Genome and Company, a leading global microbiome anti-cancer drug development company, 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."

‘GEN-001’ is an oral microbiome therapeutic candidate developed to have immune modulating activities, resulting in potential partnership with immune checkpoint inhibitors. ‘GEN-001’ consist a single-strain bacteria (Lactococcus lactis, L.lactis) isolated from gut of healthy human volunteers that has been shown to activate dendritic cells, macrophages and T cell response. In preclinical studies, ‘GEN-001’ has shown optimal safety margin and synergistic effects in combination with immune checkpoint inhibitors by enhancing the effect of suppressing the growth of both immune checkpoint inhibitor sensitive and resistant tumour models. The clinical study (Phase I/Ib) of GEN-001 is currently in progress in the US and Korea, and additionally, the IND of phase II study was approved by MFDS (Korean Ministry of Food and Drug Safety) in October 2021.

Keytruda is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.

Since its establishment in 2015, Genome and Company develops next waves of innovative drugs including anti-cancer microbiome therapeutics and novel target immune checkpoint inhibitors.