COLLEGE STATION, TX / ACCESSWIRE / July 21, 2021 / Enzolytics, Inc. (OTC PINK:ENZC) Enzolytics and Lonza Bioscience are combining their respective technologies to fast-track development and production of anti-HIV and anti-SARS-CoV-2 Monoclonal Antibodies produced by Enzolytics.
Lonza is a multinational chemicals and biotechnology company with major facilities in Europe, North America and South Asia. It has extensive development and manufacturing capability using advanced technologies to quickly and efficiently accelerate final production of monoclonal antibodies, complex proteins and recombinant proteins. Working from sequences of the antibodies produced by Enzolytics, Lonza will provide manufacturing, developability, stability assessment, process development and produce a stable cell line. Process de-risking and assessing developability and manufacturability will optimize and expedite the development of Enzolytics' Monoclonal Antibodies. Lonza's GS Xceed expression will be used for production. This will result in a significant reduction in time required for cell line creation, allowing for faster generation of clonal cell lines and ultimately reduced time to clinical trials. In addition, the application of Lonza's technology will significantly minimize the process development time and fast-tracks the IND application for both anti-HIV and anti-SARS-CoV-2 Monoclonal Antibodies.
Enzolytics Inc. continues to make progress with its defined protocol, including:
- Application of computer analysis (Artificial Intelligence - A.I.) to curate (analyze) the amino acid sequences of targeted viruses to identify the conserved, immutable, and neutralizable target sites (epitopes) on targeted viruses -
Enzolytics has identified conserved sequences for HIV, Coronavirus, HTLV-1, Influenza A, and B, and is in the process of doing the same for H10N3, H1N1 influenza, Respiratory syncytial virus (RSV), Ebola, Small-Pox, Herpes zoster, Varicella zoster, Herpes HSV 1/2, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, and Koala retrovirus.
Regarding the HIV virus, the Company has screened more than 87,336 HIV isolates, the largest known repository of HIV isolates known. From this extensive A.I. analysis, seven conserved sites (with up to 98% conservativeness) on HIV were identified. In addition, this analysis also confirmed that the site against which the Company's already produced anti-HIV monoclonal antibodies (called Clone 3) targets one conserved site on the HIV virus, which site is 98% conserved (either directly or by way of conservative amino acid substitutions) overall 87,336 HIV isolates curated (analyzed) by the Company using Artificial Intelligence. Using A.I., the Company has screened more than 50,512 Coronavirus isolates currently known and has identified conserved, immutable sites. Through the analysis, 19 conserved sequences have been identified on the Coronavirus on the basis that they are 98.71% to 99.29% conserved over the entirety of the 50,512 Coronavirus isolates analyzed. From these findings of 19 conserved, neutralizable sites (epitopes) on the Coronavirus, the Company is producing multiple (a cocktail of) targeted anti-SARS-CoV-2 monoclonal antibodies. These 19 sequences were confirmed to be conserved in the Variants of Concern as well.
- Creation of cell lines to produce fully human monoclonal antibodies targeting each identified conserved virus site (epitope) -
Multiple broad neutralization antibodies are made in this step, targeting multiple conserved, immutable epitopes on the targeted virus. The Company's methodology for producing monoclonal antibodies is unique. Antibodies are created from human "immune-B cells", obtained from convalescent individuals who have recovered from the target virus.
The antibodies produced are not 'humanized' rat and mouse monoclonal antibodies where the original antibody affinity and specificity are not maintained, and the chances of immunogenicity are increased. In addition, the antibodies are not transgenic mouse models (a human immune system that has been "grafted" within a mouse model), having been "vaccinated" with specific and selected purified proteins.
- Production of Monoclonal Antibodies for patient therapy-
Working with Lonza Bioscience, the Company will produce stable cell lines for mass producing multiple Monoclonal Antibodies for application in the early stages of infection to treat or cure patients infected by the targeted virus.
The overall protocol offers the opportunity to implement A.I. analysis of existing viruses (or mutants thereof) and any new virus immediately upon its emergence anywhere in the world. Enzolytics protocol provides a platform for creating multiple fully human Monoclonal Antibodies targeting these conserved immutable sites on the virus - providing a necessary treatment of these viruses.
Charles Cotropia, CEO of Enzolytics, stated, "We utilize Artificial Intelligence to identify conserved immutable epitope sites within infectious diseases and then use our proprietary fully human Monoclonal Antibody methodology to target these conserved immutable sites. Our primary goal is to advance our therapies to the clinic in an expeditious manner. Our mission is to translate our understanding of evolutionary biology coupled with Artificial Intelligence-driven fully human Monoclonal Antibodies into a therapeutic cure for HIV and SARS-CoV-2. We chose to partner with Lonza on this journey because of Lonza's deep experience and expertise in developing and manufacturing biotherapeutics. This agreement marks a key milestone on our path to expedite our clinical development and reduce time to the clinic."
About Lonza
Lonza (www.lonza.com) is the preferred global partner to the pharmaceutical, biotech, and nutrition markets. They work to prevent illness and enable a healthier world by supporting their customers to deliver new and innovative medicines that help treat a wide range of diseases. This is achieved by combining technological insight with world-class manufacturing, scientific expertise, and process excellence. These capabilities enable their customers to rapidly commercialize their discoveries and innovations in the healthcare sector.
Founded in 1897, today Lonza operates across five continents. With approximately 14,000 full-time employees, they are built from high-performing teams and of individual talent who make a meaningful difference to their own business, as well as to the communities in which they operate. The Company generated sales of CHF 4.5 billion in 2020 with a Core EBITDA of CHF 1.4 billion.
About Enzolytics, Inc.
Enzolytics, Inc. is a drug development company committed to commercializing its multiple proprietary therapeutics to treat debilitating infectious diseases. The Company's patented ITV-1 therapeutic suspension of Inactivated Pepsin Fraction (IPF), which studies have shown effectively treats HIV/AIDS. IPF is the active component of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has also been shown to modulate the immune system.
Additionally, the Company has proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, Coronavirus, HTLV-1, Influenza A, and B, H10N3, H1N1 influenza, Respiratory syncytial virus (RSV), Ebola, Small-Pox, Herpes zoster, Varicella zoster, Herpes HSV 1/2, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, and Koala retrovirus.
Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.
While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of the Company to establish the efficacy of ITV-1 or its other therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.
Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.
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SOURCE: Enzolytics, Inc.
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