This article is more than 5 years old. Information may no longer be current.
FDA grants orphan drug designation to LBS-007 for acute lymphoblastic leukemia
Click Here to Manage Email Alerts
The FDA granted orphan drug designation to LBS-007 for the treatment of acute lymphoblastic leukemia, according to the agent’s manufacturer.
LBS-007 (Lin BioScience) is a natural, non-ATP cell cycle CDC7 kinase inhibitor. Inhibiting CDC7 blocks the proliferation of tumor cancers and results in cancer cell death.
In preclinical studies, the agent demonstrated activity against leukemia and multiple solid tumors, according to the manufacturer. Lin BioScience plans to initiate a first-in-human study among patients with ALL later this year.
“Our focus is to find treatments for untreatable diseases, and LBS-007 is the second candidate in our pipeline to receive orphan drug designation in the last 6 months,” Tom Lin, MBA, MMed, PhD (Med), CEO of Lin BioScience, said in a company-issued press release. “We are pleased to reach this regulatory milestone with LBS-007, and we look forward to advancing the anticancer program into phase 1 clinical trials later this year.”
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.