The U.S. Food and Drug Administration has granted Orphan Drug designation to the investigational agent ELC-100 for the treatment of pancreatic neuroendocrine tumors, according to a press release from Elicera Therapeutics, the drug developer.
ELC-100 is an oncolytic virus–based therapy designed to selectively infect and kill neuroendocrine cancer cells. In the fall of 2024, Elicera announced that the final patient had been recruited for part 1 of an ongoing phase I/II clinical trial to determine the maximum tolerated dose and evaluate the treatment’s safety, with final data expected in mid-2025.
The FDA grants Orphan Drug designation to drugs or biological products designed to treat disease affecting fewer than 200,000 people in the country. This status provides incentives to sponsors including tax credits for qualified clinical trials, exemption from fees associated with applications for marketing approval, and up to 7 years of market exclusivity after approval.
