Qualigen in-licenses novel cancer drug from University of Louisville

New Formulation is Key to Fulfilling Promise of Prior Clinical Studies

CARLSBAD, Calif., July 12, 2018 /PRNewswire/ -- Qualigen, Inc., and the University of Louisville (UofL) today announced that Qualigen has licensed certain UofL patents, intellectual property and other assets associated with anti-nucleolin agent-conjugated nanoparticles, a novel molecular-based compound that has shown promise as an anticancer drug, a radio-sensitizing agent and an MRI contrasting agent.  Under the License Agreement, Qualigen will take over development, regulatory approval and commercialization of anti-nucleolin agent-conjugated nanoparticles from UofL and is responsible for maintenance of the related intellectual property portfolio.  In return, UofL will receive cash payments on the achievement of certain milestones and royalties on future drug sales, as well as potential equity in Qualigen.

Anti-nucleolin agent-conjugated nanoparticles is an aptamer-based anticancer drug that can be used to treat virtually any type of cancer.  This novel technology also has several additional potential applications, including delivery of other anti-cancer compounds directly to tumor cells, enhancement of radiation therapy and enhancement of tumor imaging.  A key component of this drug, AS1411, has been tested in over 100 patients and is well tolerated with no evidence of severe side effects, with at least 7 patients having long-lasting clinical responses where their cancers disappeared or shrank substantially.  Scientists at the University of Louisville have successfully reformulated AS1411 by attaching gold nanospheres, thereby dramatically increasing potency.  Initial preclinical studies in breast cancer utilizing AS1411 linked to gold nanoparticles showed significantly enhanced activity compared to AS1411 alone.  It is anticipated that, following limited additional optimization of the formulation and further pharmacogenetic studies, AS1411-GNP will enter clinical trials by 2020. 

"We are delighted to add AS1411-GNP to our portfolio of anticancer drug technologies.  This is a unique technology platform that is synergistic with our cancer diagnostics business and will enable us to rapidly expand into cancer therapeutics," noted Michael S. Poirier, Chairman, CEO and President of Qualigen. "This is a unique opportunity to continue development of a compound that has already undergone extensive preclinical characterization and shown promise in prior clinical studies. Thanks to the innovative work carried out by Dr. Paula Bates and her colleagues, including Drs. Tariq Malik and Martin O'Toole, at the University of Louisville, we believe that the new AS1411-GNP formulation will lead to a significant improvement in absorption in humans, thereby enabling the drug to fulfill the promise seen in the earlier studies." 

The licensed technology was developed at UofL with key support from the university's robust innovation programs, including the Coulter Translational Partnership and ExCITE, a National Institutes of Health Research Evaluation and Commercialization Hub (REACH).  These programs drive the translation of innovative research from UofL's campus to the marketplace.

"We are excited to work with Qualigen on the product development of our nanoparticle-based drug to fight cancer," said Dr. Allen Morris, Director of the Office of Technology Transfer at the University of Louisville.  "This is the kind of outcome we seek in our translational efforts – getting our research to market where it can benefit people."

About Qualigen, Inc.

Qualigen, Inc. is a medical device company focused on the development, production and commercialization of innovative medical technologies, including its flagship FastPack® point-of-care immunoassay system and novel therapeutic technologies for treatment of cancers and infectious diseases.  For more information, visit www.qualigeninc.com.

About UofL

The University of Louisville is a state-supported metropolitan research university located in Kentucky's largest city, with the University of Louisville Research Foundation (ULRF) serving as the agent of the University for promoting and supporting research projects, investigations, and other activities relating to the educational, scientific, literary, artistic, healthcare and public service missions of the University.  For more information, visit http://louisville.edu/research/