Biotechnology company Elicera Therapeutics AB (publ) announced on Monday that its drug candidate ELC-100 has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for treating pancreatic neuroendocrine tumours.

ODD supports the development of treatments for rare diseases, with benefits including tax credits for US clinical trials and potential fee waivers for marketing approval. In addition, ODD provides up to seven years of market exclusivity upon approval.

ELC-100 is based on an oncolytic virus and targets neuroendocrine cancer cells selectively. Elicera is currently conducting a Phase I/II trial to determine the maximum tolerated dose (MTD) and assess safety. The company completed patient recruitment for the trial's first part in fall 2024. Final data from this phase is expected in mid-2025.