On October 1, 2020 Qualigen Therapeutics, Inc. (NASDAQ: QLGN) reported it has entered into an amended Sponsored Research Agreement with the University of Louisville (UofL) to advance development of Qualigen’s anticancer drug candidate AS1411-GNP, also known as ALAN (Aptamer-Linked Anti-Nucleolin) (Press release, Qualigen, OCT 1, 2020, View Source [SID1234567931]).
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The work being performed under the original Sponsored Research Agreement comprises animal studies to assess antitumor efficacy and safety of different ALAN compositions designed to treat pediatric and adult acute myeloid leukemia (AML). Under the amended Sponsored Research Agreement UofL will perform preclinical studies on AML and on additional indications including glioblastoma, a malignant brain cancer that is difficult to treat because most drugs cannot pass the blood-brain membrane, and non-small cell lung cancer, which comprises approximately 85% of the 1.6 million global lung cancer cases each year.
Additionally, Qualigen and UofL will study how ALAN may inhibit metastasis of cancer cells as a potential adjuvant therapy. The recurrence of cancer after initial treatment is the cause of approximately 90% of cancer deaths and represents a pressing unmet clinical need.
"Our expanded agreement with UofL should provide Qualigen with additional data to help us achieve our goal of advancing our ALAN cancer drug candidate into clinical trials against AML next year. We are especially interested in several new applications of this drug candidate, namely the treatment of pediatric cancers such as leukemia, the treatment of glioblastoma, the deadliest form of brain cancer and as an adjuvant therapy to stop the recurrence of cancer after initial treatment. We believe these paths will become a larger part of our clinical efforts and will accelerate the expansion of our product pipeline over the coming year, as they represent high unmet needs for critically important areas of cancer treatment," stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen.
ALAN is a combination of AS1411 plus a DNA-coated gold nanoparticle, which dramatically increases its potency. This cancer drug candidate has the potential to target and destroy tumor cells in a wide variety of cancer types with minimal side effects. The Company is aiming to commence Phase 1 human trials in 2021 for AML, its lead indication. Qualigen has an exclusive worldwide license agreement from the UofL for ALAN.
"We are pleased to continue our relationship with Qualigen Therapeutics to expand the development program for ALAN," added Paula Bates, PhD, Professor of Medicine at UofL, who will be leading the project at UofL in collaboration with Martin O’Toole, PhD, and Levi Beverly, PhD. "We look forward to conducting these studies, which have the potential to demonstrate ALAN’s broad applicability as an effective therapy for these difficult-to-treat cancers."