On May 16, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it has initiated the first site for its MAGE‑A4 SPEAR T-cell study in patients with multiple malignant solid tumors. This study is now open for enrollment (Press release, Adaptimmune, MAY 16, 2017, View Source [SID1234519148]).

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This is Adaptimmune’s third wholly-owned therapeutic candidate to enter clinical trials. The Company already has ongoing studies to evaluate its T-cell therapies targeting the MAGE-A10 cancer antigen in patients with non-small cell lung cancer, urothelial cancer, melanoma, or head and neck cancers; and AFP in patients with hepatocellular carcinoma.

"We are excited to initiate this study to evaluate our MAGE-A4 T-cell therapeutic candidate in patients with multiple malignant solid tumors," said Rafael Amado, Adaptimmune’s Chief Medical Officer. "Preclinical evaluations of our MAGE-A4 affinity matured T-cell receptor show optimized targeting of, and specificity for, MAGE-A4 expressing cancer cells. MAGE-A4 is among the most commonly expressed cancer embryonic antigens; therefore, we have the opportunity to evaluate the potential of this promising therapy in a wide range of cancers."

This is a Phase I, open label, dose escalation study designed to evaluate the safety and anti-tumor activity of Adaptimmune’s MAGE-A4 therapeutic candidate in patients who are HLA-A*02 positive and have inoperable locally advanced or metastatic melanoma, urothelial, head and neck, ovarian, non-small cell lung, esophageal, and gastric cancers expressing MAGE-A4. The study will enroll up to 32 patients. The primary objective of the study is to evaluate the safety and tolerability of MAGE-A4 SPEAR T-cell therapy. Additional objectives include anti‑tumor activity, persistence of genetically modified cells in the body, and evaluation of the phenotype and functionality of genetically modified cells isolated from peripheral blood or tumor post infusion.

Additional information about this study is available at www.clinicaltrials.gov by searching on NCT03132922.