The company has used its semi-closed electroporation system to manufacture autologous CAR T cells to treat ovarian cancer and leukemia patients in two trials.
The company's T-cell product, PRIME IL-15, which is loaded with an IL-15fc nanogel, led 10 out of 17 advanced solid tumor patients to have stable disease.
The agency ordered Poseida to halt the trial in August after a patient died but is now allowing the company to resume the study with an amended protocol.
The study identified multiple clusters of engineered natural killer T cells based on RNA-seq and found that they could be effective against the disease.
Patients in the Phase II trial will receive infusions of autologous T cells that have been genetically engineered to remove the intracellular checkpoint CISH.
The Phase I/II trial will assess the safety, recommended dose, initial efficacy, and pharmacokinetics of the autologous T-cell therapy ET140203 Artemis.
