On January 9, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that the US Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application for autologous genetically modified T-cells expressing an affinity optimized T-cell receptor (TCR) specific for MAGE-A4 in patients with multiple malignant solid tumors (Press release, Adaptimmune, JAN 9, 2017, View Source [SID1234517320]). This will be Adaptimmune’s third wholly-owned therapeutic candidate to enter clinical trials. The IND is now active. Schedule your 30 min Free 1stOncology Demo! Under this IND, Adaptimmune will initiate a Phase I, open-label, modified 3+3 dose escalation study of autologous T-cells genetically engineered with an affinity optimized MAGE-A4 TCR in HLA*02 positive patients with inoperable locally advanced or metastatic melanoma, and urothelial, head and neck, ovarian, non-small cell lung, esophageal, and gastric cancers expressing MAGE-A4. Patients will receive preconditioning with modified fludarabine and cyclophosphamide as used in the Company’s ongoing synovial sarcoma study. This multi-tumor study will enroll up to 32 patients.
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