Kinex Pharmaceuticals and Zenith Technology Corporation, through its affiliate ZenRx, announced today the execution of a collaborative licensing agreement granting Zenith Technology commercial rights to Oraxol and Oratecan in New Zealand and Australia.  ZenRx will provide an upfront payment, milestones and royalties.  Importantly, Zenith Technology Corporation will commit a significant amount of resources to the Oraxol and Oratecan global development programs, providing Kinex and its Asian partner, Hanmi Pharmaceuticals (Seoul, South Korea) additional clinical programs, supporting global registrations in a non-dilutive fashion.

In December 2011, Kinex Pharmaceuticals licensed the global rights in certain territories outside of Korea, China, India, and Japan, to develop and commercialize the Orascovery program from Hanmi Pharmaceutical Company.  The program is based on an important platform technology developed by Hanmi Pharmaceuticals, compound HM30181A, a potent and selective P-glycoprotein (PGP) pump inhibitor.   Suppression of the PGP pump 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 Orascovery technology has led to the initiation of 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 a Phase I clinical trial in Korea. Additional trials are being planned in both Korea and the USA. 

Zenith Technology Corporation (Dunedin, New Zealand) is a very successful clinical contract research organization that also offers analytical and clinical laboratory services. Through its affiliate ZenRx, the company plans to expand the scope of their business.

“Zenith Technology has a very strong reputation as a Clinical Contract Research Organization. Their capabilities will be extremely helpful in advancing our global development programs for Oraxol and Oratecan.  I look forward to working closely with the Zenith team in conjunction with Hanmi Pharmaceuticals as we progress in our global development programs,” said Rudolf Kwan, Chief Medical Officer of Kinex.

Johnson Lau, CEO of Kinex Pharmaceuticals added, “The commitment of Zenith Technology to work closely with Kinex and our partner Hanmi Pharmaceuticals in the development of Oraxol and Oratecan is a critical element of our global development strategy.  We are very pleased to be working with the experienced Zenith team to move our clinical programs to the next stage.”

Dr. Jeewoong Son, Senior VP and Head of Innovation R&D at Hanmi, added “Hanmi warmly welcomes Zenith Technology Corporation to join our global development effort for our Oraxol and Oratecan programs. We have had a great collaboration with Kinex Pharmaceuticals and we welcome the expansion of this team to achieve our global development objectives.”

Dr. Cheung-Tak Hung, Executive Director of Zenith Technology concluded, “We are very impressed with the current clinical data for Oraxol and Oratecan.  These compounds, when combined with the quality and experience of the Kinex and Hanmi management teams, afford Zenith an exceptional opportunity.  We look forward to working closely with both Kinex and Hanmi to drive the global product development strategy.”

Kinex Pharmaceuticals announced that Dr. David Hangauer, co-founder and Chief Scientific Officer of Kinex, has been named the American Cancer Society’s 2013 Honoree of the year for its Cuisine for a Cure event.

“I am honored to be the 2013 honoree for the American Cancer Society Cuisine for a Cure event.  I have devoted much of my career to discovering better drugs for treating cancer, two of which have recently advanced to clinical trials.  Through these efforts I am constantly humbled by the courage and strength of the cancer patients.  To be able to work on such an important medical need is a privilege,” said Dr. David Hangauer.

“Kinex was initially founded upon a scientific platform to develop better drugs for treating cancer.  This is not solely a professional endeavor for us.  Importantly, our company is driven by a deep personal commitment as we have all been touched by both the devastation of cancer and the hope and extended life that new compounds can bring when fighting the disease.  Dave is the foundation of our efforts in Kinex.  Progress in treatment regimens will continue as extremely productive and engaged scientists like Dr. David Hangauer lead the charge in the fight against cancer,” quoted Dr. Allen Barnett, President Emeritus of Kinex.

Dr. Johnson Lau, CEO of Kinex, commented, “Both patients and Kinex are fortunate to have Dr. Hangauer dedicated to the field of cancer.  His expertise in drug discovery, coupled with tireless effort and commitment, has generated two very promising novel compounds for the treatment of various tumor types that Kinex and our drug development partners, Hanmi Pharmaceuticals, Xiangxue Pharmaceuticals, and PharmaEssentia are actively pursuing.  His focus on improving patient’s lives through the discovery and development of new and better drugs is well reflected by the recognition of his achievements at the American Cancer Society 2013 event.  Kinex is proud to have Dave as our co-founder and Chief Scientific Officer”

Kinex Pharmaceuticals and Hanmi Pharmaceutical announced today that the first patient has been enrolled in Hanmi’s Phase Ib / IIa clinical trial in Korea. Kinex’s dual Src/pretubulin Inhibitor, KX01, is being combined with intravenous (IV) paclitaxel to treat solid tumor patients in Phase Ib and then gastric and breast cancer patients in Phase IIa.

KX01 (KX2-391) is an once daily, orally administered potent small molecule Src kinase/pretubulin dual mechanism inhibitor discovered by Kinex Pharmaceuticals using its proprietary technology platforms MimeticaTM and OpalTM. KX01 differentiates itself as a non-ATP competitive Src signaling inhibitor and, therefore, offers excellent efficacy as well as safety profile. 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 activities with most taxanes, including paclitaxel which is combined with KX01 in the current Phase Ia / IIb trial. A completed Phase I study, in patients with end-stage cancer and twice daily dosing, showed a desirable safety profile and clinical stable diseases in approximately 25% of the patients. An ongoing KX01 AML mono-therapy Phase I trial has shown that once daily dosing allows much higher KX01 blood levels to be achieved while still maintaining and excellent safety profile. The composition of matter, use and synthesis/formulation of KX01 is covered by issued and pending patents globally.

David Hangauer, CSO of Kinex, commented, “We are delighted that the Hanmi team continues to be excellent partners for the development of KX01. We are very excited that they have initiated the KX01 / paclitaxel trial. KX01 has shown strong synergy in vitro and in vivo with paclitaxel and it will be an important advancement in cancer therapy if such synergy is also present in actual clinical setting.”

“Hanmi filed their Korean IND in the 3Q of 2012, it was approved in the 4Q of 2012, and they have now enrolled their first patient. Their commitment to the KX01 program is extraordinary,” said Dr. Rudolf Kwan, CMO of Kinex. “I have visited the Korean clinical sites and am extremely pleased with the very high clinical research standard set by our partner, Hanmi. The KX01 program is important in its own right, but it also allows us to further refine our strategy of combining KX01 with Oraxol, an oral paclitaxel product discovered by Hanmi that is currently being developed through a joint development program between Kinex and Hanmi.”

Dr. Jeewoong Son, Senior VP and Head of Innovation at Hanmi added, “The Hanmi and Kinex teams worked together very diligently to submit our Korean IND in a timely manner. We are pleased to see Kinex’s strong commitment to aggressively move forward with KX01 and the Orascovery program. We hope that our joint effort will lead to an oral treatment that provides an important new option for many cancer patients.”

Kinex Pharmaceuticals today announced that it has converted the company from a Limited Liability Corporation into a C-Corporation, a planned strategic step to help drive future growth.

“Converting to a C-Corporation structure provides additional opportunity to access capital markets and funding sources not typically afforded under LLC structure and is the next logical phase in the evolution of the Company. It positions Kinex to maximize value for our share and stakeholders, “said Flint Besecker, Chairman of the Audit and Finance committee. Mr. Besecker has held a number of nationwide executive positions in the healthcare and financial industry, including CRE-NYSE, CIT-NYSE, GE Healthcare Financial Services (GE-NYSE), Heller Healthcare Finance (HF-NYSE) and Healthcare Financial Partners (HCF-NYSE).

Jean-Pierre Sommadossi, PhD, board member and co-founder of Pharmasset (VRUS-Nasdaq) and founder and former Chairman and CEO of Idenix (IDIX-Nasdaq) , added, “Kinex’s pipeline continues to expand and advance clinically. This new structure will allow Kinex to explore various strategic options as we move our programs forward. This conversion also addresses the needs of shareholders as well as current and future partners.”

Kinex Pharmaceuticals, LLC and PharmaEssentia Corporation announced today the execution of a licensing agreement granting PharmaEssentia exclusive rights in certain Asian territories for the dermatology preparations of Kinex’s dual Src/Pretubulin Inhibitor, KX01.

KX01 (KX2-391) is a potent small molecule Src kinase/Pretubulin dual mechanism inhibitor discovered by Kinex Pharmaceuticals using its proprietary technology platforms MimeticaTM and OpalTM. KX01 differentiates itself as an inhibitor that targets the kinase substrate pocket and, therefore, offers an excellent efficacy as well as safety profile. 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 study, in patients with end-stage cancer, showed a desirable safety profile and clinical response in approximately 25% of the patients. Phase II studies are ongoing. The composition of matter of KX01 is covered by issued patents.

In further experiments, KX01 was found to show great potency in inhibiting the growth of keratinocytes as well as suppression of neo-angiogenesis. In addition, the compound was shown to down-regulate the production of interleukin 2. These data support KX01’s potential utility in the treatment of skin conditions like psoriasis. Preliminary research conducted by PharmaEssentia showed that KX01 can be easily formulated for dermatology indications.

Under the terms of the agreement, PharmaEssentia will acquire the rights for the development and commercialization of the dermatologic preparations for all indications in greater China and some other Southeast Asian countries. Korea, Japan, Australia and New Zealand are not included in this agreement.

PharmaEssentia plans to file for an Investigational New Drug (IND) Application to initiate clinical studies in the near future. Kinex Pharmaceuticals will assist PharmaEssentia in the filing and will collaborate with PharmaEssentia in Phase II and III global registration studies. PharmaEssentia will provide Kinex Pharmaceuticals with an up-front payment. There will also be milestones and royalties associated with product sales. A joint development team will be established to foster the collaboration.

Dr. Ko-Chung Lin, Founder and Chief Executive Officer of PharmaEssentia, former co-founder of the discovery chemistry team at Biogen, and the inventor of P1101 at PharmaEssentia stated, “KX01’s unique mechanism of action affords great promise in treating psoriasis. Our internal expertise in chemistry and formulation will allow us to advance this program in an expedited way. Psoriasis is a disease that needs better treatment and we believe that we will be in a good position to provide an effective novel therapy for these patients in Asia.”

Dr. Ching-Leou Teng, Chairperson of the Board, Chief Scientific Officer, and also a former United States Food and Drug Administration reviewer added, “We were impressed by the experience of Kinex’s management team. Our due diligence process indicated the strong potential value of KX01 in the dermatologic setting and we are delighted to partner with Kinex Pharmaceuticals to explore these indications. Kinex Pharmaceuticals has had excellent success with their regulatory filings in the United States and we are confident that we will be able to file our IND application for dermatology indications very soon.”

“We are pleased to collaborate with PharmaEssentia to develop KX01 for dermatology preparations and indications. We are highly confident in the accomplished PharmaEssentia management team and their strong commitment to research and development,” said President Emeritus 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. His team in Schering-Plough also developed Clarinex and Zetia.

Dr. David Hangauer, Chief Scientific Officer, added, “We are impressed by the ability of the PharmaEssentia team to quickly explore the dermatology formulation of KX01. Based on comparing the profile of KX01 to the various pathogenetic mechanisms involved with psoriasis, I am confident that KX01 will find a niche in dermatology. I look forward to working together with PharmaEssentia to explore the full potential of KX01 for dermatology indications.”

Dr. Jinn Wu, a Director of Kinex’s Board and President and CEO of Xenobiotic Laboratories and XBL-China, concludes, “PharmaEssentia is one of the leading biotechnology companies in Taiwan and their management consists of seasoned executives. I am confident that their know-how will foster the success of this partnership. As a native Chinese citizen who grew up in Taiwan, I am gratified to see PharmaEssentia taking the lead in the dermatology field to further foster biotechnology development in Taiwan.”