Adaptimmune Therapeutics, a clinical stage biopharmaceutical company focused on novel cancer immunotherapy products, has 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). This acceptance allows Adaptimmune to initiate an open-label Phase I/II study designed to evaluate its wholly-owned MAGE-A10 T therapeutic candidate in NSCLC.

The Company's proprietary TCR technology enables the generation of TCRs that address intracellular targets, such as MAGE-A10, which is expressed in approximately 30 percent of lung (squamous cell carcinoma), bladder, and skin melanomas. Adaptimmune's lead program is an affinity-enhanced TCR therapeutic targeting the NY-ESO cancer antigen, which has demonstrated signs of efficacy and tolerability in Phase 1/2 trials in solid tumors and in hematologic cancer types.

Key Takeaways:

• The FDA has accepted Adaptimmune's IND application for MAGE-A10 T therapeutic candidate in NSCLC, allowing the Company to initiate an open-label Phase I/II study.
• MAGE-A10 T is a novel T-cell-based immunotherapeutic candidate targeting the MAGE-A10 antigen, which is expressed in approximately 30 percent of lung, bladder, and skin melanomas.
• Adaptimmune's proprietary TCR technology enables the generation of TCRs that address intracellular targets, such as MAGE-A10, which is inaccessible to certain other experimental modalities.
• The open-label Phase I/II study will involve three doses of genetically engineered MAGE-A10 T-cells in patients with advanced NSCLC, with secondary objectives including assessment of efficacy, 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.
• Adaptimmune has identified over 30 intracellular target peptides preferentially expressed in cancer cells and is progressing eight of these through unpartnered research programs.
• The Company has a pipeline of novel proprietary TCR therapeutic candidates, including the NY-ESO TCR program, which has demonstrated signs of efficacy and tolerability in Phase 1/2 trials in solid tumors and in hematologic cancer types.

Statistics:

• MAGE-A10 is expressed in approximately 30 percent of lung, bladder, and skin melanomas.
• Adaptimmune's proprietary TCR technology enables the generation of TCRs that address intracellular targets, such as MAGE-A10.
• The open-label Phase I/II study will involve approximately 30 patients with advanced NSCLC.
• The study will assess the safety and tolerability of MAGE-A10 T in these patients, with secondary objectives including assessment of efficacy, 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.

Sources:

• Thomson Reuters ONE via COMTEX, July 2, 2015
• Adaptimmune Therapeutics website: http://www.adaptimmune.com
• Securities and Exchange Commission, Final Prospectus, May 7, 2015
• GlobeNewswire, Adaptimmune LLC, July 2, 2015