Athenex Announces the US FDA Allowance of the Investigational New Drug Application of Oratopo, A Com

Athenex, Inc., a global specialty oncology pharmaceutical company focused on the development and commercialization of next generation therapies for cancer diseases and supportive therapies, announced today that it has received United States Food and Drug Administration (US FDA) allowance to proceed into human clinical trials with the combination of oral topotecan and its proprietary P-glycoprotein (P-gp) inhibitor HM30181A. This represents Athenex's seventh investigational new drug (IND) allowance by the US FDA (6 oral anticancer drugs, one topical ointment) and is the fourth oncology clinical drug candidate in Athenex's oral absorption platform. Topotecan is an FDA approved anti-cancer drug marketed in branded and generic forms. Athenex is developing an oral form (in combination with HM30181A), called Oratopo. This would allow novel, all-oral chemotherapy regimen for the treatment of numerous cancers. The combination of topotecan and either docetaxel or paclitaxel has shown clinical activity in various cancers, including lung and ovarian. 

In the trials, Athenex will assess the effect of increasing doses of oral topotecan. Once safety, tolerability and PK data are available, novel drug combinations may be explored. Athenex's oncology oral absorption platform ("Orascovery" platform) is based on a proprietary P-gp pump inhibitor which was exclusively licensed from Hanmi Pharmaceuticals Ltd. for all major worldwide territories except Korea. Athenex is also developing oral formulations of paclitaxel, irinotecan, and docetaxel in various stages of clinical development, with the oral form of paclitaxel (in combination with HM30181A) in a Phase III clinical study for the treatment of metastatic breast cancer.

David Cutler, MD, Athenex's Vice President of Clinical Development stated, "Our team submitted to the US FDA a comprehensive IND package for Oratopo, including information on our oral absorption platform. Our P-gp pump inhibitor has been demonstrated in trials to enhance the oral absorption of some well-known oncology drugs, which we believe will further support the use of combination therapy of effective anticancer drugs by the oral route of administration. We are excited for the possibilities to make a difference in helping more cancer patients."

Gerald Fetterly, PhD, Athenex Vice President of Clinical Pharmacology added that "the conversion of intravenous high potency oncology drugs into oral forms opens the door to optimizing a wide array of patient dosing regimens. Oral dosing allows patients to be exposed to the drug over a longer period of time."

Alexander Wai, PhD, Vice President (Research and Development) of The Hong Kong, S.A.R., China Polytechnic University stated that "I am delighted to see the allowance of this IND by US FDA based on the work generated by the collaboration between The Hong Kong, S.A.R., China Polytechnic University and Athenex. This also helps build the medical technology bridge between Hong Kong, S.A.R., China/mainland China and the United States."

The Oratopo project was developed by both the Athenex Hong Kong, S.A.R., China and US Research and Development teams in collaboration with Professor Larry Chow of the Department of Applied Biology & Chemical Technology of The Hong Kong, S.A.R., China Polytechnic University. Part of the work was funded by the Hong Kong, S.A.R., China Innovation and Technology Commission through the University-Industry Collaboration Programme (UICP).

Athenex is developing the Orascovery platform in Korea with Hanmi Pharmaceuticals, the originator of the Orascovery platform, and developing Oraxol and Oratecan with PharmaEssentia in Taiwan, China, Singapore, and Vietnam, as well as with ZenRx in New Zealand and Australia.