Genom&Company Applies for IND for Phase 2 Clinical Trial of Combination Therapy for Bile Duct Cancer

[Asia Economy Reporter Chunhee Lee] Genome & Company, a specialized immuno-oncology company, announced on the 26th that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety for a Phase 2 clinical trial of the immuno-oncology microbiome therapy ‘GEN-001’ in combination with Keytruda (pembrolizumab) targeting cholangiocarcinoma.

Genome & Company signed a joint development agreement with MSD (Merck & Co., USA) in March and has been discussing the detailed requirements for the IND application. This Phase 2 trial plans to evaluate the safety and efficacy of the combination therapy of GEN-001 and Keytruda in 50 cholangiocarcinoma patients who have failed existing standard treatments.

Cholangiocarcinoma is a cancer that occurs in the bile ducts and gallbladder. Because it shows no specific symptoms in the early stages, early diagnosis is difficult, resulting in a poor prognosis with a 5-year survival rate of only about 5-15%. In the United States, approximately 23,000 people are estimated to be diagnosed with cholangiocarcinoma annually, and in South Korea, 6,659 new cases were reported in 2020.

GEN-001 is an immuno-oncology microbiome therapy candidate composed mainly of a single strain of Lactococcus lactis isolated from the intestines of healthy individuals. In addition to MSD, Genome & Company signed joint development agreements twice with Merck KGaA and Pfizer in 2019 and 2021. Through these agreements, a Phase 2 clinical trial of GEN-001 in combination with the immuno-oncology drug Bavencio (avelumab) targeting gastric cancer is underway. The interim results of this trial are planned to be announced in the first half of next year.

Seo Young-jin, CEO of Genome & Company, said, “With this IND application, we have laid the foundation to conduct clinical trials with both PD-1 and PD-L1 class immuno-oncology drugs marketed by global pharmaceutical companies. We will collaborate with leading research hospitals in Korea to ensure that clinical trials proceed swiftly after IND approval, aiming to lead the field of immuno-oncology microbiome therapies.”

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