On January 26th, 2022 Wuxi, Shanghai, and Shijiazhuang—BioCity, a clinical-stage Chinese biopharmaceutical company, reported the dosing of its first test subject in the Phase I clinical trial of BC3448 (CD3/EGFR bispecific antibody, BsAb) (Press release, Biocity Biopharmaceutics, JAN 31, 2022, View Source [SID1234633309]).

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The trial is a Phase I, open-label, first in-human dose-escalation and -expansion clinical trial evaluating the safety、tolerability、phar-macokinetic characteristics, and pre-liminary efficacy of BC3448 in patients with locally advanced or metastatic malignant solid neo-plasms. The primary objective of the study is to evaluate the safety and tolerability of BC3448 monotherapy in patients with ad-vanced solid tumors.

BC3448 is a CD3/EGFR bispecific antibody that activates T cells to kill tumors cells with EGFR expression. In preclinical in vitro and in vivo studies, BC3448 demonstrated antitumor activities regardless of the mutation status of EGFR, KRAS or BRAF genes.

Professor Caicun Zhou, Director of the Oncology Department at Shanghai Pulmonary Hospital, affiliated to Tongji University, and Director of the Tongji University School of Medicine’s Cancer Institute, stated that, " although there have been breakthroughs in the EGFR-targeted drugs including monoclonal antibodies and EGFR TKIs, challenges remain for patients after their tumors developed resistance to the available EGFR antibodies or TKIs.

Therefore, there is need to explore new approaches such as immunotherapy drugs to deal with the issues of resistance to the available EGFR-targeted agents. The CD3-based EGFR-targeting bispecific antibody BC3448 holds great promise to treat EGFR-expression tumors even after resistance to the current EGFR therapies."

The Co-CEO of Biocity, Dr. Yong jiang Hei said, "BC3448 is a CD3/EGFR bispecific antibodies designed to have a stronger binding affinity for EGFR than that for CD3, which may help re-duce the risk of cytokine release syndrome (CRS), a known safety issue associated with CD3-based bispecific antibodies.

Currently, few companies have CD3/EGFR bispecific antibodies in clinical development globally, and BC3448 is one of the leading programs in this area. We strive to accelerate the clinical development of this innovative molecule in order to better meet the unmet medical needs for patients around the world."

About BC3448

BC3448 is a CD3/EGFR bispecific anti-body independently developed by BioCity, with IND approval from the National Medical Products Administration(NMPA). It is undergoing active clinical development in China.