Elicera Therapeutics focuses on developing treatments with oncolytic viruses and CAR T cells, which target tumors. In addition, the company has developed the innovative iTANKplatform, an immune-enhancing and commercially available technology platform, that arms CAR T-cell therapies with immune-activating properties to maximize their therapeutic efficacy. Elicera has two clinical programs: a recently initiated CAR T-cell study (Phase I/IIa) in the treatment of B-cell lymphoma (CARMA study) and a fully recruited Phase I study with an oncolytic virus (ELC-100) in the treatment of neuroendocrine tumors (AdVince study).
ODD offers several advantages
On January 13, 2024, Elicera announced that it had received Orphan Drug Designation (ODD), or orphan drug status, from the FDA for the drug candidate ELC-100 for the treatment of neuroendocrine tumors of the pancreas. ODD is a status that the FDA and EMA grant to drugs that are being developed to treat rare diseases. According to the FDA's criteria, a rare disease affects fewer than 200 people in the United States. For companies like Elicera, this status means several benefits such as tax breaks for clinical trials, the possibility of avoiding certain application fees and up to seven years of market exclusivity after potential approval.
-We are very pleased that ELC-100 has been granted orphan drug status in the US. The decision from the US Food and Drug Administration is a significant milestone in our work to develop a new form of treatment for patients with neuroendocrine tumors, says Jamal El-Mosleh, CEO of Elicera Therapeutics.
Important progress
Neuroendocrine tumors (NETs) are an uncommon and heterogeneous form of cancer.
- Neuroendocrine tumors are a very heterogeneous indication, also with respect to the patients’ treatment history. In our ongoing clinical study, the severely ill patients can be divided into several subgroups. This diversity means that new therapeutic solutions need 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 where current standard treatments are not sufficient.
Elicera has recently made progress in the clinical development of ELC-100. In the fall of 2024, the company completed patient recruitment for the first part of an ongoing Phase I/IIa study. The study aims to determine the maximum tolerated dose and evaluate the safety of the treatment. The results from this first part are expected to be presented around mid-2025 and will provide crucial insights for the further development of the treatment.