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 Pancreatic Cancer
Ewing, NJ, December 3, 2020 – NovaRock Biotherapeutics Ltd, announced today that their investigational new drug, NBL-015, has been granted Orphan-Drug Designation by the U.S. Food and Drug Administration (FDA), for the treatment of pancreatic cancer.
Pancreatic cancer is the fourth leading cause of cancer deaths in the U.S., accounting for about 3% of all cancer types and about 7% of all cancer deaths (American Cancer Society®). Its poor one-year and five-year survival rates at only 24% and 9%, respectively, are partially due to the fact that 90% of pancreatic cancer patients are diagnosed at locally advanced or metastatic stages of cancer. The limited treatment options for pancreatic cancer (focused primarily on conventional chemotherapy and resection), its resistance to chemotherapy and poor prognosis present an unmet medical need for these patients.
Claudin-18.2 is a cell-surface molecule highly specific to and widely expressed in gastric and pancreatic tumors. It is viewed as an emerging novel molecular target with promising treatment potential for cancer types with elevated levels of this protein. NBL-015 is a fully human anti-Claudin-18.2 monoclonal antibody which was engineered with enhanced effector function activities. Preclinical in vitro cancer cell killing studies, in vivo pancreatic tumor model experiments and safety assessments have demonstrated that NBL-015 has significant advantages over similar drugs targeting the same molecule., including its high affinity, enhanced anti-tumor activities, low immunogenicity, and a wide safety margin. NBL-015 is a promising new drug candidate with the potential of becoming a best-in-class targeted therapy for the treatment of pancreatic and gastric cancer.
NovaRock Biotherapeutics, Ltd. is an innovative and dynamic biotech company focusing on the development of antibody therapies for cancer and autoimmune diseases. Currently being privately held, the company was founded in January 2018 in Princeton area of New Jersey by a team of veteran scientists with proven track records in the advancement of biologics from discovery to commercialization.
This orphan-drug designation will allow NovaRock to communicate with the U.S. FDA frequently and enable a faster clinical development program, earlier registration, and commercial launch of NBL-015. The company plans to file the first US clinical trial application for NBL-015 in 2021, and soon after, in other regions of the world.