On September 23, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) 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 (Press release, Athenex, SEP 23, 2020, View Source [SID1234573871]).
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TCRT-ESO-A2 is being developed by Axis Therapeutics Limited, a joint venture between Athenex and Xiangxue Life Sciences Limited ("XLifeSc"), a subsidiary of Xiangxue Pharmaceutical Co., Ltd. (Shenzhen Exchange: 300147). 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.
"The FDA’s allowance of this IND application for TCRT-ESO-A2 represents another important milestone for Athenex, as we further expand our oncology-focused pipeline in the field of T cell based cancer immunotherapy," stated Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex, and Chief Executive Officer of Axis Therapeutics. "We are extremely pleased by the allowance of this IND application, which represents the 10th IND allowed by the FDA for Athenex. We were also excited by the observed preliminary, positive clinical signals in pilot studies in China using TAEST16001 conducted by our partner, XLifeSc."
Mr. YongHui Wang, Chairman and Chief Executive Officer of Xiangxue Pharmaceutical, and Chief Executive Officer of XLifeSc, said, "This achievement with TCRT-ESO-A2 follows the IND allowance of TAEST16001 in China by the National Medical Products Association and represents the successful collaboration of our joint development team at Axis Therapeutics. XLifeSc has initiated a Phase I trial of TAEST16001 in China and we are excited to continue working with the team at Athenex to potentially bring a differentiated and valuable immunotherapy technology to cancer patients around the world."
Dr. Daniel Lang, President of Axis Therapeutics, added, "Our TCR-T cell therapy is based on the proprietary TAEST (T cell receptor Affinity Enhancing Specific T cell therapy) 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."