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Qualigen Therapeutics Secures Worldwide Rights to G4-Selective Transcription Inhibitors from University College London to Develop as Cancer Therapeutics

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Preclinical Therapeutic Program to Be Initially Focused on Pancreatic Cancer

CARLSBAD, Calif., Jan. 18, 2022 (GLOBE NEWSWIRE) -- 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.

Forward-Looking Statements

This news release contains forward-looking statements by Qualigen that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to the Company's prospects and strategy for the development of therapeutic drug candidates. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that the Company will successfully develop any drugs (including QN-302, QN-247 and RAS-F); that preclinical development of the Company's drugs (including QN-302, QN-247 and RAS-F, and the deprioritized infectious-disease drug candidate QN-165) will be completed on any projected timeline or will be successful; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline, or at all; that any future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs will receive required regulatory approvals (or Orphan Drug status) or that they will be commercially successful; that patents will issue on the Company's owned and in-licensed patent applications; that such patents, if any, and the Company's currently owned and inlicensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products (including QN-302, QN-247 and RAS-F, and QN-165); or that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business can be found in the Company's prior filings with the Securities and Exchange Commission, including its most recent Form 10-K, all of which are available at www.sec.gov.

The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investor Relations:

David Kugelman
Atlanta Capital Partners, LLC
(404) 856-9157 or (866) 692-6847 Toll Free - U.S. & Canada

Tony Schor
Investor Awareness, Inc.
(847) 971-0922

Source: Qualigen Therapeutics, Inc.