The Food and Drug Administration (FDA) has granted Orphan Drug designation to ZB131 for the treatment of pancreatic cancer.
ZB131 is a proprietary monoclonal antibody designed to target cancer-specific plectin (CSP) with high affinity and specificity. While CSP is typically found in the cytoplasm of healthy cells, the protein plectin has been found on the surface of cancer cells functioning as a driver of tumor growth and metastasis.
The Company is investigating the efficacy, safety, and tolerability of ZB131 in an ongoing phase 1/2 trial (ClinicalTrials.gov Identifier: NCT05074472) in patients with solid tumors, including cholangiocarcinoma, pancreatic, and ovarian cancers.
“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%,” said Kimberly Kelly, PhD, founder and president of ZielBio. “We appreciate the special status that the FDA has granted ZB131 with this Orphan Drug Designation for pancreatic cancer, which is typically diagnosed at an advanced stage with few effective treatment options.”
The FDA previously granted Orphan Drug designation to ZB131 for the treatment of cholangiocarcinoma.
ZielBio receives Orphan Drug designation for ZB131 for the treatment of pancreatic cancer. News release. ZielBio. Accessed December 27, 2022. https://www.prnewswire.com/news-releases/zielbio-receives-orphan-drug-designation-for-zb131-for-the-treatment-of-pancreatic-cancer-301709748.html.