This designation provides benefits during the continued development of the drug candidate and in the event of potential marketing approval of the treatment, states the company.

ELC-100

Elicera Therapeutics is developing ELC-100 as a new potential treatment for neuroendocrine tumors (NET). The drug candidate is based on an oncolytic virus and exerts its therapeutic effect by selectively infecting and killing neuroendocrine cancer cells.

In the fall of 2024, the company announced that the final patient had been recruited for the first part of an ongoing Phase I/II clinical trial aimed at identifying the maximum tolerated dose (MTD) and evaluating the treatment’s safety in patients. The company is expected to report the final data from the first part of the study around mid-2025.

The decision by the FDA is a significant milestone in our efforts to develop a new form of treatment for patients with neuroendocrine tumors.

“Neuroendocrine tumors represent a highly heterogeneous indication and in our ongoing clinical study with severely ill patients that can be divided into several subgroups, including based on treatment history. This diversity highlights the need for new therapeutic solutions to be developed with a broad understanding of the specific needs of different patient groups. We are very pleased that ELC-100 has been granted Orphan Drug Designation in the U.S. The decision by the FDA is a significant milestone in our efforts to develop a new form of treatment for patients with neuroendocrine tumors,” says Jamal El-Mosleh, CEO of Elicera Therapeutics.