Samsung Biologics Client ImmunOncia Receives FDA Approval to Initiate Phase 1 Clinical Trial

[Asia Economy Reporter Cho Hyun-ui] Samsung Biologics announced on the 23rd that ImmunOncia, with which it has signed a contract for contract development (CDO), has received approval from the U.S. Food and Drug Administration (FDA) for the clinical trial plan of the immune oncology candidate substance 'IMC-002' for Phase 1 clinical trials.

IMC-002 is an immune checkpoint inhibitor targeting macrophages responsible for immunity. It is a drug that helps macrophages attack cancer cells in the body by suppressing the immune evasion signals of cancer cells.

ImmunOncia submitted an Investigational New Drug (IND) application to the FDA on the 10th of last month (local time) for the initiation of Phase 1 clinical trials of 'IMC-002'. A Samsung Biologics official stated, "Based on our global-level CDO capabilities and close communication with our client, we supported the candidate substance to receive Phase 1 clinical trial initiation approval on the 10th, just one month after the IND submission."

Kim Tae-han, CEO of Samsung Biologics, said, “We will continue to provide the world's best CDO services with high quality, fast speed, and excellent price competitiveness to all domestic and international bio ventures possessing outstanding candidate substances.”

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