On August 1, 2023 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare diagnostic solutions development company, reported the receipt of notification by the United States Patent & Trademark Office of several patent allowances (Press release, AXIM Biotechnologies, AUG 1, 2023, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-receives-notice-of-u-s-patent-allowance-for-three-separate-patents-including-its-rapid-point-of-care-neutralizing-antibody-test [SID1234633576]).

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AXIM has been developing a proprietary diagnostic platform that can be adapted to test for a variety of analytes including, for example, SARS-Cov-2, Lactoferrin, IgE, Lacritin, MMP-9. This innovative platform allows clinicians to detect with greater speed and accuracy different conditions that, e.g., allow for point of care testing of viruses, diseases, and conditions such as Dry Eye Disease. The platform capability can also be applied to rapid testing for vaccine candidates, including COVID vaccines and a potential Fentanyl vaccine. AXIM’s proprietary platform can also be used to enable point-of-care detection for one or more cancers using a unique cancer biomarker, QSOX1-L.

The first patent application recently allowed relates to COVID and other neutralizing antibody (Nab) testing and treatment. The allowance confirms that AXIM was a pioneer in developing a rapid point of care Nab test and its novelty. Additionally, the company was notified by the USPTO of a second patent allowance for systems and methods for rapid diagnostic for various cancers. The invention relates to the discovery by AXIM scientists of a unique biomarker for cancer, QSOX1-L. A third patent allowance was received for a point-of-care apparatus and methods for detecting cancer that uniquely uses electrochemical or impedance spectroscopy (EIS).

These allowances have increased the depth of AXIM’S IP portfolio to include 13 patent applications, including the above allowed applications, that cover AXIM’s innovative platforms and technologies. The Company see’s significant value in its IP portfolio whereas it may look to either further develop the covered technologies or license the IP to larger healthcare organizations, both creating significant upside value of the organization.

"These allowances further validate both the novelty and underlaying science of our diagnostic technologies," said John Huemoeller II, CEO of AXIM Biotechnologies. "While we continue to manufacture and ship our FDA-cleared diagnostic assays to customers through our commercialization partner, we have simultaneously continued to expand our value proposition through innovations in diagnostics field, that are now protected under the USPTO. We see our growing IP portfolio as a major opportunity for the organization, with an unrealized market value which probably exceeds the company’s current market capitalization. For instance, while the original SAR COVID-19 virus which plagued the world in recent years received extensive attention from the medical community, our now protected assay methodology can be applied to any future mutations or new SARS viruses or vaccines."

Below is an overview of AXIM’s patent portfolio:

SARS-Cov-2. Neutralizing Antibody Testing and Treatment. 1 Allowed Patent; 3 Utility Patent Applications.

The invention is a diagnostic test intended for semi-quantitative measurement of neutralizing antibodies in plasma, serum or whole blood of persons who have had recent or prior infection with SARS-CoV2 or have received a COVID-19 vaccine.

DRY EYE DISEASE

1. Tests for Human Monomeric Lacritin. 1 Utility Patent Application

The invention relates to a Rapid Point of Care test for Human Monomeric Lacritin. Lacritin is a tear protein that, in its monomeric form, autonomously promotes tearing and ocular surface survival. Lower concentrations of Lacritin may diagnose several eye diseases, including Blepharitis, Sjögren’s syndrome, Dry Eye Disease and other inflammatory conditions.

2. Tear Sample Collectors Systems and Methods. 1 Utility Patent Application

Tear fluid analysis contributes to the greater understanding of various ocular and systemic diseases and obtaining adequate samples for tear analysis requires effective collection methods. Most tear sample collectors on the market use capillary designs that are intimidating to the patient. The invention relates to a laminated and looped tear sample collector that is cost-effective, easy to use and soft and non-intimidating to the user and patient.

3. Use of Micromesh Materials in Diagnostic Devices. 1 Provisional Patent Application

When small sample sizes (0.1-2 microliters) are used, such as tears, there is a need for the sample to be spread out over application area for a proper flow. The invention allows dispersion of a small sample volume into mesh cells over a wide area controllable by the mesh size. This enables homogeneous sample dispersion over the entire sample application area.

CANCER DIAGNOSTICS

Systems and Methods for Rapid Diagnostic for Various Cancers. 1 Allowed Patent Application

QSOX1-L, a splice variant of QSOX1, has been identified as a novel biomarker of bladder cancer and possibly other cancers in serum. Proprietary antibodies have been generated that selectively detect only this variant and not others. QSOX1-L has been used to develop a rapid and cost-effective diagnostic test for bladder and possibly other urologic cancers from urine.

PLATFORM TECHNOLOGY

Molecules and Related Assays, Test Kits and Methods. 1 Utility Patent Application, 1 Provisional Patent Application.

The invention relates to the use of various recombinant proteins, test kits, test kit components and methods for detecting and measuring "binding antibodies" (for example, non-neutralizing antibodies) as well as "functional antibodies" (for example, neutralizing) in a single test and at the same time. Such test kit and method can advantageously improve the diagnosis and therapy of various diseases.

NEW DIAGNOSTIC TEST

Fentanyl Diagnostic Test. 1 Provisional Patent Application

Researches have reported that broadly neutralizing antibodies may prevent lethality from the fentanyl class of synthetic opioids. The University of Houston is developing a vaccine targeting the dangerous synthetic opioid fentanyl that could block its ability to enter the brain. The invention relates to a test that can measure neutralizing antibodies against fentanyl, either therapeutic or generated by anti-fentanyl vaccine. The test can be used to monitor the vaccine’s response and help decide when a booster is needed.

NEW TECHNOLOGY

Point of Care Apparatus and Methods for Detecting Cancer Using Electrochemical Impedance or Capacitance Spectroscopy 1 allowed patent. 1 Allowed Patent, 1 Utility Patent Application

The presence of cancer biomarkers or other analytes can be detected in the bodily fluid using EIS or ECS in devices, such as handheld point-of-care devices. The devices, as well as systems and methods, utilize using EIS or ECS in combination with an antibody or other target-capturing molecule on a working electrode. Imaginary impedance or phase shift, as well as background subtraction, also may be utilized.