Athenex Announces FDA Allowance of Investigational New Drug Application

Athenex, Inc. recently announced the FDA has allowed the Investigational New Drug (IND) application for Athenex’s oral version of Eribulin currently named Eribulin ORA.

This FDA action allows Athenex to commence its clinical trial program, currently planned for first half of 2019. Eribulin, an effective treatment for metastatic breast cancer and liposarcoma, is currently limited to intravenous administration.

Utilizing Athenex’s proprietary Orascovery platform with Eribulin, we were able to demonstrate that good oral absorption of Eribulin is possible, based on preclinical studies. In addition, the Eribulin active pharmaceutical ingredient (API) has been developed internally using a novel synthetic approach. We believe these developments demonstrate the broad utility of the Orascovery platform and commitment of Athenex to becoming a major global oncology biopharmaceutical company.

Dr. Michael Smolinski, Athenex’s Head of Preclinical Research, said “Athenex is delighted that the FDA has allowed the IND of Eribulin ORA. The demonstration of a favorable pharmacokinetic profile, with lowered peak plasma concentration and longer duration of the drug within the desired plasma concentration range, provides the potential for a better efficacy and an improved safety profile for Eribulin, similar to what we have observed with Oraxol (oral form of paclitaxel) and others. We have also developed a novel and efficient synthetic process for Eribulin with an excellent purity profile. This is the eighth US IND allowance that Athenex has obtained, reflecting the passion and dedication of the company to bringing new therapies to cancer patients.”

Eribulin is an anticancer drug marketed by Eisai Company under the trade name Halaven. It is used to treat certain patients with breast cancer and liposarcoma. Eribulin is a synthetic derivative of the natural product Halichondrin B. The potent anticancer effects of this agent come primarily from its unique means of targeting microtubule dynamics, a process critical to cell proliferation.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, said “Eribulin is approved for the treatment of metastatic breast cancer patients who have received at least two prior chemotherapy regimens for late-stage disease, including both anthracycline- and taxane-based chemotherapies. It is important to note that Eribulin is active in paclitaxel-resistant tumors. This profile is expected to create a number of synergistic opportunities with the other drug candidates in our Orascovery clinical pipeline. We look forward to initiating the Phase I clinical studies soon.”

The lead compound in Athenex’s Orascovery program, Oraxol, is currently in a pivotal Phase III study. The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

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. 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, NY; Cranford, NJ; Houston, TX; Chicago, IL; Hong Kong; Taipei, Taiwan and multiple locations in Chongqing, China. For more information, visit