The IND acceptance will allow the company to begin an open label Phase I/II trial designed to evaluate its wholly-owned MAGE-A10 T therapeutic candidate in NSCLC.
Currently, the company is carrying out site initiation activities with patient enrollment expected to be started later this year.
This is an open label Phase I/II dose escalating study of three doses of genetically engineered MAGE-A10 T-cells in HLAA 0201 and HLA-A 02:06 patients with advanced NSCLC whose tumors express this antigen.
The trial is designed to evaluate the safety and tolerability of MAGE-A10 T in these patients.
MAGE-A10, which is a member of the MAGE-A family of cancer/testis tumor-associated antigens, is believed to be expressed in about 30% of lung, bladder and skin melanomas, and at a lower incidence in many other cancers.
The company said that its proprietary TCR technology allows to routinely generate T-cell receptors (TCRs) which address intracellular targets, such as MAGE-A10, that are not accessible to certain other experimental modalities.
Adaptimmune chief executive officer James Noble said: "The FDA’s acceptance of this IND represents an important step in our strategy to identify and develop new T-cell-based immunotherapeutics to combat non-small cell lung cancer and other cancers, and we are excited to be working toward initiating clinical development of another of our promising TCR therapeutic candidates.
"In addition, this validates the progress we are making in applying our platform to develop a broad pipeline of novel proprietary TCR therapeutics."
Secondary objectives of the Phase I/II trial will include the evaluation of efficacy of MAGE-A10 T, measurements of durability of persistence of MAGE-A10 T-cells in the blood, and evaluations of the phenotype and functionality of MAGE-A10 T-cells.