tradename of Merck & Co., Inc., Kenilworth, N.J., USA).

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.

Dr. Jisoo Pae, CEO of Genome and Company, said, "Genome and Company has established clinical trial collaborations to evaluate 'GEN-001' with both anti-PD-L1 and anti-PD-1 therapies through agreements with MSD, Merck KGaA, Darmstadt, Germany and Pfizer, which shows that the company is being recognized for its innovative technology by global immuno-oncology companies." He added, "Through this clinical trial collaboration, we look forward to evaluating the potential additive benefit of 'GEN-001' in combination with KEYTRUDA® as treatment for patients with biliary tract cancer."

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.