Qualigen Therapeutics Announces Partnership with Hande Sciences To Scale-Up Manufacturing To Support IND-Enabling Studies for QN-302

CARLSBAD, Calif., July 06, 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 its partnership with China-based Hande Sciences (“Hande”) to conduct manufacturing scale-up activities to support the Company’s IND-enabling good laboratory practice (GLP) studies for its lead therapeutic program, QN-302.

The Company has chosen Hande for its capabilities in performing custom synthesis and process research and development. Hande specializes in scale-up of small molecules therapeutics and is building a large good manufacturing processes (GMP) manufacturing site, which is expected to be completed in August 2022. The agreement with Hande provides for process development and scale-up batches of material for the Company’s GLP toxicology studies, which the Company expects to commence in Q3 of 2022, as previously announced.

Tariq Arshad, MD, MBA, Qualigen's Chief Medical Officer, commented, “We are on track to complete our IND-enabling studies for QN-302 in the third and fourth quarters of 2022 and are excited to partner with Hande, who has an excellent track record of performance. We look forward to continuing to execute on our key milestones with highly experienced collaborators in an efficient and cost-effective manner.”

QN-302 is Qualigen’s G-quadruplex (G4)-selective transcription inhibitor platform being developed as a potential treatment for Pancreatic ductal adenocarcinoma (PDAC), in addition to other tumors of high unmet clinical need, such as Prostate Cancer. PDAC represents the vast majority of pancreatic cancers, is one of the world's most lethal cancers, and the fourth-leading cause of cancer-related death in the United States. In 2019, there were an estimated 89,248 people living with pancreatic cancer in the United States.1 Drugs that treat rare cancers such as PDAC qualify for Orphan Drug Designation (ODD) as the prevalence is <200,000 cases.2 ODD therapeutic programs typically require smaller clinical trials and have an expedited regulatory path.

Founded in 2007, Hande Sciences is a leading pharmaceutical contract development and manufacturing organization (CDMO) in China, providing high-quality research and development (R&D) and production services for global biotech and pharmaceutical companies. It specializes in process development, scale-up and manufacturing of advanced intermediates and active pharmaceutical ingredients (APIs) under non-GMP and GMP and accelerates the launch of new drugs, providing one-stop chemistry, manufacturing, and controls (CMC) services for the full lifecycle of drug development. Hande has an internationally recognized, professional, and cohesive team supporting R&D and production. It has campuses in Suzhou and Changshu where they have recently built a state-of-the-art non-GMP and GMP pilot plant for kilo scale and commercial launch scales up to metric tons with Environmental Health and Safety (EHS) and Quality Assurance (QA) systems that meet the requirements of Asia Pacific, European and US FDA and NMPA requirements.

For more information about Hande Sciences, please visit www.handesciences.com.

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-302 and the Company’s other therapeutic drug candidates. 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-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; 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, QN-247 and RAS-F, and QN-165). 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.


Jules Abraham
JQA Partners, Inc.

Source: Qualigen Therapeutics, Inc.

  1. https://seer.cancer.gov/statfacts/html/pancreas.html
  2. https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/orphan-drug-act-relevant-excerpts