
Elicera’s candidate ELC-100 granted Orphan Drug Designation
Cell and gene therapy company Elicera Therapeutics has been granted Orphan Drug Designation (ODD) by the FDA for its drug candidate ELC-100, intended for the treatment of pancreatic neuroendocrine tumors. This highlights the potential of the oncolytic virus as a promising therapy for this challenging type of cancer.
Elicera Therapeutics focuses on developing therapies using oncolytic viruses and CAR T-cells, designed to target tumours with precision. Additionally, the company has developed the innovative iTANK platform, an immune-boosting and commercially available technology platform that equips CAR T-cell therapies with immune-activating properties to maximise their therapeutic potential. Elicera has two clinical programs: a recently initiated CAR T-cell trial (phase I/IIa) for the treatment of B-cell lymphoma (CARMA study) and a fully recruited phase I trial involving an oncolytic virus (ELC-100) for the treatment of neuroendocrine tumors (AdVince study).
Advantages of ODD
On January 13, 2024, Elicera announced that the FDA had granted Orphan Drug Designation (ODD) to ELC-100 for the treatment of pancreatic neuroendocrine tumors. ODD is granted by the FDA and EMA for drugs developed to treat rare diseases. According to FDA’s criteria, a rare disease affects fewer than 200,000 individuals in the United States. For companies like Elicera, this status offers several benefits, including tax credits for clinical trials, the possibility of waiving certain application fees, and up to seven years of market exclusivity following potential approval.
“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.
Significant progress
Neuroendocrine tumors (NETs) are a rare and heterogeneous form of cancer.
“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”, says Jamal El-Mosleh.
The company is developing ELC-100 as an innovative drug based on an oncolytic virus. The treatment works by selectively infecting and killing neuroendocrine cancer cells without harming healthy cells, making it a promising candidate for patients for whom current standard treatments are insufficient.
Elicera has recently made progress in the clinical development of ELC-100. During the autumn last year, the company completed patient recruitment for the first part of an ongoing phase I/IIa study. The study aims to determine the maximum tolerable dose and evaluate the treatment’s safety. Results from this first part are expected to be presented around mid-2025 and will provide crucial insights for the treatment’s continued development.
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