A Significant Milestone for Korean Biotech Company

A researcher at Genome & Co. works at the company's lab in Pangyo, Korea.(Photo provided by Genome & Company.)

Genome & Co. (KONEX: 314130), a Korean biotechnology company developing innovative therapeutics in immune-oncology, announced on April 20 that the U.S. 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 & Co. 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 U.S. clinical sites and the first patient is expected to be enrolled within this year.

“IND clearance from FDA for our first anti-cancer microbiome therapeutic GEN-001 is a very significant milestone as it will transition Genome & Co. into a clinical-stage biotechnology company. We hope to add meaningful value and advancement in the microbiome and immuno-oncology industry with our combinational approach to cancer patients who have progressed on prior anti-PD1/anti-PD-L1 therapy,” said Park Han-soo, chief technical officer of Genome & Co.

Genome & Company CEO Pae Ji-soo said, “This IND approval is a meaningful corporate milestone and a critical step forward to achieving new arrangements in strategic partnering. We are indeed looking forward to further investigating how our clinical data will be translated into our cancer patients. I thank all the members and partners of Genome & Co. for dedicating themselves to accomplishing this milestone.”

In January this year, Genome & Co. had entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the safety, tolerability, biological and clinical activities of GEN-001 therapy in combination with avelumab in multiple cancer indications. The combination trial is designed to be a first-in-human study including dose escalation and expansion cohorts to evaluate the safety and preliminary efficacy.

GEN-001 is an oral microbiome therapeutic candidate developed to have immune modulating activities, resulting in potential partnership with immune checkpoint inhibitors. GEN-001 consists of a single strain bacteria isolated from gut of healthy human volunteers that has been shown to activate dendritic cells, macrophages and T cell response. In preclinical studies, GEN-001 has shown optimal safety margin and synergistic effects in combination with immune checkpoint inhibitors by enhancing the effect of suppressing the growth of both immune checkpoint inhibitor sensitive and resistant tumor models.

Genome & Company. is a clinical stage biotechnology company based in South Korea that focuses on discovering and developing the next waves of innovative therapeutics in immuno-oncology through diverse modalities of microbiome, novel target immune checkpoint inhibitors and fusion proteins to fulfill the unmet needs of cancer patients.

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