The Center for Drug Evaluation (CDE) in China has indicated on its website that Immunotech Biopharm Ltd, a specialist in chimeric antigen receptor T-cell (CAR-T) therapies, has received breakthrough therapy designation (BTD) status for its EAL (amplified activated lymphocytes) product. This designation recognizes EAL’s potential use in the prevention of recurrence of primary hepatocellular carcinoma (HCC) after radical resection.
EAL’s Development and Efficacy
EAL, a multi-target tumor cell immunotherapy product under development since 2006, has demonstrated good efficacy in killing tumor target cells through in vivo pharmacodynamic tests. The product has shown an overall good safety profile, making it a promising candidate for cancer treatment. Multiple clinical studies have highlighted EAL’s significant efficacy in the field of solid tumor treatment.
Phase II Study and Broad Application
The product candidate is currently undergoing a Phase II study focused on preventing postoperative recurrence of liver cancer. Additionally, EAL is being explored for its potential in treating a range of other cancers, including lung cancer, gastric cancer, glioma, and acute myeloid leukemia. The BTD status from the CDE underscores the potential impact of EAL on the treatment landscape for these diseases.-Fineline Info & Tech
