Genome & Company's First Anti-cancer Microbiota Therapeutic Agent Approved By FDA

- Apr 20, 2020-

Genome & Company announced that the US Food and Drug Administration (FDA) has accepted GEN-001's research new drug (IND) application for joint treatment of solid cancer patients with avelumab (BAVENCIO). avelumab is an anti-PD-L1 antibody jointly developed and sold by the German Darmstadt Merck Group (Merck KGaA) and Pfizer (Pfizer Inc.).


GEN-001 is a candidate therapeutic drug for oral microbiota, which aims to have immunomodulatory activity, thereby bringing potential synergy with immune checkpoint inhibitors. GEN-001 includes a single strain of bacteria isolated from the gut of healthy human volunteers and has been shown to activate dendritic cells, macrophages, and T cell responses. In preclinical studies, by enhancing the efficacy of suppressing the growth of immune checkpoint inhibitor sensitive and drug-resistant tumor models, GEN-001 demonstrated the best safety and synergistic effects of combined immune checkpoint inhibitors.


With this permission, Genome & Company will be the sole sponsor to conduct the first human trials of anti-cancer microbiota and anti-PD1 / anti-PD-L1 combination therapy in Asia. The Phase 1 / 1b clinical trial will begin in the US clinical base, and the first patient is expected to be enrolled within this year.


In January this year, Genome & Company signed a clinical trial cooperation and supply agreement with the German Darmstadt Merck Group and Pfizer to evaluate the safety and tolerance of GEN-001 therapy and avelumab for the treatment of multiple cancer indications Sexual, biological and clinical activities. This joint trial aims to be the first human study including a dose escalation and expansion cohort to assess safety and initial efficacy.