AXIM® Biotechnologies Receives Notice of U.S. Patent Allowance for Three Separate Patents Including Its Rapid Point of Care Neutralizing Antibody Test

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.

Aulos Bioscience Raises $20 Million in Series A Extension Financing From Apple Tree Partners

On August 1, 2023 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported $20 million in Series A extension funding committed by Apple Tree Partners (ATP) (Press release, Aulos Bioscience, AUG 1, 2023, View Source [SID1234633575]). The funds will be used to advance Aulos’ lead human monoclonal antibody candidate, AU-007, through its initial Phase 2 clinical study in solid tumor cancers.

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"We are very pleased to strengthen this partnership with our visionary founders at ATP as we further develop AU-007, which has already demonstrated promising early clinical results in the treatment of solid tumors," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "This new funding underscores the potential of AU-007 and its unique mechanism of action, which prevents IL-2 from binding to Tregs, blood vessels and eosinophils while accurately redirecting IL-2 to activate cancer-killing effector T cells and NK cells. We look forward to establishing proof of concept and continuing development through the Phase 2 portion of the study."

Today’s announced funding follows ATP’s initial $40 million Series A funding announced in January 2021, soon after Aulos was spun out from co-founder Biolojic Design, a biotechnology company in Israel specializing in artificial intelligence and computationally designed functional antibodies. Biolojic Design used its machine learning algorithms to create AU-007 to harness the power of interleukin-2 (IL-2) to eradicate solid tumors. AU-007 is the first human monoclonal antibody designed using artificial intelligence to have entered a human clinical trial.

The antibody is currently being evaluated in a Phase 1/2 clinical trial that is enrolling patients with unresectable locally advanced or metastatic cancer at multiple clinical trial site locations in the United States and Australia. Interim Phase 1/2 data released during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting show that AU-007 is well tolerated in patients. Data also indicate that it is the only IL-2 therapy ever to demonstrate an overall trend in decreasing regulatory T cells (Tregs) and eosinophils, with encouraging early signs of anti-tumor activity.

"Our excitement in launching Aulos and our continued support of the company are rooted in the potential of AU-007, which offers distinct competitive advantages over other IL-2 therapies with its ability to bind to IL-2 instead of the IL-2 receptor," said Michael Ehlers, M.D., Ph.D., chief scientific officer of ATP and a venture partner at the firm. "We like what we are seeing at this early stage of clinical development, and Aulos’ management team has extensive experience and a track record of success. We believe Aulos could potentially transform the IL-2 therapeutic class and current approaches to multiple cancers."

The company anticipates transitioning to the Phase 2 portion of the AU-007 study in the fall as well as presenting updated clinical data by year-end.

About AU-007

AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

Aulos is advancing AU-007 through a Phase 1/2 study in solid tumor cancers. To learn more about the clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

2seventy bio to Participate in 2023 Wedbush PacGrow Healthcare Conference

On August 1, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immune-oncology cell therapy company, reported that members of the management team will present at the upcoming 2023 Wedbush PacGrow Healthcare Conference on August 8, 2023 at 8:00am ET in New York (Press release, 2seventy bio, AUG 1, 2023, View Source [SID1234633573]).

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