Genome & Company announced that it has initiated clinical trials of GEN-001, an anti-cancer microbiome therapeutic (NCT04601402). GEN-001 is an oral microbiome therapeutic candidate of Genome & Company. In this clinical trial, it will be administered to cancer patients by combining an immune checkpoint inhibitor for the first time among Asian microbiome development companies. The phase 1 study aims to determine the RP2D (recommended Phase 2 dose) 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 a globally renowned cancer center and one of the 51 National Cancer Institute (NCI) designated Comprehensive Cancer Centers in the U.S. Amid harsh conditions due to COVID-19, close collaboration among OHSU, contract research organization and Genome & Company enabled this clinical trial to initiate only after six months since its FDA IND clearance. In December 2019, Genome & Company inked a Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate the safety, tolerability, 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 & Company will be the sponsor of the study, and Merck KGaA, Darmstadt, Germary and Pfizer will supply avelumab for the phase 1/1b clinical trial.