Processutveckling för tillverkning av CAR-T celler
| Diarienummer | |
| Koordinator | Elicera Therapeutics AB |
| Bidrag från Vinnova | 4 993 162 kronor |
| Projektets löptid | februari 2022 - januari 2024 |
| Status | Avslutat |
| Utlysning | Nya och förbättrade biologiska läkemedel |
| Ansökningsomgång | Nya och förbättrade biologiska läkemedel i sjukvården |
Viktiga resultat som projektet gav
We have successfully established an automated process for CAR-T manufacturing (referred as MP1.0). The MP1.0 was also successfully implemented into Vecura´s GMP lab to manufacture Elicera’s CAR-T drug candidate ELC-301 in the coming CARMA-01 clinical study.
Långsiktiga effekter som förväntas
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.
Upplägg och genomförande
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.