Qualigen Therapeutics Provides Update on Developments at NanoSynex; Significant Progress Reported on Infectious Disease Diagnostic Platform

Rhea-AI Summary

Qualigen Therapeutics (Nasdaq: QLGN) provided an update on its subsidiary, NanoSynex, highlighting progress made in 2022 and objectives for 2023. Key achievements include a majority investment transaction, development of a rapid Antimicrobial Susceptibility Test (AST), and successful pilot studies. Looking ahead, NanoSynex aims to secure CE approval, ISO certification, and conduct final clinical studies for the AST, which could significantly enhance infectious disease diagnostics, potentially saving lives and reducing healthcare costs.

Positive

• Majority investment transaction closed with Qualigen for enhanced product development.
• Successful pilot study demonstrated NanoSynex system's performance exceeding FDA and CE requirements.
• Key opinion leaders added to scientific advisory team.

Negative

• None.

CARLSBAD, Calif., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (“Qualigen” or “the Company,” 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 shares an update on its majority-owned subsidiary, NanoSynex Ltd. (“NanoSynex”), the progress made during 2022, and objectives for 2023 concerning the commercialization plans for its innovative rapid Antimicrobial Susceptibility Test (AST).

Michael Poirier, Qualigen’s Chairman and CEO stated: “We are very encouraged by the milestones achieved and progress made to date by our partners in Israel. We believe NanoSynex’s AST may represent a breakthrough diagnostic test in the critical area of infectious disease. Our investment in this technology is an important part of our diagnostic portfolio, and we will continue to track its progress with interest.”

The update comes in the form of a letter provided to NanoSynex’s shareholders, including Qualigen, from its CEO, Diane Abensur, which is reproduced below:

Dear Shareholders:

The year 2022 was very productive, with several key milestones reached. In short, we are on track and within budget towards our ultimate objective of launching our Antimicrobial Susceptibility Test (AST) and are poised to have another momentous year ahead in the execution of our milestones. Key accomplishments this year include:

• Closed majority investment transaction with our strategic partner Qualigen Therapeutics for enhanced product development and commercialization of our novel antimicrobial susceptibility test platform.
• Completed development of our latest system design composed of disposable test cards, benchtop reader and real time data analysis software. This system will serve as the commercial basis for the next generation system in our pre-development planning stage.
• Performed first pilot study in a clinical site using our latest design system:
  • Study was conducted under the leadership of principal investigator Dr. Jonathan Lellouche, Director of the Laboratory Departments at the Laniado Hospital, Netanya, Israel and Former Head of Laboratory National Institute for Antibiotic Resistance & Infection Control at the Ministry of Health, Israel, as well as Dr. Svetlana Paikin, Director of the Clinical Microbiology Laboratory at the Laniado Hospital, Netanya, Israel.
  • We evaluated one hundred strains (non-fastidious and non-anaerobes) using five different card formats containing nine antibiotics. The choice of clinical strains was guided by the prevalence of Bacteremia during 2021 at Laniado Hospital, Netanya, Israel.
  • A total of 605 bacteria/antibiotic combinations were evaluated, achieving a Categorical Agreement (CA) – agreement in breakpoint definition of susceptible, intermediary or resistance strain according to regulatory standards – above the FDA and the CE requirements, demonstrating performance of the NanoSynex system in comparison with the reference method.
• Engaged three key opinion leaders to our elite team of scientific advisors in the infectious disease and clinical microbiology fields; and augmented our multidisciplinary core team of engineers, scientists, and regulatory affairs specialists.
• Attended leading international conferences and presented the company in dedicated startup booths, and on stage-panels and roundtables, including EAU Arab Health, BIOMED IL, ECCMID, and HealthIL.
• Featured on French business TV channel BFM Business.
• Pitched to delegations of Life Science innovation teams and business executives at various prestigious Israeli institutions (Microsoft Israel R&D center, Tel Aviv Stock Exchange, Peres Center for Peace & Innovation, Laniado and Ichilov-Tel Aviv hospitals).

We are looking forward to accomplishing the following key milestones in 2023

• Development, design, and manufacture of the product for which we will seek CE approval to launch commercially;
• Obtaining ISO certification;
• Commencing final clinical studies to obtain CE mark; and
• Continuing dissemination efforts through presence in leading conferences, including product demonstration, scientific abstracts submission and featuring in key media channels.

We believe it is important to keep in mind why NanoSynex is working towards this goal of commercializing this AST, which may provide critical results to be both significantly faster and more accurate than current microbial tests performed in hospitals, potentially saving many lives, and reducing the economic healthcare burden. Every year, 700,000 people are killed by superbugs, strains of bacteria, viruses, parasites, and fungi that are resistant to antibiotics and other medications commonly used to treat the infections they cause. Continuous misuse and overuse of antibiotics has the potential of leading us back to a scary pre-antibiotic era. Bacteria can adapt to the drugs that are designed to kill them and can become resistant to drugs to prolong their survival. This can render standard treatments ineffective. Antimicrobial susceptibility tests (AST) are used to determine which specific antibiotics a particular bacteria or fungus is sensitive to and can help prevent the proliferation of superbugs.

Thank you again for your support of NanoSynex. We look forward to updating you on our progress in 2023.

Sincerely,

Diane Abensur

About NanoSynex
NanoSynex aims to provide novel solutions to improve testing quality and reduce healthcare costs by potentially accelerating diagnostic processes. NanoSynex’s mission is to save lives by prescribing targeted antibiotics faster. NanoSynex aims to provide diagnostics that can help doctors make a smart choice by using rapid and personalized diagnosis.

NanoSynex is focused on the development and commercialization of a rapid innovative Antimicrobial Susceptibility Test (AST) that can potentially provide accurate AST results within hours instead of several days. The technology is based on a purely phenotypic approach and uses a microfluidic disposable test card platform and method that optimizes bacterial growth. This development was conceptualized from research discoveries at the lab of Professor Shulamit Levenberg, former Dean of the Technion Institute of Technology – Biomedical Engineering Faculty.

NanoSynex’s team is composed of passionate, dedicated business executives, top-notch biomedical engineers and microbiologist team members and supported by a network of experts, including strategic alliances with future distributors.

Visit https://nanosynex.com/ to learn more about NanoSynex.

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. 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.

Forward-Looking Statements

This news release contains forward-looking statements that involve risks and uncertainties regarding the business of the Company and its majority-owned subsidiary, NanoSynex, and reflect certain judgments as of the date of this release. These statements include the Company’s prospects and strategy, including statements related to the 2023 key milestones for NanoSynex and the development of the Company’s therapeutic drug candidates. Actual events or results may differ from these expectations. For example, there can be no assurance that NanoSynex will be able to achieve its goals on its projected timeline or that the Company will be able to successfully develop any drugs (including QN-302, RAS, and QN-247); that preclinical development of the Company's drugs (including QN-302, 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). 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 Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com

Source: Qualigen Therapeutics, Inc

FAQ

What is the recent update from Qualigen Therapeutics regarding NanoSynex?

Qualigen announced progress in 2022 for its subsidiary NanoSynex, focusing on the commercialization of its Antimicrobial Susceptibility Test (AST) and outlining milestones for 2023.

What are the key achievements of NanoSynex in 2022?

Key achievements include closing a majority investment with Qualigen, completing the development of the AST system, and successfully conducting a clinical pilot study.

What are the 2023 objectives for NanoSynex?

NanoSynex aims to secure CE approval, obtain ISO certification, commence final clinical studies, and enhance its presence at leading conferences.

How does the Antimicrobial Susceptibility Test benefit the healthcare system?

The AST aims to provide faster and more accurate results, potentially saving lives and reducing healthcare costs associated with antibiotic resistance.