CAR T-cell therapies have great potential for treating cancer, which has generated enthusiasm among researchers and oncologists. Six CAR T drugs have been approved by the FDA since 2017, and many are in clinical evaluation.
The area has become a hot topic recently, and several deals have been completed. A prime example of this came at the end of last year when a subsidiary of Legend Biotech announced a global licensing agreement with Novartis, worth over $1 billion, to advance the development of its preclinical autologous CAR T candidate LB2102.
Learn more about CAR T therapies here.
The only CAR T developer in Sweden
Cell and gene therapy company Elicera Therapeutics is the only Swedish company working with CAR T technology. Elicera has two CAR T projects in its pipeline, ELC-301 and ELC-401ELC-301 is being developed for the treatment of B-cell lymphoma, while ELC-401 is in preclinical development for the treatment of solid brain tumors, glioblastoma.
What distinguishes Elicera's CAR T therapies from those already on the market is that they are equipped with the company's proprietary immune-boosting technology, iTANK. When Elicera's iTANK-armed CAR T cells are introduced into the body, they bind to their tumor target and activate a signaling process that ultimately leads to the recruitment of other immune cells into the tumor tissue, optimizing the CAR T effect. A long-lasting immunological memory against the tumor target is generated, preventing cancer relapse. Read more about iTANK here.
ELC-301 approved for clinical development
Last week, Elicera reached a major milestone in its quest to bring new cancer cell therapies to market. The company received approval from Läkemedelsverket to initiate the CARMA Phase I/IIa clinical trial with ELC-301 in patients diagnosed with refractory CD20-positive B-cell lymphoma, mantle cell lymphoma or indolent lymphoma, or who have relapsed disease.
CARMA is a single-arm, open-label, multicenter study designed to evaluate the antitumor efficacy, toxicity and tolerability of Elicera's CAR T candidate after a single dose. The study will be conducted in two phases; a dose escalation phase (phase I) with a maximum of 12 patients, followed by a dose expansion phase (phase IIa) with a maximum of 6 patients receiving the maximum tolerated dose.
The study will be conducted at Academic Hospital in Uppsala and Karolinska University Hospital in Huddinge. According to the company's preliminary schedule, the dose escalation study is expected to be completed and reported in the second half of 2025, and Phase II is expected to be completed and reported approximately 6–12 months later. The full CARMA study is expected to be completed and reported in 2027, after a follow-up period of at least two years.
Comments from the CEO
The company's recently published Q4 report comments on the capital raising that Elicera announced in January. This guarantees a gross proceeds of at least SEK 27,5 million, which together with current cash and future research grants, gives the company a strong financial position to run the clinical study. To get a complete overview of Elicera's plans, BioStock spoke with the CEO Jamal El-Mosleh.
Stay tuned for a more detailed report follow-up from BioStock!
Jamal, how important is this milestone for Elicera?
–This is one of the most important milestones in the company's history. The ELC program will be our first CAR T-cell therapy to be brought to patients, and it will also be the first time that the iTANK technology platform will be used in a clinical setting. We are very excited to now be able to offer this treatment to cancer patients who are in desperate need of effective treatment options.
How does ELC-301 fit into the treatment landscape for B-cell lymphoma? (What differentiates ELC-301 from existing therapies in terms of technology and target indications?)
– There are three approved CAR T-cell therapies in B-cell lymphoma and one in mantle cell lymphoma, and they all target the same cancer antigen, namely CD19. ELC-301, on the other hand, targets CD20, which is also overexpressed on cancer cells in B-cell and mantle cell lymphomas, in addition to being armed with our patented and commercially available iTANK technology to induce a potent parallel immune response against multiple cancer antigen targets. We can expect that approximately 50 percent of patients with B-cell lymphoma will relapse, and most of these patients will no longer be able to continue treatment with CD19 CAR T-cell therapies due to loss of target antigen. ELC-301 is expected to be able to help these patients because it targets a different cancer antigen and because it is armed with the iTANK platform.
Is a licensing deal a possibility for this candidate if the clinical results are positive?
– Yes. Last May, Janssen licensed a CD20-targeted CAR T-cell candidate and a “dual” CAR T-cell candidate (targeting both CD19 and CD20) from Cellular Biomedicine Group for a total of $245 million in upfront payments and additional potential future milestone payments and royalties. Both candidates had completed “smaller” Phase I/II studies in China and reported strong data.
Can you further comment on the role that iTANK plays in making ELC-301 a promising candidate?
– The iTANK platform incorporates a transgene into CAR T cells that encodes a bacterial protein with strong immunostimulatory properties. The goal is twofold:
1) To activate patients' killer T cells against a wide range of cancer antigen targets, in addition to, for example, CD19 and CD20. This will be crucial for the development of effective CAR T-cell therapies in solid tumors as they are notorious for having a highly variable expression of antigen targets on tumor cells, leading to "antigen escape" and the formation of CAR T-cell resistant tumors.
2) To counteract the hostile tumor microenvironment in solid tumors and help CAR T cells fight cancer.
Finally, can you talk about the financial aspects of conducting this study and whether the upcoming capital raising will be sufficient to support the clinical study?
– The upcoming capital raising has secured gross proceeds of approximately SEK 27 million, which, combined with current cash and planned future EIC payments, is sufficient to treat all planned 18 patients. We plan to release data from the first cohort of three patients by the end of the year, with more data from the first 12 patients in the second half of 2025.