Adaptimmune's IND Application for MAGE-A10 Accepted - Analyst Blog
Adaptimmune Therapeutics plc’s ADAP Investigational New Drug (IND) application for its autologous genetically modified T-cells used in expressing enhanced T cell receptors (TCRs) specific for MAGE A10 (MAGE-A10 T) has been accepted by the FDA. The company is looking to evaluate MAGE A10 approved for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
With the FDA accepting the IND, the company can now go ahead and commence an open-label phase I/II study. The dose escalating study will evaluate three doses of genetically engineered MAGE-A10 T-cells in HLAA*0201 and HLA-A*02:06 patients with advanced (stage IIIB or stage IV) NSCLC whose tumors express this antigen.
Along with safety and tolerability, the study will assess the efficacy, durability of persistence and evaluate the phenotype and functionality of MAGE-A10 T-cells.
The company reported that site initiation activity is currently underway and it expects to start enrolling patients this year.
We note that Adaptimmune, which focuses on the development of immuno-oncology products based on its T-cell receptor platform, has a strategic collaboration and licensing agreement with GlaxoSmithKline GSK for its lead program - NY-ESO TCR. The company has several proprietary programs and has identified more than 30 intracellular target peptides preferentially expressed in cancer cells,
Adaptimmune currently carries a Zacks Rank #3 (Hold). INSYS Therapeutics, Inc INSY and Eleven Biotherapeutics, Inc. EBIO are better-ranked stocks in the health care sector, each carrying a Zacks Rank #1 (Strong Buy).
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