Elicera Therapeutics includes the first patient in the Phase I/II clinical study CARMA targeting B-cell lymphoma

Gothenburg, November 5, 2024 – Elicera Therapeutics AB (publ), a clinical stage cell and gene therapy company developing next generation cancer treatments based on its proprietary commercial technology platform iTANK, announced today that the first patient has been enrolled in the company's Phase I/II clinical study, CARMA. The study aims to evaluate the iTANK-armed CAR T-cell therapy, ELC-301, in patients with hard-to-treat B-cell lymphoma, mantle cell lymphoma, or indolent lymphoma who have not responded to standard treatment or have experienced a relapse of the disease.

The study will be conducted in two parts, with the initial phase involving dose escalation in 12 patients to determine the optimal dosing range for treatment with ELC-301. In the next phase, the maximum tolerable dose will be evaluated in an additional 6 patients, with a total of 12 patients expected to receive treatment at this dose level.

The study is being conducted at Uppsala University Hospital and Karolinska University Hospital in Huddinge. According to the company’s preliminary timeline, the dose escalation study, including 12 patients in total, is expected to be completed and reported in the second half of 2025. Data from the first dose group of three patients is expected to be reported in first quarter of 2025. Preliminary results from the second part of the study are anticipated approximately 6–12 months later. Following treatment, a follow-up period of at least two years will occur, meaning CARMA is expected to be completed and fully reported in 2028.

CARMA is a single-arm, open-label multicenter study aiming to evaluate the safety profile and treatment efficacy of a single dose of ELC-301. It targets patients diagnosed with relapsed or refractory CD20-positive B-cell lymphoma, mantle cell lymphoma, or indolent lymphoma. The study will examine, among other things, the treatment’s antitumor effect, toxicity, and tolerability.

“We are very pleased to finally begin our first clinical evaluation of ELC-301 and reach one of the most important milestones in our company history. It is an important step towards our goal of hopefully offering a new treatment for aggressive forms of B-cell cancer. The clinical development of ELC-301 will also provide us with important insights into our iTANK technology platform, which aims to generate a broad immune response against cancer cells,” 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

Mangold Fondkommission AB

About ELC-301
Elicera Therapeutics' drug candidate ELC-301 is a CAR T-cell therapy that targets CD20, a tumor antigen target expressed on B-cells, for the treatment of B-cell lymphoma, mantle cell lymphoma or indolent lymphoma. In addition to the direct cell-killing effect of CAR T-cells, they also express the immune-activating protein NAP, which is derived from a common bacterial species. In preclinical studies, the protein has been shown to be powerful in activating the body's own immune system against cancer, in parallel with the direct effect of the CAR T-cells, to effectively attack and kill tumor cells. The drug candidate has been armed with Elicera Therapeutics' technology platform iTANK.

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.