An Immuno-oncology Microbiome Therapeutic
Genome & Co., a global pioneer in microbiome therapeutics, has initiated clinical trials of GEN-001, an anti-cancer microbiome therapeutic (NCT04601402), in the United States.
GEN-001 is an oral microbiome therapeutic candidate, and in this clinical trial, it will be administered to American patients with cancer in combination with an immune checkpoint inhibitor, which is the first among Asian microbiome development companies.
The phase 1 study aims to determine the recommended Phase 2 dose (RP2D) of GEN-001 in combination with BAVENCIO® (avelumab). Avelumab is an anti-PD-L1 checkpoint inhibitor co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. In the phase 1b study, the safety and preliminary efficacy of the combination therapy at the RP2D of GEN-001 in combination with BAVENCIO® for patients with specific solid tumors will be investigated.
A total of three clinical sites including OHSU Knight Cancer Institute located in Portland, Oregon will complete the dose-escalation cohort within the first half of 2021. The OHSU Knight Cancer Institute is one of the globally renowned cancer centers and is one of the 51 National Cancer Institute (NCI) designated Comprehensive Cancer Centers in the U.S. Amid harsh conditions due to COVID-19 since the beginning of 2020, close collaboration among the OHSU, contract research organizations (CROs) and Genome & Co. enabled this clinical trial to be initiated just six months after its Investigational New Drug (IND) application was approved by the U.S. FDA.
“We are pleased to offer our patients access to a new clinical trial of the drug GEN-001 in combination with avelumab,” said Shivaani Kummar, M.D., head of the division of hematology and medical oncology in the OHSU School of Medicine, and co-director of the OHSU Knight Cancer Institute Center for Experimental Therapeutics. “Our goal is to learn more about whether this combination therapy will be effective in overcoming acquired resistance to anti-PD-(L)1 therapy in patients with advanced solid tumors whose disease has progressed on prior anti-PD-(L)1 therapy.”
Dr. Pae Ji-soo, CEO of Genome & Co., also stated, “The study will investigate the preliminary efficacy of GEN-001 in patients with various cancers. We hope to see clinically meaningful results fairly soon, which in turn would allow us to continue making progress in GEN-001 clinical trials. The drug candidate has the potential to eventually become an alternative therapeutic option in the immuno-oncology market.”
In December 2019, Genome & Co. entered into the Clinical Trial Collaboration and Supply Agreement with Merck KGaA and Pfizer Inc. to evaluate the safety, tolerability, and biological and clinical activities of GEN-001 therapy in combination with avelumab, a human anti-PD-L1 therapy, in multiple cancer indications. Under the terms of this agreement, Genome & Co. will be the sponsor of the study, and Merck and Pfizer will supply avelumab for the phase 1/1b clinical trial.
Since its establishment in 2015, Genome & Co. has been developing next waves of innovative drugs including anti-cancer microbiome therapeutics and novel target immune checkpoint inhibitors. With the acquisition of Scioto Biosciences, a U.S. 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.