Genom Company Initiates First Dosing in Phase 2 Clinical Trial of Immune-Oncology Microbiome Therapy for Stomach Cancer

[Asia Economy Reporter Lee Gwan-joo] Genome & Company announced on the 8th that it has completed the first patient dosing in the Phase 2 clinical trial of the immune-oncology microbiome therapeutic candidate ‘GEN-001’ targeting gastric cancer.

GEN-001 is an oral microbiome therapeutic candidate composed primarily of a single strain of Lactococcus lactis (L. lactis) isolated and identified from the intestines of healthy individuals. Recently, the recommended Phase 2 dose (RP2D) was established through ongoing Phase 1 and 1b clinical trials in the United States.

This Phase 2 clinical trial targets 50 gastric cancer patients who have not previously received immune-oncology treatments, are positive for the biomarker PD-L1, and have not responded to first- and second-line standard therapies. GEN-001 will be administered in combination with Bavencio (active ingredient: avelumab) to evaluate safety and efficacy.

Seo Young-jin, CEO of Genome & Company, stated, “We have entered the full-scale clinical phase where efficacy can be verified in the microbiome drug development stage,” adding, “As a leading company in the immune-oncology microbiome therapeutic market, we will focus our capabilities to achieve meaningful results in this clinical trial.”