Elicera Therapeutics is developing next-generation cell and gene therapies based on CAR T cells and oncolytic viruses, with four drug candidates in its research pipeline – two CAR T cells (ELC-301 and ELC-401) and two oncolytic viruses (ELC-100 and ELC-201).
In addition to these candidates, another important asset for the company is its immunomodulatory and commercially available technology platform. iTANKThis platform is developed to arm CAR T cells or oncolytic viruses to optimize the treatment's effect. Read more about iTANK here.
Collaboration for CAR T production
In the year-end report, Elicera's CEO writes Jamal El-Mosleh that there will be significant investments in development in 2024, especially in the CAR T programs.
The year began with the announcement of a collaborative project with Vecura – a GMP manufacturing unit for advanced therapy drugs at Karolinska University Hospital – and Uppsala University, the location for the development of production processes.
The collaboration aims to develop an automated production process of CAR T cells (ELC-401) for use in clinical studies. The project has been awarded SEK 850 from Center for Advanced Medical Products (CAMP).
The foundation for clinical development with ELC-301
With the aim of starting a Phase I/II study with the lead CAR T drug candidate ELC-301, Elicera has also announced a rights issue that guarantees gross proceeds of at least SEK 27,5 million. This, together with current cash and upcoming grant payments, gives the company a strong financial position to continue the clinical study.
According to Jamal El-Mosleh, who recently spoke to BioStock about this study, the company plans 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. Read the full interview here.
Eliciting potential in a thriving field
The CAR T field is blazing hot, with several deals expected in 2023, and two excellent examples came at the end of the year. In November, a subsidiary of Legend Biotech a global licensing agreement with Novartis worth more than $1 billion to advance its preclinical autologous CAR T candidate LB2102 for development.
A month later, announced AstraZeneca that a definitive agreement has been entered into to acquire Gracell Biotechnologies, a biopharmaceutical company headquartered in China, in a deal worth USD 1 billion. The agreement will enable AstraZeneca to expand its cell therapy pipeline.
This makes Elicera an interesting company to follow. The ELC-301 study is the first clinical study the company is conducting within the framework of its CAR T program. This is a very important milestone for the company, especially considering that Elicera is the only CAR T developer in Sweden and one of the few in Europe.
Further proof of Elicera's strength in the field came in early 2024 when co-founder and research leader, Professor Magnus Essand, was awarded a total of SEK 4,8 million from The Childhood Cancer Foundation to finance a three-year project at Uppsala University to study the ability of CAR T cells – including ELC-401 – to induce immunity against brain tumors in children. Read more about CAR T therapies here.
Comments from the CEO
To get a more complete picture of Elicera's recent achievements and future plans, BioStock turned to the CEO Jamal El-Mosleh.
Jamal, how would you describe Elicera's start in 2024?
– There is a lot going on right now. Our upcoming capital raising secures at least SEK 27,5 million in gross proceeds, which is considered sufficient to recruit and treat all planned 18 patients in our recently approved CARMA study in B-cell lymphoma. Entering the clinical phase with our first CAR T-cell candidate, ELC-301, and our CAR T technology platform, iTANK, marks one of the most important milestones in the company's history. In parallel, we are working to complete the ongoing dose-escalation study in neuroendocrine tumors with our oncolytic virus candidate, ELC-100, and continue to explore collaboration opportunities for our assets globally. Finally, we also continue to explore various soft financing opportunities for our two preclinical programs, ELC-201 and ELC-401, to be able to advance these drug candidates into clinical trials as well.
What makes Elicera's collaboration with Vecura and Uppsala University so important?
– Manufacturing CAR T cells is very complex and time-consuming. The collaboration aims to set up an automated and closed system for engineering CAR T cells for each individual patient to be treated, which minimizes the time to treatment and ensures the quality of the treatment. We have managed to achieve an automated system with a “vein-to-vein” time of only 17 days for ELC-301 and the CARMA study and now look forward to achieving the same for ELC-401 and future CAR T cell studies in glioblastoma.
CAR T-cell therapies are very popular among big pharmaceutical companies right now. Why do you think that is?
– We have long known that our own T cells can effectively kill cancer cells, but we have to “teach them” to do so. I would say that we have succeeded in doing so with genetically modified CAR T-cell therapies for various types of blood cancer, which cures many patients who previously had no effective treatment options. However, the prevalence of solid tumors is more than 10 times greater than blood cancer and no CAR T-cell therapy has yet been approved for the treatment of solid tumors. However, the potential, together with a large medical need and a large market, is there, and that is why CAR T-cell therapies are so popular with Big Pharma right now, I would say.
Do you think Elicera can ride the wave of business in the area?
– We are actively seeking to out-license our universal CAR T-cell technology platform iTANK to other CAR T-cell developers on a non-exclusive basis as we believe it can help address the key challenges these therapies face in the treatment of solid tumors. Assuming a positive outcome of the CARMA study, I expect that we will be in a strong position to out-license ELC-301 in B-cell lymphoma. This is an area that has shown significant interest from the industry, as exemplified by the $245 million upfront payment that Janssen made to CBMG last year to license two unarmed CD20-targeted CAR T-cell therapies after completing two Phase I/II clinical trials, not unlike CARMA.
It seems like you are focusing more on your CAR T projects than on the oncolytic virus projects. Is that true, and if so, why?
– Our most advanced program is actually an oncolytic virus (ELC-100). However, we believe that ELC-301 and the CARMA study, together with ELC-401 in glioblastoma, have much greater potential, both in terms of offering effective treatment options and in terms of the value of potential licensing agreements. Since our business model for iTANK is to out-license the platform on a non-exclusive basis, we are focusing a little more on CAR T-cell therapies than oncolytic viruses, although we will of course continue to drive the development of these programs as well.
Speaking of your oncolytic virus projects, ELC-100 is also in clinical development. Can you give an update on this project and a brief overview of its potential?
– The ongoing clinical phase II/II study (AdVince) in neuroendocrine tumors is a so-called dose escalation study, which aims to study safety and determine the maximum tolerable dose for further clinical development. We have treated 11 of the planned 12 patients and therefore expect this study to be completed and reported during the current year. Neuroendocrine tumors are a very heterogeneous cancer indication and the medical need differs greatly depending on which subgroup of patients we are looking at. For ELC-100, we will likely treat patients who have confirmed expression of somatostatin receptors and who have stopped responding to standard therapy. According to our estimates, this patient population has an incidence of approximately 2000 patients annually in the EU and the US. We will provide an update on the further development of ELC-100 after completion of the phase I/II study.
Finally, what will 2024 look like for Elicera?
– In the near term, we are looking to treat the first patient in the CARMA study and the last patient in the AdVince study. In the medium term, we expect to report topline data from the AdVince study and provide guidance on next steps. Later this year, we also expect to be able to report preliminary clinical data from the first three treated patients in the CARMA study. In parallel, as mentioned above, we are working to secure licensing agreements for iTANK and soft funding opportunities for clinical development of our preclinical programs ELC-201 and ELC-401. Hopefully, we will be able to deliver some news from these activities as well. Overall, I see an exciting and busy year ahead!