Gothenburg, August 11, 2026 - Elicera Therapeutics AB (publ), a clinical stage cell and gene therapy company developing next generation cancer treatments based on oncolytic viruses and CAR T-cell therapies, armed with immune-activating properties via the company's commercially available iTANK platform, today announces that the twelfth and final patient in the Phase I part of the CARMA study has been treated, and simultaneously provides a data update. Among the eleven patients evaluated to date, all have achieved disease control (no disease progression) one month after treatment, and 91 percent (10/11) have obtained an objective tumor response, including six patients (55 percent) with complete metabolic response (disease-free status) - of whom four still remain disease-free, one for at least 18 months and one for at least 12 months.
The CARMA study is a clinical Phase I/IIa trial evaluating the safety, optimal dosing, and preliminary efficacy of ELC-301 in patients with relapsed or refractory B-cell lymphoma that have undergone at least two previous lines of standard treatment with no remaining curative treatment options. The study includes a dose-escalation phase (Phase I) with twelve patients across three cohorts to identify the maximum tolerated dose, followed by further evaluation of six patients in an expansion phase (Phase IIa).
Key highlights from the data:
- 11 patients have so far undergone preliminary efficacy evaluation at the one-month follow-up.
- No dose-limiting toxicities (DLTs) have been observed, and the treatment has been well tolerated to date. The Data Safety and Monitoring Board (DSMB) has not yet assessed the third and final cohort of the Phase I part of the study.
- Among the 11 patients treated and evaluated for preliminary efficacy to date:
- Disease control rate: 100%.
- Overall response rate (ORR): 91% (10/11).
- Complete metabolic response/CMR (no active disease): 55% (6/11).
- Of the six patients with confirmed CMR at month one, four still had CMR at their most recent recorded follow-up.
- One patient has confirmed CMR for at least 18 months. Another patient has confirmed CMR for at least 12 months.
- Three of the eleven evaluated patients had previously been treated with CAR T-cells but subsequently relapsed. After treatment with ELC-301, tumor responses were observed in all three, including one with complete metabolic response.
- Of the three most recently included patients in the study, one had previously received CAR T treatment.
As soon as the twelfth and final patient in the Phase I part of the CARMA study has undergone their follow-up evaluation, the study's independent Data Safety and Monitoring Board (DSMB) will assess the third and final cohort. The DSMB's assessment will then determine the recommended Phase II dose (RP2D) to be used for continued enrollment in the dose-expansion part of the study (Phase IIa), where an additional six patients will be treated at the maximum tolerated dose.
"The eleven patients evaluated so far in the CARMA study continue to show strong data, with disease control in all patients and tumor responses in 91 percent. Three of them had previously received CAR T treatment and relapsed and are therefore defined as particularly difficult to treat. Among the three most recently included patients, one had stopped responding to their previous CAR T treatment - yet still achieved a tumor response with ELC-301. Particularly encouraging is that four of the six patients who achieved complete metabolic response remain disease-free, with one patient now disease-free for at least 18 months and another for at least 12 months. This is an early but important indication that the responses may be durable rather than temporary, which is critical for patients in this difficult-to-treat group and strengthens our confidence in the potential of ELC-301 and the iTANK platform. We now look forward to completing the evaluation of the final patient in the Phase I study, after which the DSMB will assess the last cohort ahead of the decision on continued enrollment in the dose-expansion part," says Jamal El-Mosleh, CEO of Elicera Therapeutics.
For further information, please contact:
Jamal El-Mosleh, CEO, Elicera Therapeutics AB (publ)
Phone: +46 (0) 703 31 90 51
jamal.elmosleh@elicera.com
Certified Advisor
DNB Carnegie Investment Bank (publ)
About the CARMA Study
CARMA is a phase I/IIa clinical study evaluating the safety and efficacy of the CAR T-cell therapy ELC-301 in the treatment of patients with B-cell lymphoma. The study is divided into a dose-escalation phase (phase I) and a dose-expansion phase (phase IIa). Phase I primarily aims to establish the optimal dose and safety profile in up to 12 patients, while phase IIa will further evaluate the efficacy of the maximum tolerated dose in an additional six patients. Phase I is planned to include three cohorts (dosing groups), with three patients in the first and second cohorts, and six patients in the third cohort, who are expected to receive the maximum tolerated dose. The CARMA study is being conducted at Uppsala University Hospital and Karolinska University Hospital in Huddinge.
About ELC-301
ELC-301 is a fourth-generation CAR T-cell therapy targeting the CD20 antigen, armed with the company's iTANK platform to activate a broader and more comprehensive parallel immune response against cancer. CAR T-cells are a form of cell therapy created by genetically modifying a patient's T-cells to express a synthetic receptor (chimeric antigen receptor, CAR). This receptor is specifically designed to target a single tumor antigen-a molecule visible on the surface of cancer cells-and enables the T-cells to locate, bind to, and destroy the cancer cells.
About the iTANK-platform
The iTANK technology platform has been developed 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: a very diverse set of tumor antigen targets and a very hostile tumor microenvironment. The technology is used to incorporate a transgene into CAR T-cells encoding a neutrophil activating bacterial protein (NAP). NAP secreted from the CAR(NAP) T-cells has been shown to be able to enhance the function of CAR T-cells and importantly activating a parallel bystander immune response against the cancer 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. Proof-of-concept data was published in Nature Biomedical Engineering in April 2022. The publication, titled "CAR T cells expressing a bacterial virulence factor triggers potent bystander antitumor responses in solid cancers" (DOI number: 10.1038/s41551-022-00875-5) can be found here: https://www.nature.com/articles/s41551-022-00875-5. More information about iTANK platform is available here: https://www.elicera.com/technology
About Elicera Therapeutics AB
Elicera Therapeutics AB (publ) has developed the patented gene technology platform iTANK that enables the arming of new and existing CAR T-cell therapies targeting aggressive and relapsing cancer forms. Elicera Therapeutics thereby addresses a well-defined and vast market. The company's CAR T-cell therapies have shown a potent effect toward solid tumors which are recognized as particularly difficult to treat and constitute the majority of cancer cases. The company addresses a global multibillion market in cell therapy through its offering of non-exclusive licensing of the iTANK-platform to companies in the pharmaceutical industry. Elicera Therapeutics has four internal development projects in immune therapy that separately have the potential to generate substantial value through exclusive out-licensing agreements. The company's share is traded on Nasdaq First North Growth Market. For additional information, visit www.elicera.com.
