News

ZielBio Receives Orphan Drug Designation for ZB131 for the Treatment of Cholangiocarcinoma

CHARLOTTESVILLE, Va.,/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 U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead program, ZB131, for the treatment of cholangiocarcinoma, a rare solid-tumor cancer originating from the bile duct system. ZB131 is a monoclonal antibody with a high affinity and specificity for cancer-specific plectin (CSP), a cell surface protein identified in a wide range of cancers that correlates with poor prognosis and aggressive tumors.

“Patients suffering from cholangiocarcinoma have few promising therapeutic options,” said Kimberly Kelly, Ph.D., founder and CEO of ZielBio. “Receiving this Orphan Drug Designation is a regulatory milestone for ZielBio that validates our sustained efforts to bring new treatments to underserved patients.”

ZielBio developed ZB131 to target CSP after discovering that, unlike in healthy cells where plectin exists in the cytoplasm, plectin presents on the surface of cancer cells, where it functions as a driver of tumor growth and metastasis. In preclinical studies, ZB131 demonstrated high specific binding to CSP and strong anti-cancer activity. A Phase 1/2 trial is underway to study 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 with the trial identifier NCT05074472.

FDA Orphan Drug Designation may be granted to investigational drugs or biological products which show promise in treating rare medical diseases or conditions that affect fewer than 200,000 people in the United States. About 8,000 people in the United States are diagnosed each year with cholangiocarcinoma, including both intrahepatic (inside the liver) and extrahepatic (outside the liver) bile duct cancers.

Read more here.

Recent News

07/01/2025

ISOThrive Announces Promising Phase 2 Interim Data for Novel Heartburn Treatment and Appoints Pharma Veteran Mike Walther as Chief Strategy Officer

ISOThrive Inc., a clinical-stage biopharmaceutical company, announced interim results from a Phase 2 study of its lead candidate, ISOT-101, for treatment of Non-Erosive Reflux Disease (NERD). The data showed positive trends in addressing heartburn frequency and symptom severity among proton pump inhibitor (PPI) partial-responders (PR), a patient population with major unmet medical need. These positive

07/01/2025

Gary Lowenthal Joins Focused Ultrasound Foundation’s Council

The Focused Ultrasound Foundation is pleased to welcome Gary Lowenthal to its Council, a dedicated group of goodwill ambassadors who work closely with the Board of Directors and staff to provide advice and assist with raising funds and building awareness. Mr. Lowenthal is a retired educator, entrepreneur, and executive with a career spanning education, international service,

06/25/2025

Liquet Medical Closes Oversubscribed Seed Round to Launch Pilot Study Evaluating Real-Time Hemodynamic Monitoring

Liquet Medical, a clinical-stage medical device company developing the Versus™ Catheter — a first-of-its-kind dual-tipped catheter system cleared by the FDA for controlled and selective infusion of fluids into the pulmonary vasculature and hemodynamic monitoring — announced the successful and oversubscribed close of its Seed funding round, which officially closed in May 2025. The capital