• Two posters include data on potential clinical biomarkers and transcriptomic data associated with QN-302’s mechanism of action

CARLSBAD, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, today announces the presentation of two posters on the Company’s lead compound, QN-302, at the ninth American Academy of Cancer Research (AACR) Special Conference on Pancreatic Cancer, held September 27^th to 30^th at the Westin Copley Place in Boston.

“The data from these two posters demonstrate information that is instrumental in understanding the importance of QN-302, a G-Quadruplex (G4) targeted transcription inhibitor and its potential profile in Pancreatic Cancer,” commented Tariq Arshad, M.D., M.B.A., Qualigen’s Chief Medical Officer. “The inclusion of these data at the AACR Pancreatic Cancer Research meeting provides further elucidation of our therapeutic approach in treating this devastating disease. We are delighted that QN-302's Investigational New Drug application was cleared by FDA and QN-302 is on track to enter the clinic this year.”

Highlights of the posters include:

Poster A081: “The Pan G-Quadruplex experimental drug QN-302 in PDAC: identification of potential biomarkers for clinical studies” by Ahmed Ahmed, Tariq Arshad^, and Stephen Neidle. Studies showed that increased expression of S100P and CX3CL1 correlated with human pancreatic ductal adenocarcinoma (PDAC) disease progression – both gene targets previously proposed as potential biomarkers.

Figure 1a and 1b: Western blot and RT-PCR studies on tumor material in a MIA-PACA2 xenograft mouse model at the end of 28-day dosing, with dosing 1 mg/kg BW (Twice Weekly) or QW (Once Weekly):

Figure 1A

Figure 1B

Poster A080: “Target genes in pancreatic cancer cells of the Pan G-Quadruplex clinical candidate compound QN-302 revealed by comparative transcriptome profiling” by Ahmed Ahmed, Tariq Arshad, Maria Roman-Escorza, Dan Neidle, and Stephen Neidle. Studies showed that administering QN-302 to PDAC cells produced significant changes in the pattern of down-regulated G-quadruplex (G4) genes.

Table 1: QN-302 and related chemical analogs CM03 and SOP1247 showed nanomolar potency in various cell lines, including gemcitabine-resistant MIA-PACA2 and PANC-1 cell lines, as well as significant G4 stability evident by low nanomolar binding affinity [ΔTm (°)] to G4s.

These data continue to expand the Company’s understanding of the genetic associations with QN-302.

In 2020, there were an estimated 95,389 people living with Pancreatic Cancer in the United States (NIH, 2023). Pancreatic cancer is a highly lethal disease and the third most common cause of cancer death in the United States. Pre-clinical in-vitro and in-vivo studies of QN-302 have shown that G4 stabilization may result in inhibition of target gene expression and cessation of cell growth in a variety of cancers, including PDAC, which represents 98% of pancreatic cancers.

The AACR Special Conference on Pancreatic Cancer attracts 400-500 attendees yearly and spans basic, translational, and clinical research. This year’s program focused on incorporating numerous talks from submitted abstracts to highlight the advancements and diversity of the pancreatic cancer research field. Special sessions presented cutting-edge research, career development opportunities, and discuss key areas of research in the field.

About QN-302

QN-302 is a small molecule G4-selective transcription inhibitor in Phase 1 clinical development for the treatment of G4-expressing solid tumors, such as pancreatic cancer, prostate cancer, sarcomas, and others. QN-302 stabilizes G4 complexes prevalent in the promoter region of oncogenes in many tumor types, impeding transcription of G4-containing cancer genes and may potentially offer a tumor-agnostic clinical approach to treatment. Orphan Drug Designation was granted by the FDA in January of this year for QN-302 for the intended indication of pancreatic cancer. The Company anticipates the dosing of at least 24 patients in the Phase 1 trial can be completed by the end of 2024, funded in part by proceeds received by the divestiture of the Company’s diagnostics business in July 2023.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. 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 Pan-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.

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 development of its therapeutic drug candidates, including the anticipated timeline for initiating the Company’s Phase 1 clinical trial and enrolling and dosing of patients and the identification of a late in vivo candidate. Actual events or results may differ from the Company's expectations. There can be no assurance that the Company will be able to successfully develop any drugs (including QN-302, Pan-RAS and QN-247); that preclinical development of the Company's drugs (including Pan-RAS and QN-247) 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, Pan-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 fail 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 annual report on 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.

For more information about Qualigen Therapeutics, Inc., please visit www.qlgntx.com.

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