Third quarter (July-September 2023)
Period (January-September 2023)
Key events during the third quarter
Key events during the period
Key events after the end of the period
CEO Comments
The GMP validation of ELC-301 is progressing, and we expect to be able to treat the first patient in our CARMA clinical Phase I/II trial early next year.
The validation of the GMP procedure for ELC-301 is progressing as planned
In the spring, we received conditional approval from Läkemedelsverket, the
Swedish Medical Products Agency, for the start of the CARMA Phase I/IIa trial
with ELC-301, our iTANK-reinforced CAR T-cell therapy, in patients suffering from
difficult-to-treat or metastasized diffuse large B cell lymphoma (DLBCL), mantle
cell lymphoma or indolent lymphoma. The protocol permits the inclusion of
patients who previously stopped responding to approved CD19-targeted CAR
T-cell therapies, since our CAR T-cell therapy is directed at another target
(CD20) and is expected to initiate a parallel immune response to many different
targets in the tumor cells. The conditions for being able to start the trial is that
we can demonstrate that the manufacture of ELC-301 meets the established
framework for quality assurance in the drug industry: the Good Manufacturing
Process, or GMP. Validation takes place in partnership with a qualified consulting
partner who has lengthy experience in the manufacture of biological medical
products, and it is estimated that the process will be complete by the end of
the year. Assuming full approval, we expect to be able to treat the first patient in
the study in the first quarter of 2024. CARMA consists of two partial studies and
completion is expected in 2028 with two interim reports in 2025 and 2026. The
first interim report in 2025 will provide information on potential side effects and
tumor response for the first 12 patients treated in the dose escalation portion of
the trial. The second interim report in 2026 will provide similar kinds of data for
the remaining 6 patients, who will be given the maximum tolerable dose.
iTANK receives expanded commercial protection in key market
During the past quarter, we continued to expand the patent protection for our
in-house method, iTANK, which makes it possible to strengthen the efficacy of
CAR T-cell therapies in treating cancers. This strengthening comes from initiating a parallel immune response to most targets in cancer cells and by counteracting the otherwise highly immunosuppressive microenvironment in solid
tumors. In September, the China National Intellectual Property Administration
announced a Notice of Allowance for iTANK, which opens the way to new commercial possibilities in the region and at the same time is clear proof of the scientific value of our gene technology method. Together with the patent that was
previously granted in the European market, this approval is a key component
in our long-term effort to build up the value in iTANK, both through utilizing the
technology in our internal drug projects and by launching the technology for
other companies that are developing CAR T-cell therapies. At present there are
more than 400 active CAR T-cell projects in the preclinical phase – the phase
where the integration of iTANK is most suitable – and we are actively engaged
in addressing this well-defined market with the goal of signing non-exclusive
licensing agreements.
Preclinical analyses evaluate possible administration methods for ELC-401
The development of our other iTANK-reinforced CAR T-cell therapy, ELC-401 is
in the preparatory clinical phase ahead of a potential initial trial in patients
suffering from glioblastoma, an aggressive form of brain cancer. Since the
brain is protected by the blood-brain barrier, which efficiently blocks out large
molecules and cells, we are now conducting studies to identify the optimal
method for administering the treatment. At the same time, the production of
the virus vectors to be used in manufacturing the CAR T-cells is in progress.
The viruses are produced in a GMP lab, and carry the genetic code for the
synthetic receptor (CAR) that homes in on the tumor antigen we are targeting
in glioblastoma and incorporates itself into the patient’s own T cells during the
cancer treatment. We are also evaluating the possibilities of funding the clinical
development program through partnership or soft financing. In early November, the Swedish Research Council (Vetenskapsrådet) announced that Elicera’s
CEO, Magnus Essand, had been awarded a research grant linked to his role as
professor at Uppsala University. Even if the funds will not go directly to the company, the grant will finance the research group’s efforts at developing the same
CAR T-cell therapy as the one used in ELC-401.
Survey of priority indications for ELC-201
During the autumn, we concluded an extensive survey of possible indications for
ELC-201 based on both scientific and commercial considerations. Strategic efforts
are now underway ahead of the decision on which form or forms of cancer are
to be prioritized in the clinical development of this oncolytic virus therapy armed
with iTANK. After that, we will initiate dialogue as soon as possible with relevant
regulatory agencies while continuing to evaluate various financing alternatives
for the clinical trial program. As in our other internal development projects, routine activities are in progress to establish partnerships with drug companies that
have plenty of resources, in parallel with our search for soft financing.
The Phase I/IIa trial of ELC-100 (AdVince) will soon be fully recruited
In AdVince, the Phase I/IIa trial of ELC-100, the twelfth and final patient is currently being recruited, whom we hope can be included in the trial around the end
of the year. After that, a clinical follow-up will be conducted on the patient and
we expect to be able to present the preliminary trial data in the first half of 2024.
Based on the outcome of the study, we will be able to make a more detailed
plan for the next step in the clinical development program.
In summary, we are closing in on a number of important milestones in the
company’s development that, even in the short-term perspective, will increase
its value. Owing to a high rate of development in modern gene technology, increased interest in investments in cell therapy treatments from the drug industry and clearer regulatory frameworks from government agencies, conditions are continually being strengthened for both the commercialization of iTANK and the clinical development of our innovative therapies against difficult cancers.
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;11 CET on November 14, 2023.
Elicera Therapeutics AB’s interim report for January to September 2023 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
Erik Penser Bank
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 visit www.elicera.com