Kinex Pharmaceuticals and Hanmi Pharmaceutical Co., Ltd. are pleased to announce the execution of an agreement for Kinex Pharmaceuticals to lead the development of the Orascovery program in India. The addition of this territory is part of the strategic plan to support Kinex and Hanmi’s joint effort to execute a global regulatory strategy. This also strengthens the existing agreement forged with Hanmi in December of 2011. With this agreement, Hanmi has granted to Kinex Pharmaceuticals the rights to develop and commercialize all products derived from the Orascovery program for all indications globally apart from Korea and Japan.
Kinex Pharmaceuticals will assume all development responsibility in the licensed territories. ZenRx has joined the effort to develop Oraxol and Oratecan in the New Zealand and Australia territories, and PharmaEssentia of Taiwan has joined the effort to develop Oraxol and Oratecan in Taiwan and Singapore.
Dr. Gwan Sun Lee, Chief Executive Officer of Hanmi Pharmaceutical stated: “Kinex is a faithful partner who has been successfully progressing development of the Orascovery program. We are pleased to continue to work closely with Kinex and as we work together to bring more treatment options to patients”
Mr. Flint Besecker, Chief Operating Officer and Board Member of Kinex Pharmaceuticals, commented: “Hanmi has been an excellent partner. The assignment of the Indian Territory fills a remaining gap in our execution of the overall business strategy to develop these products globally. The companies’ well-coordinated networks of key opinion leaders and development sites have been instrumental in advancing our programs and helped facilitate productive discussions with different regulatory authorities. Kinex is also delighted to note that the preclinical development of the oral version of Docetaxel is also advancing nicely with support from the Innovation and Technology Commission (ITC) of the Government of the Hong Kong Special Administrative Region* and the support of the Department of Applied Biology and Chemical Technology of the Hong Kong Polytechnic University.”
The Orascovery program is based on important platform technology initially developed by Hanmi Pharmaceutical, including compound HM30181A, which is a highly potent and selective P-glycoprotein (PGP) pump inhibitor. Suppression of the PGP pump in the gastrointestinal tract allows certain clinically important compounds, (such as paclitaxel and irinotecan, among others) which would normally be effluxed back into the gastrointestinal tract and excreted, to enter the bloodstream and be bioavailable through oral administration. Importantly, HM30181A is a very effective PGP inhibitor that is not systemically absorbed. The current lead clinical phase products include an oral formulation of paclitaxel and an oral formulation of irinotecan, both of them in in multiple clinical studies globally.
*Any opinions, findings, conclusions or recommendations expressed in this material do not reflect the views of the Government of the Hong Kong Special Administrative Region, the Innovation and Technology Commission or the Small Entrepreneur Research Assistance Programme Project Assessment Panel.
Hong Kong Feb 13, 2015 – Kinex Pharmaceuticals today announces the exclusive licensing of global rights of three patents from The Hong Kong Polytechnic University and McGill University. These three patents covered the inventions by Professor Larry Chow and Professor William Chan including novel new chemical compounds that have nanomolar potency against a molecular target named Breast Cancer Resistance Protein (BCRP). BCRP is a protein pump known to pump drugs, including anticancer drugs, from cancer cells that can lead to drug resistance; and also to pump drugs back into gastrointestinal tract, which prevent some useful drugs to be delivered to their target.
The development of this technology, if successful, will expand the current Kinex oral drug absorption development platform. That platform currently includes the inhibition of P-glycoprotein that Kinex licensed from Hanmi in 2011. The lead molecule, HM30181A, has been shown in clinical studies to enhance the absorption of anticancer drugs including paclitaxel and irinotecan into orally available drugs. The lead program, Oraxol (an oral form of paclitaxel), has demonstrated clinical efficacy and an excellent safety profile in patient studies. Kinex is also actively developing other proprietary oral drug delivery platforms. The addition of another oral absorption delivery technology platform will further strengthen Kinex’s arsenal of converting greater classes of intravenous drugs into oral versions.
The terms of this exclusive license include upfront payments, milestones and royalties. Kinex is also committing to support research programs in Professor Larry Chow’s laboratory to further develop this platform collaboratively with Kinex.
Johnson YN Lau, MBBS, MD, FRCP, Chairman and CEO of Kinex Pharmaceuticals, stated “The research of Professor Larry Chow complements Kinex’s drug development efforts. Kinex is a leader in the development of proprietary oral drug formulation and dosing for some of the important anticancer drugs including paclitaxel and irinotecan which currently have to be given intravenously. Oral versions of these drugs can be more efficacious and have fewer side effects for the patients. The discovery of lead molecules against another target such as BCRP that can enhance oral drug absorption by Professor Larry Chow and William Chan, if successfully developed clinically, will add to the arsenal of tools for Kinex. We are excited to collaborate with Professor Larry Chow to further develop this drug delivery platform and to convert more current intravenous drugs into oral form.”
Flint Besecker, COO of Kinex, said, “We have learned in the clinic that converting existing intravenous drugs into oral forms opens the door to a wide array of proprietary formulation and titrated patient dosing regimens that are not possible through IV delivery systems. Oral forms of dosing allow the patients to be exposed over a longer period of time to the active pharmaceutical ingredients with less adverse side effects. This drug development strategy has less inherent risks and we are excited of the possibilities to make a difference in helping more patients. Such an effort, if successful, will have the potential to impact healthcare delivery globally and substantially.”
Larry Chow, PhD, Professor and Associate Head of the Department of Applied Biology and Chemical Technology, commented, “I was impressed by Kinex in their ability to work with Hanmi Pharmaceuticals to advance the research program using a P-glycoprotein inhibitor to enhance the oral absorption of important drugs like paclitaxel and irinotecan and demonstrated its clinical utility. We are delighted that they will partner with us to help optimize our lead compound into a potentially useful molecule in the clinic for other drugs that are not absorbed orally because of this biologic pump system. Working with this wonderful group of industry veterans will allow us to tap into their expertise and to develop this platform further. I am excited with this collaboration.”
Nick Yang, Executive Vice President of The Hong Kong Polytechnic University, stated, ”To be able to establish successful collaborations between academia and industry is the mission of our University in transferring novel discoveries into useful applications that can help the community and serve the society. We are confident that the collaboration between PolyU and Kinex will open a new chapter for cancer drug development, bringing new hope to cancer patients globally and taking us one step closer to a revolution in cancer treatments.”
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