According to Zhitong Finance App, Youzhiyou Bio-B (02496) announced that M701, an investigational bispecific antibody (BsAb) drug that targets both epithelial cell adhesion molecule (epCAM) and differentiation cluster 3 (CD3) independently developed by the company, recently completed the enrollment of the first patient in the Phase II clinical study of malignant pleural effusion. The purpose of the malignant pleural effusion study was to study the efficacy and safety of thoracic perfusion M701 compared with thoracic drainage and/or chest chemotherapy in patients with malignant pleural effusion due to non-small cell lung cancer.

Malignant pleural effusion is a common complication in cancer patients such as advanced lung cancer and breast cancer. Its causes are abnormal endothelial cells and increased exudate due to tumor cells invading tissue and causing the release of negative factors, and lymphatic fluid accumulation due to tumor cells blocking lymphatic vessels. Malignant pleural effusion can cause patients to develop symptoms that seriously affect the quality of life, such as chest tightness, difficulty breathing, chest pain, nausea, and vomiting. It also affects doctors' evaluation of the efficacy of current systemic treatments. Domestic clinical medicine for malignant pleural effusion is still lacking. European and American countries recommend administration of talc powder in the chest cavity to cause pleural adhesion, thereby inhibiting the production of exudate, but it has strong side effects. Patients are eagerly awaiting new, safer and more effective medicines.

The bispecific antibody M701 is a new biological drug. It can simultaneously target the tumor cell target EpCAM and the immune T cell activation target CD3. The main mechanism of action is to bridge tumor cells and immune T cells through dual target binding, thereby activating T cells to kill tumor cells. Therefore, thoracic injection of M701 can activate immune cells to target clearance and inhibit tumor cells in the chest cavity, thereby achieving the effect of suppressing pleural effusion. In the phase Ib clinical study of malignant pleural effusion conducted by the company, thoracic perfusion M701 showed good safety and efficacy.