NovaRock Biotherapeutics Announces FDA Approval of IND Application for NBL-015

Ewing, NJ, May 24, 2021– NovaRock Biotherapeutics Limited announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for NBL-015, a fully human antibody, for treating advanced solid tumors that express Claudin18.2, including pancreatic adenocarcinoma and adenocarcinomas of the stomach, the esophagus and the gastroesophageal junction. The Phase I clinical trials will evaluate safety, tolerability and pharmacokinetics of NBL-015 in patients with advanced solid tumors.

About NBL-015

Claudin18.2 is a highly specific cell-surface molecule widely expressed in gastric and pancreatic tumors. In normal tissues, Claudin18.2 expression is strictly confined to differentiated epithelial cells of the gastric mucosa, but it is notably absent from the gastric stem cell zone, thus the development of therapeutic antibodies targeting Claudin18.2 has specific anti-cancer potential while avoiding off-target effects in normal tissues. NBL-015 is a fully human anti-Claudin18.2 monoclonal antibody optimized through protein engineering to achieve enhanced ADCC, CDC and ADCP effects. Preclinical studies of in vitro tumor cell killing and in mouse tumor models have demonstrated that NBL-015 has significant advantages over similar drugs including its low immunogenicity, excellent safety profile, high affinity to target cells and potent anti-tumor activity with the potential to become a best-in-class target therapy to treat pancreatic and gastric cancers. NBL-015 in combination with standard chemotherapy and PD-1 blocking immunotherapy also has the potential to achieve synergistic anti-cancer effects.

Prior to this US IND approval, NBL-015 had been granted the Orphan-Drug Designation (ODD) for the treatment of pancreatic cancer and the Orphan-Drug Designation for the treatment of gastric cancer, including cancer of gastroesophageal junction by the U.S. Food and Drug Administration (FDA).

About NovaRock Biotherapeutics Limited

Founded in 2018, NovaRock Biotherapeutics is an innovative and dynamic biotech company based in the U.S and is dedicated to the development of novel antibody therapies for cancer and autoimmune diseases. NBL-015 is the second molecule developed by NovaRock Biotherapeutics that is entering into clinical trials.  NovaRock has several additional monoclonal and multi-specific antibody molecules in its diverse pipeline in the pre-clinical and discovery stages of development.