Process development for CAR-T cell manufacturing
| Reference number | |
| Coordinator | Elicera Therapeutics AB |
| Funding from Vinnova | SEK 4 993 162 |
| Project duration | February 2022 - January 2024 |
| Status | Completed |
| Venture | Next-Generation Biologics 5 |
| Call | New and improved biological drugs in healthcare |
Important results from the project
** Denna text är maskinöversatt ** We have successfully established an automated process for CAR-T manufacturing (referred to as MP1.0). The MP1.0 was also successfully implemented into GMP lab to manufacture Elicera´s CAR-T drug candidate ELC-301 in the upcoming CARMA-01 clinical study.
Expected long term effects
** Denna text är maskinöversatt ** Autologous CAR-T therapy needs personalized patient-specific drug manufacturing. MP1.0 features automatic process for CAR-T manufacturing that significantly reduces risk of human-handling error, and batch-to-batch variations. MP1.0 also significantly reduced the whole drug delivery time, wherein the vein-to-vein (from harvesting blood from patient to CAR-T administration back to the patient) time was reduced to 17 days. This can potentially make the therapy more accessible to cancer patients.
Approach and implementation
** Denna text är maskinöversatt ** MP1.0 CAR-T manufacturing process is GMP compliance and is successfully implemented in GMP lab and will be used for ELC301 manufacturing. CARMA-01 study will evaluate the safety and efficacy of ELC301 in patients with B cell malignancies. First-patient-in is expected in Q2 2024.