Genome & Company's microbiome immunotherapy 바카라사이트 굿모닝001 shows 19% ORR in Phase 2 gastric cancer trial

[by Jin, Yu Jeong] Genome & Company announced on November 12 that it had received the final clinical study report (CSR) for the Phase 2 gastric cancer clinical trial of its microbiome-based immunotherapy candidate, ‘GEN-001’ (development code).

These findings are based on the cutoff data that was previously presented at the 2024 American Society of Clinical Oncology Gastrointestinal 바카라사이트 굿모닝s Symposium (ASCO GI). The data has now been fully verified through the finalized CSR.

This Phase 2 study enrolled 42 patients with PD-L1-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma who had progressed after two or more prior lines of standard treatment, irrespective of previous exposure to immunotherapy. The trial evaluated GEN-001 in combination with Merck KGaA's ‘avelumab,’ a PD-L1 inhibitor provided under a clinical trial collaboration and drug supply agreement.

According to the Investigator's Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, eight patients achieved a partial response (PR), corresponding to an objective response rate (ORR) of approximately 19%. "Notably, three of the eight patients (37.5%) who were refractory to existing immunotherapy achieved a response. This finding suggests meaningful clinical potential for the treatment in the cancer treatment landscape," Genome & Company explained.

In terms of safety, no serious adverse events were reported to be directly attributable to 바카라사이트 굿모닝001. Only two 바카라사이트 굿모닝001-related adverse reactions were reported (4.8% of patients, one case of diarrhea and one case of decreased appetite). Overall, the safety profile was deemed manageable.

바카라사이트 굿모닝001 is an oral microbiome-based treatment candidate derived from a single strain of Lactococcus lactis. It has a mechanism of action to modulate immune activity in the intestines, thereby promoting the activation of anticancer immune responses. The company previously presented a poster on the Phase 2 cutoff clinical data at ASCO GI in January 2024, where it was selected as one of the top five posters among approximately 220 submissions.

Building on these results, Genome & Company plans to advance a dual commercialization strategy for 바카라사이트 굿모닝001. In parallel with exploring global partnership opportunities for microbiome-based drug development, the company is also actively evaluating pathways to generate domestic revenue through local commercialization initiatives.

"The results confirmed in the Phase 2 clinical trial of GEN-001 are highly meaningful, as they demonstrate therapeutic responses even in patients who are refractory to existing immunotherapy options. Building on these clinical outcomes, we will work to maximize the commercial value of GEN-001," said Hong Yoo-seok, CEO of Genome & Company.

Conversely, Genome & 바카라사이트 굿모닝 recently completed a KRW 54.1 billion (approximately USD 36.8 million) fundraising round, providing new momentum for its mid- to long-term growth strategy. The 바카라사이트 굿모닝 plans to allocate these funds toward R&D for new target-based therapeutics and the commercialization of its microbiome, with the goal of becoming a self-sustaining enterprise that does not depend on external financing.