Linnaeus Therapeutics Granted Orphan Drug Designation for LNS8801 for the Treatment of Patients with Metastatic Cutaneous Melanoma

Linnaeus Therapeutics, a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small-molecule oncology therapeutics, has announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation for LNS8801 for the treatment of patients with metastatic cutaneous melanoma.

The FDA’s 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.

“We are extremely pleased to have received orphan drug designation for cutaneous melanoma from the FDA. This is an important milestone that has emerged from the very promising data we have seen in biomarker-defined patients with metastatic cutaneous melanoma in our dose-expansion cohorts,” commented Patrick Mooney, MD, CEO of Linnaeus. “We look forward to further opening a randomized controlled study in patients with treatment-refractory cutaneous melanoma to explore the promising results we have already seen with LNS8801 alone and also in combination with pembrolizumab.”

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.