Release Date: 16-Jul-2024
Anbenitamab, formerly known as KN026, is a recombinant humanized anti-HER2 bispecific antibody injection co-developed by Shanghai JMT-Bio Technology and Jiangsu Alphamab Oncology for the treatment of HER2-positive solid cancers. The antibody is derived from Trastuzumab and Pertuzumab, and is representative of the ongoing transformation in China’s pharmaceutical industry, which has led to the development of several innovative and novel therapeutic agents for different cancers.
Human epidermal growth factor receptor 2 (HER2), overexpressed on a variety of tumor cell types, plays an important role in proliferation, differentiation and survival. Upon administration, Anbenitamab simultaneously targets and binds to two separate, non-overlapping epitopes of HER-2, thereby inhibiting HER-2 heterodimerization and prevents the activation of associated signaling pathways. By binding to HER-2, Anbenitamab induces an antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cells that overexpress HER-2. This results in tumor cell apoptosis and inhibits tumor cell proliferation of HER-2-overexpressing tumor cells.
Alphamab and JMT-Bio are undertaking clinical trials for Anbenitamab to evaluate the candidate as monotherapy and in combination with various chemotherapies for the treatment of various solid tumors. Peking University, in addition to the two corporations, is assisting in the conduct of these experiments. Though no new clinical results for these trials have been announced, Anbenitamab demonstrated significant efficacy in treating patients who had previously failed anti-HER2 treatment in a Phase II clinical trial evaluating the safety and efficacy of Anbenitamab in patients with HER2-expressing advanced gastric cancer or gastroesophageal junction cancer.
Anbenitamab's medicinal potential is gradually being acknowledged by regulatory organizations, as indicated by the designations it has acquired. The National Medical Products Administration (NMPA) of China granted Anbenitamab Breakthrough Therapy Designation in November 2023 for the intended indication of combination chemotherapy for the treatment of HER2-positive locally advanced, recurrent, or metastatic gastric cancers, including gastroesophageal junction cancer, in patients who have failed standard first-line treatment. Anbenitamab has also gained FDA Orphan Drug Designation in combination with Erfonrilimab (KN046) for the treatment of HER2-positive or low-expressing stomach or gastroesophageal junction cancer.
Anbenitamab represents one of the many innovative treatments developed in China in the last few years as part of the new wave of drug development. Its unique designing, targeting HER2, holds the potential to revolutionize treatment of HER2-positive cancers, suggesting a path towards enhanced efficacy and reduced side effects.
For Clinical Trials Information Contact