[Press Release] Genome and Company announces MFDS approval of GEN-001

Korea’s first IND approval for both investigator-initiated trial and sponsor-initiated trial of microbiome therapeutics

“One step closer to the development of the world’s first microbiome anti-cancer treatment”


[16 November 2020] Investigational New Drug (IND) application for phase 1/1b clinical trials (NCT04601402) of an immuno-oncology microbiome therapeutic candidate (GEN-001) by Genome and Company, a leading global microbiome anti-cancer drug company, has been approved by the Korea Ministry of Food and Drug Safety (MFDS) following the IND clearance from the US FDA in this April.

As a result, both types of GEN-001 clinical trials, an investigator-initiated trial (Monotherapy) and a sponsor-initiated trial (Combination therapy) are being conducted in Korea. Following the IND approval from MFDS, it is expected that this MRCT (Multi Regional Clinical Trial) approach will expedite the patient recruitment. Also, it may provide an opportunity for cancer patients in Korea with solid tumors to join the clinical trial.

Despite the COVID-19 outbreak this year, Genome and Company was able to successfully stay on track with the MRCT schedules, 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 (Lactococcus lactis, hereinafter referred to as L. lactis). Phase 1/1b clinical trial as a combination treatment with an anti-PD-L1 antibody, avelumab (Bavencio®) is in progress. Particularly, at the end of October, first patient dosing was successfully completed at OHSU (Oregon Health and Science University) in the US.

Dr. JiSoo Pae, CEO of Genome and Company said, “the IND approval for this domestic clinical trial means that we are making one step closer to the development of a microbiome based anti-cancer drug for the first time in the world.” He also added, “we will do our best to achieve meaningful results in this clinical trial, which is being conducted simultaneously in Korea and the US.”

Genome and Company has entered into a “Clinical Trial Collaboration and Supply Agreement” with Merck KGaA and Pfizer last December for the combination treatment approach. Genome and Company will be the Sponsor of the Study, and Merck KGaA and Pfizer will supply avelumab for the phase1/1b clinical trials. Both parties will have access to the clinical data.

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▶About Genome & Company

Since its establishment in 2015, Genome & Company develops next waves of innovative drugs including anti-cancer microbiome therapeutics and novel target immune checkpoint inhibitors. With the acquisition of Scioto Biosciences, a US biotech, in August this year, the company has expanded its global microbiome pipeline into brain diseases and continues to pioneer the market in order to transform into a global microbiome healthcare group capable of research, development and production. For more information, please refer to our website http://www.genomecom.co.kr.