BioCity announces FDA clearance of Investigational New Drug application for its first-in-class CD3/EGFR bispecific antibody

On August 7, 2023 BioCity Biopharma reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for a Phase 1 study of BC3448 (CD3/EGFR Bispecific antibody, BsAb) (Press release, Biocity Biopharmaceutics, AUG 7, 2023, View Source [SID1234633894]). As a result, BioCity Biopharma will initiate a dose escalation/expansion study with BC3448, enrolling patients with advanced solid tumors in the United States.

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BC3448 is a CD3-based BsAb that recruits T cells to tumors cells with high EGFR expression resulting in T cell-driven tumor cell killing. To reduce the possibility of cytokine release syndrome (CRS), a known safety issue associated with CD3-based BsAbs, BC3448 is designed to have differential binding affinities for EGFR and CD3, with a stronger binding affinity for EGFR than that for CD3.

BC3448 is being developed in solid tumors with high EGFR expression, including NSCLC, HNSCC, mCRC, and ESC. In preclinical studies, BC3448 demonstrated antitumor activity in multiple tumor types with high EGFR expression, regardless of mutational status of EGFR, KRAS or BRAF, indicating the potential for BC3448 to be an effective therapy for EGFR-expressing tumors, including those resistant to EGFR-TKI and EGFR mAbs.

Currently, there are few CD3/EGFR BsAb in clinical development globally, making BC3448 one of the leading programs. The Phase I trial of BC3448 conducted in China has completed several dose-escalation cohorts and shown a favorable safety profile. Opening of the US IND by BioCity will accelerate the clinical development of this innovative cancer therapy globally.