Genome & Co.’s bile duct cancer drug candidate enters Phase 2 trials

Genome & Company, a South Korean developer of microbiome-based drugs, on Tuesday said its GEN-001, a leading immunotherapy drug candidate for bile duct cancer, has entered Phase 2 clinical trials.

GEN-001 will be combined with the immunotherapy treatment Keytruda of Merck Sharpe & Dohme (MSD) for testing at eight domestic hospitals on patients with the cancer whose previous treatments have shown no effect.

Treatment options for this cancer are limited and its prognosis is so low that the five-year survival rate is only 5%-15%. If the safety and effectiveness of combined therapy are proven in the trials, GEN-001 is expected to emerge as a new second-line treatment. 

The drug candidate is also undergoing Phase 2 clinical trials in combination with Bavencio, MSD’s immunotherapy treatment for cancer of the urinary tract or bladder.

GEN-001 will thus undergo testing combined with both PD-1 (Keytruda) and PD-L1 (Bavencio) classes of immunotherapy drugs. 

“Combination therapy will boost the response rate of conventional immunotherapy treatments,” Genome & Co. CEO Pae Ji-soo said.

Write to Young-Ae Lee at 0ae@hankyung.com