China’s Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, MCLA-129. The upcoming trial will evaluate the biologic product as a potential treatment for advanced solid tumors, including wild-type colorectal cancer, liver cancer, head and neck squamous cell carcinoma, pancreatic cancer, primary unknown adenocarcinoma, and squamous cell carcinoma, among others.
MCLA-129: A Bispecific Antibody Targeting EGFR and c-Met
MCLA-129 is a bispecific antibody (BsAb) that targets both epidermal growth factor receptor (EGFR) and stromal epithelial transforming factor (c-Met). This innovative drug simultaneously blocks the signaling pathways of EGFR and c-Met, inhibiting tumor growth and survival. Furthermore, MCLA-129 enhances the killing potential against tumor cells through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), offering a novel approach to cancer treatment.
Previous Clinical Approvals and Ongoing Developments
MCLA-129 has previously earned clinical approval in China for the treatment of advanced solid tumors with EGFR or MET abnormalities and for EGFR mutant advanced non-small cell lung cancer in combination with Betta Pharma’s befotertinib. These approvals highlight the potential of MCLA-129 as a significant therapeutic option in the fight against various types of cancer.-Fineline Info & Tech
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