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[Press Release] Genome & Company receives FDA IND clearance for GEN-001, its first anti-cancer microbiome therapeutic

Asia’s first company to sponsor clinical trial of combination therapy of anti-cancer microbiome and anti-PD1/anti-PD-L1 drug

Enables to initiate Phase 1/1b clinical trial on combinational therapy of Merck KGaA, Darmstadt, Germany/Pfizer’s avelumab (BAVENCIO®) with Genome & Company’s GEN-001 microbiome therapeutic

SEOUL, South Korea I April 20, 2020 I Genome & Company (KONEX: 314130), a biotechnology company developing innovative therapeutics in immune-oncology, announced today 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.

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