XLifeSc Announces that Axis Receives FDA Clearance for TCR-T Cell Therapy IND to Initiate Clinical Trials in the USA
As announced by Athenex, Inc. (NASDAQ: ATNX), Axis Therapeutics Limited, a joint venture between Athenex and Xiangxue Life Sciences Limited (“XLifeSc"), 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.
XLifeSc, a subsidiary of Xiangxue Pharmaceutical Co., Ltd. (Shenzhen Exchange: 300147), has developed the proprietary TAEST technology, an autologous cell-based cancer immunotherapy. TCRT-ESO-A2 is similar to TAEST16001 in that both therapies express the same affinity-enhanced TCR. In 2018, XLifeSc granted a license for TAEST16001 to Axis Therapeutics to research, develop and commercialize this proprietary TCR-T Therapy outside of mainland China. TCRT-ESO-A2 is being developed by Athenex, on behalf of Axis Therapeutics, in the USA.
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.”