FDA accepts Adaptimmune’s IND application for MAGE-A10 T therapeutic candidate to combat NSCLC

Jul 2 2015

Adaptimmune Therapeutics plc (Nasdaq:ADAP), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's investigational new drug (IND) application for autologous genetically modified T-cells expressing enhanced T cell receptors (TCRs) specific for MAGE A10 (MAGE-A10 T) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), and that the IND is now active.

The acceptance of this IND allows Adaptimmune to initiate an open label Phase I/II study designed to evaluate its wholly-owned MAGE-A10 T therapeutic candidate in NSCLC. Site initiation activities are now underway, and the Company anticipates that enrollment will begin in 2015.

MAGE-A10 (melanoma antigen family A10) is a member of the MAGE-A family of cancer/testis tumor-associated antigens. It is believed to be expressed in approximately 30 percent of lung (squamous cell carcinoma), bladder and skin melanomas, and at a lower incidence in many other cancers. Adaptimmune's proprietary technology enables the Company to routinely generate TCRs which address intracellular targets, such as MAGE-A10, that are not accessible to certain other experimental modalities.

"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," said James Noble, Adaptimmune's Chief Executive Officer. "In addition, this validates the progress we are making in applying our platform to develop a broad pipeline of novel proprietary TCR therapeutics."

This will be 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 (stage IIIB or stage IV) NSCLC whose tumors express this antigen. The study will assess the safety and tolerability of MAGE-A10 T in these patients. Secondary objectives will include the assessment 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.