JUNSHI BIO (01877): JS207 for non-small cell lung cancer patients receives FDA approval for Phase II/III clinical trial application for neoadjuvant therapy.

JUNSHI BIO (01877) announced that recently, Shanghai JUNSHI BIO Pharmaceutical Technology Co., Ltd. (hereinafter referred to as the "Company") has received approval from the US Food and Drug Administration (FDA) for the clinical trial application of the restructured humanized anti-PD-1 and VEGF bispecific antibody (code: JS207) for neoadjuvant treatment of operable, driver gene-negative non-small cell lung cancer patients in phase II/III open-label, two-arm, randomized, positive-controlled clinical study (referred to as "this study"). JS207 is a recombinant humanized anti-PD-1 and VEGF bispecific antibody developed independently by the Company, mainly used for the treatment of advanced malignant tumors. JS207 can bind with high affinity to PD-1 and VEGFA simultaneously, effectively blocking the binding of PD-1 to PD-L1 and PD-L2, and inhibiting the binding of VEGF to its receptor. JS207 has the therapeutic properties of immunotherapy drugs and anti-angiogenic drugs, by neutralizing VEGF to inhibit endothelial cell proliferation, improving the tumor microenvironment, increasing the infiltration of cytotoxic T lymphocytes in the tumor microenvironment, thereby achieving better anti-tumor activity. As of the disclosure date of this announcement, JS207 has been approved to enter the phase II/III clinical research stage, with several phase II clinical studies ongoing in non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, liver cancer, etc., exploring combinations with chemotherapy, monoclonal antibodies, antibody-drug conjugates (ADC), and other different drugs. Lung cancer is currently the leading malignant tumor in terms of global incidence and mortality rates. According to data released by GLOBOCAN 2022, there are approximately 2.48 million new cases of lung cancer globally in 2022, with around 1.82 million deaths. Non-small cell lung cancer is the main subtype of lung cancer, accounting for about 85% of all cases. Among them, 20% to 25% of patients can undergo surgical resection at the initial diagnosis, but even after receiving curative surgery, 30% to 55% of patients will experience recurrence and death. Currently, immune checkpoint inhibitors such as anti-PD-1 monoclonal antibodies combined with chemotherapy have been widely used in neoadjuvant therapy for resectable non-small cell lung cancer, showing significant improvements in event-free survival (EFS), pathological complete response (pCR), and overall survival (OS). However, there are still unmet clinical needs in terms of survival rates and cure rates for resectable non-small cell lung cancer patients. This study is an open-label, two-arm, randomized, positive-controlled international multicenter phase II/III clinical study, aimed at comparing the efficacy and safety of JS207 and nivolumab monoclonal antibody for neoadjuvant treatment of operable, driver gene-negative non-small cell lung cancer patients in phase II/III. This study represents the first confirmatory study of a dual-target PD-1/VEGF drug in the operable population and will be led by Professor Wu Yilong from Guangdong Provincial People's Hospital as the principal investigator.