Aankondiging • Apr 24
Enzolytics Inc. Announces Dismissal of The Dimitar Savov Lawsuit in Nevada Enzolytics, Inc. disclosed that on April 9, 2024, the US District Court of Nevada dismissed the lawsuit, 22-cv-00401-GMN-DJA brought by Dimitar Savov against IMMB bringing to an end the claims alleged in this suit. Originally filed on March 3, 2022 against the corporation that ENZC had its assets, including ITV-1, IMMB and ENZC have successfully defended their position against the plaintiff through 2 years of litigation. Enzolytics will continue to aggressively defend any litigation. Aankondiging • Jun 27
Enzolytics Offers Update on Virogentics, Inc ITV-1 African Project Enzolytics, Inc. provided an update regarding Virogentics, Inc.'s ("VIRO") ITV-1 African Project. The final protocol for the administration of the ITV-1 immunotherapy treatment under the supervision of Neuro Pharma Ltd. - Rwanda, to be dispensed to volunteers under a fast-track protocol at HEAL Africa Hospitals, GOMA, PRC and Panzi Hospital, Bukavu, DRC, has been completed and delivered to the DRC Ministry of Health Department of HIV and Aids for final approval. The vials with the necessary informational inserts are awaiting the approval of the final protocol report for distribution. The impact of the treatment on the HIV/AIDS virus present in the volunteers will be reported after the 17-week cycle is complete. The next step for VIRO is to acquire and fund the insurance premiums for the volunteers. VIRO expects ITV-1 to be dispensed under the trial in late July /early August 2023. VIRO has also recently submitted an application with GNC for IPF Immune to be sold on-line. VIRO continues to sell out of the inventory shipped to Amazon and WalMart. VIRO expects to be able to increase production in the near future to meet the growing market demand for this FDA registered nutraceutical. Aankondiging • Feb 09
Enzolytics Announces Preliminary Results of GLP Toxicology Study for its anti-HIV Therapeutic ITV-1 and Production of ITV-1 for Initiation of Registration in Africa Enzolytics Inc. announced the preliminary results of Toxicology studies of the Company's ITV-1 anti-HIV therapeutic confirming that the therapy is non-toxic and demonstrating the safety of administration of this patented proprietary immunotherapy. Establishing this result is essential to permitting under the European Medicines Agency (EMA) and the acceptance for administration of ITV-1 to HIV-infected patients in Africa. The tests and protocol being conducted are a GLP-Compliant Intramuscular Dose (approximately 28-Day) Study, followed by a 4-Week Recovery Period of ITV-1 in Sprague-Dawley Rats. The objective of the study is to characterize any toxicity of ITV-1 when administered intramuscularly (IM) into Sprague-Dawley rats twice per week (Days 0, 1, 7, 8, 14, 15, 21, and 22) for 4 weeks (8 total doses) followed by a 4-week observation period for selected animals. Based on all clinical parameters, analysis, and observations of the studies completed, ITV-1 was well tolerated, up to 2.5 mg per intramuscular injection. With the preliminary results of the Toxicology study, Enzolytics is anticipating entry into the markets of Rwanda, DR Congo, Botswana, and Kenya. Enzolytics' Chief Science Officer, Harry Zhabilov, manages the manufacture of ITV-1 and will travel to Africa in late March to confer with principals regarding the administration of the therapeutic to patients. The World Health Organization estimates a population of over 4,000,000 HIV infected individuals living with HIV in the four African countries where the Company will register the therapy. It is estimated that the hospitals will administer the treatment to 40,000 - 50,000 patients in the first year after the initial product production is completed. In addition, with the initial results of the ITV-1 Toxicology, the Company is moving forward with Pharmacokinetic Analysis necessary for advancing the therapeutic for use in European countries under the EMA. The completion of toxicology studies is necessary for EMA registration. Approval under the EMA will allow use of the therapeutic in the EU, followed by seeking FDA approval for use in North America. Aankondiging • Jan 04
Enzolytics to Develop Feline Monoclonal Antibodies Enzolytics announced its ongoing efforts to develop fully feline Monoclonal Antibodies. Enzolytics utilizes its proprietary Artificial Intelligence (AI) platform to produce species-specific monoclonal antibodies. Abveris, a Boston-based biotechnology company providing contract research services to biopharmaceutical industry partners, will use feline donor PBMC samples and peptide screening tools provided by Enzolytics to perform a B cell screening-based Ab discovery project to identify antigen-binding antibodies for further characterization by Enzolytics. The resulting fully feline monoclonal antibodies are expected to be used in scientific applications, including ELISA, Western Blot, immunohistochemistry, and immunocytochemistry for diagnostics. There are more than 150 million cats in the U.S. and over 25% of households in America own cats. Production of monoclonal antibodies targeting feline viruses may be more direct and the time to market will be significantly less than is the case required for monoclonal antibodies developed for the treatment of humans. Enzolytics has initiated discussions with animal health providers who express an interest in this technology. Aankondiging • Dec 14
Enzolytics, Inc. Announces U.S. Distribution of IPF Immune(TM) and Progress in each of its Therapeutic Platforms Enzolytics Inc.' focus is on the production and distribution of the Company's therapeutics and advancing its research and development programs. The Company sees the coming year as a transformative period in which it plans to advance its three synergistic therapeutic platforms generating multiple clinical products for human and veterinary use. The Company's IPF Immune therapeutic, a dietary supplement that supports the body's self-defense system, is now available in the U.S. and will be widely available through national retailers and their internet platforms and websites. To meet demand, additional production of IPF Immune is ongoing. The Company is also advancing production of its ITV-1 anti-HIV therapeutic moving forward toward its use in Africa and EMA approval for use in Europe. In addition, the Company is advancing its AI platform technology and production of monoclonal antibodies against multiple infectious diseases for both humans and animals. The Company plans to move forward with its technology for diagnostics, therapeutics, and vaccines, with each new discovery to be covered by PCT International Patent protection. Enzolytics IPF Immune is a nutritional dietary supplement that provides support to the body's natural immune system. The product supports normal immune function beneficial to maintaining good health. The product is natural and tested for safety. This product enters the market as annual sales of American Dietary Supplements in North American reach $50.11 Billion. Dietary Supplement sales are forecast to increase to $77.10 Billion in 2028. The Company's ITV-1 therapeutic is a therapy for treating individuals with HIV. It has been produced and earlier clinically tested in human trials under the Bulgarian Drug Agency requirements. The following positive therapeutic effects of ITV-1 have been demonstrated in prior European clinical trials. Inhibits the infection of CD4 T-cells by HIV. Produced an 80.5% drop in viral loads. Replaces or complements current antiretroviral therapies. Is less costly and less toxic. May be effective as a periodic therapy instead of a daily one. Is unaffected by HIV mutations that can hamper antiretroviral therapies (HAART). Raises CD4 T-cell counts to healthier levels, a 68% increase in CD4+T-lymphocytes. Use achieved an increase in the CD4/CD8 index. Demonstrated an excellent effect on opportunistic infections. Had good compatibility with other antiretroviral drugs. There was good tolerance without any side effects. Use resulted in a decrease in the absolute number and the relative percent of CD8 lymphocytes. Boosts the immune system to fight HIV infections. The methodology implemented by the Company to produce monoclonal antibodies is proprietary and the subject of pending Patent Cooperation Treaty (PCT) International Patent applications. In the initial process step, Artificial Intelligence (computer analysis - A.I.) is used to identify conserved, immutable epitopes on the target virus utilizing Enzolytics' proprietary A.I. platform. In the A.I. initial analysis step, the sequences (structure) of over 2 million Coronavirus isolates have been analyzed. From that analysis, 19 epitopes (target sites) have been identified as being immutable and conserved across all 2 million isolates curated. The Company production process is then employed to produce monoclonal antibodies targeting these identified conserved sites. For HIV, the Company used A.I. to analyze 87,000 HIV isolates to identify 8 conserved epitopes sites against which monoclonal antibodies are being produced. As a part of the production process, 3 Dimensional models of these conserved targets are generated, and the targets are analyzed for linearity, accessibility by antibodies, and neutralizability by antibodies. Enzolytics' methodology for producing monoclonal antibodies is unique and innovative, unlike other biotech companies. The Company's antibodies are produced from human "immune-B cells" obtained from convalescent individuals who have recovered from the target virus. The Company's monoclonal antibodies are not "humanized" but are fully human monoclonal antibodies where the original antibody affinity and specificity are maintained. The methodology starts with human "immune cells" obtained from convalescent individuals who have recovered from the virus. From these human B cells, the Company then produces antibodies that target conserved immutable sites (neutralizable epitopes) on the virus' surface envelope proteins that will be ever-present, rendering the virus neutralizable even through mutation, thus voiding "virus escape". These antibodies also retain the original natural antibody's affinity and specificity and have a very low risk of immunogenicity when used as a therapeutic. Enzolytics is developing Class switched IgA1/2 Clone 3 Antibodies. This therapy will expectedly provide a protective immunological defense against an initial exposure to HIV at mucosal surfaces, such as in the passage of the virus from mother to child through maternal breastfeeding. HIV mucosal infection plays a critical role in virus transmission and AIDS pathogenesis, affecting mucosal surfaces of the gastrointestinal tract early on by depleting CD4+ T helper cells independently of the virus transmission route. Although current antiretroviral therapy is intended to control HIV infection in most patients, it cannot eradicate the virus from the human host. Therefore, the development and use of HIV microbicides (i.e., topical pre-exposure prophylaxis) have become a most promising approach to preventing HIV transmission. Thus, the development of Class switched Clone 3 IgA1/IgA2 is highly significant. In addition to the anti-HIV monoclonal antibody already produced and tested, Enzolytics is producing monoclonal antibodies targeting the additional seven conserved targets identified by the A.I. platform. Producing antibodies for the treatment of Feline Leukemia Virus and Feline Immunodeficiency Virus is significant because these viruses are the most common infectious diseases in cats. There are more than 150 million cats in the U.S. and over 25% of households in America own cats. These Feline viruses a significant percentage of the cat population in the United States and around the world. Production of monoclonal antibodies targeting these viruses will be more direct and the time to market will be significantly less than is the case required for monoclonal antibodies developed for the treatment of individuals. The Company has initiated discussions with animal health providers who express an interest in this technology and its end product. Enzolytics has a wholly owned Artificial Intelligence platform that drives: Early Drug Discovery and Development; Builds a valuable Intellectual Property Portfolio; Allows for strategic entry into the personalized medicine market. Aankondiging • Oct 25
Enzolytics, Inc. Appoints Dr. Kirsten Bischof to Its Advisory Board Enzolytics Inc. announced the addition of Dr. Kirsten Bischof to its Advisory Board. Dr. Bischof brings the Company her vast experience as a Surgeon and healthcare research professional with an established track record of exceptional performance in healthcare. Dr. Bischof is a well-known Trauma and Critical care specialist. She has spent her career treating patients in South Africa, where the HIV burden is unprecedented. Her appointment is a significant step as Enzolytics positions itself to strengthen its Artificial Intelligence (A.I.) platform. She will assist Enzolytics in identifying innovative early biomarkers for critical care monitoring and advanced hemodynamic management. In addition, her skills will be crucial as Enzolytics advances its HIV therapeutic ITV-1 in Africa. Dr. Bischof will guide the Company in further developing its A.I. technology. The A.I. platform drives the Company's drug discovery and development and represents an overall strategy to build a strong Intellectual Property portfolio. In addition, she has been working with the Company's collaborators in Estonia to develop this platform for assessing the effects of nutrition, genetics, and microbiome on diseases. Aankondiging • Oct 06
Enzolytics Inc. Reports Successful Completion of an MTD Tolerability Study of Its ITV-1 anti-HIV Therapeutic Leading to the Start of a 28-day GLP Toxicology Study Enzolytics Inc. announced the completion of the first phase of the animal toxicology studies on its ITV-1 anti-HIV therapeutic. The initial toxicology study showed "no adverse effects at maximal dose of the product" and confirmed the product is safe at maximum dose, leading the way for a GLP Compliant 28-day Repeat Dose Toxicity Study. This is a major step forward for Enzolytics as it completes a significant step necessary for producing and delivering the Company's anti-HIV therapy in Africa and Europe. Completing the toxicology study allows Enzolytics to introduce ITV-1 for use in certain African countries. These toxicology studies will also be used in the Company's progress toward clinical trials necessary for EMA approval. The ITV-1 therapeutic has succeeded in the clinical investigation earlier, and the Company is planning additional trials leading to EMA approval. As that approval is underway, the ITV-1 therapeutic will be provided to the Central and Eastern regions of Africa once all toxicology study phases are completed. The Company has made significant progress on its multiple therapeutic platforms. These platforms include the Company's ongoing development of multiple monoclonal antibodies for the treatment of numerous diseases, an AI (Artificial Intelligence) platform that makes possible rapid production of effective multiple monoclonal antibodies, including those targeting both human and animal viruses, and an effective nutritional supplement, IPF Immune™, that is currently in production. Aankondiging • Dec 02
Enzolytics Inc. (OTCPK:ENZC) completed the acquisition of BioClonetics Immunotherapeutics, Inc. Enzolytics Inc. (OTCPK:ENZC) executed a non-binding letter of intent to acquire BioClonetics Immunotherapeutics, Inc. on September 15, 2020. Enzolytics Inc. entered into an agreement to acquire BioClonetics Immunotherapeutics, Inc. on October 19, 2020. The BioClonetics Clone 3 recombinant mAbs will be combined with the Enzolytics' flagship compound ITV-1 which is a suspension of Inactivated Pepsin Fragment. The proposed merger anticipated in the non-binding LOI will result in Charles Cotropia being appointed as Chief Executive Officer of the merged entity and Harry Zhabilov and Joseph Cotropia, Managing Director, being appointed as Co-Cso. Gaurav Chandra, Managing Director, will serve as Chief Operating Officer of the merged entity. As of October 1, 2020, Harry Zhabilov, Chief Executive Officer of Enzolytics will also be joining the Board of Directors of BioClonetics.
Enzolytics Inc. (OTCPK:ENZC) completed the acquisition of BioClonetics Immunotherapeutics, Inc. on December 1, 2020. Aankondiging • Oct 02
Enzolytics Inc. (OTCPK:ENZC) executed a non-binding letter of intent to acquire BioClonetics Immunotherapeutics, Inc. Enzolytics Inc. (OTCPK:ENZC) executed a non-binding letter of intent to acquire BioClonetics Immunotherapeutics, Inc. on September 15, 2020. The BioClonetics Clone 3 recombinant mAbs will be combined with the Enzolytics' flagship compound ITV-1 which is a suspension of Inactivated Pepsin Fragment. The proposed merger anticipated in the non-binding LOI will result in Charles Cotropia being appointed as Chief Executive Officer of the merged entity and Harry Zhabilov and Joseph Cotropia, Managing Director, being appointed as Co-Cso. Gaurav Chandra, Managing Director, will serve as Chief Operating Officer of the merged entity. As of October 1, 2020, Harry Zhabilov, Chief Executive Officer of Enzolytics will also be joining the Board of Directors of BioClonetics.