Genome&Company Collaborates with MSD on Phase 2 Clinical Trial of Bile Duct Cancer Treatment 'GEN-001'
[Asia Economy Reporter Lee Gwanju] Genome & Company, a specialist in immuno-oncology, announced on the 4th that it has signed a clinical trial cooperation and supply contract (CTCSA) with global pharmaceutical company MSD for cholangiocarcinoma.
Following the CTCSA agreement, Genome & Company will conduct a Phase 2 clinical trial to evaluate the safety and efficacy of combination therapy using MSD's immuno-oncology drug Keytruda and 'GEN-001' in patients with cholangiocarcinoma. Genome & Company will act as the sponsor overseeing the clinical trial, while MSD will supply Keytruda used in the trial as a co-researcher.
'GEN-001' is an oral microbiome therapeutic candidate composed primarily of a single strain of Lactococcus lactis isolated and identified from healthy individuals. Cholangiocarcinoma has limited treatment options restricted to chemotherapy, and is one of the cancers with poor prognosis, with a 5-year survival rate of only 5-15% after diagnosis. In preclinical studies, GEN-001 enhanced the growth inhibition effect in immune checkpoint inhibitor-sensitive and resistant tumor models, showing optimal safety and synergistic effects when combined with immune checkpoint inhibitors. Since receiving approval from the Ministry of Food and Drug Safety in October last year, clinical trials are currently underway in the United States and Korea.
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Jisoo Bae, CEO of Genome & Company, stated, "Genome & Company is expanding combination clinical trials of its flagship pipeline GEN-001 from the existing German Merck & Pfizer Bavencio to MSD Keytruda, conducting clinical trial collaborations with global pharmaceutical companies in both PD-1 and PD-L1 classes." He added, "Through this clinical trial cooperation, both companies hope that the combination therapy of GEN-001 and Keytruda® will become a useful treatment option for patients with cholangiocarcinoma."
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