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CST: 24/10/2019 00:24:00   

Athenex Announces Xiangxue Life Sciences Receives IND Allowance from China’s National Medical Products Administration for Cancer Immunotherapy Drug Candidate

216 Days ago

This company-sponsored IND allows Xiangxue Life Sciences (XLifeSc) to proceed to the next stage of clinical studies in China

Encouraging positive clinical safety and efficacy signals were observed in preliminary investigator-initiated pilot studies in China

Athenex is XLifeSc’s partner (ex-China) for cancer immunotherapy development and global development of this technology is being conducted through Axis Therapeutics Limited, a joint venture between Athenex and XLifeSc

BUFFALO, N.Y., March 21, 2019 (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 its partner in cancer immunotherapy, Xiangxue Life Sciences (XLifeSc), a wholly-owned subsidiary of Xiangxue Pharmaceutical Co., Ltd. (Shenzhen Exchange: 300147), has received an allowance by China’s National Medical Products Administration (NMPA, formerly known as the China Food and Drug Administration) of its company-sponsored Investigational New Drug (IND) application to initiate registrational related clinical studies in China of T-cell receptor Affinity Enhanced Specific T-cell (TAEST) therapy in patients with solid tumors that are HLA-A*02:01 positive and NY-ESO-1 positive. The cancer immunotherapy product, named TAEST16001 injection, is based on TAEST technology generated T-cells, with enhanced binding affinity, against the antigen NY-ESO-1 and is HLA-A*02:01 restricted.

On October 15, 2018, Athenex and XLifeSc announced preliminary results of investigator-initiated pilot studies in China of patients receiving TAEST therapy which showed encouraging positive clinical safety and efficacy signals. Among six patients that received TAEST therapy after the standard lymphodepletion protocol, two patients showed partial response and four patients showed stable disease, with two of the stable disease patients showing significant tumor necrosis. In addition, the safety profile is believed to be within the range for cancer immunotherapy, with no CNS adverse events observed. Importantly, it was observed that TAEST technology generated T-cells persisted for several months in these patients, highlighting the potential long-term effects of this treatment. An abstract with more detailed data has been submitted for presentation to an international scientific meeting.

In July 2018, Athenex and XLifeSc 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.

Mr. YongHui Wang, Chairman and Chief Executive Officer of Xiangxue Pharmaceutical and Chief Executive Officer of XLifeSc, commented, “We are excited with the quick allowance by China’s NMPA of our IND for TAEST16001 and are ready to initiate registrational related clinical studies. Athenex has been a great collaborative partner and the joint development team established will allow our joint venture to move forward with the development of TAEST16001 in other geographic regions.”

Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex and Chief Executive Officer of Axis Therapeutics, said, “We congratulate our partner, XLifeSc, and its parent company, Xiangxue Pharmaceutical, for obtaining the allowance of this company-sponsored IND to initiate their registrational related clinical studies. We are impressed by their scientific approach and pre-clinical data, and excited by the encouraging preliminary safety and efficacy results from the investigator-initiated pilot studies in China. Axis Therapeutics is also preparing an IND application to the U.S. Food and Drug Administration and we look forward to starting clinical studies in the U.S. in the near future. Our collaboration with XLifeSc and Xiangxue Pharmaceuticals has been extremely rewarding. Exploring the combination of this exciting approach in conjunction with select Athenex pipeline products may lead to the development of more effective therapies for cancer patients.”

About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in 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 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, please visit www.athenex.com

About Guangzhou Xiangxue Pharmaceutical Co., Ltd. (XPH)
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 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 about XPH, visit www.xphcn.com

Forward-Looking Statement Disclaimer/Safe Harbor Statement
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,” “continue,” “could,” “estimate,” “expect,” “foresee,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “will,” 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 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; competition; intellectual property risks; risks relating to doing business in China; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Investor Relations Department. 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

Investor Relations:
Tim McCarthy
Managing Director, LifeSci Advisors, LLC
Tel: +1 716-427-2952 
Direct: +1 212-915-2564

Athenex, Inc.:
Randoll Sze
Chief Financial Officer
Email: randollsze@athenex.com  

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

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