Fourth quarter (October-December 2024)
Period (January-December 2024)
Key events during the fourth quarter
Key events during the period
CAR T-cell production that has been awarded research support of SEK 850
thousand.
Key events after the end of the period
CEO Comments
Elicera Therapeutics’ clinical phase I/IIa study with ELC-301 is making significant progress and is expected to report preliminary data in the coming year.
First Patient Successfully Treated in the Clinical Phase I/IIa CARMA Study
patient enrolled in CARMA
In early November, we were delighted to announce that the first patient had been included in CARMA, the company’s clinical phase I/IIa study aimed at documenting the safety and efficacy of our CAR T-cell candidate, ELC-301, in patients with B-cell lymphoma. The study consists of two parts: a dose-escalation phase (phase I) involving 12 patients and a dose-expansion phase (phase IIa) with 6 patients. The cell therapy ELC-301 incorporates our proprietary iTANK platform technology, which is intended to initiate a parallel immune activation to enable a broader and more effective attack against cancer cells.
At the end of January, Elicera Therapeutics presented observational data from CARMA at the scientific conference Cancer Crosslinks in Oslo, Norway. It was revealed that the first patient treated with ELC-301 in the study had achieved a complete response at the one-month follow-up after treatment, with no severe side effects. These are promising initial results and we now continue recruiting more patients to generate more robust clinical data.
We plan to report structured and consolidated results from the study as each dosing group is completed. These results are expected to be presented at scientific conferences in 2025 and 2026. The exact timing of our data reporting will depend on the pace of the study and the scheduling of relevant conferences.
Elicera Therapeutics Participates in Several Strategic Meetings
In December, Elicera Therapeutics was invited to present its technology and commercial projects at the Innovation and Entrepreneurship Exchange and Cooperation Forum. This high-profile event brought together representatives from governmental and scientific institutions as well as commercial players in the life science industry in both China and Sweden. The meeting provided a valuable opportunity to highlight the therapeutic potential of the company’s gene and cell therapies, as well as to emphasize the rapidly growing global development of cell therapies.
Our co-founder and Chief Scientific Officer, Magnus Essand, was invited to participate in Cancer Crosslinks 2025, an annual scientific meeting in Oslo, Norway, aimed at bridging the gap between research and clinical oncology. There, he presented our initial observational data from the CARMA study. This highly regarded event, which gathers global scientific experts and commercial stakeholders, highlights the latest advancements in cancer diagnostics and the treatment of both solid and hematological cancers.
We look forward to an intense conference schedule in 2025, which, as noted earlier, includes participation in scientific conferences where we can present summarized data from each cohort in the CARMA study.
Key Milestone for ELC-100: Orphan Drug Designation from the FDA
Finally, in January, we announced that the company’s drug candidate ELC-100 has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine tumors in the pancreas. This designation provides benefits during the program’s continued development and potential market approval, including seven years of market exclusivity in the US. Neuroendocrine tumors represent a highly heterogeneous condition, and in our ongoing phase I clinical study, severely ill patients can be categorized into several subgroups, even based on their treatment history. This diversity necessitates the development of new therapeutic solutions with a broad understanding of the specific needs of different patient groups. We look forward to analyzing and reporting final data from the phase I study around mid-2025, after which we will announce how we plan to proceed with the program’s development.
In Summary
All the above demonstrates the significant progress Elicera Therapeutics has made as we enter an exciting 2025. I would like to extend a heartfelt thanks to our team and partners for their outstanding work and support that has brought us this far. I also wish to express my gratitude to our shareholders for their continued support and confidence in our journey!
Jamal El-Mosleh
CEO and co-founder
The interim report has been approved by the board and the CEO for publication. The information was submitted for publication distributed through the contact person below at 08;16 CET on February 3, 2025.
Elicera Therapeutics AB’s Year-end report for January to December 2024 is available at the company home page : https://www.elicera.com/investors-2/financial-reports.
For further information please contact:
Jamal El-Mosleh, CEO, Elicera Therapeutics AB
Phone: +46 (0) 703 31 90 51
jamal.elmosleh@elicera.com
Certified Advisor
Mangold Fondkommission AB
About the iTANK platform
The iTANK- (immunoTherapies Activated with NAP for efficient Killing) platform is the company's own fully developed commercially available technology platform for arming and enhancing CAR T-cells to meet two of the major challenges CAR T-cell therapies face in the treatment of solid tumors: tumor antigen heterogeneity and a hostile tumor microenvironment. The technology is used to incorporate a transgene into CAR T-cells encoding a neutrophil activating protein (NAP) from the bacterium Helicobacter pylori. Upon activation, NAP secreted from the CAR(NAP) T-cells has been shown to be able to enhance the function of the CAR T-cell in addition to activating a parallel immune response via CD8+ killer T-cells. This is expected to lead to a broad attack against most antigen targets on cancer cells. The iTANK-platform is used to enhance the company's own CAR T-cells but can also be universally applied to other CAR T-cell therapies under development. More information about iTANK-platform is available here: https://www.elicera.com/technology
About Elicera Therapeutics AB
Elicera Therapeutics AB is a clinical stage cell and gene therapy company that develops next generation immuno-oncology treatments based on iTANK-armed oncolytic viruses and CAR T-cells. The work is based on high-profile long-standing research conducted by Professor Magnus Essand's research group at Uppsala University and has resulted in the development of four drug candidates, including two CAR T-cells and two oncolytic viruses. The iTANK-technology platform can be used to arm any CAR T-cell therapy in development and activate killer T-cells against cancer. The company addresses an international billion-dollar market in cell therapy development by offering out-licensing of iTANK to the majority of players in the pharmaceutical industry. The company’s share (ELIC) is traded on Nasdaq First North Growth Market. For more information, please visit www.elicera.com