Athenex Announces FDA Allowance of IND Application for TCRT-ESO-A2, a TCR-T Cell TherapyAthenex’s first T cell therapy product cleared to advance to the first stage of clinical development in the U.S.

BUFFALO, N.Y., Sept. 23, 2020 (GLOBE NEWSWIRE) -- 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, today announced 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.

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.”

About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to the discovery, development and commercialization 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 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 treatments with improved tolerability profiles. Athenex has offices in the United States, Hong Kong, China, Taiwan, the United Kingdom and Latin America. For more information, please visit www.athenex.com.

About Guangzhou Xiangxue Pharmaceutical Co., Ltd.
Founded in 1997, Xiangxue Pharmaceutical, or XPH, 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 subsidiary of Xiangxue Pharmaceutical focused on TCR-based therapies for cancer and has developed a new generation TCR-T, named TAEST (TCR Affinity Enhancing 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 about XPH, visit www.xphcn.com.

About Axis Therapeutics Limited
In 2018, Athenex and XLifeSc entered into an agreement to establish a joint venture named Axis Therapeutics Limited, which owns the global rights to the TAEST technology, excluding China (XLifeSc retains the mainland China rights). 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.

Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; our ability to obtain and maintain regulatory approvals for our product candidates; our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and need to raise additional capital to continue as a going concern; uncertainties around our ability to meet funding conditions under our financing agreements and access to capital thereunder; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, cash flow and financial condition; our ability to integrate acquired assets and businesses into our existing operations; competition; intellectual property risks; risks relating to doing business internationally and in China; the risk of production slowdowns or stoppages or other interruptions at our Chongqing facilities; and the other risk factors set forth from time to time in our SEC filings. All information provided in this release is as of the date hereof and we assume no obligation and do not intend to update these forward-looking statements, except as required by law.

CONTACTS
Athenex, Inc.:
Daniel Lang, MD
Corporate Development and Corporate Communications
Email: danlang@athenex.com

Jacqueline Li
Corporate Development and Investor Relations
Email: jacquelineli@athenex.com

Investor Relations:
Tim McCarthy
Managing Director, LifeSci Advisors, LLC
Email: tim@lifesciadvisors.com