ZielBio receives orphan drug designation for ZB131 for the treatment of pancreatic cancer

A Phase 1/2 clinical trial of ZB131 is actively enrolling patients with advanced solid tumors

CHARLOTTESVILLE, Va., Dec. 27, 2022 /PRNewswire/ — ZielBio, Inc.a clinical-stage biotechnology company discovering new treatments for cancer and other serious diseases through its innovative drug discovery platform, today announced that the US Food and Drug Administration (FDA). granted Orphan Drug Designation to its lead program, ZB131, for the treatment of pancreatic cancer, a rare solid tumor originating in the pancreas. ZB131 is a proprietary monoclonal antibody with a high affinity and specificity for cancer-specific plectin (CSP), a cell surface protein identified in a broad range of cancers that is correlated with poor prognosis and aggressive cancers, including cancer to the pancreas. ZielBio previously received orphan drug designation for ZB131 for the treatment of cholangiocarcinoma (cancer of the bile duct).

ZielBio, Inc. (PRNewsfoto/ZielBio, Inc.)

“More than 62,000 people in the United States are diagnosed with pancreatic cancer each year, and the five-year survival rate is only 11 percent,” said Kimberly Kelly, Ph.D., founder and president of ZielBio. “We appreciate the special status the FDA has granted to ZB131 with this orphan drug designation for pancreatic cancer, which is typically diagnosed at an advanced stage with few effective treatment options.”

ZielBio developed ZB131 to target the CSP after discovering that, unlike healthy cells where plectin exists in the cytoplasm, plectin occurs on the surface of cancer cells, where it functions as an engine of tumor growth and metastasis. In preclinical studies, ZB131 demonstrated high specific binding to CSP and strong antitumor activity. A Phase 1/2 study is ongoing to investigate the safety, tolerability, and efficacy of ZB131 in patients with solid tumors, including cholangiocarcinoma, pancreatic, and ovarian cancers. Additional study details are available at clinicaltrials.gov under the trial identifier NCT05074472.

FDA orphan drug designation can be granted to investigational drugs or biological products that show promise in treating rare diseases or medical conditions affecting fewer than 200,000 people in the United States. Certain benefits associated with orphan drug designation encourage the continued development of medicines that bring new solutions to disadvantaged patients. Approximately 32,970 men and 29,240 women in the United States are diagnosed with pancreatic cancer each year.

About ZielBio

ZielBio is a clinical-stage biotechnology company that identifies new disease targets and develops therapeutic interventions to improve patient outcomes. Its proprietary drug discovery platform combines the power of high-throughput, functional screening with big data analytics to identify high-value targets. ZielBio has a promising pipeline of therapeutics and targets, including the new lead asset ZB131 (proposed nonproprietary international name Ibentatug), a humanized monoclonal antibody against cancer-specific plectin.

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SOURCE ZielBio, Inc.

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