NovaRock Receives Orphan-Drug Designation by the U.S. FDA for NBL-015 – a Fully Human Antibody Targeting Claudin-18.2 for the Treatment of Gastric Cancer
Ewing, NJ, April 7, 2021 – NovaRock Biotherapeutics Ltd announced today that their investigational new drug, NBL-015, a Claudin18.2 eADCC antibody, was granted Orphan-Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer, including cancer of gastroesophageal junction. This is the second orphan-drug designation for NBL-015. The first ODD was received in December 2020 for pancreatic cancer treatment.
Gastroesophageal cancers are among the malignancies with the highest unmet medical needs. In patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, the median overall survival (mOS) is no more than 10 months. Relapse is inevitable and patients become refractory to treatment. The five-year survival is about 5–20% for patients with advanced gastric cancer. Based on World Health Organization GLOBOCAN 2020 data, gastric cancer is the third leading cause of cancer death worldwide. The poor prognosis of gastric cancer highlights the need for new treatment approaches. New target therapy with better efficacy and safety windows will greatly benefit gastric cancer.
Claudin-18.2 is a highly specific cell-surface molecule widely expressed in gastric and pancreatic tumors. In normal tissues, Calduin18.2 expression is strictly confined to differentiated epithelial cells of the gastric mucosa, but it is absent from the gastric stem cell zone. Thus the development of therapeutic antibodies targeting Claudin-18.2 has high anti-cancer potential. NBL-015 is a fully human anti-Claudin-18.2 monoclonal antibody optimized through protein engineering to achieve enhanced ADCC, CDC and ADCP effects. Preclinical studies demonstrated that NBL-015 has significant advantages over similar drugs in terms of low immunogenicity, good safety, high affinity and high anti-tumor activity, providing a promising prospect of becoming the best-in-class target therapy to treat gastric cancer. NBL-015 also has the potential to be combined with standard chemotherapy and PD-1 blocking immunotherapy to achieve high anti-cancer synergy.
This orphan-drug designation will allow the Group to communicate with the U.S. FDA frequently and speed up the clinical development, registration and launch of NBL-015. NovaRock plans to file the clinical trial application for this investigational drug in China and the United States in the coming months.