Adaptimmune Therapeutics (ADAP) Commences MAGE-A10 SPEAR Phase I T-Cell Therapy Triple Tumor Study

October 18, 2016 8:10 AM EDT
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Adaptimmune Therapeutics plc (NASDAQ: ADAP) announced that it has initiated a Phase I triple tumor study using its wholly owned MAGE-A10 SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in patients with inoperable or metastatic urothelial cancer (transitional cell cancer of the bladder, ureter, or renal pelvis), melanoma, or squamous cell carcinoma of the head and neck.

This is the first collaborative study under the recently announced multi-year strategic alliance between Adaptimmune and The University of Texas MD Anderson Cancer Center, designed to expedite the development of novel adoptive T-cell therapies for multiple types of cancer. The two teams are collaborating in a number of areas including preclinical and clinical development of Adaptimmune’s first and second generation SPEAR T-cell therapies across a number of cancers.

"We are excited to initiate this triple tumor study with our partners at MD Anderson," said Dr. Rafael Amado, Adaptimmune’s Chief Medical Officer. "While important advances are being made with immune therapies in inoperable or metastatic tumors of the urothelium, and in melanoma and head and neck cancers, there remains a significant unmet medical need for more effective therapies for patients suffering with these cancers. It is our hope that this study will prove to be a positive first step towards the development of this SPEAR T-cell therapy in patients who are HLA-A2 positive and have advanced solid tumors expressing MAGE-A10."

This is a Phase I, open-label, modified 3+3 dose escalation study of autologous T-cells genetically engineered with an affinity optimized MAGE-A10 T-cell receptor in HLAA*0201 and HLA-A*0206 positive patients with inoperable or metastatic urothelial cancer (transitional cell cancer of the bladder, ureter or renal pelvis), melanoma, or squamous cell carcinoma of the head and neck expressing the MAGE-A10 antigen.

The study is part of a multi-center study intended to enroll up to 12 patients in leading clinical centers in the United States, with MD Anderson Cancer Center being the first site initiated, and will assess the safety and tolerability of Adaptimmune’s affinity enhanced T-cell therapy targeting MAGE-A10. Secondary objectives will include the assessment of clinical efficacy, measurements of durability of persistence of MAGE-A10 T-cells in the blood, and exploratory tumor biomarker studies and evaluations of the phenotype and functionality of MAGE-A10 T-cells.



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