UCL School of Pharmacy Partners with Qualigen Therapeutics to Develop Cancer Therapeutics

Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, today announces the exclusive worldwide in-license of a genomic quadruplex (G4)-selective transcription inhibitor drug development program, including lead and back-up compounds, preclinical data and a patent estate, from University College London (UCL). Qualigen intends to develop the lead compound, now called QN-302, as a treatment for pancreatic ductal adenocarcinoma (PDAC), which represents the vast majority of pancreatic cancers. This license agreement was carried out by UCL Business Limited, the commercialization company for UCL.

“QN-302 is a promising candidate with a novel mechanism of action, supported by preclinical data from one of the leading pharmacology institutions in the world. This program aligns with our oncology focused therapeutics pipeline, expands our IP portfolio, and positions Qualigen well in this exciting area of G4 cancer research,” commented Michael Poirier, Qualigen’s Chief Executive Officer. “The scientific work UCL completed on the G4 platform could enable us to proceed with IND-enabling studies in 2022 toward an initial indication of pancreatic cancer.”

QN-302 was supported by the UCL Technology Fund, and in the earlier years, in part by Cancer Research UK funding, and is a small molecule that targets regions of cancer genes which have a disproportionately high number of G4s. Preclinical studies show that QN-302 selectively binds to G4s, forming a complex that prevents the G4 structures from “unwinding” at the cancer cells’ key regulatory regions. By preventing such “unwinding,” QN-302 would inhibit transcription. Through this mechanism, QN-302 has demonstrated anti-tumor activity in multiple tumor types, including in-vivo PDAC models, without toxicity at proposed therapeutic doses. Further, studies suggest encouraging anti-tumor activity against gemcitabine-resistant tumors.

Very limited options exist to treat pancreatic cancer, and it has one of the lowest survival rates of all cancer types, with a fatality rate of one in four within the first month of diagnosis. Accordingly, QN-302 may ultimately be eligible to obtain Orphan Drug Designation, with potential for key regulatory and commercial advantages.

Qualigen’s in-licensed G4-binder program was developed by Professor Stephen Neidle and his team from the UCL School of Pharmacy, in Great Britain, one of the top ten pharmacy and pharmacology research institutions in the world. Professor Neidle has a distinguished 30+ year history in nucleic acid research and drug design with over 500 published papers and 14 patents. “The positive early outcomes in evaluating the G4 approach have been encouraging, particularly in pancreatic cancer. We look forward to further exploring this approach against this disease, including those tumors that have shown little to no response to standard chemotherapeutic treatments such as gemcitabine,” added Professor Neidle.

About Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a biotechnology company focused on developing treatments for cancer, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for 20 years. QN-302 is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. QN-247 inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells; QN-247 may thereby be able to inhibit the cells’ proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). The compounds within Qualigen’s RAS-F family of RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. Such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems to physician offices and small hospitals for the management of prostate cancer and other diseases and health conditions.

For more information about Qualigen Therapeutics, Inc., please visit www.qualigeninc.com