WUXI, China, Aug. 7, 2023 /PRNewswire/ -- BioCity Biopharma today announced 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). As a result, BioCity Biopharma will initiate a dose escalation/expansion study with BC3448, enrolling patients with advanced solid tumors in the United States.
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.
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.
Founded in December 2017, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including chronic kidney diseases (CKD). The company has established a pipeline of more than 10 innovative drug candidates including small molecules, monoclonal and bispecific antibodies as well as antibody-drug conjugates (ADCs).
Currently, BioCity Biopharma has 6 oncology projects in Phase 1 development, including the first-in-Class CDH3-targeting ADC, and agents targeting the DNA damage response (DDR) pathway via a WEE1 and an ATR inhibitorATR inhibitor, and agents targeting the immune system with a T cell engager (CD3/EGFR BsAb), an immune checkpoint inhibitor (TIM-3 mAbTIM-3 mAb), and a T cell activator (4-1BB mAb4-1BB mAb). In addition, an endothelin A(ETA)-receptor selective antagonist designed for CKD has entered phase 2 development.
For more information, please visit www.biocitypharma.com
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