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Adaptimmune Announces FDA Acceptance of IND Application for Affinity Enhanced T-Cell Therapy Targeting AFP in Liver Cancer

PHILADELPHIA and OXFORD, United Kingdom, April 07, 2016 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (ADAP), a leader in the use of TCR engineered 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 affinity enhanced T-cell receptors (TCRs) specific for alpha fetoprotein (AFP) in patients with locally advanced or metastatic hepatocellular carcinoma, the sixth most common cancer worldwide. The IND is now active.

This will be Adaptimmune`s second wholly-owned therapeutic candidate to enter clinical trials. The company initiated a study in December 2015 to evaluate its unpartnered T-cell therapy targeting the MAGE-A10 cancer antigen in patients with non-small cell lung cancer.

The acceptance of this IND allows Adaptimmune to initiate an open label Phase I study designed to evaluate the safety and anti-tumor activity of its AFP therapeutic candidate in hepatocellular carcinoma (HCC). Site selection activities are under way, and the company anticipates that enrollment will commence in the second half of 2016.

"Hepatocellular carcinoma is one of the most common and deadly types of cancer in the world and it represents a significant unmet medical need, as there is a dearth of effective therapies for advanced disease," said Rafael Amado, Adaptimmune`s Chief Medical Officer. "We are pleased to initiate clinical evaluation of our AFP T-cell therapeutic candidate in this patient population."

AFP is believed to be highly expressed in approximately 30 percent of hepatocellular carcinomas. Expression has been shown to be absent or very low in most adult non-reproductive tissues and will be evaluated prior to enrollment. Adaptimmune`s proprietary technology enables the company to routinely generate TCRs which address intracellular targets, such as AFP, that are not accessible to other therapies.

This will be a Phase I open label clinical trial evaluating the safety and anti-tumor activity of autologous T-cells expressing enhanced TCRs specific for AFP in HLA-A2 positive subjects with advanced HCC. The study will enroll up to 30...


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