Athenex, Inc. Announces Commencement of Patient Enrollment for Oraxol-plus-Ramucirumab Phase 1b Clinical Trial in Gastric Cancer

BUFFALO, N.Y., July 19, 2017 -- Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, today announced that its global Phase 1b clinical trial of Oraxol (oral paclitaxel) plus ramucirumab in gastric cancer has commenced with first patient dosed recently.

“A Phase 2 clinical trial of Oraxol in the second-line treatment of gastric cancer patients showed an encouraging overall median survival of 10.7 months. The expected overall survival for advanced gastric cancer patients who have failed previous chemotherapy and do not receive second-line therapy is typically around 4 months,” stated Dr. Rudolf Kwan, Athenex’s Chief Medical Officer. “Ramucirumab is an FDA-approved antiangiogenic therapy for the second-line treatment of advanced gastric cancer. Successful patient enrollment to this clinical trial using Oraxol plus ramucirumab in gastric cancer reflects our commitment to developing Oraxol as a global anti-cancer treatment.”

Mr. Jeffery Yordon, Athenex’s Chief Operating Officer, also commented, “This event underscores our global development plan for Oraxol, a novel oral formulation of paclitaxel, for the treatment of advanced cancers. A Phase 3 clinical trial of Oraxol in the treatment of breast cancer patients is also currently ongoing.”

Athenex has licensed the global rights (outside of Korea) for the Orascovery program which uses the novel P-gp inhibitor HM30181A initially developed by Hanmi Pharmaceuticals to enable oral administration of Oraxol and other anti-cancer clinical drug candidates.

PharmaEssentia Corp., licensed the Taiwan rights to Oraxol from Athenex and is a partner in the development of Oraxol in Taiwan.

Ramucirumab, as a single agent or in combination with paclitaxel, is FDA-approved for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is manufactured and marketed by Eli Lilly and Company.

About Athenex, Inc.

Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery and development 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. Athenex’s Oncology Innovation Platform generates clinical candidates through an extensive understanding of kinases, including novel binding sites, human absorption biology and through the application of Athenex’s proprietary research and selection processes in the lab. The Company’s current clinical pipeline is derived from two different platform technologies Athenex calls Orascovery and Src Kinase Inhibition. The Orascovery platform is based on the novel oral P-glycoprotein pump inhibitor molecule HM30181A, through which Athenex is able to facilitate oral absorption of traditional cytotoxics, which Athenex believes may offer improved patient tolerability and efficacy as compared to IV administration of the same cytotoxics. The Src Kinase Inhibition platform refers to novel small molecule compounds that have multiple mechanisms of action, including the inhibition of the activity of Src Kinase and the inhibition of tubulin polymerization during cell division. Athenex believes the combination of these mechanisms of action provides a broader range of anti-cancer activity as compared to either mechanism of action alone. 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.

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