Linnaeus Therapeutics gets FDA Orphan Drug Designation for skin cancer drug

Jan. 19, 2023

Linnaeus Therapeutics, a New Jersey-based biotech focused on small-molecule oncology treatments, announced this week that the FDA had granted Orphan Drug designation to its metastatic cutaneous melanoma therapy, LNS8801.

Orphan drug designation helps support drug candidates in development for rare diseases that affect fewer than 200,000 people in the United States every year, by providing benefits like market exclusivity upon approval and application fee exemption.

Metastatic cutaneous melanoma is a rare, aggressive form of skin cancer. Approximately 4% of people diagnosed with melanomas suffer metastasis, and people with fair complexion or light hair are more at risk of developing it.

LNS8801 is an oral GPER antagonist and it works by activating the protein which helps deplete c-Myc protein levels. In preclinical models, the drug has shown anti-tumor activities both in the shrinking of tumors and also inducing immune memory.