Athenex, Inc. (ATNX)

Axis Therapeutics Announces Research Collaboration with PharmaEssentia for Development of TCR-T Cell Therapy in Taiwan

BUFFALO, N.Y., Oct. 12, 2020 (GLOBE NEWSWIRE) -- Axis Therapeutics Limited, a joint venture between Athenex, Inc. (NASDAQ: ATNX) and Xiangxue Life Sciences Limited (“XLifeSc”), focused on the research, development, and commercialization of T cell immunotherapy, today announced that it has entered into a research collaboration with PharmaEssentia Corporation (Taipei Exchange: 6446). The collaboration involves the development of T Cell Receptor (TCR)-T therapy (based on the proprietary TAEST (T cell receptor Affinity Enhancing Specific T cell therapy) technology platform) in Taiwan. Under the terms of the agreement, Axis Therapeutics and PharmaEssentia will collaborate to conduct an initial clinical study of Axis Therapeutics’ TCRT-ESO-A2 therapy, targeting solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients, and to manufacture the investigational products, in Taiwan. PharmaEssentia will be responsible for all activities relating to the clinical development in Taiwan.Athenex recently announced that the U.S. Food and Drug Administration (FDA) has allowed the Investigational New Drug (IND) application for this same compound.Dr. Johnson Lau, CEO of Athenex, and CEO of Axis Therapeutics, stated, “PharmaEssentia represents an important long-term partner of Athenex. We are excited to expand our relationship beyond the Orascovery and Src Kinase platforms to include a collaboration with Axis Therapeutics for the development of TCR-T therapy. We look forward to collaborating with PharmaEssentia on the development of this novel T-cell technology in Taiwan.”Dr. Daniel Lang, President of Axis Therapeutics, added, “The agreement expands the longstanding relationship between Athenex and PharmaEssentia. We are excited to work with such a trusted partner to further advance our TCR-T therapy.”Dr. Kochung Lin, CEO of PharmaEssentia, stated, “We have benefitted from our longstanding strategic relationship with Athenex through the development of Athenex’s Orascovery and Src Kinase platforms. We bring rich experience in clinical studies, as well as significant experience in regulatory approval and market access in Taiwan, Japan, and Korea. The expansion of our relationship to include Axis Therapeutics and its associated TCR-T therapy represents an opportunity to further our successful collaboration.”About Axis Therapeutics Limited  Axis Therapeutics, a joint venture between Athenex, Inc. (NASDAQ: ATNX) and XLifeSc, is a cancer immunotherapy company focused on the development of T cell therapies. The company is developing a novel class of innovative TCR-T therapies designed to harness the immune system to recognize and destroy cancerous cells and aims to develop more effective cell therapies for cancer patients around the world. Through the TCR-T technology platform, the Company has generated engineered T cells with higher binding affinity and specificity for a defined tumor antigen. In 2018, Axis Therapeutics licensed from XLifeSc, 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. For more information, please visit: www.axistherapeutics.com.About PharmaEssentia Corporation PharmaEssentia is a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of proprietary therapeutics. Its portfolio includes various stages, ranging from preclinical to late stage development, and commercialized products. The company focused on treatments for myeloproliferative neoplasms, hepatitis and other diseases. Its first product, Besremi (Ropeginterferon alfa-2b), has been approved in Europe and Taiwan and has been assigned a PDUFA date of March 13, 2021 from the U.S. FDA. The company’s world-class cGMP biologics facility in Taichung is certified by the European Medicines Agency (EMA) and the Taiwan Food and Drug Administration (TFDA). For more information, please visit www.pharmaessentia.com .About Guangzhou Xiangxue Pharmaceutical Co., Ltd. Founded in 1997, Xiangxue Pharmaceutical, or XPH, is located in Guangzhou Science City, China, 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 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 Therapy, 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 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.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, but are not limited to: the expected development of our business, partnerships and joint ventures, the development stage of our 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 our business; our history of operating losses and need to raise additional capital to continue as a going concern; execution of our vision and growth strategy; future liquidity, working capital, and capital requirements; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, cash flow and financial condition; competition; intellectual property risks; risks relating to doing business internationally and in China. 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 Daniel Lang, MD President, Axis Therapeutics; Senior Director, Corporate Development, Athenex Email: danlang@athenex.com Steve Rubis Senior Director, Investor Relations, Athenex Email: stevenrubis@athenex.com