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Genome & Co. In Clinical Trial And Supply Deal With Merck KGaA, Pfizer

South Korea's Genome & Co. late Monday announced that it has entered into a clinical trial collaboration and supply agreement with Germany's Merck KGaA and US drug major Pfizer Inc.

The trial will evaluate the safety, tolerability, biological and clinical activities of GEN-001, Genome's microbiome-based immuno-oncology therapy, in combination with Merck KgaA and Pfizer's avelumab (BAVENCIO), a human anti-PD-L1 therapy, in multiple cancer indications.

Under the terms of the agreement, Genome & Co. will be the sponsor of the study. Merck KGaA and Pfizer will supply avelumab for the phase 1/1b clinical trial that is expected to be commenced in 2020 in the U.S. Both parties will have access to the clinical data.

The company expects to initiate the clinical trial in the coming months.

The combination trial is designed to be a first-in-human or FIH study including dose escalation and expansion cohorts to evaluate the safety and preliminary efficacy.

Avelumab in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma or RCC.

Avelumab is currently approved for patients within 50 countries globally. Majority of these approvals are in a broad indication that is not limited to a specific line of treatment.

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