Genome & Company announced that the United States (US) Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for GEN-001 for combination treatment with avelumab (BAVENCIO®) in patients with solid cancers. Avelumab is an anti-PD-L1 antibody co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. With this clearance, Genome & Company will be the first Asian company to initiate a first-in-human trial of anti-cancer microbiome and anti-PD1/anti-PD-L1 combination treatment as a sole sponsor. The phase 1/1b clinical trial will be initiated at the US clinical sites and the first patient is expected to be enrolled within this year.