Kinex Pharmaceuticals, LLC and Hanmi Pharmaceutical Co., Ltd. announced today the execution of a license agreement granting Hanmi Pharmaceuticals exclusive rights to their lead compound, KX01, for all oncology indications in selected Asian Territories.
KX01 (KX2-391) is a potent, orally available small molecule Src kinase/pretubulin dual mechanism inhibitor discovered and currently developed by Kinex Pharmaceuticals using its proprietary technology platforms Mimetica™ and Opal™. KX01 differentiates itself as an inhibitor that targets the kinase substrate pocket and therefore, offers an excellent efficacy as well as safety profile. The composition of matter of KX01 is covered by issued patents.
KX01 has been shown to be very effective against a broad range of cancers in both in vitro experiments and in animal cancer models. Importantly, the compound has synergistic/additive activities with most first line chemotherapeutic agents. A completed Phase I study, in patients with end-stage cancer, showed a desirable safety profile and clinical response in approximately 25% of the patients. Clinical data support either once or twice daily dosing. Phase II studies are ongoing.
Under the terms of the agreement, Hanmi Pharmaceuticals will acquire the rights to the development and commercialization of KX01 for all oncology indications in certain Asian territories, including Korea, greater China and some Southeast Asian Countries. Japan, India, Australia and New Zealand are not included in this agreement.
Hanmi Pharmaceuticals will assume all development responsibility and associated costs in the licensed territories and will participate with Kinex Pharmaceuticals on Phase III global registration studies. Hanmi Pharmaceuticals will also provide Kinex Pharmaceuticals with an up-front payment, milestone payments and royalties. A joint development team will be established to foster the collaboration.
Dr. Gwan Sun Lee, Chief Executive Officer of Hanmi Pharmaceuticals states: "This collaboration is an important strategic decision for Hanmi Pharmaceuticals as this will facilitate our company to further expand our oncology franchise to China and other Asian Countries."
Dr. Jeewoong Son, Chief Medical Officer and Senior Vice-President of Research and Development, states: "The profile of KX01 is excellent and this compound will complement our oncology business strategy very well. We are excited to have the opportunity to work with the Kinex team to take this compound through the various development phases to obtain its approval in Korea and China to help Asian patients with cancer."
Hanmi Pharmaceuticals is one of leading pharmaceutical companies in Korea. Hanmi Pharmaceuticals has established a strong Research and Development team in Korea and one of their focuses is in the field of oncology.
"We have selected Hanmi Pharmaceuticals as our Asian partner because we are impressed by their strong commitment to Research and Development. We are also impressed by their business growth strategy", states Chief Executive Officer of Kinex Pharmaceuticals, Dr. Allen Barnett, who was credited for his effort in the discovery and development of Claritin when he was working at the Schering-Plough Research Institute.
Dr. David Hangauer, Senior Vice-President of Research and Development states: "Kinex Pharmaceuticals is delighted to have a chance to work with this well established research and development team. Their experience in oncology will be critical in helping to drive this project to regulatory approval."
"We are impressed by the clinical research commitments of Hanmi Pharmaceuticals. Together with our internal programs, we are confident that our joint effort will expedite the realization of the full potential of KX01," states Chief Medical Officer of Kinex Pharmaceuticals, Dr. Rudolf Kwan, who was previously Vice-President of Clinical Research, Schering-Plough Research Institute.
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