The kick-off meeting of PragmaTIL, a project that will finance a pioneering academic clinical trial in advanced therapies, coordinated by VHIO, was held on May 26 at Cosmocaixa Barcelona.
“The main objective of the project is to optimize the treatment with tumor-infiltrating lymphocyte adoptive cell therapy (TIL-ACT) of patients with melanoma, lung cancer, or cervical cancer. and substantially expand and improve the clinical application of this treatment modality in academic hospitals,” explains Dr. Elena Garralda, director of the Molecular Cancer Therapy Research Unit (UITM)- Caixa Research, head of the Early Clinical Drug Development Group, and coordinator of the PragmaTIL project.
Adoptive cell therapy with TILs
TILs are the T lymphocytes of the immune system that occur naturally in the tumor microenvironment. Adoptive cell therapy with TILs is a type of immunotherapy that involves extracting these lymphocytes from the patient’s tumor tissue, producing them in large quantities in the laboratory, and re-infusing them into the patient to help the immune system fight the tumor.
“The clinical trial will allow us to determine whether it is possible to reduce the toxicity associated with high doses of interleukin-2 (IL-2), a cytokine necessary for the expansion and activation of TILs in patients, while maintaining the efficacy of the treatment,” says Dr. Garralda. “This improved tolerability will facilitate the clinical management of patients and improve their quality of life, two important barriers to the application of this treatment.”
The study will compare the adverse effects of normal IL-2 with a recombinant IL-2 supplied by the pharmaceutical company Anaveon.
The consortium is made up of 12 centers and includes the participation of some of the largest TIL (tumor infiltrating lymphocyte)-producing hospitals in Europe: the Netherlands Cancer Institute Antoni Van Leeuwenhoek (NKI AVL), Herlev Hospital (Region Hovedstaden, Denmark), Karolinska University Hospital (Region Stockholm, Sweden), and worldwide, Sheba Medical Center (Israel). This project will allow the coordination of all these centers within the same clinical trial, each with its own TIL product, an innovative concept in the field of advanced therapies produced in academic centers, as indicated by Dr. Silvia Martín Lluesma, head of the AECC Program of Excellence Accelerator of Advanced Therapies at VHIO, with additional support from the CAIMI Program of the BBVA Foundation. This complex regulatory procedure will be managed by the PragmaTIL partner Asphalion, who will also oversee the pharmacovigiliance of the clinical trial.
In addition, the project has the participation of recognized experts in the field, including IGR, UNICANCER, SEINTINELLES, and la Caixa Foundation, in collaboration with IrsiCaixa. This set of experts has worked closely with a group of patients to select self-reported outcomes, which will allow us to accurately capture the subjective experiences of those participating in the trial. The project will also include a health technology assessment and a return on investment plan by BCN Health and Innovandum Health, respectively.
The PragmaTIL project is funded with nearly six million euros by the European Union in the framework of the European Commission’s Cancer Mission, under the Horizon Europe: Research and Innovation Actions program.
To learn more about PragmaTIL, please visit www.pragmatil.eu
