CARMA, our first clinical CAR T-cell study, is expected to start soon and will generate vital findings for both our CAR T-cell therapy ELC-301 and our iTANK gene technology method.
Early in the year, we received final approval to commence CARMA, the first clinical trial with ELC-301, our CAR T-cell therapy developed in-house. The two-part study is intended to evaluate safety and treatment efficacy in patients with severe forms of cancer that affect the immune system’s B cells. In part one, 12 patients will be treated with increasing doses so as to define an optimal dosage interval and identify the maximum possible dose that does not cause side effects that limit the dosage. In part two, an additional 6 patients will be treated with the highest dose, which is a crucial step in documenting the side-effect profile of the treatment. The plan is for a total of 12 patients to undergo treatment with the highest tolerable dose.
The study will be conducted at the clinical trial divisions at Uppsala University Hospital and Karolinska University Hospital in Huddinge, and the treatments are being prepared by our supplier, Vecura. According to the current timetable, we expect to be able to treat the first patients after summer and thus present interim data from the first dosage group with three patients at the turn of the year 2024/2025. Provided we reach that milestone on schedule, it should be possible to complete and present a full report on the dose-escalation study in the second half of 2025. The preliminary findings from the second part of the study will be expected approximately 6 to 12 months later. After the treatment phase, a monitoring period of at least two years will follow, which means that CARMA is planned to be completed and reported on in full in 2028.
The clinical trial with ELC-301 is also important as an initial clinical assessment of our patented iTANK gene technology, which arms CAR T-cells with the NAP bacteria protein. When the CAR T-cell binds to its target on the cancer cell – for ELC-301, this target is CD20 – a signaling process is activated that leads to the release of NAP. NAP activates the body’s immune system, and causes a range of different types of immune cells to collect in the tissue of the tumor. These immune cells can then attack and kill cancer cells that the CAR T-cells themselves are unable to. iTANK thus gives the treatment the potential to break down the tumor tissue completely. In addition, iTANK leads to the creation of an immunological memory. If new cancer cells should emerge, the memory cells can quickly trigger an immune response and prevent the development of new tumors – dramatically reducing the risk of relapse.
Like our oncolysis therapy candidate ELC-201, both of Elicera’s CAR T-cell therapy projects – ELC-301 and ELC-401 – are armed with iTANK. Apart from the key role the platform plays in our internal projects, part of our business model consists of outlicensing iTANK to other cell and gene technology companies and academic institutions that evaluate potential immunological treatments.
In parallel with the clinical projects, the development of the company’s preclinical therapy candidates is progressing. Earlier in the quarter, we announced that we had received SEK 850,000 as part of an external collaboration project with the Vecura R&D division at Karolinska University Hospital and Uppsala University. Vecura is part of the Karolinska Cell Therapy Center and specializes in the manufacture of advanced therapy drugs such as CAR T-cells. 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, which we have already done for ELC-301.
Recently, we were pleased to announce that Elicera Therapeutics’s co-founder and head of research, Professor Magnus Essand, had been awarded a total of SEK 4.8 million from the Swedish Childhood Cancer Fund. This research grant will finance a three-year project in Magnus’s research group at Uppsala University, with the goal of studying the capacity of CAR T-cells – ELC-401 included – to induce immunity against brain tumors in children. At the end of April, Magnus took part in the Scandinavian Society of Neuro-oncology (SNOG) Symposium 2024, where he presented one of the keynote addresses and touched upon subjects including the ELC-401 scientific study that was published in Nature Biomedical Engineering. Alongside the invitations to speak at the prestigious Eighth International Cancer Immunotherapy Conference (CICON) in September, this recent address is further proof of Magnus’s leading position in this field of research. The conference is an annual gathering of scientific leaders on the front line of global cancer research and is a key meeting place for discussing new and groundbreaking treatments.
In the coming quarter, we hope to be able to report on the findings of the AdVince Phase I/II study in which we are evaluating the drug candidate ELC-100. We have only one patient left to enroll in the dose-escalation study, which has taken longer than expected, but we are working closely with our clinical partner to conclude the study as fast as possible. In conjunction with the report, we will also provide a clearer description of the continued clinical development program for ELC-100.
The global cell therapy market is currently experiencing robust growth. Modern gene technology and clearer regulatory frameworks have meant that the global pharmaceutical industry is investing major resources in CAR T, and early projects are predominant in their pipelines. The willingness to invest is illustrated by the acquisitions of CAR T-cell therapies by Novartis and AstraZeneca during the autumn, the aggregate value of which was in the billions of USD. The market for iTANK is also significant – currently over 400 CAR T-cell projects are in the preclinical phase, and together they are creating a concrete market for our patented technology platform. We feel very secure with our business model, which provides possibilities for two income streams: licensing of our clinical projects and non-exclusive licensing agreements for iTANK to academic and preclinical cell therapy projects. Together with the right partners, we believe that our therapies – strengthened by iTANK – have good potential to reshape the treatment of solid tumors and cure cancer in patients who today lack satisfactory alternatives.
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;13 CET on May 27, 2024.
Elicera Therapeutics AB’s interim report for January to March 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 enhanced 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. In addition, Elicera has developed a technology platform called iTANK that can be used to optimize all CAR T-cells in development and activate killer T-cells against cancer. The company’s share (ELIC) is traded on Nasdaq First North Growth Market. For more information, please visitwww.elicera.com