Kinex Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization of next generation therapies for cancer and immunomodulatory diseases, announced that the United States Food and Drug Administration (US FDA) has allowed its Investigational New Drug (IND) application for Oratecan, an oral form of an approved anti-cancer drug irinotecan with enhanced oral absorption.

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 programme 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 commercialisation 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.

Dr. Lyn Dyster, senior vice president of research operations, stated, “Our continued partnership with Hanmi has been very rewarding.  The collaborative Kinex/Hanmi team effort has resulted in the submission of two INDs with the US FDA in the last 10 months and Kinex is grateful to the team for their tremendous effort in accomplishing this objective.”

“Our partnership with Hanmi continues to build tremendous momentum.  On top of the Korean clinical studies, Kinex has recently initiated Oraxol studies in the US and New Zealand. In addition, two US INDs based on the same technology approach validates the value of the Orascovery platform and I am delighted to see our preclinical colleagues, led by our CSO Dr. David Hangauer, working on additional potential drug candidates” added Dr. Rudolf Kwan, chief medical officer of Kinex.  “We are working with our partners to initiate additional studies in various geographic sites for both Oraxol and Oratecan. Our global development strategy, through highly committed partnerships, has been executing extremely well. Kinex sincerely thanks our partners for their full support.”

Dr. Gwan Sun Lee, chief executive officer of Hanmi Pharmaceutical said, “Hanmi’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. Jeewoong Son, senior VP and Head of Innovation R&D at Hanmi, commented, “The joint efforts of Kinex and Hanmi have led to tremendous progress in a short period of time on both Oraxol and Oratecan. Kinex is an excellent collaboration partner in both the Orascovery and KX01 programme. The Phase 1 data on Oratecan in conjunction with Capacitabine conducted in Korea has been very encouraging. Developing good new medicine for cancer patients globally remains the top priority for both Hanmi and Kinex”.

Dr. Tak Hung, managing director of Zenith Technology Corporation, New Zealand, stated, “I am delighted to see the rapid progress of the Oraxol and Oratecan programmes, which we have joined as part of the partnership team to develop these compounds globally. An Oraxol clinical study has commenced in New Zealand and we are proud to be a contributing member to this global alliance.”

Dr. KoChung Lin, chief executive officer, of PharmaEssentia, Taiwan, commented, “We are really impressed by the progress of these programmes. Kinex has a top-notch management team with tremendous experience in advancing preclinical and clinical programmes. We are proud to have recently joined their global development effort and will be an active contributor to this strategic goal.”

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 a 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 programme that is partnered with Xiangxue Pharmaceuticals for the greater China Territory.  A Phase 1 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.