Composition of Matter Patent for QN-302 Granted by United States Patent and Trademark Office

Rhea-AI Summary

Qualigen Therapeutics announces the grant of U.S. Patent No. 11,560,380 for its lead oncology drug candidate, QN-302. This patent protects the composition of matter for QN-302, a small molecule selective transcription inhibitor targeting G4 complexes in solid tumors, including pancreatic cancer, with exclusivity until 2040. The company also received a Notice of Intent for a similar patent in the E.U. CEO Michael Poirier emphasized the importance of this patent for QN-302's development, and the company is preparing to submit an Investigational New Drug (IND) application soon. QN-302 has already received Orphan Drug Designation from the FDA for pancreatic cancer.

Positive

• U.S. Patent No. 11,560,380 granted for QN-302, ensuring exclusivity until 2040.
• Notice of Intent received for a similar patent in the E.U.
• Strengthens strategic position for the upcoming IND application.

Negative

• None.

CARLSBAD, Calif., March 21, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (“Qualigen” or “the Company,” 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 the United States Patent and Trademarks Office (USPTO) has granted the Company patent number 11,560,380 for QN-302, its lead oncology investigational drug candidate, a small molecule selective transcription inhibitor with strong binding affinity to G4 complexes prevalent in cancer cells being investigated for solid tumors, including pancreatic cancer.

The patent protects composition of matter for QN-302 and back-up compounds, with exclusivity to the Company into 2040. Concurrently, the Company has received Notice of Intent from the European Patent Office to grant a similar patent in the E.U.

“A key pillar in the development of therapeutic drugs is a company’s intellectual property portfolio,” commented Michael Poirier, CEO and Chairman of Qualigen. “This particular U.S. patent is of paramount importance to us, as it protects the formulation itself and is integral to our development of QN-302. Further, it strengthens our strategic position as we complete the necessary steps toward submission of an Investigational New Drug (IND) application in the coming months. We look forward to providing additional updates as they develop.”

About QN-302

QN-302 is a small molecule G-Quadruplex (G4)-selective transcription inhibitor in development for the treatment of G4-expressing tumors, such as pancreatic cancer (PDAC), prostate cancer, sarcomas, Gastrointestinal Stromal Tumors (GIST), and others. Orphan Drug Designation (ODD) was granted by the FDA in January of this year for pancreatic cancer. QN-302 is currently in IND enabling studies.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, while also commercializing diagnostics. 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. The investigational compounds within Qualigen’s 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. 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). 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, including statements related to the development of QN-302, including the anticipated timing for executing on our IND-enabling studies and IND application submission, and the Company’s other 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 be able to successfully develop any drugs (including QN-302, RAS, and QN-247); that preclinical development of the Company's drugs (including QN-302, RAS, and QN-247, 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, RAS, and QN-247). 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.

FAQ

What is the significance of the U.S. Patent No. 11,560,380 granted to Qualigen for QN-302?

The patent protects the composition of QN-302, ensuring its exclusivity until 2040, which is crucial for its development in treating various solid tumors.

Has QN-302 received any designations from regulatory authorities?

Yes, QN-302 has received Orphan Drug Designation from the FDA for pancreatic cancer.

What is the next step for Qualigen regarding QN-302?

Qualigen plans to submit an Investigational New Drug application in the coming months for QN-302.

What types of cancers is QN-302 being developed for?

QN-302 is being developed for solid tumors, including pancreatic cancer, prostate cancer, and sarcomas.

What are the future plans for Qualigen's drug development?

Qualigen is focused on completing the necessary steps for IND application submission and continuing the development of its oncology drug candidates.