Athenex announced that preliminary results of pilot studies in China in which patients received T-cell receptor affinity enhancing specific T-cell therapy, or TAEST, showed "encouraging positive" clinical signals in terms of efficacy and safety. The pilot studies are being conducted in China by Xiangxue Life Sciences, a wholly-owned subsidiary of Xiangxue Pharmaceutical. In July, XLifeSc and Athenex entered into an agreement to establish a new joint venture named Axis Therapeutics, which owns the global rights to the TAEST technology, excluding China and in this territory Axis Therapeutics is leading the research, development and commercialization efforts of T-cell receptor-engineered T cells, a form of cancer immunotherapy. The pilot studies are focused on the testing of TAEST technology generated T-cells, with enhanced binding affinity, against the antigen NY-ESO-1 and is HLA-A restricted. Preliminary results of TAEST technology generated T-cell therapy studied in nine end-stage cancer patients who failed all standard treatments showed the following: In the first three patients, dose escalation in one patient and full dose in two patients were tested. All three patients showed an acceptable safety profile. Two of the patients showed stable disease with survival of six and 10 months, respectively. One patient with lung cancer showed a small tumor reduction, and a reduction in pain and softening of the subcutaneous metastasis following treatment. Lymphodepletion was added to the protocol in patients four through nine. Treatment was well tolerated with fever, chills, weakness and mild skin rash observed. Two patients had more than 40% reduction in tumor size, as measured by CT scans. The patient with breast cancer also had healing of two skin metastatic ulcers. Two other patients showed stable disease. Both of these patients showed significant tumor necrosis shortly after the treatment, resulting in the formation of cavitation in the middle of the tumors. Clinically, there was also symptomatic relief of local pain reported during the period of radiologic evidence of increased tumor necrosis. The remaining two patients with lung cancer had stable disease for more than 60 days after treatment. This study also observed the expected cytokine response, detection of TCR-expression on T-cells, and persistence of the introduced TCR-gene in all patients during therapy.
