Elicera Therapeutics submits GMP validation data to the Swedish Medical Products Agency for the CARMA study to supplement the conditionally approved clinical trial application

December 22, 2023

Gothenburg, December 22, 2023 – 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 it has submitted complementary data to the Swedish Medical Product Agency (MPA) that validates the GMP-level production standard of the CAR T-cell therapy ELC-301. The data package is submitted to meet the MPA’s request for additional information which was queried in its conditional approval of Elicera Therapeutic’s clinical Phase I/IIa study CARMA.

In January 2023, Elicera Therapeutics submitted a Clinical Trial Application (CTA) to the MPA to conduct a clinical Phase I/IIa study (CARMA) aimed at evaluating the safety and efficacy of ELC-301, a CD20-directed iTANK-armed CAR T-cell therapy, in patients with relapsed and/or refractory B-cell malignancies. In April, the company received a conditional approval from the MPA, requesting complementary data to validate the production process of ELC-301 according to GMP standards. Elicera Therapeutics has now generated preclinical validation data, confirming high and consistent quality of its active pharmaceutical substance, and submitted the complementary information to the regulatory agency. The MPA will now review the data, for a period of maximum 14 weeks, and subsequently inform the company whether it can initiate the Phase I/IIa study CARMA or if additional data is needed.

"We are glad to have finalized our validation of ELC-301 and achieved a production process worthy of GMP standards. Next, we look forward to the MPA’s hopefully speedy review of our full clinical trial application and aim to be able to initiate the CARMA study in the first part of 2024,” says Jamal El-Mosleh, CEO of Elicera Therapeutics.

Elicera Therapeutic’s candidate therapy ELC-301 constitutes a fourth generation CAR T-cell therapy that targets the CD20 antigen, which is expressed on the cell surface of B-cell lymphoma cells. ELC-301 has been armed with iTANK to elicit a dual mode-of-action, partly via a direct cancer cell-killing effect by CAR T-cells, partly by activating the patients’ own killer T-cells against a wide array of target antigens. Thus, the patient’s killer T-cells are expected to target cancer cells independent of CD19 or CD20 expression

For further information please contact:

Jamal El-Mosleh, CEO, Elicera Therapeutics AB

Phone: +46 (0) 703 31 90 51

About CAR T-cell therapies

CAR T-cell therapy was named "Advance of the Year 2018" by ASCO (American Society of Clinical Oncology), one of the world's largest cancer organizations, thanks to the curative potential shown by the treatment in various types of blood cancer such as leukemia and lymphoma. Between 30-40% of patients with various types of blood cancer are expected to achieve a complete ongoing response and for this patient group there are currently six approved CAR T-cell therapies around the world. So far, however, no CAR T-cell therapy has been approved for the treatment of solid tumors. Solid tumors have a strong immunosuppressive tumor microenvironment that counteracts CAR T-cells’ ability to attack the cancer cells. In addition, solid tumors have a high degree of heterogeneity, meaning that different parts of the tumor have different genetic mutations, making it difficult to direct a single CAR T-cell to target all 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: 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. 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 the CARMA study

The clinical phase I/IIa-study (CARMA) aims to evaluate the safety and efficacy of one dose of CD20-directed CAR T-cells, which have been armed with bystander immune activating properties using the iTANK-platform, in patients with relapsed and/or refractory B-cell malignancies. The evaluation is based on several parameters, including tolerance, toxicity, biological effects, and anti-tumor responses. The clinical trial will be conducted at the Academic hospital in Uppsala and at Karolinska University Hospital in two stages: a dose escalation stage (Phase I) to minimize the risk of serious side effects and to identify the appropriate testing dosage, followed by treatment in Phase IIa of the remaining six patients with the optimal dose identified in Phase I. A total of 12 patients are expected to evaluable for safety and efficacy with the maximum tolerable dose. The dose escalation stage is expected to be completed and reported in the second half of 2025, and stage 2 is expected to be completed and reported about 6-12 months later. The CARMA-study is expected to be completed and reported during 2027, after a minimum two-year follow-up-period.

About ELC-301

ELC-301 a CD20-directed CAR T-cell therapy for the treatment of B-cell malignancies. ELC-301 has been armed with the company's iTANK-platform for activation of endogenous killer T-cells against the whole set of relevant target antigens on tumor cells, thus generating a powerful parallel immune response against cancer.

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.

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