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Generating specific cell lineages from induced pluripotent stem cells and embryonic stem cells is the holy grail of regenerative medicine. Guiding iPSCs toward a target cell line has garnered much attention, but the process remains challenging. Now, researchers from Japan have discovered that an anti-nucleolin DNA aptamer, iSN04, can determine a cell’s lineage during differentiation. By demonstrating the generation of cardiomyocytes from murine pluripotent stem cells, their concept shows promise as a regenerative therapy. Generating specific cell lineages from induced pluripotent stem cells and embryonic stem cells is the holy grail of regenerative medicine. Guiding iPSCs toward a target cell line has garnered much attention, but the process remains challenging. Now, researchers from Japan have discovered that an anti-nucleolin DNA aptamer, iSN04, can determine a cell's lineage during differentiation. By demonstrating the generation of cardiomyocytes from murine pluripotent stem cells, their concept shows promise as a regenerative therapy. Self-renewal and pluripotency-the capacity to form any cell lineage-are inherent characteristics of induced pluripotent stem cells (iPSCs). Furthermore, they are highly prized in regenerative therapies targeting cardiovascular, neurological, and metabolic diseases as they are immunologically suitable for transplantation back into a donor. Unfortunately, regenerative medicine is not yet feasible outside a laboratory setting as available protocols to generate target cells are complicated and expensive. This raises a pertinent question: Can regulating the fate of stem cells in clinical settings and at scale be made more economical? A team of researchers from Shinshu University, the National Institute of Advanced Industrial Science and Technology, and the University of Shizuoka in Japan set out to address this question by leveraging nucleic acid aptamers. Aptamers are single-stranded pieces of DNA that bind to target proteins and are able to modulate signaling cascades during cell differentiation when a stem cell commits to a specific functional role or phenotype. They hold promise in regenerative medicine as they are easily modified, can be synthesized economically, and are suitable for long-term storage. The team, led by Associate Professor Tomohide Takaya from the Department of Agricultural and Life Sciences at Shinshu University, recently discovered that an anti-nucleolin aptamer, myogenetic oligodeoxynucleotide iSN04, induced myocardial differentiation in embryonic stem cells (ESCs). The study was led by Mina Ishioka, a graduate student in Dr. Takaya's laboratory, and published in The International Journal of Molecular Sciences on 21 September 2023. "We had previously found that iSN04 promoted myogenic precursor cells (myoblasts) to differentiate into skeletal muscle cells and had hypothesized that the aptamer also enhanced differentiation of pluripotent stem cells. We were intrigued by the prospect of using iSN04 to promote iPSC differentiation into cardiomyocytes as this could lead to regenerating heart tissue," says Dr. Takaya, elaborating on the team's motivation to pursue the research. Using various assays like RNA sequencing, cell staining and imaging, and molecular interaction and pathway analysis, the researchers investigated iSN04's effect on murine ESCs and iPSCs. iSN04 treatment under differentiating conditions inhibited stem cell commitment to the cardiac lineage. However, when these pluripotent stem cells were treated after experiencing differentiating conditions for five days, specific marker genes were upregulated, and the cells committed to forming beating cardiomyocytes. "Ours is the first report to confirm a DNA aptamer that allows cardiomyocytes to develop from iPSCs," explains Dr. Takaya when asked about the significance of the work. "We uncovered two mechanisms of nucleolin interference with iSN04 at play whereby early treatment inhibits cardiomyogenesis, while treatment at a later stage enhances the generation of cardiac progenitors. First, iSN04 governs the translocation of nucleolin protein between the cytoplasm, plasma membrane, and nucleus. Second, it results in the modulation of the Wnt signaling pathway that governs cell differentiation." The immunostaining experiments revealed that nucleolin was retained in the nucleoli following iSN04 treatment. Nucleolar nucleolin has a role in chromatin remodeling and gene transcription, and interestingly enough, Wnt pathway genes were differentially expressed in the RNA-seq data following iSN04 suppression. The team postulates that the iSN04-anchored nucleolin alters gene expression and Wnt signaling. Ultimately, terminal cell differentiation commits to the cardiomyocyte lineage. And how could these findings impact regenerative medicine and patients' lives in the long term? Dr. Takaya provides insights into the broader implications of their work. "We believe there is a strong case to be made for further studies evaluating DNA aptamers in regenerative medicine. Aptamers are cost-effective and open up the possibility of producing specific cells from the patient's stem cells. But it doesn't end there! Since the aptamers can regulate stem cell fate, they can serve as therapeutic agents for many conditions linked to stem cell dysfunction," he concludes.

All cash deal with Chembio Diagnostics, a US Subsidiary of the French Diagnostics Company BIOSYNEX, SA, solidifies Qualigen’s strategic priority on therapeutics CARLSBAD, Calif., July 24, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a therapeutics company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announces today that it has sold its FastPack® diagnostics business to Chembio Diagnostics, Inc., an American subsidiary of French diagnostics provider BIOSYNEX Group, a leader in the design and distribution of rapid tests. The all cash transaction, which closed on July 20, 2023, enables the Company to further streamline operations and enhance its focus with additional capital on its therapeutics pipeline, in particular QN-302, its small molecule G-Quadruplex (G4) selective transcription inhibitor, and its pre-clinical pan-RAS inhibitor platform. QN-302 has strong binding affinity to G4s prevalent in cancer cells and is being developed for the potential treatment of solid tumors including pancreatic cancer, for which it was granted Orphan Drug Designation in January. Michael Poirier, Qualigen's Chairman and CEO, commented, “We are proud of the legacy our FastPack® rapid immunodiagnostics system has established by providing patients and doctors with quality laboratory solutions for over two decades. However, as we have transitioned our focus to cancer therapeutics, it is appropriate that we re-align our priorities and resources. BIOSYNEX, with their proven track record in rapid diagnostics, has the expertise and resources to further expand FastPack’s footprint throughout the in vitro diagnostics (IVD) market worldwide. In the meantime, we now have the ability to strengthen our efforts towards advancing our cancer therapeutics portfolio and look forward to reporting further developments soon.” AboutQualigenTherapeutics,Inc. Qualigen Therapeutics, Inc. is a 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. 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). About BIOSYNEX Founded in 2005, French laboratory BIOSYNEX is a leading healthcare diagnostics group, specializing in rapid tests, monitoring of biotherapy and molecular diagnostics. As a key player in the medicine of the future, promoting improved access to healthcare, BIOSYNEX offers innovative healthcare solutions to a large range of users, including laboratories, hospitals, doctors and the general public, to improve overall patient care. For the general public: the BIOSYNEX Pharma division, specialized in self-diagnostics and family health products. It markets a complete range of well established brands in the fields of prevention, diagnosis and natural care to a large network of pharmacies and parapharmacies in Europe. For professionals: the BIOSYNEX Diagnostic division, a technology based business positioned in growing sectors, develops and offers in vitro diagnostic medical devices such as rapid diagnostic tests (RDTs), molecular biology tests and point-of-care (POC) tests for screening, and diagnosis to laboratories, hospitals, doctors and nursing homes. Headquartered in Illkirch-Graffenstaden, Alsace, the BIOSYNEX Group employs over 500 people and has a presence in 95 countries. The Group generated sales of €196.6 million in 2022. Listed on Euronext Growth (FR0011005933 ALBIO), BIOSYNEX is eligible for the French PEA PM scheme. 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. Actual events or results may differ from the Company's expectations. For example, 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 QN-302, pan-RAS and QN-247, 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, RAS and QN-247, and QN-165). 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 . 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 . Contact: Investor Relations 760-530-6487 ir@qualigeninc.com Source: Qualigen Therapeutics, Inc.

Preclinical Data Show Potential to Overcome Resistance to Key KRAS-G12C Therapeutic Compounds CARLSBAD, Calif., June 05, 2023 (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, announces today that a poster featuring the Company’s pan-RAS inhibitor program in pancreatic cancer will be presented as part of the Scientific Program at the American Society of Clinical Oncology’s (ASCO) 2023 Annual Meeting held June 2-6, 2023 in Chicago. Michael Poirier, Qualigen's Chairman and CEO, commented, “Our scientific programs continue to focus on orphan indications, including pancreatic cancer, and we are gratified that data regarding our novel pan-RAS inhibitor platform were accepted as a poster. The data continue to be encouraging, even at this early stage, and we continue to collaborate with the University of Louisville (UofL) Research Foundation in the development of this entire program. As we remain on track toward identifying a lead candidate later this year, we appreciate the opportunity to share these findings at the ASCO meeting.” Abstract #4155 “Impact of novel pan-RAS inhibitors on efficacy and resistance to AMG-510 and MRTX-1133 in pancreatic cancer cell lines.” Howard Donninger, Rachel Ferrill, Becca Von Baby, Joe Burlison, John O. Trent, Michael Sabo, Tariq Arshad, Geoffrey J. Clark Poster Board #476 The poster outlines results of concurrent administration of the Company’s pan-RAS inhibitor molecules with commonly used therapeutics against pancreatic cancer. In vivo activity was confirmed in xenograft experiments with cell lines and PDX models, and the molecules were shown to co-operate with AMG-510 (sotorasib) (G12C specific inhibitor) and MRTX1133 (G12D specific inhibitor) against pancreatic cancer cell lines. The agents were also shown to suppress resistance to MRTX1133 in vitro, which led authors to believe these pan-RAS compounds may overcome resistance to AMG-510 and MRTX1133 in vivo. The Company had two abstracts accepted to the meeting, the other of which is “A novel pan-RAS inhibitor for luminal B breast cancer.” Tariq Arshad, Howard Donninger, Mike Sabo, John Trent, Geoffrey J. Clark, Joe Burlison. This abstract can be found in the ASCO 2023 Annual Meeting Abstract Book. Qualigen’s pan-RAS inhibitor platform is a family of small molecules designed to prevent mutated RAS gene proteins from binding to their effector proteins. Exclusively in-licensed from UofL, compounds from this discovery engine have been shown to impact tumor growth in multiple in vivo models. Qualigen is evaluating promising compounds generated from this partnership in various RAS-driven advanced solid tumors such as pancreatic, breast, colorectal, and lung cancers. About Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, while also commercializing diagnostics. 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 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. 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). 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. Contact: Jules AbrahamJQA Partners, Inc.917-885-7378jabraham@jqapartners.com Attachment Qualigen Therapeutics, Inc.