Qualigen Therapeutics Engages TD2 as Contract Research Organization for Preclinical Development of QN-302

Rhea-AI Summary

Qualigen Therapeutics (Nasdaq: QLGN) has appointed Translational Drug Development (TD2) to oversee the preclinical development of its lead drug candidate, QN-302, targeting pancreatic ductal adenocarcinoma (PDAC). This partnership aims to navigate the IND process efficiently and expedite clinical trials. QN-302 is a genomic quadruplex-selective transcription inhibitor, potentially eligible for Orphan Drug Designation due to the high unmet medical need in treating PDAC, which currently lacks effective options.

Positive

• Appointment of TD2 enhances preclinical development capabilities for QN-302.
• QN-302 targets pancreatic ductal adenocarcinoma, a cancer with significant medical need.
• Potential eligibility for Orphan Drug Designation could provide regulatory advantages.

Negative

• None.

CARLSBAD, Calif., March 30, 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 appointed the renowned contract research organization (CRO) Translational Drug Development (TD2) to lead the preclinical development of lead drug candidate QN-302. Qualigen is initially investigating QN-302 for the potential treatment of pancreatic ductal adenocarcinoma (PDAC), which represents the vast majority of pancreatic cancers.

“This is an important step forward in our development work to bring QN-302 through the IND process and into the clinic,” stated Tariq Arshad, M.D., M.B.A., Qualigen’s Chief Medical Officer. “TD2’s expertise is focused on early stage preclinical and clinical oncology drug development. Its unique approach, geared at identifying clinical and regulatory strategies where there is the greatest opportunity for success in the clinic, was among the key reasons for partnering with TD2.”

TD2 is a precision oncology drug development organization integrating preclinical, clinical, and regulatory expertise and providing expert drug development services, including the design and execution of oncology clinical trials. TD2 has a proven track record of obtaining IND clearances and managing complex trial designs, including recruitment for Orphan diseases, to accomplish first patient dosing as quickly as possible.

“We are eager to begin our collaboration with Qualigen and to develop a research program for QN-302 that results in a suitable dataset for regulatory clearance. Our shared goal is to accelerate the compound into the clinic where it may address an unmet medical need that, to date, has few options,” added Stephen Gately, Ph.D., President and CEO of TD2.

QN-302 is Qualigen’s genomic quadruplex (G4)-selective transcription inhibitor platform being developed as a potential treatment for PDAC, in addition to other tumors of high unmet clinical need. PDAC 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 United States—are diagnosed with PDAC, and it annually causes approximately 430,000 deaths worldwide and 48,000 in the United States. Qualigen believes that QN-302 may ultimately be eligible to obtain Orphan Drug Designation, with potential for key regulatory advantages.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for 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.

About Translational Drug Development (TD2), Inc.

TD2 is a leader in precision oncology, providing innovative services for improved drug development. Using a dedicated, expert team with broad experience and understanding in cancer medicine, TD2 is uniquely positioned to support accelerated development of novel therapeutics. Rigorous and high-throughput translational preclinical development services, combined with regulatory affairs expertise, enables customized clinical trial design and execution. The broad suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process with the ultimate goal of accelerating patient access to promising treatments. For more information, visit www.TD2inc.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 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 in-licensed 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.

Contact:

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

Source: Qualigen Therapeutics, Inc.

FAQ

What is the purpose of QN-302 in cancer treatment?

QN-302 is being developed as a treatment for pancreatic ductal adenocarcinoma, one of the most lethal cancers.

Who is leading the preclinical development of QN-302?

Translational Drug Development (TD2) has been appointed to lead the preclinical development of QN-302.

What is the significance of Orphan Drug Designation for QN-302?

Orphan Drug Designation may provide regulatory advantages, expediting the drug's development and approval process.

What is the current status of QN-302's development?

QN-302 is in the preclinical stage as Qualigen prepares for the IND process.

How prevalent is pancreatic ductal adenocarcinoma?

Globally, an estimated 460,000 people are diagnosed with PDAC annually, making it a significant public health concern.