Jinom&Company Confirms Recommended Dose for Immuno-Oncology Microbiome Therapy 'GEN-001' in Phase 2 Clinical Trial

[Asia Economy Reporter Lee Gwan-joo] Genome & Company announced on the 28th that through the Safety Review Committee (SRC) of the immune-oncology microbiome therapeutic 'GEN-001' solid tumor Phase 1/1b clinical trial, the recommended Phase 2 dose (RP2D) for the combination therapy of GEN-001 and avelumab has been confirmed.

Genome & Company is conducting the combination therapy of GEN-001 and avelumab (brand name Bavencio) under collaboration with Merck Germany and Pfizer, targeting two separate clinical trials and four indications.

A Phase 1b clinical trial is being conducted for indications of lung cancer, head and neck cancer, and urothelial carcinoma where disease progression has been confirmed after treatment with existing immune-oncology drugs or post-treatment, and a Phase 2 clinical trial will be conducted domestically for PD-(L)1 positive gastric adenocarcinoma or gastroesophageal junction adenocarcinoma patients who have no prior experience with immune-oncology treatment.

Jisoo Bae, CEO of Genome & Company, stated, “Verification of efficacy will be crucial in the microbiome drug development stage,” adding, “With the recommended Phase 2 dose now determined, we will pursue indications and expansion within our existing microbiome pipeline, increasing the probability of success in new drug development.”

Genome & Company’s main pipeline, the immune-oncology microbiome therapeutic GEN-001, is an oral microbiome therapeutic candidate composed primarily of a single strain of Lactococcus lactis isolated and identified from healthy individuals, known to have immune-oncology efficacy by activating the immune system of cancer patients.