Elicera’s first clinical CAR T-Cell study CARMA set to begin
Elicera Therapeutics is on the brink of launching its first clinical CAR T-cell study, CARMA, which aims to generate crucial data for its lead CAR T-cell candidate ELC-301 and the iTANK immune-boosting technology.
– 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, says CEO Jamal El-Mosleh in Elicera’s 2024 Q1 report.
The global cell therapy market is steaming hot, experiencing significant growth over the last few years with substantial investments from major pharmaceutical companies like Novartis and AstraZeneca. Over 400 CAR T-cell projects are currently in the preclinical phase, highlighting the market potential for Elicera Therapeutics – the only CAR T-cell developer in Sweden. Two CAR T-cell candidates are in its pipeline – ELC-301 and ELC-401. The former is about to enter clinical evaluation, and it will be the company’s first clinical CAR T-cell therapy incorporating the Elicera’s patented iTANK gene technology – more on that later.
Towards clinical evaluation with CAR T candidate
The CARMA phase I/IIa trial is a two-part study designed to assess the safety and efficacy of ELC-301 in patients with severe B cell-related cancers. The first part involves twelve patients receiving increasing doses to determine the optimal and maximum tolerable dose without significant side effects. In the second part, an additional six patients will receive the highest dose to document the side-effect profile thoroughly. In total, twelve patients will be treated with the highest tolerable dose.
The clinical trial will be conducted at Uppsala University Hospital and Karolinska University Hospital in Huddinge, with supplier Vecura preparing the treatments. Interim data from the first dosage group anticipated by the end of 2024, and a full report on the dose-escalation study should be ready by the second half of 2025. Preliminary findings from the second part of the study will follow 6 to 12 months later, with a complete report on CARMA expected by 2028.
Elicera’s iTANK technology in the spotlight
A key highlight of the study Elicera’s patented iTANK gene technology, which is being developed to arm not only ELC-301, but also other gene therapies to give them immune-boosting properties. This is what sets Elicera’s CAR T therapies apart from those already on the market and what drives a significant part of the company’s market potential.
When introduced into the body, iTANK-armed CAR T-cells bind to their tumour target, activating a signalling process that ultimately recruits other immune cells in the tumour tissue, thus optimising the CAR T effect. A long-term immunological memory against tumour targets is generated, which prevents cancer relapse. Read more about iTANK here.
For this reason, a key component of Elicera’s business model consists of outlicensing iTANK to other cell and gene technology companies and academic institutions that evaluate potential immunological treatments. To this effect, recently Elicera announced entering a Material Transfer Agreement (MTA) with a prominent, still undisclosed, cancer centre based in the US to evaluate iTANK in a novel CD4-directed T-cell receptor therapy (TCR-T). The therapy will be evaluated in preclinical proof-of-concept studies targeting melanoma and lung cancer. Read all about this here.
Funding through rights issue and strategic partnerships
Elicera undertook a preferential rights issue to fund the CARMA study and other pipeline projects, generating 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.
In addition to clinical trials, Elicera is advancing its preclinical therapy candidates. The company has secured SEK 850,000 from a collaboration with Vecura and Uppsala University to develop an automated production flow for ELC-401. Additionally, Elercera’s co-founder and head of research, Professor Magnus Essand, received SEK 4.8 million from the Swedish Childhood Cancer Fund for a three-year project investigating CAR T-cells’ ability to combat brain tumours in children.
Overall, Elicera’s Q1 report suggests that an exciting period is on the horizon for the company, and will merit close attention. Stay tuned for an in-depth Q&A with Elicera’s CEO Jamal El-Mosleh from the BioStock Studio next week!
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.
