On November 16, 2020 Genome & Company, a leading global microbiome anti-cancer drug, immuno-anti-cancer microbiome treatment (GEN-001), reported that followed by the US FDA for a company-led phase 1/1b clinical trial (NCT04601402) The Clinical Trial Plan (IND) was approved by the Korea Food and Drug Administration (MFDS) (Press release, Genome & Company, NOV 16, 2020, View Source [SID1234571049]). As a result, Genome & Company is planning to accelerate the development of GEN-001 by obtaining approval for both research-led clinical trials (GEN001 alone therapy) and company-led clinical trials (GEN001 combination therapy) in Korea.

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With the approval of this clinical trial, a domestic clinical trial site will be added in addition to the US clinical trial site, and it is expected that the clinical trial period will be shortened through rapid patient recruitment, and opportunities for treatment through participation in clinical trials will be expanded to domestic terminal cancer patients. In particular, amidst global clinical trials being delayed in the aftermath of COVID-19 this year, Genome & Company and its partners are expected to successfully digest the scheduled clinical trial schedule through rapid crisis response capabilities.

‘GEN-001’ is an immuno-anticancer microbiome treatment based on a single strain of microbiome ( Lactococcus lactis , hereinafter L. lactis ), and is preclinical through co-administration with an immuno-anticancer drug, PD-L1 inhibitor. Based on the safety and efficacy results of the phase, a phase 1/1b clinical trial is currently in progress. In particular, at the end of October, OHSU (Oregon Health & Science University) among the US clinical trial sites successfully administered the first patient.

Bae Bae-soo, CEO of Genome & Company said, "The approval of GEN-001 for this domestic clinical trial is one step closer to the development of a microbiome immune chemotherapy drug for the first time in the world." I will not spare any effort for it."

Meanwhile, Genome & Company signed a’clinical trial cooperation and supply contract’ with Merck and Pfizer in December last year to conduct clinical trials of anticancer drugs. Genome & Company will oversee the entire clinical trial process, and Merck and Pfizer will cooperate in overall clinical trials, including providing advice on clinical trial operation, and will seek joint commercialization after successful clinical trials are over.