Qualigen Therapeutics Reports Positive QN-247 Readout in Triple Negative Breast Cancer in Vivo Model

Rhea-AI Summary

Qualigen Therapeutics, Inc. (Nasdaq: QLGN) announced the completion of its in vivo efficacy analysis for QN-247 in solid tumors, specifically in a model for triple negative breast cancer (TNBC). The results indicate robust efficacy and no safety concerns, leading the company to pursue further investigations. Qualigen plans to submit an IND for its QN-302 program targeting G-Quadruplex expressing solid tumors in the coming months. CEO Michael Poirier confirmed the company's strong cash position and readiness to raise capital as needed.

Positive

• Successful completion of in vivo efficacy analysis for QN-247 in TNBC, showing robust efficacy.
• No safety signals or adverse events reported during the study.
• CEO indicates significant future opportunities for QN-247 and plans for IND submission of QN-302.

Negative

• None.

CARLSBAD, Calif., Aug. 01, 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 completed its in vivo efficacy analysis of QN-247 in solid tumors. Data demonstrates robust efficacy and no safety signals in a triple negative breast cancer (TNBC) model.

Committed to an in vivo data readout in the third quarter of 2022, the Company has been conducting in vivo testing on multiple potential indications. QN-247 demonstrated a robust efficacy signal and showed no adverse events or toxicities at the tested therapeutic dose in an animal model for triple negative breast cancer (TNBC), a rare, highly aggressive and difficult to treat form of breast cancer. QN-247 demonstrated a favorable safety profile with stable body weights throughout the study. Qualigen believes the encouraging efficacy and safety results in TNBC animal model warrant further investigation and future investment.

Michael Poirier, Qualigen's Chief Executive Officer, commented, “We are encouraged by these positive results and believe there are significant opportunities to evaluate which indications for QN-247 merit further development. We are also on schedule toward becoming clinical-stage with another oncology asset, namely, the IND submission of our lead therapeutic program QN-302, in the coming months for the potential treatment of G-Quadruplex expressing solid tumors such as pancreatic cancer, among other cancers.”

”We currently have sufficient cash to execute on our near-term plans. Notwithstanding our current cash position, we have positioned the Company to raise capital should the need arise, based on the emerging strength of our multiple programs across both pillars of our business, therapeutics, and diagnostics, and we determine that market conditions are more favorable. Our focus for 2022 remains on execution and achieving our value driving milestones,” Mr. Poirier added.

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. 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-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-247, the timing for in vivo data readout, and the Company’s capital needs and financing plans. 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-247, QN-302 and RAS-F); that preclinical development of the Company's drugs (including QN-247, QN-302 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-247, QN-302 and RAS-F). 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 QN-247's efficacy results for Qualigen (QLGN)?

The efficacy results for QN-247 in TNBC indicate robust performance and lack of safety concerns, prompting further development.

When will Qualigen submit the IND for QN-302?

Qualigen plans to submit the IND for QN-302 in the coming months.

Is Qualigen (QLGN) financially stable for its upcoming projects?

Yes, Qualigen has sufficient cash to execute its near-term plans and is positioned to raise more capital if needed.

What type of cancer does QN-247 target?

QN-247 targets triple negative breast cancer (TNBC), a challenging form of breast cancer.

Did Qualigen report any safety issues with QN-247?

No, the analysis showed no safety signals or adverse events for QN-247.