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Athenex Announces Initiation of Phase I Clinical Study in China of KX2-361 Oral by Partner Guangzhou Xiangxue Pharmaceutical

984 Days ago

BUFFALO, N.Y., Sept. 11, 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, Guangzhou Xiangxue Pharmaceutical Co., Ltd., initiated a Phase I study in China of KX2-361 (formerly known as KX-02) oral treating advanced malignant solid tumors.

KX2-361, which is being developed for the treatment of glioblastoma multiforme (GBM), is the second compound derived from Athenex’s Src kinase inhibition platform. It is a closely related structural analog of Athenex’s tirbanibulin (formerly known as KX2-391 or KX-01) with a distinct ability to cross the blood brain barrier, making it a potential therapeutic candidate for treating brain cancers, including GBM, as well as brain metastases. Studies of KX2-361 oral in preclinical mouse GBM tumor models resulted in complete tumor eradication as well as extended survival compared to the current standard of care, temozolomide.

“KX2-361 is a potentially valuable treatment option for GBM patients, and we are initiating this Phase I study on the strength of encouraging results in preclinical studies,” stated Mr. YongHui Wang, Chairman of Xiangxue Pharmaceutical. “We are excited to advance this promising candidate in the clinic to potentially improve the lives of patients with GBM.”

“We are impressed by the R&D capabilities of our partner and delighted by their decision to advance another product candidate from our Src kinase inhibition platform,” stated Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. “KX2-361 may potentially expand the range of cancers we can address with our broad oncology pipeline, especially for rare diseases with significant unmet medical need like GBM.”

The Phase I clinical study in China is a single-center, open-label dose escalation trial that will enroll 36-72 patients with advanced malignant solid tumors who have no standard treatment or standard treatment failed.

In 2012, Athenex out-licensed KX2-361 to Xiangxue Pharmaceutical for development and marketing in Greater China and Singapore. In May 2017, the China National Medical Products Administration (NMPA) (formerly China FDA) allowed Xiangxue’s IND to commence clinical trials of KX2-361 in China. Athenex also received U.S. IND allowance for KX2-361 in 2014 and the product candidate was granted Orphan Drug Designation by the U.S. FDA.

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; multiple locations in Chongqing, China; and Manchester, UK. For more information, please visit www.athenex.com.

About   Guangzhou Xiangxue Pharmaceutical Co., Ltd.   (XPH)
XPH was 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. For more information about XPH, visit www.xphcn.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,” “continue,” “could,” “estimate,” “evaluate,” “expect,” “foresee,” “guidance,” “intend,” “investigate,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “prepare,” “potential,” “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 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; the uncertainty of when, if at all, we will be able to resume producing API in our Chongqing plant; 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.


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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