Genome & Company completes CSR for phase 2 trial of GEN-001 in gastric cancer
Genome & Company announced on Wednesday that it has received the final results report for the phase 2 clinical trial of its microbiome-based immuno-oncology drug, GEN-001, for gastric cancer.
These results follow the cutoff data presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) and are now confirmed figures through the Clinical Study Report (CSR).
The phase 2 trial enrolled 42 patients with PD-L1-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma who had failed two or more lines of standard therapy, regardless of prior immunotherapy. The trial used avelumab (a PD-L1 inhibitor) as combination therapy, provided by Merck KGaA (Germany) under a clinical trial collaboration and supply agreement.
According to the investigator's Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessment, partial response (PR) was confirmed in 8 patients, yielding an objective response rate (ORR) of approximately 19%.
Notably, three of eight patients (37.5%) who were previously refractory to existing immuno-oncology agents responded, a finding considered significant and indicative of potential clinical utility in cancer treatment.
Furthermore, no serious adverse events directly related to GEN-001 were reported in the safety assessment. Two GEN-001-related adverse events (4.8 percent, one case each of diarrhea and decreased appetite) were identified and were generally considered manageable.
GEN-001 is an oral microbiome therapy based on a single strain of Lactococcus lactis. It works by modulating immune responses in the gut to activate anti-cancer immunity.
In January 2024, a poster on phase 2 cutoff data was presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2024).
Based on this achievement, Genome & Company plans to pursue a dual commercialization strategy for GEN-001. This includes seeking overseas partnerships for microbiome drug development and actively exploring domestic commercialization opportunities for GEN-001 in the local market.
"Phase 2 clinical trial results show GEN-001 achieves significant responses, even in patients unresponsive to current immuno-oncology drugs," said Genome & Company CEO Hong Yoo-seok. "We will leverage these results to maximize GEN-001's commercial value."
Genome & Company recently completed a 54.1 billion won ($36.8 million) funding round to fuel R&D for new target-based therapeutics and commercialize its microbiome platform. This funding supports the company’s goal of becoming self-sustaining and reducing reliance on external sources.