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FDA grants orphan drug designation to ZB131 for cholangiocarcinoma


November 19, 2022

1 min read

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The FDA granted orphan drug designation to ZB131 for treatment of cholangiocarcinoma, according to the agent’s manufacturer.

ZB131 (ZielBio) is a monoclonal antibody with a high affinity and specificity for cancer-specific plectin. The cell surface protein — identified in a variety of malignancies — is associated with aggressive tumors and poor prognosis, according to a ZielBio-issued press release.

FDA HQ in Washington

ZB131 showed high specific binding to cancer-specific plectin and strong anti-cancer activity in preclinical studies, according to the release.

A phase 1/phase 2 trial is underway to study ZB131’s safety, tolerability and efficacy among patients with solid tumors, including cholangiocarcinoma, pancreatic cancer and ovarian cancer.

“Patients suffering from cholangiocarcinoma have few promising therapeutic options,” Kimberly Kelly, PhD, founder and CEO of ZielBio, said in the release. “Receiving this orphan drug designation is a regulatory milestone for ZielBio that validates our sustained efforts to bring new treatments to underserved patients.”

About 8,000 people in the United States are diagnosed each year with cholangiocarcinoma.

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.



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