This is the Company’s second IND to be allowed in the past 10 months that uses the Orascovery technology platform for oral delivery of anti-cancer drugs.
In July 2013, the US FDA allowed the IND for Oraxol, an oral formulation of paclitaxel, which is currently in phase I clinical studies in the United States and New Zealand, and Phase 2 studies in Korea with encouraging preliminary clinical data. Both Oraxol and Oratecan are orally administrated anti-cancer drugs.
The Orascovery program represents a successful partnership between Kinex Pharmaceuticals and Hanmi Pharmaceuticals based on the initial discovery of a highly potent, highly selective, locally active P-glycoprotein inhibitor of the gastro-intestinal tract, HM30181.
Potent and selective suppression of the PGP pump allows certain clinically important compounds (such as paclitaxel, irinotecan, and others), which would normally be effluxed back into the gastrointestinal tract and excreted, to enter the bloodstream and become bioavailable through oral administration.
Through this collaboration, Kinex has global development and commercialization rights for Oratecan, excluding Korea, Japan and India that are owned by Hanmi. With its attractive preclinical profile, additional Orascovery partnerships have been established with Zenith Technology Corporation for the New Zealand and Australia Territory, and with PharmaEssentia for the Taiwan and Singapore Territory.
Through these partnerships and collaborations, a global drug development alliance has been established, with all partners involved in the clinical development of the drug candidates in a coordinated fashion for the overall global registration strategy.
Hanmi Pharmaceutical CEO Dr Gwan Sun Lee noted that the company’s collaboration with Kinex has been extremely fruitful as evidenced by two IND’s allowed in 10 months.
"Hanmi is delighted to see HM30181 being developed through this global development and registration strategy and Hanmi will continue to work closely with Kinex to develop Oraxol and Oratecan, as well as other candidates in our pipeline. Hanmi is proud of this collaborative partnership with Kinex," Dr Lee added.
Through another collaboration with Hanmi, one of Kinex’s internally developed compounds, KX2-391 (KX01), is currently in clinical trials in both the USA and Korea in a variety of indications. Through collaboration with PharmaEssentia, KX01 is also being developed for dermatological indications.
Kinex has received US FDA allowance for the IND for KX2-361 (KX02), a program that is partnered with Xiangxue Pharmaceuticals for the greater China Territory. A Phase I clinical study in the US is expected to commence soon.
Kinex is also working on additional Orascovery-based drug candidates in collaboration with Hanmi Pharmaceuticals and some of the projects received research funding support from the Innovation and Technology Commission (ITC) of the Government of the Hong Kong Special Administrative Region through Kinex Pharmaceuticals (HK) Limited and the support of the Department of Applied Biology and Chemistry of the Hong Kong Polytechnic University.