QLGN Qualigen Therapeutics Inc

Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today provides data from published abstracts from the American Association of Cancer Research (AACR) demonstrating positive in vivo data on the Company’s lead compound QN-302 (previously known and referenced in the abstracts as SOP1812).

QN-302 is the Company’s genomic quadruplex (G4)-selective transcription inhibitor being developed as a potential treatment for pancreatic ductal adenocarcinoma (PDAC), in addition to other tumors of high unmet clinical need. The abstracts accepted by AACR outline the potential binding to a quadruplex target for the compound, as well as significant anti-tumor activity in relevant animal models. 

“These data represent an important step forward in our lead development program, QN-302, particularly with regard to pancreatic cancer and prostate cancer,” commented Michael Poirier, Qualigen’s CEO. “The presentation of these data at AACR shows promising information regarding the key properties of this therapeutic target.”

“The potent quadruplex-binding compound SOP1812 shows anti-tumor activity in patient-derived in vivo models of pancreatic cancer” (lead author Dr. Stephen Neidle, to be posted April 13). These abstract reports that QN-302 showed significant anti-tumor activity in three patient-derived xenograft (PDX) models for pancreatic ductal adenocarcinoma (PDAC). One model is from a primary PDAC tumor at stage I, and the two others are from patients with stage IV PDAC”. Transcriptome studies on cellular responses to QN-302 previously demonstrated that expression of several oncogenes and their signaling pathways are down-regulated by this agent. This supports the hypothesis that the mechanism of action of QN-302 in vivo involves targeting of quadruplex-containing genes, which is also corroborated by the PDX data since these tumors have elevated levels of several quadruplex-containing genes previously identified in cells and in vivo. QN-302 is bio-available at proposed therapeutic doses and has been shown to be well tolerated at these levels in animal models. 

“The potent quadruplex-binding compound SOP 1812 shows potent anti-proliferative activity in a prostate cancer cell panel and anti-tumor activity in an in vivo model of metastatic prostate cancer” (lead author Dr Stephen Neidle, to be posted April 13). In this study, the authors evaluated the activity of QN-302 in the PC3 xenograft model using a twice-weekly 1 mg/kg dose regimen intravenously administered against control and the established prostate cancer drug abiraterone, at a daily dose of 200 mg/kg, administered by the oral route, both over a 28-day period. No weight loss was observed in treated animals with either drug. QN-302 produced statistically significant tumor shrinkage (p=0.0008) relative to the control. The study authors concluded that QN-302 was bio-available at therapeutic doses and was well tolerated at these levels in this animal model. 

“Structure-based design of quadruplex-binding small molecule compounds: The essential role of water molecules” (lead author Dr Stephen Neidle, to be posted April 11), describes the design of the compound QN-302 targeted against human DNA quadruplexes by means of computer modelling. This was based on co-crystal structures of 1st-generation substituted naphthalene diimides with human intramolecular telomeric quadruplexes. The abstract further describes the optimization of an existing naphthalene diimide compound leading to QN-302, which has single-digit 1-20 nM anti-proliferative activity in a panel of human pancreatic ductal adenocarcinoma (PDAC) cell lines.

The AACR Conference, being held in New Orleans from April 8-13, 2022, is a focal point of the scientific cancer community where scientists, clinicians, other health care professionals, survivors, and patients review the latest advances in cancer science and medicine.

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.

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 AbrahamJQA Partners, Inc.917-885-7378

jabraham@jqapartners.com

Source: Qualigen Therapeutics, Inc.