Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced the commencement of patient enrollment in a Phase III clinical trial for its antibody-drug conjugate (ADC), BL-M05D1, in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This milestone marks a significant advancement in the development of BL-M05D1, which targets a critical unmet need in ESCC treatment options.
The ADC, BL-M05D1, has demonstrated promising therapeutic signals in various epithelial tumor indications, including non-small cell lung cancer, small-cell lung cancer, nasopharyngeal cancer, ESCC, and breast cancer. The drug’s innovative mechanism involves targeting EGFR and HER3, with a strong potential to impact patient outcomes in these hard-to-treat cancers.
In a concurrent development, BL-M05D1 received breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic nasopharyngeal carcinoma that has failed prior treatments involving PD-1/PD-L1 monoclonal antibodies and at least two lines of chemotherapy. This designation underscores the drug’s potential to offer new hope to patients with limited treatment options.
The Phase III trial’s primary focus will be on the safety and efficacy of BL-M05D1 in esophageal cancer, a disease with high morbidity and mortality rates. The study’s results could position BL-M05D1 as a leading treatment option for patients with ESCC and other solid tumors, offering a much-needed alternative to existing therapies.- Flcube.com
