Genom Company Receives MFDS Approval for Phase 2 Clinical Trial of 'GEN-101 and Keytruda Combination' in Bile Duct Cancer

[Asia Economy Reporter Lee Gwanju] Genome & Company announced on the 8th that it has received approval from the Ministry of Food and Drug Safety for the phase 2 clinical trial plan (IND) of the immune-oncology microbiome treatment 'GEN-001' in combination with Keytruda for patients with cholangiocarcinoma.

Genome & Company obtained approval for the clinical trial plan about eight months after signing a joint development agreement with the global pharmaceutical company MSD in March this year and through subsequent consultations. With this approval, GEN-001 will enter full-scale combination therapy clinical trials not only with the PD-L1 immune checkpoint inhibitor Bavencio but also with the PD-1 immune checkpoint inhibitor Keytruda.

The phase 2 clinical trial plans to evaluate the safety and efficacy of the combination therapy of GEN-001 and Keytruda in patients with cholangiocarcinoma who have not responded to existing standard treatments. In particular, a cohort study method will be applied, dividing patient groups based on prior experience with immune checkpoint inhibitor treatments, which is expected to facilitate verification of GEN-001's efficacy.

Seo Youngjin, CEO of Genome & Company, said, "With the approval of this clinical trial plan, we will conduct clinical trials with all PD-(L)1 immune checkpoint inhibitors currently marketed by global pharmaceutical companies," adding, "We will accelerate the development of immune-oncology microbiome treatments by expanding the indications for GEN-001 combination therapy clinical trials."

This content was produced with the assistance of AI translation services.