Genome & Company Announces Positive Topline Results from Phase 2 Clinical Trial of Combination of GEN-001 and Bavencio® for the Treatment of Gastric Cancer Poster presented at ASCO GI

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• Results showed partial response being confirmed in 7 out of 42 patients
• Partial response was observed in 3 out of 8 patients who were previously treated by immunotherapy

SEOUL, South Korea, Jan. 24, 2024 /PRNewswire/ -- Genome & Company (KOSDAQ: 314130), a clinical stage biotech leading in microbiome therapeutic development announced on January 18th that a poster was presented on the positive topline results from the phase 2 clinical trial (NCT05419362) in gastric cancer of its microbiome immunotherapy, GEN-001 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2024).

GEN-001 is an oral therapeutic candidate consisting of a single strain of Lactococcus lactis, and the phase 2 clinical trial for gastric cancer was conducted in combination with avelumab (Bavencio^®) developed and commercialized by Merck KGaA, Darmstadt, Germany.

As a result of the efficacy evaluation of 42 patients participating in the phase 2 clinical trial, partial responses (PRs) were observed in 7 out of 42 patients. Furthermore, 3 out of 8 patients among 42 patients who were previously treated by immunotherapy experienced PRs (overall response rate, ORR 37.5%).

In addition, the topline results revealed the median progression free survival (PFS) at 1.7 months and the median overall survival (OS) at 7.9 months.

Prof. Jeeyun Lee (M.D.) from the Department of Hemato Oncology at Samsung Medical Center, the coordinating investigator of the study stated, "while there are limited treatment options available for patients with metastatic gastric cancer, combination of GEN-001 and avelumab demonstrated favorable therapeutic effects leading to an extended survival. The overall response rate (ORR) of 37.5% is particularly promising among PD-L1-positive refractory patients to prior immunotherapy. We intend to further validate these results in subsequent clinical studies to establish this treatment regimen as a viable third-line treatment." Expressing enthusiasm, she added, "we are excited that this marks the first clinical study to showcase the potential of microbiome therapeutics in the treatment of gastric cancer."

Dr. Jisoo Pae, CEO of Genome & Company, said, "we plan to establish a future development strategy from obtaining further data in response duration, biomarker analysis, and overall survival."

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