FDA grants orphan drug designation to KN046 for thymic epithelial tumors
Click Here to Manage Email Alerts
The FDA granted orphan drug designation to KN046 for the treatment of patients with thymic epithelial tumors, according to a manufacturer-issued press release.
KN046 (Jiangsu Alphamab Biopharmaceuticals/Alphamab Oncology) — a recombinant humanized PD-L1/CTLA-4 bispecific antibody — induced a high response rate with long-lasting responses and favorable safety among patients with thymic epithelial tumors treated in a phase 1 trial.
A phase 2 registration trial is underway, with plans to treat patients at 10 centers in China and the U.S.
Thymic epithelial tumors — with an estimated 7,000 to 10,000 cases in the U.S. this year — are inoperable with a poor prognosis in metastatic cases. The tumor cells highly express PD-L1, making it a favorable target for immune checkpoint inhibition.
KN046 also is under investigation in more than 10 cancer types, including non-small cell lung cancer, triple-negative breast cancer, esophageal squamous cell carcinoma and pancreatic cancer.
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.
Click Here to Manage Email Alerts