Genome & Company, a local clinical-stage biotechnology business, said that it has entered into a clinical trial collaboration and supply agreement with Merck and Pfizer.
The three companies plan to evaluate the safety, tolerability, biological and clinical activities of GEN-001, Genome & Company’s oral microbiome therapeutic candidate developed to have immune-modulating activities, in combination with Merck Group and Pfizer's Bavencio (Ingredient: avelumab), a human anti-programmed death-ligand 1 (PD-L1) therapy, in multiple cancer indications.
Under the contract, Genome & Company will be the sponsor of the study, and Merck Group and Pfizer will supply Bavencio for phase 1 and 1b clinical trial. The company plans to begin the trial in 2020 in the U.S., and both parties will have access to the clinical data.
"The combination trial is designed to be a first-in-human (FIH) study, including dose-escalation and expansion cohorts, to evaluate the safety and preliminary efficacy," the company said.
Genome & Company CEO Pae Ji-soo said, "GEN-001 has been developed as the backbone of Genome & Company's immuno-oncology pipeline, and we are delighted to collaborate with the global leaders in oncology such as Merck Group and Pfizer on this phase 1 and 1b clinical trial for this combination of GEN-001 and Bavencio."
The company is excited to investigate how the preclinical data of this combination will be translated to humans and look forward to initiating this clinical trial in the coming months, Pae added.
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