[Asia Economy Reporter Jang Hyowon] STCube, a bio company developing immune checkpoint inhibitors, announced on the 27th that it has signed a contract with Charles River Laboratories, a US-based contract research organization (CRO), to outsource all clinical trial-related tasks for the clinical trial of its new drug pipeline candidate, the ‘STT-003’ antibody.


Through this contract, the innovative first-in-class ‘STT-003’ antibody entrusted to Charles River is one of STCube’s main pipeline candidates and a new drug substance co-developed with the US MD Anderson Cancer Center (hereinafter MDACC).


The ‘STT-003’ antibody is expressed at a high rate in various cancer cells while its expression is limited in normal tissue cells. It is also expressed in immune cells such as T lymphocytes at levels similar to PD-1, acting as an immune regulatory substance that comprehensively suppresses immune function in cancer patients by inhibiting STT-003. Its anticancer effects have been confirmed through numerous animal experiments.


STCube is currently producing the ‘STT-003’ antibody for clinical trials and has signed a contract with Charles River to conduct preclinical toxicity tests as a step prior to clinical trials.


Charles River, established in 1947 and based in the US, is the world’s largest CRO company providing various preclinical and clinical laboratory services on a contract basis. It is listed on the New York Stock Exchange and is the largest nonclinical CRO company. It is known that about 85% of FDA-approved drugs have received clinical services from Charles River.



A company official stated, “The STT-003 antibody is being produced through a contract development and manufacturing organization (CDMO) under a contract for development and production. We are sharing all data jointly with MDACC and other leading US medical institutions, and are preparing all necessary steps to start clinical research from next year.”


This content was produced with the assistance of AI translation services.

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