Full speed ahead for Elicera in 2024
Elicera Therapeutics has kicked off the year in boost mode. The Swedish cell and gene therapy company will get moving on the newly approved phase I/IIa study with lead CAR T candidate ELC-301, made possible by a major financing round coming later this month. Speaking to Elicera’s CEO Jamal El-Mosleh, it’s clear that the company is ready for a busy 2024, where now two pipeline candidates are in the clinic.
Elicera Therapeutics develops 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).
Besides these candidates, a key asset for the company is its immune-boosting technology platform, the commercial-ready iTANK. This platform is developed to arm CAR T-cells or oncolytic viruses to optimise the therapy’s effect. Read more about iTANK here.
Collaboration for CAR T production
With the release of the year-end financial report, Elicera’s CEO Jamal El-Mosleh alludes to a significant push forward in the company’s development in 2024, particularly with its CAR T programmes.
The activities started rolling in early in the year with a collaborative project with Vecura – a GMP manufacturing unit for advanced therapy medicinal products at Karolinska University Hospital – and Uppsala University, the site of production process development.
The collaboration is aimed at developing an automated production process of CAR T-cells (ELC-401) for use in clinical studies. The project has been awarded SEK 850,000 from the Center for Advanced Medical Products (CAMP).
The basis for clinical development with ELC-301
With the prospect of starting a phase I/II study with lead CAR T drug candidate ELC-301, Elicera has also announced a preferential rights issue that guarantees gross proceeds of at least SEK 27.5 million. This, together with current cash and upcoming grant payments, puts the company in a strong financial position to pursue the clinical study.
According to Jamal El-Mosleh, who spoke to BioStock recently about this study, the company plans to release data from first cohort of three patients late this year, with more data from the first 12 patients in the second half of 2025. Read the full interview here.
Elicera’s potential in a booming field
The CAR T field is steaming hot with several deals being made in 2023, and two prime examples came late in the year. In November, a subsidiary of Legend Biotech announced a global licensing agreement with Novartis worth more than USD 1 billion to advance its preclinical autologous CAR T candidate LB2102 for development.
A month later, AstraZeneca announced entering into a definitive agreement to acquire Gracell Biotechnologies, a biopharmaceutical company headquartered in China, in a deal worth USD 1 billion. The agreement allows AstraZeneca to expand its cell therapy pipeline.
This makes Elicera an interesting case to follow. The study with ELC-301 is the first clinical study undertaken by the company with its CAR T programme. This is a very important milestone for the company, especially considering that Elicera is the sole CAR T developer in Sweden and one of few in Europe.
More proof of Elicera’s strength in the field came early in 2024 when Co-founder and Head of Research, Professor Magnus Essand, was awarded a total of SEK 4.8 million from the Swedish Childhood Cancer Fund to finance a three-year project at Uppsala University to study the ability of CAR T-cells – ELC-401 included – to induce immunity against brain tumours in children. Read more about CAR T therapies here.
CEO insights
For a more complete look at Elicera’s latest achievements and future plans, BioStock turned to CEO Jamal El-Mosleh.
Jamal, how would you describe Elicera’s start to 2024?
– There’s a lot going on right now. Our upcoming capital raise secures at least 27,5 MSEK in gross proceeds, which is deemed sufficient to recruit and treat all planned 18 patients in our newly approved CARMA-study in B-cell lymphoma. Entering clinical phase with our first CAR T-cell candidate, ELC-301, and our CAR T-arming technology platform, iTANK, marks one of the most important milestones in the history of the company. In parallel, we working to complete the ongoing dose escalation study in neuroendocrine tumors with our oncolytic virus candidate, ELC-100, and continue to explore partnering opportunities for our assets globally. Finally, we also keep exploring different soft funding opportunities for our two preclinical programs, ELC-201 and ELC-401, to be able to advance these drug candidates into clinical trials also.
Why is Elicera’s collaboration with Vecura and Uppsala University important?
– Manufacturing of CAR T-cells is very complex and time consuming. This collaboration aims to set up an automated and closed system for construction of CAR T-cells for each individual patient to be treated which minimizes time to treatment and secures the quality of the therapy. 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 are now looking to achieve the same for ELC-401 and future CAR T-cell studies in glioblastoma.
CAR T-cell therapies so popular with big pharma at the moment. Why do you think that is?
– We have known for quite a long time that our own T-cells can effectively kill cancer cells, but we have to “teach them” how to. I would say that we have been successful in doing that with genetically modified CAR T-cell therapies in different types of blood cancer, curing many patients that were previously without any effective treatment alternatives. However, the prevalence of solid tumors is more than 10 times larger than blood cancers and no CAR T-cell therapy has yet to be approved for treatment of solid tumors. The potential, along with high unmet medical need and a large market, is there however, and that is why CAR T-cell therapies is so popular with Big Pharma at the moment I would say.
Do you believe that Elicera can ride the wave of business deals in the field?
– We are actively seeking to outlicense our universal CAR T-cell arming technology platform, iTANK, to other CAR T-cells developers on a non-exclusive basis as we believe that it can help meet the most important challenges these therapies face in the treatment of solid tumors. Also, assuming positive outcome of the CARMA-study, I expect that we will be in a strong position to outlicense ELC-301 in B-cell lymphoma. This is area that has been shown strong interest from the industry as exemplified by the 245 MUSD upfront payment Janssen did to CBMG last year to license two unarmed CD20 directed CAR T-cell therapies after completion of two clinical phase I/II-studies, not unsimilar to CARMA.
It seems that Elicera is putting more focus on its CAR T projects than its oncolytic virus projects. Is that the case, and, if so, why?
– Our most advanced program is actually an oncolytic virus (ELC-100). However, we believe ELC-301 and the CARMA-study, along with ELC-401 in glioblastoma, have much greater potential, both with regards to offering efficacious treatment options and with regards to the value of potential licensing deals. Also, since our business model for iTANK is to outlicense the platform on a non-exclusive basis, we are naturally placing a bit more focus on the CAR T-cell therapies than oncolytic viruses, even though we of course continue to pursue the development of those programs as well.
Speaking of your oncolytic virus projects, ELC-100 is also in clinical development. Can you give an update on that and a short overview of its potential?
– The ongoing clinical phase II/II-study (AdVince) in neuroendocrine tumors is a so-called dose escalation study, aiming to study safety and determine the maximum tolerable dose for continued clinical development. We have treated 11 out of planned 12 patients and are thus expecting this study to be completed and reported during this year. Neuroendocrine tumors is a very heterogenous cancer indication and the unmet medical need differs greatly depending on which subgroup of patients we are looking at. For ELC-100, we will most likely look to treat patients that have confirmed expression of somatostatin receptors and that have stopped responding to standard therapy. According to our estimations this patient population has an incidence of around 2000 patients annually in EU and US. We will provide an update on continued development of ELC-100 after completion of the ongoing phase I/II-study.
Finally, what will 2024 look like for Elicera?
– In near term we are looking to treat the first patient in the CARMA-study and the last patient in the AdVince-study. In mid-term, we are expecting to report top-line data from the AdVince-study and provide guidance on next steps. Later this year, we also expect 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 deals 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. All in all, I see an exciting and busy year ahead!
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
