Elicera Therapeutics AB (publ) received conditional approval from the Medical Products Agency on its CAR T-cell Clinical Trial Application to test ELC-301 (CARMA-study). In pace with nearing the start of the clinical Phase I/IIa study, see a clear need for strengthening the company's financial position. The company plan to report data from the first dosage group, consisting of three patients, already at the end of 2024 and complete results from all 12 patients in the second half of 2025.

The project is financed by the Centre for Advanced Medical Products (CAMP) and is intended to develop a fully automated production flow of ELC-401 for use in future clinical trials. The company have only one patient left to include in the dose-escalation study. In conjunction with the report, will provide a clearer description of the continued clinical development program.

The company has developed a portfolio consisting of the patented iTANK gene technology platform and four drug candidates in clinical and preclinical development phase. This platform thus opens the door to new possibilities for treating solid tumors where current CAR T-cell therapies have not yet been successful. Elicera's business model is to develop and, over the long term, outlicense its in-house and patented arming technology iTANK and treatment methods for cancers.

The strategy for generating revenue from commercial partnerships is built on: Conducting preclinical and clinical trials that demonstrate the mechanism of action and efficacy of the programs. Elicera has developed iTANK, a patented and commercially available platform technology for expanding the areas of application for CAR T-cell therapy. iTANK makes it possible to impact the microenvironment in solid tumors, activate a robust immune response against cancer and develop a long-term immunological memory related to several different tumor targets, which counteracts recurrences of cancer. All together, the results from the preclinical study support the possibilities of using Elicera's unique method to create CAR T-cell therapies against a range of solid forms of cancer - something that at present is very difficult.

The results from the study were published in 2022 in Nature Biomedical Engineering1, one of the world's foremost scientific journals, and constitutes a fundamental pillar for the validity of the scientific concept and a cornerstone in dialogues with potential partners. The ELC-301 program is being developed to treat B-cell lymphoma. In the first half of 2024, Elicera expects to start a clinical Phase I/IIa trial, called the CARMA-study, with ELC-301 in patients with severe or recurring DLBCL.

Since the study is open, the results may be presented after every dose group. The ELC-401 program is being developed to treat glioblastoma (GMB). In a preclinical study, the company was able to demonstrate that IL13Ra2 is an effective tumor target for CAR T-cells strengthened with iTANK.

The results included the finding that the CAR T-cell had a potent cell-killing efficacy and prolonged survival in the disease model. As a next step in the development of ELC-401, clinical trials are planned for which Elicera is seeking soft financing and/or partnerships with other companies in order to conduct them. Alongside its CAR T-cell program and ELC-100, Elicera is developing ELC-201, a program to develop oncolytic virus treatment with the potential to treat several different forms of solid cancer.

The company has extensively surveyed potential cancer indications for ELC-201 based on both scientific and commercial considerations, and is now evaluating alternatives for financing the program of clinical trials, with a focus on commercial partnership and various types of soft financing. ELC-100, also known as AdVince, is a program for developing and treating neuroendocrine tumors (NETs), which arise from cells in the neuroendocrine system.ELC-100 is currently undergoing a clinical Phase I/II trial (ClinicalTrials.gov identifier: NCT02749331) with Uppsala University as sponsor (agreements).