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BioCity Biopharma CD3/EGFR Bispecific Antibody Granted FDA Clearance for IND Application

Tuesday, August 08, 2023

BioCity Biopharma has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with an Investigational New Drug (IND) application for their experimental drug BC3448 to conduct a Phase 1 study of BC3448, a CD3/EGFR bispecific antibody (BsAb).

BC3448 is a CD3-based bispecific antibody (BsAb) designed to attract T cells to tumour cells displaying elevated EGFR expression, leading to T cell-mediated destruction of the tumour cells. To mitigate the risk of cytokine release syndrome (CRS), a potential complication linked to CD3-based BsAbs, BC3448 is engineered with distinct binding affinities for EGFR and CD3.

BC3448 is under development for solid tumours characterised by significant EGFR expression, such as NSCLC, HNSCC, mCRC, and ESC. In preclinical investigations, BC3448 exhibited notable antitumor effects across various tumour categories exhibiting elevated EGFR levels. BC3448 holds promise as a potential therapy for EGFR-expressing tumours, for those unresponsive to treatments like EGFR-TKI and EGFR monoclonal antibodies (mAbs).

Currently, a limited number of CD3/EGFR bispecific antibodies (BsAbs) are undergoing clinical development on a global scale. Among these programmes, BC3448 stands out as one of the forefront candidates. 

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