Athenex & Xiangxue Life Sciences Announce Preliminary Study Results

Athenex, Inc. recently announced that preliminary results of pilot studies in China in which patients received T-cell receptor affinity enhancing specific T-cell therapy (TAEST) showed encouraging positive clinical signals in terms of efficacy and safety.

The pilot studies are being conducted in China by Xiangxue Life Sciences (XLifeSc), a wholly-owned subsidiary of Xiangxue Pharmaceutical Co., Ltd. In July 2018, XLifeSc and Athenex entered into an agreement to establish a new joint venture named Axis Therapeutics Limited, which owns the global rights to the TAEST technology, excluding China (XLifeSc retains the mainland China rights), and in this territory Axis Therapeutics is leading the research, development, and commercialization efforts of T-cell receptor-engineered T cells (TCR-T, including the TAEST technology), 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*02:01 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 6 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 (n=5), chills (n=4), weakness (n=4), and mild skin rash (n=3) observed. Two patients (one breast cancer, one synovial sarcoma) 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 (one liver cancer patient with retroperitoneal recurrence after resection, one with thyroid cancer) 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.

An abstract with more detailed data will be submitted for presentation at an international scientific meeting.

Dr. Yi Li, Chief Scientific Officer of Axis Therapeutics and XLifeSc, said “We believe our TAEST technology has four distinct advantages: first, our engineered TCR has an improved binding affinity; second, our engineered TCR has excellent expression level on the engineered T-cells; third, we have demonstrated in this pilot study that our engineered TCR genes persisted in these patients; and finally, we have developed other HLA subtypes and we will be able to treat more patients with different HLA subtypes in the near future.”

Dr. Johnson Lau, Vice Chairman and CEO of Axis Therapeutics and Chairman and CEO of Athenex, added “We are excited by the positive clinical signal observed in this group of patients. The safety profile is within expectations and within acceptable limits of cancer therapy. The observation of clinical signal in these patients, with tumor reduction of more than 40% in two patients and significant tumor necrosis after treatment in two others, indicates that this approach showed anti-tumor activity even in late stage cancer patients. We have also followed the circulating level of the engineered T-cells and inserted gene expression and so far, their persistence in the patients’ circulation suggested that this approach can have the desired effect of having a consistent anti-tumor immune response for at least a moderate amount of time. More work will be done soon to define the best treatment protocol to advance this program. We are very grateful to Perceptive Advisors for their support and confidence in our team which made this joint venture possible.”

Mr. YongHui Wang, Chairman of Axis Therapeutics and Chairman and CEO of Xiangxue Pharmaceutical, said “We are very impressed by the scientific and management skills that Athenex team contributes to this joint venture. We are excited to see these encouraging preliminary clinical data. We have full confidence in our collaboration and strongly believe that we will make a meaningful contribution to the arsenal of cancer treatment options for patients worldwide.”

Axis Therapeutics is also announcing the line-up of the management team, with Mr. YongHui Wang as the Chairman of the Board, Dr. Johnson Lau as Vice-Chairman and CEO, Dr. Yi Li as Chief Scientific Officer, Dr. WingKai Chan as Chief Medical Officer, and Ms. Jacqueline Li as the Chief Financial Officer.

Founded in 2003, Athenex, Inc. is a global clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery and development of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform and a Global Supply Chain Platform. The company’s current clinical pipeline is derived from four different platform technologies: (1) Orascovery, based on non-absorbed P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. Athenex has offices in Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan and multiple locations in Chongqing, China. For more information, visit www.athenex.com.

Founded in 1997 and is located in Guangzhou Science City, Guangzhou Economic & Technical Development District (GETDD), which is part of the core area of Guangdong, Hong Kong and Macao, or the Greater Bay Area. XPH is a high-tech enterprise integrating manufacturing, operation and R&D of products including pharmaceuticals, biological medicine, functional food, Chinese medicines and medical devices. XPH is recognized as one of pharmaceutical enterprises with most development potential in the industry in China and was listed in Shenzhen Stock Exchange in 2010 (stock code: 300147). XPH has directed its attention to leading biomedical technologies since 2012. XPH has built an international cooperative innovation system focusing on focused scientific research led by talent teams to introduce new medical innovative technologies. One important focus is on clinical immunotherapy development using the cutting-edge technologies involving high affinity specific T-cell receptor (TCR). Xiangxue Life Sciences (XLifeSc) is a wholly-owned subsidiary of Xiangxue Pharmaceutical, focused on TCR-based therapies for cancer and has developed a new generation TCR-T, named TAEST (TCR affinity enhanced specific T-cell-therapy), consisting of the expression of affinity enhanced T-cell receptors on the engineered T-cells to target HLA-antigenic peptide complex on certain types of cancer cells. Early clinical studies in China demonstrated a good safety profile in patients. For more information, visit www.xphcn.com.