In 2015, the U.S. Food and Drug Administration (FDA) accepted the company’s investigational new drug (IND) application to evaluate MAGE-A10 T-cell therapy in people with certain types of advanced non-small cell lung cancer (NSCLC).
How MAGE-A10 T-cell therapy works
MAGE-A10 T-cell therapy consists of a patient’s own T-cells that are modified to recognize and kill cancer cells. The T-cells are first drawn from the patient’s blood. They are then genetically modified in the laboratory using the company’s SPEAR (specific peptide enhanced affinity receptor) T-cell platform and made to produce an engineered T-cell receptor (TCR) protein that recognizes the cancer antigen called MAGE-A10, which is found at high levels in a number of solid tumors.
The engineered T-cells are allowed to multiply in the laboratory before being administered back into the bloodstream of patient, who have been pre-treated with chemotherapy to prevent the rejection of the injected cells. The engineered cells further multiply in the patient’s body, and are designed to specifically target and destroy MAGE-A10-producing tumors.
MAGE-A10 T-cell therapy in clinical trials
Clinical trials that aim to evaluate the safety and anti-tumor activity of MAGE-A10 T-cell therapy in people with lung cancer, bladder cancer, melanoma, and head and neck cancers are ongoing.
An open-label, dose-escalation, first-in-human Phase 1 clinical trial (NCT02592577) is investigating the safety and efficacy of MAGE-A10 T-cell therapy in up to 28 adults with late-stage (stage 3 or 4) NSCLC that is positive for MAGE A10 protein expression, meaning either the protein or gene. Patients will be administered one of three escalating doses of modified T-cells to evaluate the safety of the treatment. Efficacy will be assessed through assessments of response rate, the duration of the response, progression-free survival, and overall survival. The study is currently enrolling patients in the U.S. and Canada; more information is available by clicking on its identification number. It expects to be completed in April 2019.
Another open-label, dose-escalation Phase 1 study (NCT02989064) aims to assess the safety and tolerability of MAGE-A10 T-cell therapy in up to 10 patients with MAGE-A10-positive urothelial cancer, melanoma, and head and neck cancer. The treatment’s potential effectiveness will be assessed by overall response rate, the duration of the response, progression-free survival, and overall survival. This study is also recruiting patients in the U.S. and Canada, and is expected to finish in 2020.
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