Qualigen Therapeutics Engages Professor Stephen Neidle as Scientific Advisor in the Development of Lead Program QN-302

Rhea-AI Summary

Qualigen Therapeutics, Inc. (Nasdaq: QLGN) has appointed Professor Stephen Neidle as a scientific advisor to enhance the development of its lead compound QN-302, aimed at treating pancreatic ductal adenocarcinoma (PDAC). With over 30 years of experience and numerous publications, Neidle will collaborate with Qualigen's team to conduct essential IND-enabling studies. Qualigen believes QN-302 could also achieve Orphan Drug Designation, which could offer regulatory advantages. Pancreatic cancer remains a significant health concern, with high mortality rates and a growing number of diagnoses.

Positive

• Appointment of Professor Stephen Neidle enhances QN-302 development.
• Potential for QN-302 to obtain Orphan Drug Designation, offering regulatory advantages.
• Neidle's expertise expected to improve IND-enabling studies.

Negative

• No guarantee that QN-302 will successfully enter clinical trials.
• Dependence on Neidle's availability and effectiveness as an advisor.
• Risks associated with achieving regulatory approvals for drugs.

Innovator Behind Pancreatic Cancer-Focused Program Becomes Scientific Advisor

CARLSBAD, Calif., Feb. 01, 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 announced that it has engaged Professor Stephen Neidle as a scientific advisor. Professor Neidle is a world-renowned scientist at University College London and is the key innovator of the Company’s in-licensed genomic quadruplex (G4)-selective transcription inhibitor platform. Qualigen is developing this platform’s lead compound, now called QN-302, as a potential treatment for pancreatic ductal adenocarcinoma (PDAC), which represents the vast majority of pancreatic cancers.

“Professor Neidle’s extensive knowledge in the development of QN-302 to date, as well as in the pancreatic cancer field in general, make him a key asset as we progress in bringing this lead program forward,” commented Michael Poirier, Qualigen’s CEO. “Professor Neidle will play an integral role as a scientific advisor by working with our Chief Medical Officer, Dr. Tariq Arshad and the Qualigen team as we advance QN-302 toward the clinic.”

Mr. Poirier continued, “We expect Professor Neidle to help to ensure all experiments are performed thoroughly, as we work toward conducting IND-enabling studies and the preparations necessary to bring the compound into clinical trials. He will also serve to build scientific understanding regarding data results, including authorship and presentation to the scientific community. Finally, we hope to leverage Professor Neidle’s experience in discovery and development of drugs that have been granted Fast Track designation by the FDA.”

Qualigen’s in-licensed QN-302 program was developed by Professor 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.

Pancreatic cancer is one of the world's most lethal cancers, and the fourth-leading cause of cancer-related death in the United States. Each year, an estimated 460,000 people globally—and 60,000 in the U.S.—are diagnosed with pancreatic cancer, and it annually causes approximately 430,000 deaths worldwide and 48,000 in the U.S., Qualigen believes that QN-302 may ultimately be eligible to obtain Orphan Drug Designation, with potential for key regulatory and commercial advantages.

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 Professor Neidle will provide services as expected or that the results of his advice will be favorable, 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 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 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
dk@atlcp.com

Tony Schor
Investor Awareness, Inc.
(847) 971-0922
tony@investorawareness.com

Media:

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

Source: Qualigen Therapeutics, Inc.

FAQ

What is the significance of Professor Neidle's appointment for QLIGN?

Professor Neidle's appointment as a scientific advisor is expected to enhance the development of QN-302, a treatment for pancreatic cancer.

What is QN-302 and what is its intended use?

QN-302 is a lead compound developed by Qualigen aimed at treating pancreatic ductal adenocarcinoma, a common type of pancreatic cancer.

What are the potential benefits of Orphan Drug Designation for QN-302?

Receiving Orphan Drug Designation can provide QN-302 with key regulatory advantages, facilitating its development and commercialization.

What are the risks associated with the development of QN-302?

Risks include the uncertainty of successful clinical trials and the need for regulatory approvals.

How does pancreatic cancer impact patient outcomes?

Pancreatic cancer is one of the deadliest cancers, with a high mortality rate globally, underscoring the need for effective treatments.