Qualigen Therapeutics Announces Pre-IND Feedback from U.S. Food and Drug Administration Regarding QN-302 for the Treatment of G4-Targeted Advanced Solid Tumors

Rhea-AI Summary

Qualigen Therapeutics (Nasdaq: QLGN) has announced that it received FDA feedback following a pre-Investigational New Drug interaction for its QN-302 compound, aimed at treating advanced solid tumors. This guidance will aid in the preparation of their IND application, expected to be submitted in the first half of 2023. CEO Michael Poirier emphasized the importance of FDA input and collaboration with their Scientific Advisory Board as they advance QN-302 towards clinical trials.

Positive

• Received FDA guidance for IND application submission regarding QN-302.
• Plans to submit IND application in the first half of 2023.

Negative

• None.

CARLSBAD, Calif., Dec. 07, 2022 (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 that it has received feedback from the FDA following a pre-Investigational New Drug (pre-IND) interaction regarding the development pathway to a Phase 1 clinical trial of QN-302 for the treatment of G4-targeted advanced solid tumors. The purpose of the pre-IND interaction was to inform the proposed content of the Company’s IND application and request guidance from the Division on specific questions prior to submission of the IND application. The FDA’s response provides Qualigen with clear guidance for formally submitting an IND application for QN-302 after accounting for the agency’s comments and suggestions.

“We are pleased to have received the feedback from the FDA that informs our plans for the proposed Phase 1 study intended for patients with advanced solid tumors as well as the proposed content of the initial IND application. We remain on track to submit the IND application around the first half of 2023,” said Tariq Arshad, M.D., M.B.A., Qualigen’s Chief Medical Officer.

Qualigen Chairman and CEO, Michael Poirier added, “We value the input we received from the Agency and will ensure that our development team takes into account the FDA’s guidance as we continue our preparations toward IND filing, with input from our Scientific Advisory Board of world class oncology experts from leading cancer research institutions. We look forward to providing updates on our lead therapeutics program, QN-302 as we advance toward the clinic.”

About Qualigen Therapeutics, 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. 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 our 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 Qualigen Therapeutics' QN-302 compound?

QN-302 is an investigational drug being developed for the treatment of G4-targeted advanced solid tumors.

When does Qualigen plan to submit the IND application for QN-302?

Qualigen plans to submit the IND application for QN-302 in the first half of 2023.

What kind of feedback did Qualigen receive from the FDA?

Qualigen received feedback that provides clear guidance for the formal submission of their IND application for QN-302.

What is the significance of the FDA's feedback for Qualigen?

The feedback is crucial as it informs the development pathway and proposed content of the IND application, enhancing the likelihood of successful clinical trial initiation.

What is the focus of Qualigen Therapeutics?

Qualigen Therapeutics focuses on developing treatments for adult and pediatric cancers and commercializing diagnostics.