China-based biotechnology company BioCity Biopharma has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its cluster of differentiation-3 (CD3) epidermal growth factor receptor (EGFR)-targeted bispecific antibody (BsAb), BC3448. With this approval, the company will now initiate a Phase I dose escalation/expansion study for the molecule, which will focus on patients with various solid tumors.
BC3448: A Novel CD3-EGFR BsAb for Solid Tumor Treatment
BC3448 is a CD3-based BsAb designed to recruit T cells to tumor cells that express high levels of EGFR, leading to T cell-driven tumor cell killing. This innovative approach aims to enhance the immune response against cancer cells. To mitigate the risk of cytokine release syndrome (CRS), a known safety concern associated with CD3-based BsAbs, BC3448 is engineered with differential binding affinities for EGFR and CD3, exhibiting a stronger binding affinity for EGFR than for CD3.
Phase I Trial Progress
A Phase I trial for BC3448 has already been completed in China, marking a significant step in the global development of this potential cancer treatment. The upcoming Phase I study in the US will further evaluate the safety, tolerability, and preliminary efficacy of BC3448 in patients with solid tumors, building on the existing data from China.-Fineline Info & Tech
