Elicera Therapeutics receives approval to initiate clinical Phase I/II-study CARMA with CAR T-cell therapy ELC-301 in B-Cell lymphoma

Gothenburg, February 9, 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, today announced that the company has received approval from the Swedish Medical Products Agency to start the clinical phase I/II study CARMA in patients with B-cell lymphoma that no longer respond to standard treatment or have relapsed.

CARMA is a single-arm, unblinded, multicenter study that aims to evaluate the safety profile and treatment effect after one dose of ELC-301. It is carried out on patients diagnosed with difficult-to-treat CD20-positive B-cell lymphoma, mantle cell lymphoma or indolent lymphoma, or who have relapsed in the disease. Among other things, the study will examine the treatment's anti-tumor effect, toxicity and tolerability.

The CARMA-study is carried out in two stages; a dose escalation phase (phase I) with a maximum of 12 patients, aimed at determining the optimal dose range, followed by a dose expansion phase (phase IIa) with a maximum of 6 patients receiving the maximum tolerated dose. A total of 12 patients are planned to be treated with the maximum tolerated dose. The study will be conducted at Uppsala University Hospital and Karolinska University Hospital in Huddinge. According to the company's preliminary timetable, the dose escalation study is expected to be completed and reported in the second half of 2025, and phase 2 is expected to be completed and reported approximately 6-12 months later. The full CARMA-study is expected to be completed and reported in 2027, after a follow-up period of at least two years.

"We are pleased that the Swedish Medical Products Agency has given the go-ahead for the start of our clinical study with ELC-301 in difficult-to-treat or recurrent B-cell lymphoma. The treatment has the potential to become a very important alternative for those patients whose disease no longer respond to standard therapy and thus lack effective treatment options. The study is also an important step in proving the enhancing function of our technology platform iTANK, which has the potential to activate the body's own immune system against cancer cells," says Jamal El-Mosleh, CEO of Elicera Therapeutics.

For further information please contact:

Jamal El-Mosleh, CEO, Elicera Therapeutics AB

Phone: +46 (0) 703 31 90 51
jamal.elmosleh@elicera.com

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 treatment method has been developed using Elicera Therapeutics' commercial 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 trigger potent bystander antitumour 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. The company’s certified advisor is Carnegie Investment Bank AB (publ), www.carnegie.se. For additional information, visit www.elicera.com.