Wuhan YZY Biopharma Co., Ltd. announce that, the first patient has recently been enrolled in a Phase II clinical trial of M701, a bispecific antibody drug candidate dually targeting epithelial cell adhesion molecule and cluster of differentiation 3 independently developed by the Company, for treatment of malignant pleural effusion. The MPE Study aims to investigate the efficacy and safety of M701 through intrapleural infusion compared to thoracentesis and/or thoracic chemotherapy in patients with malignant pleural effusion caused by non-small cell lung cancer. MPE is a complication commonly found in patients with advanced tumors, such as lung cancer and breast cancer.

It is caused by tumor cells invading tissues and triggering the release of negative factors, leading to endothelial cell dysfunction and increased exudates. Tumor cells obstruct lymphatic vessels, resulting in fluid accumulation. MPE not only causes symptoms that significantly impact patients' quality of life, such as chest tightness, dyspnea, chest pain, nausea and vomiting, but also affects physicians' evaluation of the efficacy of current systemic therapies.

There is still a lack of clinical drugs for MPE in China. In European countries and America, intrapleural administration of talcum powder is recommended for MPE to promote pleural adhesion, thereby inhibiting the production of exudates. However, this approach has severe side effects.

Safer and more effective innovative drugs are urgently needed for patients. M701, a BsAb, is an innovative Category I biological drug that can target both EpCAM (as the target on tumor cells) and CD3 (as the immune T cell activation target). Its main mechanism of action involves binding to both tumor cells and immune T cells through these targets, thereby activating T cells to kill tumor cells.

Therefore, intrapleural infusion of M701 can activate immune cells to selectively eliminate and suppress tumor cells in the chest cavity, thereby achieving the effect of inhibiting pleural effusion. In the Phase Ib clinical trial conducted by the Company, intrapleural infusion of M701 demonstrated good safety and efficacy for MPE.