ATNX - FDA OKs Athenex IND application for TCRT-ESO-A2

Athenex (ATNX) announced that the USFDA has allowed its investigational new drug application for TCRT-ESO-A2, an autologous T cell receptor ((TCR))-T cell therapy targeting solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients. TCRT-ESO-A2 is similar to TAEST16001, an autologous cell-based therapy being developed simultaneously by XLifeSc for clinical application in China in that both therapies express the same affinity-enhanced TCR. Dr. Daniel Lang, President of Axis Therapeutics, added, “Our TCR-T cell therapy is based on the proprietary TAEST technology platform that provides high binding affinity of TCRs while reducing their off-target toxicity.We are encouraged by the preclinical and early clinical findings that indicate this TCR-T cell therapy technology could potentially be an effective treatment for multiple tumor types.We look forward to rapidly advancing the therapy into clinical development in the U.S.” Source: Press Release

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FDA OKs Athenex IND application for TCRT-ESO-A2