Genome and Company's GEN-001 cleared for clinical trial

By Nam Hyun-woo

Genome and Company CEO Pae Ji-soo

Microbiome anti-cancer drug developer Genome and Company said Monday it was granted approval for Phase 1/1b clinical trials for its immune-oncology microbiome therapeutic candidate, GEN-001, from the Ministry of Food and Drug Safety.

According to the company, the ministry granted approval Nov. 6 and trials in Korea began right after. The sponsor-initiated trials are testing a combination therapy using GEN-001.

GEN-001 has received an approval for investigator-initiated phase 1 monotherapy trials from the ministry in May, and a team from Jeonbuk National University Hospital is conducting separate studies. As the company was cleared to launch sponsor-initiated trials too, it said the development of GEN-001 will pick up speed and provide greater opportunities for cancer patients in Korea with solid tumors to join the trials.

In developing GEN-001, Genome and Company has taken a multi-regional clinical trial approach, and won an investigational new drug (IND) application from the U.S. Food and Drug Administration in April. The company said it was able to successfully stay on track with trial schedules in both countries despite the COVID-19 pandemic, thanks to the determination and risk management capabilities of Genome and Company and its partners.

GEN-001 is an immuno-oncology microbiome therapeutic candidate based on a single strain microbiome. The phase 1/1b clinical trials are in progress as a combination treatment with an anti-PD-L1 immunotherapy, avelumab, also know by the brand name Bavencio. In the U.S., the first patient dosing was completed at Oregon Health and Science University in October.

For the combination treatment trials, Genome and Company are teamed up with global drug giants Merck KGaA and Pfizer. They entered into a clinical trial collaboration and supply agreement last December. Genome and Company is the sponsor of the Study, and Merck KGaA and Pfizer are supplying avelumab for the trials. Both parties will have access to the clinical data and are eligible for joint commercialization.

“The approval for this domestic clinical trial means that we are one step closer to the development of a microbiome based anti-cancer drug for the first time in the world,” Genome and Company CEO Pae Ji-soo said. “We will do our best to achieve meaningful results in this clinical trials, which are being conducted simultaneously in Korea and the U.S.”