The U S Food and Drug Administration (FDA) has allowed Kinex Pharmaceuticals' Investigational New Drug (IND) application for Oraxol. Oraxol allows for oral delivery of paclitaxel when combined with Hanmi Pharmaceutical’s absorption enhancer, HM30181A.
Kinex has global development and commercialization rights for Oraxol, excluding Korea, Japan and India that are owned by Hanmi, and New Zealand and Australia which were recently licensed to Zenith Technology Corporation. Kinex, Hanmi and ZenRx will jointly develop Oraxol globally through a collaborative effort. Oraxol is Kinex’s second IND to be allowed this year and the company will proceed to phase I/Ib clinical protocols as planned.
Oraxol is only one of many compounds that could be developed by Kinex and Hanmi through the Orascovery programme. Orascovery is based on an important platform technology developed by Hanmi Pharmaceuticals using compound HM30181A, a potent and selective P-glycoprotein (PGP) pump inhibitor. 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. Importantly, HM30181A is a very potent PGP inhibitor that is not systemically absorbed.
The Orascovery technology has led to the initiation of clinical trials being conducted with both an oral formulation of paclitaxel (Oraxol), currently in phase II clinical trials in Korea, and an oral formulation of irinotecan (Oratecan), which has completed phase I clinical trials in Korea. Further trials are being planned in Korea, the USA, New Zealand/Australia, and China.
Recently, Kinex has received US FDA allowance on the KX02 IND, a program that Kinex has partnered with Xiangxue Pharmaceuticals for the greater China Territory. Through their collaboration with Hanmi, one of Kinex’s internally developed compounds, KX01, is also currently in clinical trials in both the USA and Korea in a variety of indications.
Dr Lyn Dyster, senior vice president of Operations, stated, “Working with the Hanmi team on the Oraxol IND has been terrific. Their expertise and dedicated team, combined with our internal efforts, lead to a timely IND submission. Given that Hanmi is in phase II in Korea, their extensive preclinical and clinical knowledge of the compound was invaluable to our efforts. Oraxol is an important program for both companies and we are excited to move forward with our clinical programs in the United States.”
“The allowance of the Oraxol IND by the US FDA is a major step in our global development strategy,” added Dr. Rudolf Kwan, chief medical officer of Kinex. “Combined with Hanmi’s significant Oraxol clinical efforts in Korea and the potential for trials in New Zealand to begin in the near future, we are on track to leverage our team’s combined infrastructure and development capabilities on a global basis. We believe this approach will produce meaningful data in the most time efficient manner. I am very excited with this programme.”
Dr Gwan Sun Lee, chief executive officer of Hanmi Pharmaceutical said, “The Kinex team moved the IND process forward in a precise and expert manner. This is another major step forward in the collaboration between Kinex and Hanmi. I believe that as part of our global growth strategy, our partnership with Kinex will benefit Hanmi by providing participation in major markets outside of our traditional territories. US and New Zealand clinical trials are an important example of that opportunity. We have great confidence in the Kinex team and our expanding relationship.”
Dr Jeewoong Son, senior VP and head of Innovation R&D at Hanmi, commented, “We are very proud to have Oraxol proceeding to clinical studies in the United States. This is a great achievement. The Hanmi and Kinex alliance continues to deliver important milestones. Hanmi has seen promising resultsin terms of efficacy and reduced toxicity with our Oraxol clinical trials in Korea and we hope to see the same benefits for patients in the US trials. We look forward tomoving ahead with ZenRx and Kinex with additional trials in New Zealand later this year.”
“I am proud to have a chance to work with the Kinex management team. I was impressed by their domain knowledge. Their execution is also very impressive. I look forward to finalizing the New Zealand and Australia development plan with them very soon,” added Dr Cheung-Tak Hung, managing director for Zenith Technology Corporation.