Announcement • Dec 09
AXIM Biotechnologies, Inc. Files Form 15 AXIM Biotechnologies, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.0001 per share. Announcement • Nov 14
AXIM Biotechnologies, Inc. announced delayed 10-Q filing On 11/13/2024, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Aug 14
AXIM Biotechnologies, Inc. announced delayed 10-Q filing On 08/13/2024, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • May 17
AXIM Biotechnologies, Inc. announced delayed 10-Q filing On 05/15/2024, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Apr 02
AXIM Biotechnologies, Inc. announced delayed annual 10-K filing On 04/01/2024, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Nov 15
AXIM Biotechnologies, Inc. announced delayed 10-Q filing On 11/14/2023, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Sep 13
AXIM Biotechnologies Develops First Non-Invasive, Rapid, Point-Of-Care, Diagnostic Test for Parkinson's Disease AXIM Biotechnologies, Inc. announced that it has successfully developed the world's first rapid, point-of-care, non-invasive diagnostic assay for the detection of abnormal alpha-synuclein, a known biomarker for Parkinson's Disease (PD). A new study released in April of 2023 by the Michael J. Fox Foundation shows that the presence of abnormal alpha-syn nuclein was detected in an astonishing 93% of people with Parkinson's who participated in the study. Furthermore, emerging evidence shows that a-synuclein assays have the potential to differentiate people with PD from healthy controls, enabling the potential for early identification of at-risk groups. These findings suggest a crucial role for a-synuclein in therapeutic development, both in identifying pathologically defined subgroups of people with Parkinson's disease and establishing biomarker-defined at-risk cohorts. The revolutionary nature of AXIM's new test is that it is non-invasive, inexpensive and it can be performed at a Point-of-Care. It does not require a lumbar puncture, freezing, or sending samples to a lab. Additionally, studies have shown that total lactoferrin content is reduced in patients with PD. AXIM is already marketing a lactoferrin assay, which may be used in conjunction with the newly developed novel Synuclein test. According to The Parkinson's Foundation, nearly one million people in the U.S. are living with PD. More than 10 million people worldwide are living with PD. There are currently 219 PD trials going at various Phase I, II and III stages, according to Global Data's Clinical Trial Database supported by a variety of organizations, from institutions to pharmaceutical companies. Announcement • Aug 03
AXIM Biotechnologies, Inc. Receives Notice of U.S. Patent Allowance for Three Separate Patents Including Its Rapid Point of Care Neutralizing Antibody Test AXIM Biotechnologies, Inc. announced the receipt of notification by the United States Patent & Trademark Office of several patent allowances. 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. Lower concentrations of Lacritin may diagnose several eye diseases, including Blepharitis, Sjogren's syndrome, Dry Eye Disease and other inflammatory conditions. 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. 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. 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 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. Announcement • May 24
AXIM Biotechnologies, Inc. Appoints Kurt Phinney as Chief Operating Officer AXIM Biotechnologies, Inc. announced the appointment of Kurt Phinney as its new Chief Operating Officer. Phinney, a seasoned healthcare operations executive, will play a vital role in scaling and optimizing AXIM's manufacturing operations for its proprietary ophthalmological diagnostic assays to meet the rising demand. With an extensive background in healthcare operations management and scaling diagnostic companies, Phinney brings valuable expertise to AXIM. In previous roles, he successfully reduced costs, increased capacity, and shortened production time, boosting manufacturing output from 11,000 assays to an impressive 225,000 assays per week. Phinney also enjoys a track record of implementing and managing Quality Management Systems (QMS) and has successfully teamed to obtain CLIA-waiver applications with the FDA, which he aims to replicate at AXIM. The addition of Kurt Phinney to the team aims to increase this capacity by at least 50% by fourth quarter 2023. This expansion is essential to meet the growing demand driven by AXIM's commercialization partner, which is actively securing clinics across the country for the implementation of AXIM's diagnostic assays. Announcement • May 16
AXIM Biotechnologies, Inc. announced delayed 10-Q filing On 05/15/2023, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Jan 18
AXIM Biotechnologies, Inc. Files Patent on Fentanyl Neutralizing Antibody Test, Applies for Drug Enforcement Administration License to Work with Controlled Substance AXIM Biotechnologies, Inc. announced that it has filed a provisional patent application with the U.S. Patent and Trademark Office on an innovative new test designed to measure the neutralizing antibodies against fentanyl, a synthetic opioid responsible for the world’s leading cause of overdose. Additionally, the Company has filed for a license to handle the controlled substance with the Drug Enforcement Administration (DEA) as required for research. Fentanyl is a powerful synthetic opioid that is 50 to 100 times stronger than morphine and has a strong addiction profile and associated overdose risk. Prevention of fentanyl addiction and overdose within the current healthcare landscape is difficult. However, new research is being conducted on potential immunotherapies (source) and vaccines (source) that prevent fentanyl from breaching blood-brain barrier to preemptively circumvent its overdose effects. Recent research suggests that fentanyl neutralizing antibodies may prevent overdose deaths, but scientists will need to quantitatively measure a patient’s neutralizing antibodies throughout clinical studies and for relapse prevention from boosters, and such a test does not currently exist on the market. As a result and leveraging its experience in diagnostics and working with neutralizing antibodies, AXIM® is developing a rapid point-of-care diagnostic assay that will detect and measure levels of fentanyl neutralizing antibodies. This breakthrough in diagnostic solutions will enable therapeutic and vaccine scientists to expedite transition of their research from lab to clinic using AXIM’s new test given the test’s quick time to result at clinical settings. AXIM’s ongoing discussions with various academic and research groups on potential collaboration on the new test signal broad enthusiasm among the scientific community for its development and commercialization. Fentanyl addiction and overdose has skyrocketed in recent years amid the widely covered “opioid crisis.” According to the CDC, over 150 people die every day in the US from overdoses related to synthetic opioids like fentanyl and the drug is the primary driver of overdose deaths in the United States. (source) For this reason, the US and other government and regulatory bodies are incentivizing organizations through grants and licenses to conduct research on potential therapeutics or vaccines that may prevent overdose or addiction. AXIM plans to market its newly developed test to these research institutions as a leading way to measure neutralizing antibodies in clinical trial patients. Announcement • Dec 14
AXIM Biotechnologies, Inc. Develops Novel Dual IgE/MMP-9 Rapid Ophthalmological Diagnostic Test and Files Provisional Patent AXIM Biotechnologies, Inc. announced that it has filed a provision patent application with the U.S. Patent and Trademark Office on an innovative new rapid ophthalmological diagnostic solution designed to reliably measure both Ocular Immunoglobulin E (IgE) and MMP-9 in a single test. The test is slated for further clinical development in the first quarter of 2023 and, once FDA approved, will be added to AXIM’s expanding catalog of ophthalmological diagnostic tools available to clinicians throughout North America. The test is designed to be administered at the point-of-care and will measure both IgE and MMP-9 levels in patients, rendering results in 10 minutes. Unlike other MMP-9 tests commercially available that require a tear sample from patients of up to approx. 10 microliters, AXIM’s new dual test will be able to measure both IgE and MMP-9 levels in a 20-2,000ng/mL using just a two microliter sample. This sample size significantly reduces patient discomfort in tear collection, where only one sample is needed to measure levels of both biomarkers. Additionally, other commercially available tests only provide a qualitative result (positive/negative) whereas AXIM’s new test measures actual levels of each biomarker, enabling clinicians to differentiate between the underlying causes of a patient’s eye condition and prescribe treatment accordingly and instantly at the point-of-care. Once developed and cleared, the test will be added to AXIM’s growing portfolio of FDA-cleared ophthalmological diagnostics tools, which includes rapid point-of-care tests for both IgE and Lactoferrin. The new combination test measures levels of matrix metalloproteinase, or MMP-9, in patient tear samples, along with IgE which is a key biomarker primarily associated with non-specific, allergic conjunctivitis, which often mimics Dry Eye Disease. MMP-9 is an enzyme that has been linked to signs of inflammation on the surface of the eye. This inflammation can be caused by a variety of indications including dry eye or chemical or mechanical damage to the eyes. The higher the level of MMP-9, the higher the degree of inflammation. Upon review of the results of the new test, clinicians will be able to prescribe either anti-inflammatory, antihistamine or both promptly during a patient’s visit, greatly increasing patient care and treatment outcomes. Announcement • Aug 30
AXIM Biotechnologies, Inc. announced that it has received $0.1 million in funding On August 29, 2022, AXIM Biotechnologies, Inc. closed the transaction. The Company sold the securities in reliance upon an exemption from registration contained in Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder. Announcement • Aug 17
AXIM Biotechnologies, Inc. announced delayed 10-Q filing On 08/16/2022, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Jul 27
AXIM Biotechnologies, Inc. Enhances IgE Testing Capabilities; Responds to Global Warming's Impact on Allergy Season AXIM Biotechnologies, Inc. announced that it has launched an enhanced version of its rapid Ocular Immunoglobulin E (IgE) test in response to a study recently published in Nature by researchers at the University of Michigan Department of Climate and Space Sciences and Engineering. The article titled “Projected climate-driven changes in pollen emission season length and magnitude over the continental United States” showcases that climate change is making allergy season occur sooner and for a longer period of time than in recent years. Spring pollen emissions are projected to begin 10 to 40 days earlier and last five to 15 days longer in the summer and fall. This is important to know because allergic conjunctivitis, allergic reactions caused by airborne allergens, has become increasingly prevalent. But even though approximately 40% of the U.S. population experiences it annually, it is severely underdiagnosed due to the industry’s lack of diagnostic tools. AXIM’s enhanced rapid IgE test helps in the assessment of total tear IgE levels and is useful for the clinical diagnosis of allergic conjunctivitis and its severity. The test has been optimized to provide results nearly 50% faster than the non-optimized IgE test with no loss in sensitivity or specificity. This change will result in quicker patient throughput and give physicians the ability to test more patients per day in the same amount of time. Announcement • Jul 13
AXIM Biotechnologies Publishes Study Highlighting Neutralizing Antibody Levels of Poor Vaccine Responders with A Third Covid-19 Vaccine Dose AXIM Biotechnologies, Inc. announced their publication in collaboration with researchers at Arizona State University (ASU) entitled, “Third COVID-19 Vaccine Dose Boosts Neutralizing Antibodies in Poor Responders” in Communications Medicine, part of the Nature family of journals. AXIM and ASU performed a clinical study using their co-developed rapid test and discovered that even after two doses, COVID-19 RNA vaccines were unable to elicit high levels of neutralizing antibodies in 25% of vaccine recipients. However, a third vaccine dose rescued these “vaccine poor responders”, boosting their neutralizing antibodies to levels that are highly protective within two weeks of receiving a third dose. The rapid 10-minute test quantitatively measures levels of neutralizing antibodies in a finger stick drop of blood. Announcement • May 26
AXIM Biotechnologies, Inc Completes Optimization of Only FDA-Cleared IgE Rapid Diagnostics Test – In-House Manufacturing Lowers Cost and Eliminates Supply Chain Expenditures AXIM Biotechnologies, Inc. announced that its scientific team has completed the optimization of a rapid diagnostics test for the quantitative measurement of Ocular Immunoglobulin E, a biomarker for ocular allergies. The test is a simple, rapid, and non-invasive immuno-chromatographic test that enables the identification of allergic conjunctivitis in one single step. This quantitative test is the only FDA-cleared and reimbursable rapid test for IgE and is of high clinical utility in the confirmation of the presence of active ocular allergens. AXIM acquired the technology for this test and has since been optimizing the test to provide quicker and more accurate results. The test when acquired was a 15-minute test and the development team has been able to miniaturize the test and reduce time to result to seven minutes. Although approximately 40% of the general population experiences allergic conjunctivitis, it is often underdiagnosed and consequently undertreated due to the lack of diagnostic tools. AXIM’s rapid IgE test helps in the assessment of total tear IgE levels and is useful for the clinical diagnosis of allergic conjunctivitis and its severity. The presence of an allergen often mimics the signs and symptoms of Dry Eye Syndrome associated with aqueous deficiency and evaporative dry eye or both. Announcement • May 18
AXIM Biotechnologies, Inc. announced delayed 10-Q filing On 05/17/2022, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • May 12
AXIM Biotechnologies, Inc. Develops Novel Tear Sample Collector System, Files Patent Application AXIM Biotechnologies, Inc. announced that it has developed a novel tear sample collector system and has filed for a provisional patent application for it with the U.S. Patent and Trademark Office. Tear fluid analysis is a non-invasive method to obtain valuable information about the health condition of various ocular and systemic diseases, including Dry Eye Disease, since tear fluid contains several molecular constituents that may be altered under abnormal conditions. However, obtaining adequate samples for tear analysis requires an effective collection method. Most tear sample collectors on the market use capillary designs that are intimidating to patients, difficult for untrained personnel to use, and expensive to manufacture. AXIM’s novel tear sample collector system provides a more comfortable experience for patients, features an indicator that appears on the strip when enough tear fluid has been absorbed, makes it easy for untrained personnel to use, and is extremely cost-effective to produce on a mass scale. It is especially important that it is easy to mass produce because of the growing prevalence of ocular diseases, including Dry Eye Disease, which affects approximately 6.8% of the U.S. population. AXIM plans to add this tear collection system to aid the advancement of its four Point-of-Care Biomarker Tests designed to accelerate the diagnosis of Dry Eye Disease. These tests include its recently announced Lacritin test, MMP-9 test, and FDA 501(k) cleared tests for Lactoferrin and IgE. Announcement • Apr 28
AXIM Biotechnologies, Inc. Develops Quantitative Rapid Diagnostic Test for Lacritin, Now Boasts Four Dry Eye Disease Point-Of-Care Biomarker Tests AXIM® Biotechnologies, Inc. announced that it has successfully developed a rapid quantitative tear test for Lacritin, a tear protein that autonomously promotes tearing and is deficient in all forms of Dry Eye Disease. While Dry Eye Disease knowingly affects approximately 6.8% of the U.S. population, an estimated six million people have reported experiencing DED symptoms but have not been diagnosed or have received treatment. DED can significantly impair visual acuity, workplace productivity, and quality of life and increases with age but is hard to diagnose because it is a multifactorial disease with many disparate causes and has a highly variable symptom profile at different stages of the disease. These factors also make it difficult for DED patients to find lasting relief. Lacritin is a secreted protein found in tears. Lacritin also promotes tear secretion, the proliferation and survival of epithelial cells, and corneal wound healing. Several tear proteins are deficient in different forms of Dry Eye. A growing number of studies suggest that lacritin may be differentially downregulated in dry eye, including contact lens-related dry eye. Announcement • Apr 01
AXIM Biotechnologies, Inc. announced delayed annual 10-K filing On 03/31/2022, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Mar 10
AXIM Biotech Develops Rapid Quantitative Tear Test for MMP-9 AXIM Biotechnologies, Inc. announced that it has successfully developed a rapid quantitative tear test for MMP-9, an inflammatory biomarker for Dry Eye Disease. Dry Eye Disease, though widespread, is under-diagnosed, in part because symptoms do not always correlate with objective signs. It has a highly variable symptom profile at different stages of the disease, and there is often a discordance between signs and symptoms. A patient can have severe symptoms yet show no sign of ocular surface damage, while others have advanced ocular surface damage, yet report no symptoms. This lack of correlation between clinical signs and symptoms of Dry Eye Disease makes diagnosing and treating patients a challenge. Often times, inflammation is present before the clinical signs of Dry Eye Disease. The challenge has been in early detection of inflammation. Matrix metalloproteinase-9 (MMP-9), an inflammatory biomarker consistently elevated in the tears of dry eye patients, may accelerate early diagnosis when detected. Announcement • Dec 22
Centers for Disease Control and Prevention Publishes Axim Biotechnologies-Sponsored Study on Covid-19 Neutralizing Antibodies AXIM Biotechnologies, Inc. announced that the Centers for Disease Control and Prevention (CDC) highlighted a study that the Company sponsored on neutralizing antibodies in its recent COVID-19 Science Update: Edition 116. Using AXIM’s rapid neutralizing antibody test, Dr. Douglas Lake and Alexa Roeder, co-lead authors of the study, reported that 25% of two-dose RNA vaccine recipients did not generate high levels of neutralizing antibodies (<50% neutralization). They called this group “vaccine poor responders.” Fortunately, a third dose converted these vaccine poor responders into strong responders with an average of 20-fold increase in neutralizing antibody levels two to four weeks after their third dose. Announcement • Aug 17
AXIM Biotechnologies, Inc. announced delayed 10-Q filing On 08/16/2021, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • May 27
AXIM Biotechnologies, Inc. Completes Pre-Clinical Drug Studies on SPX-1009 Compound Proving Suppression of Melanoma Cells AXIM Biotechnologies, Inc. announced that it has completed pre-clinical drug studies on its patent pending compound SPX-1009, demonstrating the suppression of malignant metastatic melanoma cells. The independent research was completed by Dr. Douglas Lake’s laboratory at Arizona State University. Melanoma is the most serious type of skin cancer because of its ability to spread to other organs rapidly if it is not treated at an early stage. According to SkinCancer.org, an estimated 207,390 cases of melanoma will be diagnosed in the U.S. in 2021 and an estimated 7,180 people will die of melanoma in the U.S. in 2021. SPX-1009 was first screened in a cell-free enzymatic assay for its ability to inhibit Quiescin Sulfhydryl Oxidase I (“QSOX1”), a tumor-derived enzyme that is important for cancer growth, invasion and metastasis, and was then tested for its ability to inhibit growth and invasion of a well-established A375 melanoma cell line and a low-passage patient-derived melanoma. 2D invasion assays and 3D tumor spheroid assays were employed to measure the effect of the compounds on tumor invasion. As a next step, AXIM intends to initiate animal studies to demonstrate the ability of SPX-1009 to suppress tumor growth and metastasis in a murine model of melanoma. AXIM’s intellectual property related to the SPX-1009 technology is the subject of numerous patent-pending applications. Announcement • May 15
AXIM Biotechnologies, Inc. announced delayed 10-Q filing On 05/14/2021, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • May 06
AXIM® Biotechnologies’ Manufacturing Partner Empowered Diagnostics Files for Approval for Use of Rapid Covid-19 Neutralizing Antibody Test in Whole Blood At Point-Of-Care Locations in Canada and the EU AXIM® Biotechnologies, Inc. announced that the Company’s manufacturing partner Empowered Diagnostics has filed for emergency approval to use ImmunoPass™, the Company’s rapid test that semi-quantitatively measures levels of COVID-19 neutralizing antibodies, to detect COVID-19 neutralizing antibodies in whole blood at point-of-care locations throughout Canada and the EU. Empowered Diagnostics’ application is currently under review by Health Canada for approval for use in the country. Additionally, the Company has filed for a CE mark, which is required to distribute a product or device on the EU market and signifies that the Company has met the necessary safety, health and environmental protection requirements for sale. Once granted a CE mark, the Company will have approval to manufacture and commercialize ImmunoPass™ for use in point-of-care locations across the EU. Last month, AXIM announced that Empowered Diagnostics filed an Emergency Use Authorization (EUA) application with the US Food and Drug Administration (FDA) for approval to use ImmunoPass™ to detect COVID-19 neutralizing antibodies in whole blood at point-of-care locations. Announcement • May 05
AXIM Biotechnologies, Inc. Introduces Diagnostics to Measure Immunity Against Emerging SARS-CoV-2 Variants AXIM Biotechnologies, Inc. announced a new ELISA test that measures levels of neutralizing antibodies against six common variants of SARS-CoV-2 virus. The Company has also filed for patent protection for the diagnostic test. SARS-CoV-2 variants from Brazil, South Africa, California and Britain have been shown to be more infectious and potentially more deadly than the original Wuhan strain due to mutations in the viral spike protein. This has caused concern because current COVID-19 vaccines are based on the spike protein in the Wuhan strain and it is not known how well the vaccines protect against the other variants. AXIM Biotechnologies recently developed a new test that measures levels of immune protection against each of the variants of SARS-CoV-2 in parallel fashion. The test takes less than two hours to complete and can provide an indication of relative risk of infection with each variant. The ELISA test is the most widely used type of immunoassay in diagnostic and research labs. ELISA is a high throughput test used to detect or quantify various biomolecules, including antibodies against pathogens or pathogen-derived proteins. ELISA is simple, sensitive, requires only microliter quantities of test samples and can be automated. Announcement • Mar 31
AXIM Biotechnologies, Inc. announced delayed annual 10-K filing On 03/30/2021, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Mar 10
AXIM Biotechnologies Successfully Completes Point-of-Care Clinical Trials on its Rapid COVID-19 Neutralizing Antibody Test AXIM Biotechnologies, Inc. announced that it has successfully completed point-of-care clinical trials on its much awaited ImmunoPass rapid test that semi-quantitatively measures levels of COVID-19 neutralizing antibodies to help understand COVID-19 immunity, validate vaccine’s effectiveness and estimate how long the vaccine will be effective in patients. The Company conducted two studies, one in partnership with the Company’s manufacturing partner Empowered Diagnostics and the second in partnership with a top accredited university medical center. The main goal of these studies was to identify the ability of operators to successfully utilize ImmunoPass to accurately measure each participant’s level of neutralizing antibodies. Study findings reveal that operators found ImmunoPass easy to use and that they encountered no issues in using the Company’s test to measure participants’ COVID-19 neutralizing antibodies. Announcement • Feb 04
AXIM Biotechnologies Begins Clinical Trials on Its ImmunoPass Rapid Diagnostic Test With Vaccine Recipients AXIM Biotechnologies, Inc. announced the initiation of clinical trials for ImmunoPass, the Company’s rapid point-of-care test that semi-quantitatively measures levels of neutralizing antibodies to COVID-19. As a variety of COVID-19 vaccines begin rolling out to the general public, immunity monitoring is starting to play a critical role in determining whether the vaccine is effective, for how long, and when it is time to get a booster shot. Since immunity to the virus is not anticipated to last forever, the immunity monitoring could continue for many years even after widespread vaccination throughout the world. Measuring neutralizing antibodies in people after vaccination may give a better look at how vaccine responses hold up over time. That way, when levels of neutralizing antibodies eventually dip, researchers will have a sense of when they're unacceptably low and a revaccination is needed. The most widely used antibody tests on the market do not specifically identify neutralizing antibodies. Instead, they measure a large family of antibodies that bind to various parts of the virus, but not necessarily neutralize it. To address this shortcoming, AXIM® Biotech developed a patent-pending rapid diagnostic test called ImmunoPass, which is specifically focused on measuring the levels of functional neutralizing antibodies that prevent SARS-CoV-2 from attaching to human cells. The test is based on blocking the interaction between human cell receptors and the viral spike protein that mimics the virus neutralization process in the body. AXIM’s ImmunoPass has shown a significantly better statistical correlation with SARS-CoV-2 neutralization assays than the currently available antibody tests. Since the rapid test agrees well with live virus-based assays, it could serve as an effective low-cost alternative to lab-based assays for monitoring large numbers of vaccine recipients for neutralizing antibodies. Although clinical trials indicated that COVID-19 vaccines may be remarkably successful, even 95% effectiveness will leave millions of Americans unprotected. Neutralizing antibody testing may help determine efficacy and should help indicate whether a person is protected against the virus. Announcement • Jan 12
AXIM Biotechnologies Releases Preprint Manuscript Describing the Development of Company’S Rapid Point-Of-Care Test That Measures Covid-19 Neutralizing Antibodies AXIM Biotechnologies, Inc. (“AXIM Biotech,” “AXIM” or “the Company”) announced that it has released a preprint of its manuscript describing the development of ImmunoPass, the Company’s rapid point-of-care test that semi-quantitatively measures levels of neutralizing antibodies to COVID-19. The manuscript is co-authored by several executives of AXIM’s subsidiary Sapphire Biotech, Inc., including Chief Clinical Officer Douglas F. Lake, Chief Scientific Officer Sergei Svarovsky and Chief Technology Officer Alim Seit-Nebi. Neutralizing antibodies are pivotal in halting the spread of the virus as they prevent the COVID-19 virus from infecting cells. As the world begins receiving the COVID-19 vaccine, recipients are reporting varying levels of neutralizing antibodies as each body responds differently to the vaccine. For this reason, it is important for recipients to measure their neutralizing antibodies regularly in order to know if and when it is time for a booster dose. AXIM’s ImmunoPass can serve as a convenient and effective testing option, as it has been proven to have 98% accuracy in detecting neutralizing antibodies using the benchmark of actual SARS-CoV-2 neutralization assays performed in a BSL3 laboratory. The advantages of AXIM’s ImmunoPass include that it uses only a single drop of blood, is smaller than the palm of a hand, highly portable, semi-quantitative, less expensive than a laboratory-based blood test, and can be used longitudinally to monitor increases and decreases in protective immunity after either natural infection or vaccine. Announcement • Dec 17
AXIM Biotechnologies, Inc. Completes Successful Covid-19 Live Virus Test and Files Amended EUA for Portable 10 Minute Rapid Diagnostic Test for Neutralizing Antibodies AXIM® Biotechnologies, Inc. announced that it has filed an amended Emergency Use Authorization (EUA) application with the US Food and Drug Administration (FDA). AXIM first filed the EUA in September for measuring COVID-19 neutralizing antibodies in plasma and serum through its rapid diagnostic test. The Company amended the EUA to include positive results from a Biosafety Level 3 (BSL-3) live virus test that positively correlates the rapid 10-minute lateral flow assay test that accurately detects and measures levels of functional COVID-19 neutralizing antibodies in plasma. According to a receiver operating characteristic (ROC) curve, AXIM’s ImmunoPass shows 97.8% accuracy in detecting neutralizing antibodies. In comparison, Ortho Clinical Diagnostics’ VITROS® Total an IgG COVID-19 Antibody Test, which is FDA authorized and considered the gold standard, shows 85.8% accuracy. Announcement • Dec 04
AXIM Biotechnologies Develops ELISA-Based Neutralizing Antibody Diagnostic Test for COVID-19 AXIM® Biotechnologies, Inc. announced the development and patent filing for an enzyme-linked immunosorbent assay (ELISA)-based diagnostic test (the “Test”) for the detection of SARS-CoV-2 neutralizing antibodies. This application marks AXIM’s fourth COVID-19 neutralizing antibody-focused patent application. The Company heavily focuses its resources on advancing research on what it believes will soon become the most prevalent need in the post-vaccine COVID-19 fight, the need to know levels of neutralizing antibodies in longitudinal studies of vaccine response. AXIM has internally developed the Test, and its own reagents and proteins used in the test kits. The Company has just completed live SARS-CoV-2 virus microneutralization tests at a Biosafety Level (BSL-3) laboratory with samples from COVID-19 patients to validate diagnostic tests per current Food and Drug Administration (FDA) guidelines. AXIM intends to file its third Emergency Use Authorization (EUA) with the FDA soon. The Company’s additional pending COVID-19 testing-focused patents include: Rapid point-of-care neutralizing antibody test that delivers results in 10 minutes; NeuCovix-HT™, a high throughput (HT) diagnostic test that measures levels of functional neutralizing antibodies in plasma or serum; and Recombinant virus binding protein (VBP) for SARS-CoV-2 that is more potent and stable than current VBP options on the market. The ELISA test is the most widely used type of immunoassay in diagnostic and research labs. ELISA is a high throughput test used to detect or quantify various biomolecules, including antibodies against pathogens or pathogen-derived proteins. ELISA is simple, sensitive, requires only microliter quantities of test samples and can be automated. Announcement • Nov 18
AXIM Biotechnologies, Inc. announced delayed 10-Q filing On 11/16/2020, AXIM Biotechnologies, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Oct 04
Axim Biotechnologies Files Patent for Face Mask Designed to Capture SARS-CoV-2 COVID-19 AXIM Biotechnologies, Inc. announced that it has filed a provisional patent for a first-in-class face mask that captures and deactivates SARS-CoV-2, the coronavirus responsible for the ongoing COVID-19 pandemic. According to Market Study Report, LLC, the global face mask market size was valued at $4.58 billion in 2020, and is estimated to reach $21.2 billion by 2026. The outbreak of respiratory infection based pandemic diseases like COVID-19 is fueling global demand for face masks among frontline health workers such as first responders, nurses, and medical practitioners. Most commercially available masks are unable to efficiently filter the tiny aerosols that contain the virus. Viruses that are attached to the filtering materials can penetrate through a moist mask and, thus, increase the risk of infection. AXIM’s novel face mask is designed to provide enhanced protection from infection by capturing the viruses in the face mask filter layer before it reaches or after it exits the user's respiratory system. To accomplish the goal of capturing SARS-CoV-2 on the face mask, AXIM developed a cost-effective treatment for the face mask surfaces that utilizes a proprietary set of reagents that are permanently embedded into the mask filter which then captures the virus instantaneously on contact. Numerous studies have shown that the SARS-CoV-2 spike protein enters human host cells by locking its spike protein to cell-surface proteins. AXIM’s initial laboratory testing has demonstrated that the SARS-CoV-2 spike protein tightly binds to the capture reagents finely interspersed throughout face mask fibers, therefore significantly increasing its capture efficiency when compared to the commercially available masks and further preventing the virus from entering or exiting the user’s respiratory system. Announcement • Sep 17
AXIM Biotechnologies Files Emergency Use Authorization with the FDA for First–In-Class Covid-19 Rapid Diagnostic Test for Neutralizing Antibodies AXIM Biotechnologies, Inc. announced it has filed an Emergency Use Authorization application with the Food and Drug Administration for measuring COVID-19 neutralizing antibodies in plasma and serum through its first-in-class rapid diagnostic test. Announcement • Jun 16
AXIM Biotechnologies, Inc. announced a financing transaction AXIM Biotechnologies, Inc. (OTCPK:AXIM) announced that it will receive $5,000,000 in funding on June 10, 2020. The company will issue convertible preferred stock, convertible debt and option, warrant or other right to acquire another security in the transaction. The minimum investment accepted from any outside investor is $100. The company intends to continue the transaction for more than one year. The company will issue securities pursuant to exemption provided under Regulation D.