On September 25, 2023 BioCity Biopharma and AstraZeneca reported to have signed an agreement to collaborate on a Phase Ib/II clinical study to evaluate the safety and efficacy of BioCity’s BC3402, a monoclonal antibody (mAb) targeting the T cell immunoglobulin and mucin domain-containing protein 3, also known as TIM-3, in combination with AstraZeneca’s anti-PD-L1 mAb IMFINZI (durvalumab) for the treatment of advanced hepatocellular carcinoma (HCC）in China (Press release, AstraZeneca, SEP 25, 2023, View Source [SID1234635471]). BioCity will lead the trial, which has received IND approval by the National Medical Products Administration (NMPA). The study will be conducted at Zhongshan Hospital with Prof. Jia Fan who is a renowned liver cancer surgeon, member of the Chinese Academy of Sciences, president of Zhongshan Hospital, and will serve as the principal investigator of the study.
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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 also been demonstrated to efficiently block the binding of CEACAM1, PtdSer and Gal-9 to TIM-3, alleviate the inhibitory effects of Tregs, and restore 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. TIM-3, PD-1, and CTLA-4 are immune checkpoint inhibitors.
The unmet medical needs are significant for HCC treatments in China with the 5-year survival rate of patients with advanced disease being about 7%. The collaboration between BioCity and AstraZeneca will evaluate the potential for the combination of BC3402 with durvalumab to improve the clinical outcome of subjects with HCC. Both companies may be expected to explore further collaboration opportunities to boost innovation in China in HCC and possibly other types of cancer.