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Link: https://ir.athenex.com/news-releases/news-release-details/athenex-announces-initiation-phase-i-clinical-study-china-kx2

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.