BAILI-BIOPHARMACEUTICAL CO., LTD. and its wholly owned subsidiary, SystImmune Inc. announced that it has entered into a clinical trial collaboration and supply agreement with AstraZeneca to evaluate the combination of Baili's cancer therapy, SI-B001, an EGFR x HER3 bispecific antibody, in combination with AstraZeneca's third-generation, irreversible epidermal growth factor receptor ("EGFR") TKI, TAGRISSO® (osimertinib), in a new Phase 2a study, sponsored and conducted by Baili, for patients with non-small cell lung cancer ("NSCLC"). SI-B001 is a bispecific antibody designed with the proprietary platform technology developed by Baili and SystImmune. It can bind to EGFR and HER3, and simultaneously inhibits the ligand induced EGFR×EGFR homodimers, the formation of EGFR×HER3 heterodimers and the activation of its downstream signal pathway.

SI-B001 can also induce endocytosis of EGFR and HER3, and down-regulate the levels of EGFR and HER3 tumor cells. In preclinical studies, SI-B001 has demonstrated superior tumor killing activities. SI-B001 Phase 1 trials have shown good safety and preliminary efficacy.

Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths. More than a third of the world's lung cancer patients are in China. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.

The majority of NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis. For patients with resectable tumors, the majority of patients eventually develop recurrence despite complete tumor resection and adjuvant chemotherapy. Approximately 10-25% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated NSCLC.

These patients are particularly sensitive to treatment with an EGFR TKI which blocks the cell-signaling pathways that drive the growth of tumor cells.