Qualigen Therapeutics
Promising Therapeutics that Target Viruses and Cancers

Michael S. Poirier, CEO and Chairman

On the anti-viral front, the body of pharmaceutical and immunotherapy research has grown tremendously over the last fifteen months in large part due to the COVID-19 pandemic. The comprehensive wave of government support, industry focus, and investment has dramatically accelerated the development and availability of vaccines.

Despite this tremendous progress in the right direction, there remains a need for anti-viral therapeutic treatments against COVID-19. The Delta and Gamma variants of COVID-19 still pose serious threats worldwide. Moreover, hundreds of patients, aptly called breakthrough cases, were recently diagnosed with COVID-19 despite having been fully vaccinated. The pandemic exposed just how unprepared the world was and serves as a cautionary admonition that vaccines alone will not be the end-all solution to viral pandemics that can still afflict us in the future.

The most advanced therapeutic candidate in the Qualigen pipeline is QN-165, a broad-based antiviral drug candidate in-licensed from the University of Louisville with an initial targeted indication for the treatment of COVID-19. “QN-165 is an exciting and innovative approach which we believe will continue to be effective regardless of any mutations a virus goes through,” expresses Michael Poirier. He further states, “The key to how QN-165 works and why it is important is due to a protein called nucleolin.” Nucleolin is present in all cells in the body. QN-165 is a piece of synthetic DNA that targets and binds to the nucleolin protein. As an anti-viral, numerous studies have shown that viruses, and especially COVID-19, use the nucleolin protein to gain access to cells so that they can turn these cells into what essentially become factories that produce increasingly more virus. QN-165, by tying up nucleolin, blocks that mechanism. Upon development through clinical trials and, ultimately, regulatory approval, QN-165 aims to arm doctors with an effective and safe treatment to combat COVID-19 alongside a slew of other viruses.

Poirier provides an analogy of how a successful anti-viral drug can become insufficient. “When Tamiflu was developed and introduced into the market, it was very effective against influenza. However, over time, as the flu viruses mutated, the medicine was unable to be as effective as needed against the mutated virus,” he says.

QN-165 is an exciting and innovative approach and we believe it will continue to be effective regardless of any mutations a virus goes through

On the anti-cancer front, thousands of patients are on standby, waiting desperately for treatments for conditions such as Acute Myeloid Leukemia (AML) and Pancreatic cancer. Qualigen’s pipeline also includes QN-247, which is being developed to treat various cancer types, with an initial target indication of AML. QN-247 is a piece of synthetic DNA conjugated to a gold nanoparticle, which is believed to increase its potency as a cancer-fighting agent. This drug candidate may be developed as a monotherapy cancer drug, or as a companion to radiation therapy. “QN-247 is being developed to be effective as a combination therapy owing to the fact that its potency-improving gold nanoparticles also absorb radiation for quicker recovery,” explains Poirier.

The company will also be developing another potentially promising cancer drug, RAS-F, to counteract a mutation in RAS cells that leads to pancreatic, lung, and colorectal cancers. RAS-F has shown to be extremely efficient in inhibiting the effect of such mutations in multiple cancer models. Qualigen intends to target pancreatic cancer in RAS-F’s initial indication and is optimistic that it may also be effective in other tumor types where downstream RAS mutations play a major role.

While the company boasts a robust therapeutics pipeline of multiple assets, Qualigen also has an established and commercialized diagnostics division with the FastPack System. For more than two decades in diagnostics, the company has consistently demonstrated its ability to develop products, successfully get them approved through the regulatory agencies, commercialize them, and generate revenue from a dedicated customer base. FastPack is a rapid immunoassay testing system consisting of an analyzer and a single-use, disposable test pouch with the FastPack reagent chemistry that produces highly accurate results. This proprietary solution helps doctors and researchers test for prostate cancer, thyroid function, and metabolic disorders, among other diseases and conditions. Since 2001, the FastPack diagnostic system has helped save the lives of a multitude of prostate cancer patients and is a dominant player in the physician office lab arena.

Qualigen is well situated in the southern California biotech hub that allows the company to take advantage of the scientific bench strength, while leveraging the company’s strong medical-devices development and commercial track records.

Qualigen is steadfastly committed to improve patient outcomes while building shareholder value.