Elicera Therapeutics' drug candidate ELC-100 receives Orphan Drug Designation in the U.S. for the treatment of pancreatic neuroendocrine tumors
Gothenburg, January 13, 2025 – Elicera Therapeutics AB (publ), a clinical stage cell and gene therapy company developing next generation cancer treatments based on its proprietary commercial technology platform iTANK, announces today that the company's drug candidate ELC-100 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic neuroendocrine tumors. This designation provides benefits during the continued development of the drug candidate and in the event of potential marketing approval of the treatment.
Orphan Drug Designation (ODD) is intended to promote the development of drugs that address rare diseases. In the United States, the Food and Drug Administration (FDA) grants this status to drugs or biological products designed to treat diseases affecting fewer than 200,000 people in the country. During the development of the drug candidate, this designation provides certain advantages, such as tax credits for clinical trials conducted in the U.S. At a later stage, ODD offers the opportunity to waive fees associated with applications for marketing approval, as well as up to seven years of market exclusivity.
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.
"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.
For further information, please contact:
Jamal El-Mosleh, CEO, Elicera Therapeutics AB (publ)
Phone: +46 (0) 703 31 90 51
jamal.elmosleh@elicera.com
Certified Advisor
Mangold Fondkommission AB
About Elicera Therapeutics AB
Elicera Therapeutics AB (publ) has developed the patented gene technology platform iTANK that enables the arming of new and existing CAR T-cell therapies targeting aggressive and relapsing cancer forms. Elicera Therapeutics thereby addresses a well-defined and vast market. The company’s CAR T-cell therapies have shown a potent effect toward solid tumors which are recognized as particularly difficult to treat and constitute the majority of cancer cases. The company addresses a global multibillion market in cell therapy through its offering of non-exclusive licensing of the iTANK- platform to companies in the pharmaceutical industry. Elicera Therapeutics has four internal development projects in immune therapy that separately have the potential to generate substantial value through exclusive out-licensing agreements. The company’s share is traded on Nasdaq First North Growth Market. For additional information, visit www.elicera.com.