WUXI, China, Dec. 20, 2023 -- BioCity Biopharma today announced dosing of the first patient in a Phase Ib/II clinical trial of its anti-TIM-3 monoclonal antibody (mAb) BC3402 in combination with IMFINZI (durvalumab) for the treatment of advanced hepatocellular carcinoma (HCC) in China. The study is being conducted at Zhongshan Hospital with Prof. Jia Fan as the principal investigator. Dr. Fan is a world-renowned liver cancer surgeon, member of the Chinese Academy of Sciences, and president of Zhongshan Hospital.

Liver cancers are highly prevalent in China, with 410,000 newly diagnosed patients (appx. 50% of all new cases worldwide) and responsible for 390,000 deaths annually. Among liver cancers, 90% are HCC. The unmet medical need for impactful novel treatments are significant for HCC treatments in China in which the 5-year survival rate for subjects with advanced disease is about 7%.

Based on previous research, TIM-3 is highly expressed by HCC, lung, and other cancers that are resistant to monoclonal antibodies targeting immune checkpoints, particularly PD-1 and PD-L1. Simultaneous inhibition of PD-1/PD-L1 and TIM-3 prevents T cell exhaustion and promotes tumor killing. Synergy has been observed with the combination of BC3402 and anti-PD-1/CTLA-4 treatment in pre-clinical and translational studies. In addition, encouraging clinical outcomes have been reported in clinical trials with other anti-TIM-3 antibodies in combination with anti-PD1/L-1 antibodies.

BioCity and AstraZeneca will work closely with the investigators to advance this clinical study. It is hoped that this trial will help demonstrate the potential clinical benefit of BC3402 in combination with durvalumab for the management of advanced HCC.

About BC3402

BC3402 is a potential best-in-class anti-TIM-3 mAb that binds to multiple TIM-3 epitopes and has a higher binding affinity than other anti-TIM-3 mAbs in development. BC3402 has been demonstrated to efficiently block the binding of CEACAM1, PtdSer and Gal-9 to TIM-3, alleviating the inhibitory effects of Tregs, and restoring IL-2 production by T cells. Moreover, BC3402 has shown synergistic anti-cancer activity with mAbs targeting PD-1 and CTLA-4, which are important clinical targets for liver cancer.

BC3402 has completed a phase I clinical study in advanced solid tumors showing a favorable safety profile and antitumor activity. Multiple phase Ib/II clinical studies are on-going with BC3402 in combination with other agents in solid tumors as well as hematological malignances.

About BioCity

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, and antibody-drug conjugates (ADCs).

Currently, BioCity Biopharma has 6 oncology assets in Phase 1 development, including the first-in-Class CDH3-targeting ADC, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and agents targeting the immune system including a T cell engager (CD3/EGFR BsAb), an immune checkpoint inhibitor (TIM-3 mAb), and a T cell activator (4-1BB mAb). In addition, an endothelin A (ETA)-receptor selective antagonist for CKD is in phase 2 clinical development.