Elicera Therapeutics provides update on preclinical CAR T-cell program ELC-401 for glioblastoma: preclinical development concluded and clinical trial planning underway

ELC-401 is an iTANK-armed CAR T-cell therapy targeting the tumor antigen IL13Ra2, which is overexpressed in most glioblastoma tumors. The program leverages Elicera's iTANK technology to enhance CAR T-cell efficacy by promoting a broader immune response against the immunosuppressive tumor microenvironment characteristic of solid tumors like glioblastoma.

Key milestones and updates:

• Preclinical development of ELC-401 has been successfully concluded.
• Through preclinical studies, the company has determined that local administration of CAR-T cells represents the optimal route of delivery to overcome the blood-brain barrier (BBB) and ensure effective CAR T-cell trafficking to tumors in the brain.
   

Elicera has advanced toward clinical development with a planned phase I/Ib dose-escalation/expansion trial. The proposed study design includes:

• Enrollment of 12 patients across four arms (three patients per arm), phase Ia.
• Two dose levels (low and high), with repeated CAR T-cell dosing in all arms.
• All patients will have previously undergone standard treatment, including surgical resection of the primary tumor, allowing for confirmation of IL13Ra2 expression-the selected target antigen for ELC-401.
• Patients will be eligible for treatment if they exhibit IL13Ra2-positive expression and have recurrent disease scheduled for a second surgery (re-resection).
• The most optimal arm identified in the phase Ia study may later be expanded in a phase Ib study with additional patients.
   

The trial incorporates a unique design to generate valuable translational data:

• One arm at each dose level (low and high) will receive an initial dose of ELC-401 pre-surgery. This provides a key opportunity to assess mode-of-action by analyzing immune cell infiltration in resected tumor tissue post-treatment, allowing comparison with untreated tumors (from baseline biopsies) and between the two dose levels.
   

The proposed study design will be discussed with the Swedish Medical Products Agency (MPA) during a scientific advice meeting scheduled for mid-June 2026. These plans remain preliminary and are subject to feedback and agreement with the MPA. In parallel, Elicera is currently conducting process development studies to establish a robust and efficient manufacturing process that ensures high-quality CAR T-cells in appropriate formulations suitable for clinical use. Following this, a technology transfer to a selected manufacturer will be required. Assuming alignment on the study design with the MPA and successful completion of these manufacturing-related activities, the clinical trial could potentially commence during the second half of 2027.

Jamal El-Mosleh, CEO of Elicera Therapeutics, commented:

"Completing preclinical development and identifying optimal local administration routes for ELC-401 marks a major step forward in our mission to address the devastating challenge of glioblastoma. The planned trial design is innovative, incorporating pre- and post-surgical dosing to generate critical insights into CAR T-cell biology in the brain while prioritizing patient safety. We look forward to constructive discussions with the MPA in June and continue to explore multiple avenues to support the program's advancement.

Elicera is actively pursuing several opportunities to secure non-dilutive ("soft") funding through grant applications from various sources. Responses to these applications are expected throughout 2026 and will hopefully help support the funding of the planned clinical trial for ELC-401."