Qualigen Therapeutics Announces IND-Enabling Studies to Advance Lead Program QN-302 Toward Clinical Trials

A Potential Treatment for Pancreatic Cancer in Addition to Other Tumors of High Unmet Clinical Need

CARLSBAD, Calif., June 07, 2022 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces it has initiated Investigational New Drug, or IND-enabling, studies for its lead therapeutic program, QN-302. These initial safety and pharmacology studies represent an important milestone for QN-302, which is being developed to treat pancreatic cancer, and potentially prostate cancer and other solid tumors.

The Company also announces that it has established an in vivo maximum tolerated dose of QN-302, which corroborates a therapeutic window for target indications as demonstrated in earlier efficacy studies. Qualigen’s recently initiated IND-enabling studies, combined with the data package in-licensed from University College London (UCL), align with the timeline for the submission of an IND application to the U.S. Food and Drug Administration (FDA) during the first half of 2023.

Tariq Arshad, M.D., Qualigen’s Chief Medical Officer, commented, “To date, we are on target to hit our key milestones regarding the pre-clinical development of our exciting lead program QN-302. We are encouraged by the progress we have made through these initial IND-enabling studies, and we are confident that we will continue to advance this program towards clinical trials within budget and on schedule.”

The Company expects to initiate exploratory toxicology during the third quarter, followed by initiation of GLP (good laboratory practice) toxicology studies, and a pre-IND interaction with the FDA targeted for the fourth quarter of 2022 to generate input for the initial clinical study plan.

QN-302 is Qualigen’s G-quadruplex (G4)-selective transcription inhibitor platform being developed as a potential treatment for PDAC, in addition to other tumors of high unmet clinical need. Pancreatic ductal adenocarcinoma (PDAC), which represents the vast majority of pancreatic cancers, is one of the world’s most lethal cancers, and the fourth-leading cause of cancer-related death in the United States. In 2019, there were an estimated 89,248 people living with pancreatic cancer in the United States.¹ Drugs that treat rare cancers such as PDAC qualify for Orphan Drug Designation (ODD) as the prevalence is < 200,000 cases.² ODD therapeutic programs typically require smaller clinical trials and have an expedited regulatory path.

AboutQualigenTherapeutics,Inc.

Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, as well as maintaining and expanding its core FDA-cleared FastPack^® System, which has been used successfully in diagnostics for over 20 years. Our investigational QN-302 compound 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. Our investigational QN-247 compound 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 investigational 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. In theory, 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-LookingStatements

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, including statements related to the development of QN-302 and the Company’s other therapeutic drug candidates. Actual events or results may differ from the Company’s expectations. For example, here can be no assurance that the Company will be able to 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 Fast Track designation 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 in-licensed patents would prevent competition; or 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). 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.

Contact:

Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com

Source: Qualigen Therapeutics, Inc.

1. https://seer.cancer.gov/statfacts/html/pancreas.html
2. https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/orphan-drug-act-relevant-excerpts