On July 2, 2015 Adaptimmune reported 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 Schedule your 30 min Free 1stOncology Demo! The acceptance of this IND allows Adaptimmune to initiate an open label Phase I/II study designed to Know more, wherever you are: MAGE-A10 (melanoma antigen family A10) is a member of the MAGE-A family of cancer/testis tumorassociated
(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 (Press release, Adaptimmune, JUL 2, 2015, View Source [SID:1234506018]).
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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.
Latest on CAR/TCR Therapies in Oncology, book your free 1stOncology demo here.
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 MAGEA10
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.
About Adaptimmune’s TCR Technology
Adaptimmune’s proprietary TCR technology enables the Company to genetically optimize T-cell receptors
(TCR) in an effort to equip them to recognize and bind cancer antigens that are presented in small
quantities on the surface of a cancer cell, whether of intracellular or extracellular origin, thus initiating cell
death. The Company’s differentiated, proprietary technology allows it to reliably generate parental TCRs to
naturally presented targets, affinity optimize its TCRs to bind cancer proteins from solid and hematologic
cancers that are generally unavailable to naturally occurring TCRs, and to significantly reduce the risk of
side effects resulting from off-target binding of healthy tissues.
About NSCLC
Lung cancer is the third most common form of cancer in the US after prostate cancer in men and breast
cancer in women. However, it is by far the leading cause of cancer deaths in both men and women in the
United States. Non-small cell lung cancer or NSCLC is the most common type of lung cancer, representing
approximately 85 percent of lung cancers. The 1- and 5-year relative survival rates for lung cancer are 44
percent and 17 percent, respectively. More than half of lung cancer patients (57 percent) are diagnosed at
a late stage of cancer development, for which the 1- and 5-year survival is only 26 percent and 4 percent,
respectively.