By Baek Byung-yeul

Seo Young-jin, the chief operating officer at Genome and Company, speaks during an online press conference, Friday. Screenshot from the conference

Genome and Company, a local biotech company, said Friday that it is building a partnership with global biopharmaceutical company MSD to conduct a joint clinical trial for biliary tract cancer patients.

Under the agreement, Genome and Company will conduct a Phase 2 clinical trial to evaluate the safety and efficacy of its immuno-oncology microbiome therapeutic candidate GEN-001 in combination with MSD's anti-cancer drug, Keytruda, in patients with biliary tract cancer.

"The Phase 2 clinical trials will be conducted to verify the stability and effectiveness of combination therapy in patients with biliary tract cancer. Genome and Company will be the sponsor of the clinical trial to supervise the entire trial process while MSD will supply Keytruda," Seo Young-jin, the chief operating officer of Genome and Company, said during an online press conference.

Established in 2015, Genome and Company is the country's leading microbiome anti-cancer drug developer. A microbiome refers to complex communities of microbes that live in the human body. They are known to have various effects on cancer treatment and immunity.

Genome and Company develops microbiome-based drugs and targets immune-cancer drugs using clinical data and genetic analysis. Its GEN-001 is an orally-administered immuno-oncology microbiome therapeutic candidate consisting of Lactococcus lactis, a single live bacterial strain isolated from a healthy human. The GEN-001 has been recognized for its innovative technology, as the company has conducted clinical trials for combination therapy of its candidate and Merck KGaA and Pfizer's immuno-oncology drug, Bavencio.

After diagnosis, biliary tract cancer is known for its poor prognosis due to limited treatment options with patients seeing a five-year survival rate of only 5 percent to 15 percent.

Pae Ji-soo, the CEO of Genome and Company, said he expects that the combination of GEN-001 and Keytruda will be a useful treatment for biliary tract cancer patients. "Through this clinical trial collaboration, we look forward to evaluating the potential additive benefit of GEN-001 in combination with Keytruda as a treatment for patients with biliary tract cancer," Pae said.

Revealing the company's future vision, Seo said that the company will conduct four to five clinical trials using its GEN-001 candidate and SB-121, a candidate developed by U.S. subsidiary Scioto Biosciences.

With its new drug development pipelines, Seo said that the company aims to become a first-in-class pharmaceutical company that is capable of the research, development and manufacturing of microbiome drugs. In 2021, the company acquired a 60-percent stake in the U.S.-based microbiome manufacturing company, List Labs.

"We are pursuing a fully integrated business model that includes not only research and development but also production and commercialization. As the microbiome market opens, Genome and Company, which has production facilities, will have an absolute advantage. This is what differentiates us from other companies," he said.