Qualigen Therapeutics Engages TD2 as Contract Research Organization for Preclinical Development… | Your money

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 designation of orphan drug, while commercializing diagnostics, today announces that it has appointed 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 accounts for the vast majority of pancreatic cancers.

“This is an important milestone in our development work to move QN-302 through the IND process and into the clinic,” said Tariq Arshad, MD, MBA, Medical Director of Qualigen. “TD2’s expertise is focused on the preclinical and clinical development of early-stage oncology drugs. Its unique approach, focused on identifying clinical and regulatory strategies where there is the greatest chance of success in the clinic, was a key reason 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 deliver the first patient as quickly as possible.

“We look forward to beginning our collaboration with Qualigen and developing a research program for QN-302 that will result in a suitable dataset for regulatory clearance. Our shared goal is to accelerate the introduction of the compound into the clinic where it could 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 transcriptional inhibitor platform being developed as a potential treatment for PDAC, in addition to other tumors with high unmet clinical need. PDAC is one of the deadliest cancers in the world and the fourth leading cause of cancer death in the United States. Each year, approximately 460,000 people worldwide and 60,000 in the United States are diagnosed with PDAC, and it causes approximately 430,000 deaths worldwide and 48,000 in the United States each year. Qualigen believes QN-302 may ultimately be eligible for orphan drug designation, with potential for key regulatory benefits.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing cancer treatments, as well as maintaining and expanding its core, FDA-cleared FastPack® System, which is successfully used in diagnostics for over 20 years. Our investigational compound QN-302 is a small molecule selective transcriptional inhibitor with high binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing G4s against “unwinding”, help inhibit cancer cell proliferation. Our investigational compound QN-247 inhibits nucleolin, a key multifunctional regulatory protein that is overexpressed in cancer cells; QN-247 could thus be able to inhibit cell proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). Qualigen’s investigational RAS-F family of small molecule inhibitors of RAS oncogene protein-protein interaction compounds are thought to inhibit or block the binding of proteins from mutated RAS genes to their effector proteins, leaving the mutated RAS proteins incapable of causing further harm. In theory, such a mechanism of action may be effective in treating around a quarter of all cancers, including some forms of pancreatic, colorectal and lung cancers. In addition to its oncology drug pipeline, Qualigen has a well-established diagnostics business that manufactures and distributes proprietary, highly accurate rapid blood test systems to medical practices and small hospitals for the management of prostate cancer and other diseases and health problems.

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 the development of improved drugs. With a team of dedicated experts with extensive experience and understanding of cancer medicine, TD2 is uniquely positioned to support the accelerated development of new therapies. Rigorous, high-throughput translational preclinical development services, combined with regulatory affairs expertise, enable the design and execution of personalized clinical trials. The wide range of features encourages the rapid selection of patient populations most likely to benefit from a new agent and the rapid identification of clinically significant parameters. 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 press release contains forward-looking statements by Qualigen that involve risks and uncertainties and reflect the judgment of the Company as of the date of this release. These statements include those relating to the Company’s outlook 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 the 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 schedule or will be successful; that any clinical trial will be approved to commence or will proceed as anticipated by any anticipated schedule, or at all; that all data from future clinical trials will be favorable or that such trials will confirm any improvement over other products or have no negative impacts; that any drug will receive required regulatory approvals (or Fast Track designation or orphan drug status) or be commercially successful; that patents will issue on patent applications owned and licensed by the Company; that these patents, if any, and the patents currently owned and licensed by the Company would prevent competition; that the Company will be able to source or earn sufficient working capital to complete the development, testing and launch of the Company’s potential 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 adversely affected if any of the events or trends contemplated by the forward-looking statements do not occur or are delayed or if any actual future event otherwise differs from expectations. Additional information regarding these and other risk factors affecting the Company’s business can be found in the Company’s previous 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 intention or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This warning is made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.


Jules Abraham JQA Partners, Inc. 917-885-7378 [email protected]

Source: Qualigen Therapeutics, Inc.

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