Linnaeus Therapeutics, Inc. (Linnaeus) is a privately held clinical-stage biopharmaceutical company focused on development and commercialization of novel small-molecule oncology therapeutics. In January 2023 it was announced that the US Food and Drug Administration (FDA) had granted orphan drug designation for LNS8801 for the treatment of patients with metastatic cutaneous melanoma. The FDAs Office of Orphan Drug Products grants orphan drug status to support drug candidates in development for underserved patient populations or rare disorders that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain benefits, including market exclusivity upon FDA approval, exemption of FDA application fees, and tax credits for qualified clinical trials. Having completed dose escalation, Linnaeus is currently testing LNS8801 in its phase 1/2 adaptive-design clinical trial as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) in various cancers and patient populations.
