Enzolytics Inc (ENZC)

[Mutat]

There are a lot of people on this board that need to read these again because some have lost direction on what they own.

Enzolytics Inc. and Samsung Biologics Announce Development and Manufacturing Agreement for Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibody Therapy – October 7
Enzolytics Inc. to leverage Samsung Biologics’ development and manufacturing expertise to advance both Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibody Therapy to IND.
Samsung Biologics to offer a seamless, end-to-end CDMO service with support from its San Francisco R&D Center.
California, U.S. and Incheon, S. Korea, October 7, 2021 – Samsung Biologics (KRX: 207940. K.S.), a leading contract development and manufacturing organization and Enzolytics, a drug development company committed to commercializing multiple proprietary therapeutics to treat debilitating infectious diseases, announced the signing of a strategic CDMO partnership agreement.
Under the terms of the agreement, Samsung Biologics will provide end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibody Therapy for the treatment of HIV and SARS-CoV-2. In addition, there will be continuing discussions for other Monoclonal Antibodies being developed by Enzolytics.
The Enzolytics protocol offers the opportunity to implement A.I. analysis and provides a platform for creating multiple fully human Monoclonal Antibodies targeting conserved immutable sites on the virus and offering a cure for these viruses. A stable cell line will be manufactured with support from Samsung Biologics' R&D Center in San Francisco. Its related clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.
“Partnering with Enzolytics reinforces the value of our fully integrated, end-to-end business model, which is designed to meet the unique needs and goals of our biotech clients,” said John Rim, CEO of Samsung Biologics. “We look forward to providing comprehensive services and professional support for the manufacturing of this important class of Monoclonal Antibody therapeutics for the treatment of HIV and SARS-CoV-2, helping to accelerate the process of drug development to IND filing and bring these life-saving products to patients.”
"The collaboration with Samsung Biologics is a significant milestone for Enzolytics' Artificial Intelligence enabled Monoclonal Antibody Platform. We chose to partner with Samsung Biologics because of Samsung Biologics' extensive experience and expertise in developing, producing, and manufacturing Monoclonal Antibodies for Infectious Diseases and Oncology.” said Dr. Gaurav Chandra, Chief Operating Officer Research and Development at Enzolytics. “This partnership marks a pivotal milestone for Enzolytics to significantly advance the clinical development of our universal, durable, broadly neutralizing Monoclonal Antibodies and reduce time to the clinic and offer the much-needed treatment for patients."
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, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, and Koala retrovirus.
Enzolytics 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.
About Samsung Biologics Co., Ltd.
Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com
Samsung Biologics Forward-Looking Statement
This press release contains certain statements that constitute forward-looking statements, including statements that describe Samsung Biologics' objectives, plans or goals. All such forward-looking statements, and the assumptions on which they are based, are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. There can be no assurance that the results and events contemplated by the forward-looking statements contained herein will in fact occur. Except as required by law, Samsung Biologics will not update any forward-looking statements to reflect material developments that may occur after the date of this press release.
Enzolytics Investor Relations Contact:
Title: Ten Associates, LLC
Name: Tom Nelson
Contact Info: Enzolytics, Inc.
2000 North Central Expressway
Plano, TX 75074 USA
Samsung Biologics Contact:
Senior Director of Global Public Relations
Claire Kim
[e-mail]
National HIV/AIDS and Aging Awareness Day – September 18
COLLEGE STATION, TX September 18, 2021 / Enzolytics wishes to recognize and highlight National HIV/AIDS and Aging Awareness Day—a day to call attention to the growing number of people living longer with HIV and to aging-related challenges of HIV prevention, testing, treatment, and care.
Those with HIV are living longer than in earlier years of the pandemic. Because almost ½ of those with HIV are now 50 or older and approximately 1 in 6 new diagnoses of HIV occur in this age group, people aging with HIV can face treatment-related challenges, such as drug interactions between HIV medicines and medicines used for other conditions. Additionally, because older individuals are more likely not to be diagnosed with HIV, a delayed diagnosis means treatment is also delayed, resulting in HIV potentially causing more damage to the immune system.
Enzolytics is proud to be on the leading edge of developing more effective and strategic therapeutics to successfully treat HIV. The Company’s focus is on treatments that do not cause the significant negative side effects caused by antiretroviral (ARV) therapies – currently the only therapy available to treat HIV. The negative side effects caused by ARV treatment are well documented and include kidney problems, kidney failure, liver damage (hepatotoxicity), heart disease, osteoporosis, diabetes, or insulin resistance, an increase in fat levels in the blood (hyperlipidemia), and changes in how the body uses and stores fat (lipodystrophy). [https://www.healthline.com/health/hiv-aids/antiretroviral-drugs-side-effects-adherence#other-side-effects].
As HIV patients live longer, these side effects become all the more problematic. Moreover, antiretroviral treatment is only accessible to 74% of the over 37 million people infected worldwide – leaving 26% of infected HIV patients with no treatment. And while this day is a focus on the older HIV patients, the world must not lose sight of the fact that of the 37 million individuals living with HIV, over 1.8 Million are children and of those, 47% have no access to any treatment whatsoever. And 320 children and adolescents die every day from HIV. [https://www.unaids.org/en/keywords/children].
The Company’s focus is on a superior therapy for treating HIV as compared to the current treatment using ARVs. Specifically, the Company is producing fully human monoclonal antibodies that neutralize the virus. Experts in the field have consistently acknowledged that a cure for HIV will require the administration of “multiple broadly neutralizing monoclonal antibodies”. Just as multiple anti-CoronaVirus monoclonal antibodies are now widely recognized as successful in treating those with COVID-19, the same will be true for anti-HIV monoclonal antibodies. But to be successful, such antibodies must be “broadly neutralizing” – namely not subject to mutant strains of the HIV virus. Such monoclonal antibodies are precisely what Enzolytics is producing.
Enzolytics, Inc. is a drug development company with two separate but complementary therapy platforms for treating HIV. The Company is in the final development of the recombinant of one of its antibodies, identified as “Clone 3”, which has been shown in in vitro studies conducted in 5 international laboratories to fully neutralized over 95% of all strains and viral subtypes of HIV-1 against which it was tested. The basis for its broad-spectrum efficacy is the fact that Clone 3 mAb targets an immutable epitope on the HIV virus. The targeted epitope has remained present in 98% (either directly or by way of conserved substitutions) of all 87,336 HIV isolates analyzed by the Company’s use of Artificial Intelligence (A.I.). The failure of other mAbs, such as the NIH/Vaccine Research Group VRC01, resulted from the targeting of mutable epitopes on the HIV virus [Bar KJ, et al. Effect of HIV Antibody VRC01 on Viral Rebound after Treatment Interruption. N Engl J Med. 2016;375(21):2037-50. PMCID|5292134].
To expand on the Company’s proprietary technology for producing fully human monoclonal antibodies, the Company has applied Artificial Intelligence (A.I.) to identify additional conserved, immutable target sites on the HIV virus. Using this process, an additional seven (7) conserved sites (with up to 98% conservativeness) on HIV have been identified. This analysis also confirmed that the site against which the Company’s already produced anti-HIV monoclonal antibody (Clone 3) targets one of these identified conserved sites on the HIV virus, which site is 98% conserved overall 87,336 HIV isolates analyzed by the Company use of A.I.
The Company is producing multiple antibodies targeting each of these 7 epitope sites.
Because the Company's monoclonal antibodies are produced to target epitopes on the virus that do not change, virus mutations will not negate the neutralizing effect of the monoclonal antibody therapy. Significant testing has demonstrated the basis for this expectation. Specifically, in in vitro tests conducted in five independent laboratories, Clone 3 was tested against 43 clinical HIV isolates (strains) of the virus. In those tests, Clone 3 successfully neutralized 41 of the 43 HIV isolates against which it was tested (100% effective against over 95% of the HIV strain against which it was tested). The Company’s Clone 3 antibody is the only fully human monoclonal antibody found to neutralize the Clade C isolate found in Africa, China, and India. Clone 3 also neutralizes the Clade B isolate that is predominate in North America and Europe.
These results, demonstrating in vitro neutralization effect against geographically distinct clinical HIV (primary) isolates, were achieved in testing in the following 5 independent laboratories:
1. University of California, San Francisco, CA, USA
2. University of South Florida, Tampa, FL, USA
3. Polymun Scientific, GmbH, Vienna, AUSTRIA
4. Duke University, Durham, NC, USA (
5. Dana Farber Cancer Institute (DFCI), Harvard Medical School, Boston, MA, USA,
In these tests, Clone 3 neutralized [at IC90] 41 of 43 (>95%) of the clinical HIV-1 group M, N, and O isolates. Clone 3 neutralized 3 of 3 group O HIV isolates tested at 10 µg/ml in PBMC-based assay. In another study of Clone 3 tested against one group N primary HIV-1 isolate, results indicated that the IC90 for Clone 3 versus the HIV primary isolate YBF30 was 3.72 µg/ml. Further, Clone 3 has also been demonstrated to effectively neutralize 4 of 4 virulent pediatric South African clade C isolates [ZA349, ZA562, ZA600, ZA737]; and at 10 µg/ml, neutralize [IC99] a pediatric Zambian clade C HIV-1157, as well as the simian immunodeficiency virus, construct SHIV-1157ip. Therefore, of the 43 HIV isolates against which Clone 3 has been tested, it neutralized 41 (over 95%).
These Company monoclonal antibodies have been amino acid sequenced using denovo mass spectrometry and polymerase chain reaction (PCR) methodologies. Using these identifying sequences, the Company’s partnering CRO labs are applying recombinant protein technology in FDA-approved CHO cell lines to create pharmaceutical-grade material for use in final PBMC in vitro validation testing, followed by animal and clinical trials.
Multiple antibodies targeting the identified 7 conserved immutable sites on the HIV virus are being created and this same procedure is followed to produce multiple monoclonal antibodies. This will permit the administration of a “cocktail” therapy which will be significantly more effective than administrating just one monoclonal antibody.
Additionally, the Company’s separate but complimentary anti-HIV therapeutic, a patented antiviral peptide designated ITV-1, is being advanced to clinical trials. In earlier completed clinical studies at the National Center of Infectious and Parasitic Diseases in Bulgaria, this therapeutic demonstrated effectiveness in the treatment of HIV patients in various stages of the disease. In these clinical trials, the therapeutic showed significant efficacy. In 68% of those individuals tested, there was an increase in CD4+ T lymphocytes. This increase was accompanied by an increase in the CD4/CD8 index and CD4% in over 50% of those tested. The increase in these parameters demonstrated statistical significance compared to the control group. The absolute number and the relative percent of CD8+ T lymphocytes decreased. And the viral load in 80.5% of those tested was below the threshold of detection.
This ITV-1 anti-HIV treatment is now being advanced through the certification stage in Europe under the European Medicines Agency to thereafter be made available for patient therapy.
It is expected that there will be a synergistic effect achieved by combining the Company’s two distinctive therapies, its monoclonal antibodies and its ITV-1 therapeutic. The Company will be reporting the progress made on these therapeutics as it is achieved.
Company Contact:
Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843
Enzolytics Progress Update
COLLEGE STATION, TX August 25, 2021 / With over 1,000 U.S. deaths per day (and rising) and 150,000 new daily infections of COVID-19, monoclonal antibodies are now being recognized as a significant therapeutic for addressing the CoronaVirus pandemic. Enzolytics has always recognized this fact and is aggressively producing targeted anti-CoronaVirus monoclonal antibodies for the treatment of the virus. This progress report provides an update on both the production of the Company’s anti-CoronaVirus monoclonal antibodies and the production and clinical trials of the Company’s ITV-1 anti-HIV therapeutics.
Monoclonal Antibodies Are Now Being Fully Recognized as a Significant Therapeutic for Addressing the CoronaVirus Pandemic.
The Company is in active production of anti-CoronaVirus fully human monoclonal antibodies in its Texas lab. The monoclonal antibodies being produced target multiple specific epitopes on the virus. To be effective, monoclonal antibodies produced against viruses must target immutable, conserved epitopes (sequences) on the virus or the antibodies will be ineffective due to virus mutation. This has occurred with regard to anti-CoronaVirus monoclonal antibodies recently produced by Eli Lilly and AstraZeneca, antibodies now withdrawn from the market. [https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab]; [https://www.reuters.com/business/healthcare-pharmaceuticals/astrazeneca-says-its-antibody-treatment-failed-in-preventing-covid-19-exposed-2021-06-15/].
The monoclonal antibodies being produced by Enzolytics against the CoronaVirus target 19 conserved immutable sites on the virus, sites which the Company has now confirmed are conserved sites not only on the initial virus strains but also existing in the Delta and Lambda variants, as well as in the Alpha, Beta and Gamma variants.
The Company’s process for producing monoclonal antibodies against infectious diseases begins with conducting an Artificial Intelligence (A.I.) analysis of the epitope sequences to identify conserved sites with a conservativeness of up to 99%. In the case of the CoronaVirus, the Company initially analyzed 50,512 CoronaVirus isolates and has now analyzed over 1 million isolates resulting in the identification of 19 conserved, immutable sites. These 19 conserved sites were confirmed as 98.71% to 99.29% conserved over the entirety of all 1 million CoronaVirus isolates analyzed. From further analysis of the Delta variant, Lambda variant, Alpha, Beta, and Gamma variants, the Company has confirmed that the 19 sites against which it is producing monoclonal antibodies exist in these variants.
With this information, the Company is producing fully human monoclonal antibodies targeting these sites. Early in 2021, the Company filed patent applications claiming these 19 conserved CoronaVirus epitope sites and its methodology for the production of such antibodies.
Following the production of the multiple monoclonal antibodies in its Texas lab, the monoclonals will be processed at CRO/CDMO labs contracted by the Company where the sequencing of the antibodies will be determined using denovo mass spectrometry. Peptide sequences will also be determined using polymerase chain reaction (PCR) methodology. Once the sequencing of the antibodies is determined, the antibodies will be produced using recombinant protein technology in FDA-approved Cho cell lines to create pharmaceutical-grade material for animal and clinical trials.
These follow-on steps, after monoclonal antibodies are produced in the Company lab, will be conducted in specialized CRO/CDMO labs under the Company’s guidance and pursuant to contracts. The Company has multiple therapeutics which it is developing. For each, the Company engages and interfaces with CROs and CDMOs to conduct follow-on process steps necessary to produce clinical-grade therapeutics for trials.
From the essential information created by the Company, namely the specific amino acid sequences necessary to produce the final therapeutics, the Company engages CRO/CDMO entities to produce the clinical-grade anti-SARS-CoV-2, anti-HIV, anti-HTLV-1, and many other therapeutic monoclonal antibodies which the Company is producing. Moreover, for each of these viruses, multiple monoclonal antibodies (targeting precise conserved sites on the viruses) will be produced for use in combination therapy.
There are many highly qualified international CRO/CDMO companies engaged by Enzolytics. All are experts in their fields and fully capable of conducting the follow-on steps necessary to advance Enzolytics’ initial monoclonal antibodies to the production of pharmaceutical-grade material for animal and clinical trials. In the engagement of CROs/CDMOs as a part of the production of the Company’s targeted therapeutics, the application of the follow-on processes they provide comes into play subsequent to the production of monoclonal antibodies produced by Enzolytics and under the Company’s complete control.
ITV-1 anti-HIV Therapeutics Development Progress.
With regard to the Company’s additional therapeutics under development to treat HIV, agreements have been reached with Danhson [https://danhson.bg/en/] and Clinic Design [https://clinicdesign.eu/] and progress is proceeding to advance the Company’s anti-HIV therapeutic ITV-1 to production and clinical trials. These steps are prefatory to approval by the European Medicines Agency (EMA), leading to patient use authorization.
Production of the therapeutic is being accomplished at Danhson pharmaceutical company facilities, to be followed by clinical trials conducted by Clinic Design. Production of the therapeutics is expected to be completed in the next few months followed by clinical trials to be conducted immediately thereafter. The protocol of the trials will be guided by Pharmalex [https://www.pharmalex.com/], an EU regulatory consulting company.
Monoclonal Antibodies Are Now Being Recognized as a Significant Therapeutic for Treating COVID-19.
A new wave of recognition is now emerging in the healthcare and political arenas regarding the significance of monoclonal antibodies. The U.S. government has spent $2.65 Billion on the Regeneron monoclonal antibodies and on August 20, 2021, the UK approved the Regeneron/Roche antibodies cocktail for COVID-19. There is now widespread recognition of the potential effectiveness and role that monoclonal antibodies can play in current and future pandemics.
The Enzolytics process differs from the process used by Regeneron. Regeneron antibodies are produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system. Enzolytics’ process does not use mice with a genetically modified human immune system. The Enzolytics’ proprietary methodology for creating hybridomas produces a specific monoclonal antibody secreted by human immune B cells—obtained from convalescent donor patients—followed by isolating a single cell that produces a monoclonal antibody that targets an identified conserved epitope on the virus.
A primary distinction of the Enzolytics process for creating fully human monoclonals is the starting point is from human “immune-B cells” from humans who have survived successfully from a "natural" CoronaVirus infection. These antibodies will retain the original natural antibody affinity and specificity and have a lower risk of immunogenicity when used as a therapeutic. They are expected to provide broad-spectrum coverage against viral variants with increased potency, stability as a single-domain molecule, and, in the recombinant form, will have accessibility to the virus epitopes (binding sites) not accessible with a whole antibody.
On August 21, 2021, Florida Governor Ron DeSantis announced that the State of Florida opened a new monoclonal antibody therapy treatment site in Broward County. “We are working to raise awareness about monoclonal antibodies because they save lives and reduce severe illness and risk of hospitalization,” said Governor DeSantis. “Today, I am proud to further expand access to treatment with the opening of a monoclonal antibody treatment site in Broward County. We will continue to open more sites to support Floridians’ ability to receive this treatment which has been proven to be safe and effective.”
In his statement, Governor DeSantis acknowledged that monoclonal antibodies are proven as successful therapies in other illnesses and do not carry the suspect confusion that surrounds the mRNA technology used to produce the current anti-CoronaVirus vaccines. Indeed, monoclonal antibodies are not new to medicine. They were invented in 1976 by Georges Köhler and César Milstein who were awarded the Nobel Prize for their discovery. They are currently successfully produced and administered in treating autoimmune diseases, cancer tumors, Ebola, Respiratory syncytial virus (RSV), and others. Use to date has been limited but is expanding as their unique effectiveness and safety are being recognized.
Monoclonal antibodies are being recognized as prime therapeutics on many levels. This week, Erin McCreary, director of stewardship innovation at the University of Pittsburgh Medical Center, which has treated 3,427 patients with the drugs since December 9, 2020, stated, “We have a long way to go on how do we reach the general public where they are. It is absolutely the standard of care for Covid-19,” she said. “It is my hope that clinics know that.”
[https://www.washingtonpost.com/health/covid-monoclonal-abbott/2021/08/19/a39a0b5e-0029-11ec-a664-4f6de3e17ff0_story.html].
Enzolytics has recognized this fact for decades having produced anti-HIV monoclonal antibodies.
The process of producing monoclonal antibodies follows nature’s role in the body in attempting to ward off infection where the body naturally produces antibodies to counteract viruses. Unfortunately, while the body, through its B cells, recognizes viruses, it produces polyclonal antibodies in response—not all of which are neutralizing. In its process, the Company isolates a single B cell and clones it so that it produces monoclonal antibodies to a specific part of the virus. To be successful and avoid virus escape due to mutation, an immutable target must be identified and the antibody produced must singularly attack that site. This is accomplished by the Company through initially screening over 57,000 CoronaVirus isolates followed by screening over 1 million and identifying the conserved sites which are then targeted.
In his comments this week, even Governor DeSanctis noted that monoclonal antibodies are a therapy that simulates what the body does to protect us from viruses and bacteria. They are not manipulated therapies like the mRNA vaccine that causes many to question the safety of vaccines produced by the mRNA methodology.
In a podcast in August 2020 [https://www.youtube.com/watch?v=VdRXTcI7rs8], Dr. Anthony S. Fauci, head of the NIAID/NIH, reported that the U.S. government had commissioned and prepaid millions for doses of anti-CoronaVirus monoclonal antibodies that would be available in October of 2020. Successful monoclonal antibodies did not surface in the Fall of 2020 as reported in that podcast. This demonstrates the critical importance of producing monoclonal antibodies that target a precise and immutable site on the virus.
More recently, in Dr. Fauci’s presentation on August 3, 2021, at the Center for Strategic and International Studies about the ongoing development of coronavirus treatments (Reuters), he commented that “monoclonal antibodies turned out to be an early success but they have had their vulnerability particularly when you deal with the variants we have had to face.” One interpretation of Dr. Fauci’s statement is the early monoclonal antibodies produced by the NIH, and apparently, those from Eli Lilly and AstraZeneca failed because of virus mutation, the emergence of “variants”. Enzolytics has recognized all along that mAbs must target “immutable”, “conserved” sites. With Artificial Intelligence and the screening of over 1 million CoronaVirus isolates and identifying 19 that are conserved across all those analyzed at a level of up to 99%, the Company has identified those sites that do not mutate and is now producing monoclonal antibodies targeting those sites.
This history highlights the fact that the process is one that is complex and must be precisely executed. If the produced antibody attacks a part of the virus that mutates, as the NIH did in the production of anti-HIV monoclonal antibodies VRC01 and VRC02, they fail. [https://www.jci.org/articles/view/134395]. The Emergency Use Authorization (EAU) for Eli Lilly’s and AstraZeneca’s anti-CoronaVirus monoclonal antibodies were earlier revoked due to lack of effectiveness.
Enzolytics is producing 19 fully human monoclonal antibodies each targeting a conserved immutable site on the CoronaVirus. These monoclonal antibodies are being created and tested and expectedly will be administered as a successful therapy against the virus. While experts now agree that one monoclonal antibody is good, they likewise agree that multiple antibodies are better. Moreover, monoclonal antibodies may be produced against multiple viruses and the Company has on its agenda production of such antibodies against a long list of viruses, including H10N3, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Ebola, Small-Pox, Tetanus, Diphtheria, Rabies, Herpes zoster, Varicella zoster, Anthrax, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, and Koala retrovirus. The Company looks forward to demonstrating success with each of these monoclonal antibodies in the future.
Forward Looking Statements
This progress update may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of our company, are generally identified by the use of words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “seek,” “strive,” “try,” or future or conditional verbs such as “could,” “may,” “should,” “will,” “would,” or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Some of the factors that could cause our actual results to differ from our expectations or beliefs include, without limitation, the risks discussed from time to time in our filings with the Securities and Exchange Commission or OTC Markets. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Certain forward-looking statements may 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 monoclonal antibodies, 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 and abroad, 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 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.

ENZOLYTICS REPORTS ITS PROGRESS TOWARD COMPLETION OF CLINICAL TRIALS FOR ITS ITV-1 ANTI-HIV THERAPEUTIC AND SECURING USE AUTHORIZATION UNDER THE EUROPEAN MEDICINES AGENCY
COLLEGE STATION, TX July 28, 2021 / Enzolytics, Inc. has completed arrangements and agreements with Danhson (https://danhson.bg/en/) and Clinic Design (https://clinicdesign.eu/) to advance its anti-HIV therapeutic ITV-1 to production and clinical trials. These steps are prefatory to approval by the European Medicines Agency (EMA), leading to patient use authorization.
Production of the therapeutic will be accomplished at Danhson pharmaceutical company facilities, to be followed by clinical trials conducted by Clinic Design. Production of the therapeutics is expected to be completed in the next few months followed by clinical trials to be conducted immediately thereafter. The protocol of the trials will be guided by Pharmalex (https://www.pharmalex.com/), an EU regulatory consulting company.
Earlier in the year, the Company announced the formation of International Medical Partners (“IMPL”), a Bulgarian Limited Liability Company, of which the Company is 50% owner. Pursuant to that formation, the Company will fund the initial production of the ITV-1 therapeutic and the Company’s partners in IMPL will fund the cost of the clinical trials and cost of EMA permitting.
IMPL will be the exclusive distributor of the ITV-1 therapeutic in the European Medicines Agency member countries (namely all 27 European Union member states and Iceland, Liechtenstein and Norway) as well as the countries of Russia, Georgia, Ukraine, Moldova, Belarus, Armenia, Azerbaijan, Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan, Estonia, Latvia and Lithuania. IMPL may distribute the ITV-1 therapeutic outside of its exclusive territory where an exclusive license does not otherwise exist.
All documentation for registration of IMPL has been filed with the Registry Office in Sofia. The initial funding of IMPL, by Enzolytics and its partners, has been provided by the partners.
The Company’s two-year audit is proceeding in accordance with GAAP requirements and will be completed and filed as soon as completed. The audit is proceeding as planned without any unanswered issues.
Harry Zhabilov, CSO of Enzolytics, stated, “We are excited about the progress we have made with the assistance of our IMPL partners. Contracting with Danhson, Clinic Design and PharmaLex is integral to the success of the EMA permitting process. As this is the second time our ITV-1 therapeutic has progressed through clinical trials and the first trials were successful, we are fully confident that we will succeed in the permitting process. With the reciprocal treaty between the EMA and FDA, we believe that the EMA approval with lead to further advancement of our ITV-1 as a successful therapy.”
Company Contact
Enzolytics, Inc.
2000 North Central Expressway
Plano, TX 75074
and
Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843
ENZOLYTICS ANNOUNCES ITS PROGRESS TOWARD COMPLETION OF CLINICAL TRIALS FOR ITS ANTI-HIV ITV-1 THERAPEUTIC AND PLANS FOR ITS DISTRIBUTION THROUGHOUT EUROPE
COLLEGE STATION, TX / ACCESSWIRE / June 14, 2021 / Enzolytics, Inc. (OTC PINK: ENZC) (https://enzolytics.com/) has concluded definitive plans to advance its previously tested ITV-1 anti-HIV therapeutics to clinical trials and distribution throughout Europe. Completion of these steps will establish its anti-HIV therapy as a significant revenue source for the Company, a meaningful milestone for both human health and Company profitability.
The Company’s ITV-1 anti-HIV therapeutic earlier progressed toward certification under the Bulgarian Drug Agency (BDA), but that process was interrupted before completion. However, in that process, significant positive clinical trial results in patients were documented. These positive results give the Company complete confidence that the now planned clinical trials under the European Medicines Agency (EMA) will likewise be successful.
The steps now in place to accomplish the Company’s goal of bringing its anti-HIV ITV-1 therapeutic to patients are:
The Company has formed International Medical Partners Ltd. (IMPL) in partnership with European partners.
IMPL is owned equally by the Company and its partners and has the license to distribute the ITV-1 therapeutic in the 27 European countries covered by the European Medicines Agency plus Russia, Georgia, Ukraine, Moldova, Belarus, Armenia, Azerbaijan, Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan, Estonia, Latvia, and Lithuania.
The Company has engaged the Contract Manufacturing Organization (CMO) Danhson Ltd. to produce the initial quantity of ITV-1 used in preparing the required Best Methods Report for future production and clinical trials documentation.
The Company has engaged the Contract Research Organization (CRO) Clinic Design Ltd. to prepare the protocol for human clinical trials that will lead to the licensing of the Company’s ITV-1 therapeutic under the European Medicines Agency (EMA).
The production at Danhson Ltd. will produce initial production quantities of the therapeutic to be used for completion of preclinical testing and then initiating clinical trials with Clinic Design Ltd.
IMBL is contracting with PharmaLex, a leading EU regulatory consulting company, to manage document review of product compliance according to EMA requirements.
The clinical trials will be funded fully by the Company’s European partners in IMPL. None of the clinical trial costs will be borne by the Company.
The Company’s two-year audit is proceeding in accordance with GAAP requirements and will be completed and filed as soon as possible. No unanswered issues have arisen.
Harry Zhabilov, CSO of ENZC, stated, “We are excited about the progress we have made with the assistance of our partners at IMPL. Engaging Danhson Ltd., Clinic Design Ltd., and PharmaLex is an integral step toward our success in the EMA permitting process. As this is the second time ITV-1 has gone through clinical trials and the first trials were successful, our confidence is at an all-time high regarding permitting, and with the reciprocal treaty between the EMA and FDA, we believe that the “redo” on clinical trials will be a blessing in disguise in the long run.”
CEO Charles Cotropia said, “The Company’s objective is to provide new, better, and safer therapeutics to treat HIV. Currently, treatment is solely through the lifelong use of antiretrovirals (ARVs) which are expensive and have long-lasting, serious negative effects on the body. The costs for such ARVs are high - from $27,540 per year for Dovato by ViiV/Glaxo SmithKline to $42,635 per year for Biktarvy by Gilead and a lifetime costs of up to $350,000 – and even then, only 54% of those infected by HIV have access to such treatments – leaving 46% with no treatment. New and improved therapies that are less expensive and more effective are desperately needed. Providing these better therapies is our Company’s objective.”
About Enzolytics, Inc.
Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins and monoclonal antibodies for the treatment of debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in treating 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.
The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for producing fully human monoclonal antibodies is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the Coronavirus (SARS-CoV-2) and HTLV-1.
I.R. contact
TEN Associates, LLC
Tom Nelson, CEO
[phone]
Investor Relations Contact
Company Contact

Enzolytics, Inc.
2000 North Central Expressway
Plano, TX 75074
And
Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-44
SOURCE: Enzolytics, Inc.
ENZOLYTICS ANNOUNCES A COMPREHENSIVE THERAPEUTIC PROTOCOL FOR THE PRODUCTION OF MONOCLONAL ANTIBODIES TO ADDRESS ONGOING AND FUTURE PANDEMICS
COLLEGE STATION, TX / ACCESSWIRE / June 7, 2021 / Enzolytics, Inc. (OTC PINK: ENZC) (https://enzolytics.com/) has announced a coherent protocol that it intends to execute to meet the Company’s objective of producing a therapeutic cure for HIV as well as a planned protocol to address existing and future pandemics. This protocol has been defined as a result of the Company’s collaboration with Intel Corporation in the field of applying computer analysis (Artificial Intelligence – A.I.) to accelerate health care discoveries and development.
The Company’s collaboration with Intel is discussed in a recently published White Paper (https://www.intel.com/content/www/us/en/healthcare-it/resources/enzolytics-whitepaper.html) and in an internet streamed presentation (https://www.youtube.com/watch?v=8peEJdTRoe8) featuring Intel representatives Clifton Roberts and Nikhil Deshpande with Enzolytics' COO, Dr. Gaurav Chandra. Enzolytics’ collaborative partnership with Intel focuses on achieving groundbreaking drug discovery and development pathways. This collaboration includes exploring the interaction of monoclonal antibodies with viruses in 3-dimensional matrices. This opens new innovative pathways for drug discovery and development.
The Company is actively exploring biotech partnerships, and in the same way, the Company is working with Intel Corporation to advance and provide effective therapies and cures for existing and new viral illnesses. In combination with the Company’s patented and clinically tested anti-HIV peptide ITV-1, the Company proposes a collaboration to fully implement the following protocol for developing and deploying therapeutics to address existing and future pandemics.
The Company’s defined protocol includes:
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 accomplished this goal for HIV, the Coronavirus, HTLV-1 and is in the process of doing the same for H10N3, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Ebola, Small-Pox, Tetanus, Diphtheria, Rabies, Herpes zoster, Varicella zoster, Anthrax, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, and Koala retrovirus.
The protocol includes the implementation of A.I. analysis of existing viruses (or mutants thereof) and on any new virus immediately upon its emergence anywhere in the world.
The A.I. analysis identifies the conserved, immutable, and neutralizable target sites on the subject virus. It provides for the production of multiple monoclonal antibodies, each targeting an immutable epitope for the administration of combination therapy.
Creation of cell lines to produce fully human monoclonal antibodies targeting each identified conserved virus site (epitope). In this step, multiple broadly neutralizing antibodies are produced targeting multiple conserved, immutable epitopes on the targeted virus.
The Company’s methodology for producing monoclonal antibodies is unique.
Antibodies are produced from human "immune-B cells," obtained from convalescent individuals who have recovered from the target virus.
The antibodies 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.
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.
Given the production method, a "Black Box Warning" (a warning of potential adverse reactions) would not be expected to be applicable to the Company’s produced antibodies.
Administering multiple monoclonal antibodies in the early stages of infection as treatment or cure of the targeted virus.
This protocol is now being executed and may be applied to any virus using the Company’s existing technology. The first step of using A.I. to identify conserved, immutable target sites has been completed by Enzolytics for HIV, the Coronavirus (SARS-CoV-2), and the HTLV-1 virus. With regard to 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 (7) conserved sites (with up to 98% conservativeness) on HIV were identified. 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.
Likewise, the Company has completed the same type of analysis for the Coronavirus and HTLV-1. Using A.I., the Company screened more than 50,512 Coronavirus isolates currently known and has identified conserved, immutable sites which are neutralizable. Through the analysis, nineteen (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.
Experts acknowledge the necessity of treating with multiple monoclonal antibodies. More importantly, the target sites must be conserved, immutable sites to avoid “virus escape” for the therapeutics to be effective. Producing antibodies against each conserved targeted site on the virus permits the creation and administration of a "cocktail" of antibodies, each of which will have an effect without regard to the mutation of the virus. Using the Company’s proprietary methodology for producing fully human monoclonal antibodies, the Company is producing antibodies targeting these virus sites in its lab at Texas A&M University in the University's Institute for Preclinical Studies.
Patents have been filed on these discoveries claiming the inventive findings. These patents claim the discovered epitope/antigens, with proposed vaccine claims, antibody claims, and related prophylactic/therapeutic method claims relating to these identified epitope/antigens.
The Company is also curating (analyzing) the amino acid sequences of other significant viruses, covered by patents claiming the identified antigens/epitopes and associated therapeutics. Using A.I. analysis, the Company is now identifying, and it will claim the conserved epitopes/antigens on the infectious diseases caused by Ebola, Influenza A and B, H1N1 influenza, H10N3, Respiratory syncytial virus (RSV), Small-Pox, Tetanus, Diphtheria, Rabies, Herpes zoster, Varicella zoster, Anthrax, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, and Koala retrovirus.
The Company expects to accelerate its development of these highly significant therapeutics and test its monoclonal antibodies in combination with its patented and clinically tested anti-HIV peptide ITV-1. Such tests are expected to validate the expected synergistic effect of combining the two anti-HIV therapeutics. The Company is actively seeking and dialoguing with pharma companies active in developing therapeutics for treating infectious diseases.
About Enzolytics, Inc.
Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins and monoclonal antibodies for the treatment of debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in treating 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.
The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for producing fully human monoclonal antibodies is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the Coronavirus (SARS-CoV-2) and HTLV-1.
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 Enzolytics to establish the efficacy of ITV-1 or its therapeutic monoclonal antibodies 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 and involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and 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.
I.R. contact
TEN Associates, LLC
Tom Nelson, CEO
[phone]
Investor Relations Contact
Company Contact
Enzolytics, Inc.
2000 North Central Expressway
Plano, TX 75074
And
Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-44
SOURCE: Enzolytics, Inc.
ENZOLYTICS INC. AND INTEL CORPORATION CO-AUTHOR WHITE PAPER ON USE OF ARTIFICIAL INTELLIGENCE FOR SOCIAL GOOD
COLLEGE STATION, TX / ACCESSWIRE / May 17, 2021 / In a significant white paper, Enzolytics Inc. (OTC PINK: ENZC) (https://enzolytics.com/) and Intel Corporation (https://www.intel.com) have published a thought leadership collaboration. The white paper titled "Optimizing Empathetic A.I. to Cure Deadly Diseases" [https://www.intel.com/content/www/us/en/healthcare-it/resources/enzolytics-whitepaper.html] highlights Intel's Artificial Intelligence Analytic tools and Enzolytics' innovative approach and groundbreaking contributions to create universal, durable, and broadly effective treatment targeting all virus variants.
This collaborative effort approaches the future of medicine, a future wherein the process of healthcare evolves from reactive to anticipatory, as exemplified by P4 Medicine, a term coined by Biologist Leroy Hood:
Predictive - Our genetic makeup can predict the diseases we are at risk for.
Preventative - Medicine that refocuses care on the future rather than the present.
Personalized - Every human is genetically different and unique. This kind of approach will give autonomy to individuals as they transition from health to disease.
Participatory - This pillar is a crucial aspect that involves (i) convincing physicians of the potential of adopting newer technology, (ii) educating patients about the opportunities, challenges, and responsibilities of adopting the technology, and (iii) revolutionizing the entire medical community's mindset.
The White Paper underscores Intel's recognition of the premise of P4 Medicine and embraces Artificial Intelligence to deliver on the promise. Intel has made incredible advances in Artificial Intelligence's applications to Empathetic A.I., outsourcing healthcare tasks and decisions to rational machines, freeing up time for healthcare professionals to engage in empathetic care, and cultivating trusting relationships with their patients.
While Empathetic A.I. is promising, scientific and healthcare-related studies generate large amounts of invaluable data. Intel is empathetic to this challenge and has responded by building a graph analytics processor that can process streaming graphs thousands of times faster and at much lower power than current processing technology. Graph representation of data enables a schema of independent analytics that scales with the data size and data types. Knowledge Graphs - a significant class of graphical representations of data - are expected to play a substantial role in several spaces: investment insights, fraud prevention, cybersecurity, government analytics, enterprise A.I. analytics, social media insights, drug discovery & repurposing, and predictions of virus mutations.
A breakthrough of traversing issues with scalability, Intel's Programmable Integrated Unified Memory Architecture (PIUMA) offers solutions. Both PIUMA and graph analytics will add velocity to drug discoveries, repurposing of existing drugs, and predictions of virus mutations. Dr. Gaurav Chandra, Chief Operating Officer of Enzolytics, talking about Intel's A.I. Analytic tools, says, "There is excellent potential for Intel's Innovative Artificial Intelligence Analytics to pioneer the way for a paradigm shift in healthcare. We are confident that Intel's PIUMA and Graph Analytics will advance drug discoveries and prognosticate virus mutations. "
Intel commends the discovery of Dr. Joseph Cotropia, CSO of Enzolytics, and Dr. Gaurav Chandra. Dr. Cotropia discovered a genetic amino acid sequence designated KLIC in the outer envelope of HIV. Discovering this sequence is like finding a "needle in a haystack" and retrieving the needle. This immutable site has been identified, and the antibody that targets this site was created. This antibody (Clone 3) can lock onto the KLIC epitope. Once bound by the antibody, the virus cannot infect a human cell and cannot ultimately reproduce.
Patented by Dr. Cotropia, this HIV monoclonal antibody has been successfully tested in five international labs. In those tests, Clone 3 antibody neutralized [at an IC90] 95% of all HIV primary isolate strains (41/43) - across all clades and groups - against which it was tested. For an antibody to be effective, it has to attack a neutralizable site on the virus that is always present and does not mutate. Knowing the binding site for the monoclonal Clone 3 antibody on the HIV-1 virus and then examining the Coronavirus amino acid sequence, a correlation in the structures has been identified by Drs. Cotropia and Chandra. Having identified the correlative sequence on the Coronavirus, Enzolytics is now producing monoclonal antibodies targeting that site.
Specific antibodies that broadly neutralize are necessary to provide effective therapy and prevention of disease. Producing multiple neutralizing monoclonal antibodies for use in passive immunotherapy is now possible by using AI to identify multiple conserved sites, followed by applying Enzolytics' proprietary method of producing neutralizing monoclonal antibodies targeting those sites. Thus, Enzolytics' primary focus is now on identifying conserved, immutable sites on viruses and then creating monoclonal antibodies that bind to such conserved sites resulting in the neutralization of even mutant strains of viruses. Dr. Chandra recognized A.I.'s potential and, based on knowledge of these homologous viral structures, targeting the corresponding "Achilles Heel" site on a virus, an expected conserved immutable and neutralizable site was identified.
Consequently, Dr. Chandra worked with Denver Scientific's genetics molecular biology data science team to screen more than 50,512 Coronavirus and 87,336 HIV isolates, the largest known repository of HIV and Covid- 19 isolates in the world. From this very complex and extensive A.I. analysis, conserved sites immutable on HIV and Covid-19 were identified. Through this search, the earlier identified correlative structure to the neutralizable site on HIV was confirmed as also conserved and expectedly neutralizable. Additionally, another seven conserved sequences have also been identified using A.I. technology, while in another breakthrough, 19 conserved sequences over the entirety of the 50,512 Coronavirus isolates analyzed have been identified. These immutable sites on the SARS-CoV-2 virus have also been confirmed as existing (100%) in the U.S. SARS-CoV-2 virus variants that have surfaced in United Kingdom, Brazil, and South Africa.
As a trifecta, Intel technology, P4 Medicine, and the efforts of Enzolytics require effective public policy - policies that will fuel this trifecta as a promising thought leadership experiment - a necessary journey of experimentation as humanity bravely marches towards cures for society's most deadly diseases and a more Empathetic A.I. Cultivating a technology-neutral public policy and a regulatory government-investment environment are paramount to this end. The consensus is for five primary policy drivers to cultivate trust, empathy, and velocity that will assist in realizing the potential described in the White Paper. The five policy drivers are to:
1.perpetuate public-private partnerships
2.foster secure federated machine learning
3.implement standards and frameworks to address structured and unstructured data challenges
4.ethically liberate datasets for evolving regulatory environments
5.minimize bias to optimize empathetic A.I.
The conclusion described in the White Paper is that Enzolytics Inc's use of Artificial Intelligence underscores a novel approach in assessing millions of virus sequences to identify the conserved segments essential for virus survival. Through effective public and private sector symbiosis and the fostering of a technology-neutral regulatory environment, the genuine power of A.I., coupled with advanced techniques in proprietary technologies illustrated in the Enzolytics immunotherapeutics, will no doubt create universal, durable, and broadly effective treatment targeting all virus variants.
Charles Cotropia, the CEO, said: "We are honored and privileged to work with the preeminent international corporation Intel in a collaborative manner focused on the optimum way to advance healthcare using science and technology together. Combining science with technology will guarantee success."
I.R. contact
TEN Associates, LLC
Tom Nelson, CEO
[phone]Investor Relations Contact
Company Contact
Enzolytics, Inc.
2000 North Central Expressway
Plano, TX 75074
And
Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-44
SOURCE: Enzolytics, Inc.
ENZOLYTICS, INC. ANNOUNCES THE GRANT OF A DISTRIBUTORSHIP LICENSE FOR THE RIGHT TO DISTRIBUTE ITS ANTI-HIV-1 THERAPEUTIC ITV-1 AND A STOCK AGREEMENT VALUED IN TOTAL AT $7 MILLION US DOLLARS
College Station, TX, May 12, 2021/PRNewswire/ Enzolytics, Inc. (OTC Markets “ENZC” or the “Company”) today announced it had granted a distributorship license to a European pharma entity (the Licensing Entity) for the right to distribute the Company’s anti-HIV-1 therapeutic ITV-1 in the countries of India, Pakistan, UAE, Indonesia, Philippines, Nigeria, Benin and Togo, Kenya, Tanzania, Rwanda, Libya, Uganda, North Sudan, Egypt, Morocco, and Tunisia (the Licensed Territory). The Licensing Entity is the owner of a pharmaceutical plant in Eastern Europe. Pursuant to the Agreement, Enzolytics will receive $1 Million USD and 50% ownership in the Licensing Entity valued at $8 Million. The License is granted with a commitment by the Licensee to sell and distribute the ITV-1 therapeutic in the Licensed Territory.
In addition, the Licensing Entity will invest $2 Million USD in the Company in exchange for Company Preferred Series E stock bring to the Company $3 Million in cash plus a 50% ownership in the Licensing Entity. This agreement will result in establishing a committed partner for the sale and distribution of the Company’s ITV-1 therapeutic in the Licensed Territory as well as 50% ownership in Licensee and its profit derived from sales in the Licensed Territory.
Charles Cotropia, the CEO, stated, “This is yet another milestone in our Company’s progress toward producing revenue from our technology and the therapeutics produced from it. We gratefully acknowledge Harry Zhabilov’s years of commitment to the Company that is making possible the partnerships and agreements now being finalized. As a result of his efforts, we have another European transaction which we expect to consummate and report in the coming week. Just as important as the investments being made into the Company are the partners and licensees being engaged – all individuals who have strategic contacts within the countries in which they will be distributing our therapeutics. These strategic contacts and their familiarity with geographic areas being served is as significant as any aspect of the arrangements we are completing.”
“For many years, we have been developing and strengthening the relationships that are now leading to our current significant partnerships. With the advances, the Company is making toward preparation for and completion of clinical trials in Europe, which will lead to approval from the EMA, we are meeting our goal of bringing our technology to those in need”, said Harry Zhabilov, CSO.
About Enzolytics, Inc.
Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins for the treatment of debilitating infectious diseases.
Enzolytics' flagship compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in the treatment of 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.
About BioClonetics Immunotherapeutics, Inc.
BioClonetics Immunotherapeutics, Inc., a wholly-owned subsidiary of Enzolytics, is a Dallas and College Station, Texas biotech company with proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for producing fully human monoclonal antibodies is currently employed to produce monoclonal antibody therapeutics for other infectious diseases, including the Coronavirus (SARS-CoV-2).
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 US 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 Enzolytics to establish the efficacy of ITV-1 in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of ITV-1 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 and involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and 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, and the Company expressly disclaims any intention or obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements.
IR contact
TEN Associates, LLC
Tom Nelson, CEO
[phone]
Investor Relations Contact
Company Contact
Enzolytics, Inc.
2000 North Central Expressway
Plano, TX 75074
and
Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-44
SOURCE: Enzolytics, Inc.
PRESENTATION OF TECHNOLOGY ON THE EMERGING GROWTH CONFERENCE
Enzolytics was recently invited to present at The Emerging Growth Conference (https://emerginggrowth.com/conference/), where we discussed our technology. Those presentations may be viewed here on YouTube: https://youtu.be/LD9qeDdiRvY.
ENZOLYTICS REPORTS PROGRESS ON ITS MULTIPLE THERAPEUTICS PLATFORMS AND INITIATIVES
News Release April 19, 2021
We continue to make great strides in applying our multiple platforms for the production of therapeutics for treating infectious diseases. Our future success will follow as we meet our goals to bring these therapeutics to market with new developments made possible by our extensive platform for producing new and effective therapies.
We acknowledge our partners Genscript (https://www.genscript.com), STC Biologics (https://stcbiologics.com), and California National Primate Research Center (University of Southern California) for their continued support in our research and development efforts. We are also grateful for the overwhelming support from world-renowned scientists and continue to expand our team of advisors to build a strong company based on research and development.
We are encouraged by the positive feedback received from pharmaceutical companies who have acknowledged an interest in partnering upon the achievement of defined milestones. The milestones we have set include the following:
Monoclonal Antibodies for Treatment of HIV Milestones
1st Milestone: Testing of anti-HIV Monoclonal Antibodies at University of Montana
Status: in process. Time to completion: 1 month
2nd Milestone: Broad-based neutralization testing of existing anti-HIV Monoclonal Antibodies at University of Strasbourg, France
Status; in process. Time to completion: 2 months
3rd Milestone: Animal Studies of anti-HIV Monoclonal Antibodies at California National Primate Research Center, University of Southern California
Time to completion: 6 months following in vitro testing in process.
4th Milestone: Using Artificial Intelligence, identification of conserved immutable target sites (epitopes) on the HIV-1 virus
Status: Completed
5th Milestone: Production of additional Monoclonal Antibodies targeting identified sites (epitopes) on the HIV
Status: in process. Time to completion: 5-6 months
COVID-19
We are proud of the significant advances we have made in the development of Monoclonal Antibodies for treating Covid-19. We have reported that the Monoclonal Antibodies being produced by the Company will target immutable, conserved sites on SARS-CoV-2 (Coronavirus) that exist on the variant strains of the virus from the UK, Brazil, and South African.
These findings are considered highly significant in that the Center for Disease Control ("CDC") has reported these "variants of concern" are ones "for which there is evidence of an increase in transmissibility, more severe disease (meaning increased hospitalizations or deaths), a significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures."
Our AI platform developed in collaboration with Denver Scientific has been one of our many successes. The patentable discoveries will be significant in our ongoing partnering dialogue with pharmaceutical companies interested in treatments for the Coronavirus and numerous other infectious diseases.
We are intent to expedite our development of anti-Coronavirus Monoclonal Antibodies, including an eventual fast-track clinical trial to progress to market.
SARS-CoV-2 (Coronavirus) Monoclonal Antibodies Milestones
1st Milestone: Using Artificial Intelligence, identification of conserved, immutable target sites (epitopes) on the Coronavirus
Status: Completed
2nd Milestone: Production of Monoclonal Antibodies targeting identified sites (epitopes) on the SARS-CoV-2 virus
Status: In process. Time to completion: 3-4 months
3rd Milestone: Fast-Track Clinical Studies
Time to Completion: 6 months following the production of Monoclonal Antibodies
ITV-1 anti-HIV Therapeutics
Clinical trials are planned for the Company’s patented anti-HIV therapeutics ITV-1. Earlier this year, we announced the execution of Articles of Association to form International Medical Partners ("IMPL"), a Bulgarian Limited Liability Company of which the Company is 50% owner. The Company's partners in IMBL will fund the total cost of the Clinical trials under the European Medicine Agency (the "EMA") standards, and the application cost for the EMA permit for the Company's ITV-1 patented therapeutics for treating HIV. Under the Mutual Recognition Agreement (the "MRA") between the EMA and the United States Federal Drug Administration (the "FDA"), the Company believes that issuance of the EMA permit for the ITV-1 compound could qualify ENZC's treatment for recognition by the FDA. IMBL has entered negotiations to engage a CRO to begin the clinical trials required under EMA standards.
We will have a definitive timeline for the expected date of initiation and completion of clinical trials of ITV-1 in the coming weeks.
Production of Monoclonal Antibodies for HTLV-1/2
We are committed to developing universal, durable, and broadly neutralizing Monoclonal Antibodies for many infectious diseases. We have entered into an "intent to partner" agreement with a pharmaceutical company to create Monoclonal Antibodies against HTLV-1/2. We expect to complete the production by the end of 2021.
Monoclonal Antibodies for HTLV-1/2 Milestones
1st Milestone: Using Artificial Intelligence, identification of conserved immutable target sites (epitopes) on the HTLV1/2 virus
Status: in process. Time to Completion: 2-3 months
2nd Milestone: Creation of anti-HTLV1/2 Monoclonal Antibodies
Time to completion: 6-8 months following identification of target epitopes
CEO Charles Cotropia said, “The strength of our Company lies in our multiple technology platforms and the ability to produce fully human Monoclonal Antibodies against conserved and immutable targets on identified viruses. The viruses that may be addressed using our technology range from HIV to the Coronavirus to HTLV-1/2 to Ebola and many more. These numerous targeted viruses and bacteria are listed on our website [https://enzolytics.com/proprietary-therapeutics/]. We will continue to provide updates on our developments and progress toward completing the milestones we have set. We thank all our shareholders for their ongoing support of our Company and its technologies.”
CORONAVIRUS TARGETED EPITOPES CLAIMED IN ENZOLYTICS’ PENDING PATENT APPLICATIONS ARE VERIFIED AS FULLY CONSERVED IN THE UK, BRAZIL, AND SOUTH AFRICAN VARIANTS OF THE CORONAVIRUS (SARS-COV-2).
College Station, TX, April 5, 2021/PRNewswire/ Enzolytics, Inc. (OTC Markets "ENZC" or the "Company").
In a significant development, recent findings have revealed that the monoclonal antibodies being produced by the Company against targeted sites on the Coronavirus are directed against epitopes that exist conservatively on each of the variant strains of the virus from the UK, Brazil, and South African.
These findings are considered by the Company as highly significant in that the Center for Disease Control (the "CDC") recently reported this Coronavirus as "variants of concern," defining them as ones "for which there is evidence of an increase in transmissibility, more severe disease (meaning increased hospitalizations or deaths), a significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures."
These Coronavirus variants are largely responsible for the recent increase in COVID-19 cases across the U.S., with the UK variant (B.1.1.7) accounting for 26 percent of all infections in the U.S. This variant, which is between 50 and 70 percent more transmissible, is the predominant strain in at least five regions of the country, according to Rochelle Walensky, MD, CDC director. Mutations in viruses are common, but most are insignificant and do not cause any change in the viruses’ ability to transmit or cause serious infection. But some mutations, like the ones in the UK or South Africa variant lineages, make the virus more infectious and, in some cases, even deadlier.
Significantly, Federal officials have halted the distribution of Eli Lilly's bamlanivimab monoclonal antibody treatment in three states (California, Arizona, and Nevada) due to concerns about a homegrown COVID-19 variant that renders it ineffective. There are reports of the "double mutant" COVID-19 variant discovered in India and the United States. "Such [double] mutations confer immune escape and increased infectivity."
The Company’s targeted approach is to produce fully human monoclonal antibodies against the identified conserved epitopes on the Coronavirus. Using computer analysis (Artificial Intelligence [AI]), the Company has identified 19 conserved sequences 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. Significantly, these conserved sequences have been identified in the UK, Brazil, and South African variants.
This discovery is significant in Enzolytics’ continued commitment to producing therapeutics for the treatment of COVID-19. Specifically, Enzolytics creates human heterohybridoma cell lines using convalescent human patients' peripheral "immune" human B cells to create fully human monoclonal antibodies directed individually against the identified conserved sites on the virus S1 protein and S2 (transmembrane) protein on the Coronavirus. These monoclonal antibodies will expectedly have a universal effect (on all known variants) and durable. As the virus mutates, the targeted site will still exist in the virus, subjecting it to neutralization. Such therapeutics would have universal (worldwide application), be durable (have successful long-term benefit), and thereby prevent failure of successful vaccines and/or provide effective treatment, which are both points of failures that have occurred as a result of “mutational virus escape.”
This capability is highly significant in that experts, such as Dr. Paul Offit, MD, Director of the Vaccine Education Center at Children's Hospital in Philadelphia, have stated that even though successful vaccines have been developed and deployed, we can expect the Coronavirus to be with us going into the future, with a resurgence year to year. Thus, therapeutics to treat the virus will be necessary for the future. Additionally, the Company’s monoclonal antibodies may be used in conjunction with other pharma antibodies, such as Eli Lily’s bamlanivimab monoclonal antibody in combination therapy.
The Company’s pending patents claim the identified target sites and include patent claims to the CDR sequences of the produced antibodies. Such patent claim structure will expectedly provide the Company the exclusive rights to therapeutics based on these findings for 20 years from the date of filing. International patent coverage is also being sought.
CEO Charles Cotropia said, “The discoveries made by our AI team, and implemented by our research team, are extremely significant. The creation of monoclonal antibodies that target the Achilles’ heels of the Coronavirus, which will be present even in mutated strains worldwide, means that a therapeutic may be produced that will affect the world for the expected continuous lifecycle of the Coronavirus. These findings have their origin in the critical analysis performed by our AI team, which has used sophisticated computer analysis and years of AI experience to curate the amino acid sequences (which are in the tens of thousands) of each of the over 50,000 Coronavirus isolates now known. Our AI team has identified the “golden needles” in an enormous haystack of data from this analysis. This is a remarkable achievement.
Recently, we have become aware of commentators on our technology who, rather than fairly and validly analyzing our technology and our findings, instead propound, for what we perceive as some self-serving reasons, erroneous and irrelevant assertions to mislead those interested in knowing the fundamental truth about our discoveries. For example, one “red flag” raised by one commentator has been to criticize our AI team - not based on the technology and substance of its findings - but by focusing on the date of incorporation of the partner. The date an entity is incorporated is irrelevant when those on the research team have decades of experience with the knowledge, skill, and capability to analyze the amino acid sequences (containing thousands in number) of each of over 50,000 different Coronavirus isolates. From this sophisticated analysis and resulting findings, the Achilles’ heels of the Coronavirus are revealed, namely, those epitopes that must be and that can be targeted by monoclonal antibodies to treat the virus not only today effectively but into the future. We question the motive behind these grossly misdirected comments, made for what we perceived as self-serving reasons, and not to provide an honest, fair, and truthful dialogue about a most serious medical crisis. While we perceive such irrelevant and misleading comments as intending to divert attention from the problem at hand and the solutions that are possible, we stand resolved to focus on the science and applying our capabilities to achieve success for all who will confront this virus – a virus that has and will do societal damage around the world, not only today but in the future”.
About Enzolytics, Inc.
Enzolytics, Inc. is a drug development company committed to commercializing its proprietary proteins for the treatment of debilitating infectious diseases.
Enzolytics' flagship compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in the treatment of HIV/AIDS. IPF is the active drug substance of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has been shown to modulate the immune system.
About BioClonetics Immunotherapeutics, Inc.
BioClonetics Immunotherapeutics, Inc., a wholly-owned subsidiary of Enzolytics, is a Dallas and College Station, Texas biotech company with proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for producing fully human monoclonal antibodies may be used to produce therapeutics treatments for many infectious diseases, including the Coronavirus.
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 US 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 Enzolytics to establish the efficacy of ITV-1 in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of ITV-1 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.
IR Contact:
Enzolytics, Inc.
2000 North Central Expressway
Plano, TX 75074
and
Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-4478
SOURCE: Enzolytics, Inc.
Enzolytics Technologies Targeting HIV and the CoronaVirus
This interview of the Company’s CEO, Charles Cotropia, was conducted by and published in CEOCFO Magazine.
CEOCFO: Mr. Cotropia, what is the concept behind Enzolytics, Inc?
Mr. Cotropia:
Enzolytics, Inc. is a drug development company with two separate but complementary therapy platforms for treating infectious diseases, including treatment for HIV. One technology, invented by Harry Zhabilov, the CSO of the Company, includes a patented antiviral peptide that has been tested in clinical studies at the National Center of Infectious and Parasitic Diseases in Bulgaria. In these trials, this therapeutic, known as ITV-1, demonstrated effectiveness in the treatment of HIV patients in various stages of the disease. In trials conducted in 31 patients, the therapeutic showed efficacy; specifically, in 68% of those individuals tested, there was an increase in CD4 + T lymphocytes. This increase was accompanied by an increase in the CD4/CD8 index and CD4% in over 50% of those tested. The increase in these parameters demonstrated statistical significance compared to the control group. The absolute number and the relative percent of CD8 + T lymphocytes decreased. And the viral load in 80.5% of those tested was below the threshold of detection.
This Enzolytics anti-HIV treatment is now being advanced through the certification stage to thereafter be made available for patient therapy.
The Company is now combining this technology with recently acquired technology, created by BioClonetics Immunotherapeutics, for creating fully human anti-monoclonal antibodies for treating HIV. Using this technology, the Company has produced a fully human anti-monoclonal antibody that has been tested in 5 international labs where it neutralized over 95% of all strains of the HIV virus against which it was tested. Additional neutralizing antibodies are being produced.
The therapies of Enzolytics’ two technologies, that produced by Enzolytics and that created by BioClonetics, are expected to be synergistic. Additionally, because the HIV virus and the CoronaVirus have correlative structures and with our knowledge of how our monoclonal antibodies neutralize HIV, we are now developing monoclonal antibodies for treating the CoronaVirus.
CEOCFO: Isn’t HIV pretty well taken care of now?
Mr. Cotropia:
That is the view, particularly in the U.S., but it is a misconception. There are over 36 million people in the world infected with HIV. There are more than 2 million new infections every year, and over one million people die from the virus annually. Ten percent of the HIV deaths are children – amounting to over 300 child deaths per day. The number of children who die from HIV is greater than those that die from cancer.
The reason there is the belief that HIV is no longer a problem is that there is now, and has been for years, a treatment but no cure. The treatment is through administering antiretrovirals, a treatment that must be taken daily and for life. There is no effective anti-HIV monoclonal antibody on the market for treating HIV, and that is the focus of the therapies developed by Enzolytics. In recent months, the entire world has now come to know “monoclonal antibodies.” This is what was used in a treatment provided to President Trump for the CoronaVirus and is now being developed by several companies. In contrast, the current (and for decades) treatment for HIV has been antiretrovirals, which do not cure HIV patients but rather just keep the virus at bay. Monoclonal antibody therapy offers the promise of total viral neutralization and, as a result, an effective cure in place of the present antiretroviral therapy, which requires lifelong treatments.
There are several downsides to the use of antiretrovirals. Because antiretroviral drugs are chemotherapy and not a humoral immunobiological therapeutic such as monoclonal antibodies, long-term side effects of the chemotherapy can result – including kidney problems, involving kidney failure, liver damage (hepatotoxicity), heart disease, osteoporosis, heart disease, diabetes, or insulin resistance, an increase in fat levels in the blood (hyperlipidemia), and changes in how the body uses and stores fat (lipodystrophy).
Moreover, the antiretroviral treatment is only accessible to 40% of the over 36 million people infected in the world – leaving 60% of the 36 million infected HIV patients with no treatment.
Thus, these issues can be resolved by the implementation of a better HIV treatment, using immunotherapy with the administration of our technologies, including broadly neutralizing monoclonal antibodies.
CEOCFO: I think to a lot of people, it seems the crisis is over.
Mr. Cotropia:
Your observation is exactly right! The perception is that the HIV crisis is over, but it is a misconception. The extent of the world crisis can be appreciated by the facts I just mentioned; namely, there are over 36 million people in the world infected, and only 40% of those have access to the antiretroviral therapy now used to treat HIV. There are over two million new infections per year, and more than one million people die from the virus annually.
The current antiretroviral therapy is not a cure, and as mentioned earlier, the side effects of lifelong use are significant. Also, the yearly average costs of treatment on antiretrovirals are $14,000 to $20,000 per year, and the average lifetime cost is calculated as $379,000. The cost of an anti-HIV therapy we are proposing would be a fraction of this cost since the treatment would be for a limited time and would not require life-long use.
Just as monoclonal antibodies were made available to successfully treat President Trump when he contracted the CoronaVirus, monoclonal antibodies can be made available to treat HIV patients, and we believe we are on the verge of providing and validating specific therapies in order to safely and successfully treat HIV.
CEOCFO: From your recent press release, you have a proprietary methodology for producing fully human OGG1 monoclonal antibodies. How is your approach different?
Mr. Cotropia:
There are a number of different ways of producing monoclonal antibodies. The procedure is significant, and our procedure differs from those used by other pharma companies.
In some cases, other pharma companies produce “humanized” rat and mouse monoclonal antibodies where the original antibody affinity and specificity are not maintained, and the chances of immunogenicity are increased. Our methodology also differs significantly from other pharma approaches using the transgenic mouse model, which is a human immune system that has been “grafted” within a mouse model having been "vaccinated" with specific and selected purified virus proteins.
In contrast, our method starts with human "immune-B cells," obtained from convalescent individuals who have recovered from the target virus. The primary distinction of our process for creating fully human monoclonals is the starting point – namely, from human “immune-B cells” obtained from humans who have survived successfully from a "natural" infection. From these human “immune-B cells,” we then produce antibodies that target conserved immutable sites (neutralizable epitopes) on the virus’ surface envelope proteins – which will thereby avoid “virus escape,” which has been frequently demonstrated to occur as a consequence of mutations in the HIV virus surface structure.
Additionally, our antibodies retain the original natural antibody affinity and specificity and have a lower risk of immunogenicity when used as a therapeutic. They will provide broad-spectrum coverage against viral variants with increased potency, stability as a single-domain molecule, in what is called the camelid structure form, and, in the recombinant form, will have greater accessibility to the virus binding sites not accessible with a whole antibody. We believe that our method is one that produces an antibody that will be more effective with less risk of adverse reaction.
There is an infinite number of distinct anti-HIV and anti-CoronaVirus monoclonal antibodies that can exist – some disease neutralizing, some perhaps of no benefit, and some perhaps disease enhancing. Thus, specific antibodies that neutralize are necessary to provide effective therapy. Enzolytics’ method of producing effective monoclonal antibodies focuses on identifying immutable binding sites on the virus and then creating monoclonal antibodies that bind to such sites and neutralize the virus. In this way, the virus cannot mutate around the therapy. For example, the antibodies administered to President Trump to treat him for the CoronaVirus may target a site on the virus that will mutate. Thus, the same antibodies may not be effective for you or me later if the CoronaVirus has mutated, changed structure at this binding site. Our anti-HIV monoclonal antibody binds to a site on the HIV virus that is conserved in 98% of the more than 6000 strains of the HIV-1 viruses now known, sequenced, and archived in the Los Alamos National Laboratory HIV Database. The same will have to be achieved for successful anti-CoronaVirus monoclonal antibodies.
CEOCFO: What are you looking at regarding COVID?
Mr. Cotropia:
We have produced an HIV monoclonal antibody that had been successfully tested in five international labs where it neutralized 95% of all strains against which it was tested. There are 6000 different strains of the HIV virus now known. We know that our antibody is effective, and we know the target site on the virus resulting in neutralization of the HIV virus. For an antibody to be effective, it has to attack a neutralizable site on the virus that is always there, does not mutate from strain to strain. Knowing the binding site of our HIV monoclonal antibody and then examining the CoronaVirus amino acid sequence, a correlation in the structures has been identified by our CSO, Dr. Joseph Cotropia, between the CoronaVirus and the HIV virus. With knowledge of these homologous viral structures, monoclonal antibodies will be created that target the corresponding “Achilles Heel” site on the CoronaVirus, an expected conserved immutable and neutralizable site on the virus. Additionally, using artificial intelligence, we will examine the numerous different strains of the virus to identify other conserved sites and produce additional monoclonal antibodies targeting them. This is for the purpose of producing a “collection” or “cocktail” of antibodies for therapeutic use. We recognize that there are now known over 16,000 different variations or strains of the CoronaVirus, each slightly different due to mutation. A successful monoclonal antibody “cocktail” therapy must include multiple antibodies that specifically target several immutable sites and which results in neutralization.
For example, we all now know that President Trump received a combination of two Regeneron antibodies. Eli Lilly has also produced an anti-CoronaVirus antibody. However, what we do not know is whether those antibodies will be successful as the virus mutates. As I mentioned, there are now known 16,000 different variants to the CoronaVirus, and immutable sites must be targeted in order to be effective in the long run.
Also, as all experts in the field of monoclonal antibodies agree, including Dr. Anthony Fauci, head of the NIAID/NIH, to have an effective therapy, we must have multiple monoclonal antibodies that target various sites on the virus - and in fact, even President Trump was given a cocktail of two. Therefore, it is imperative to identify conserved neutralizing binding sites on the CoronaVirus and create multiple monoclonal antibodies that target these critical neutralizable and immutable structures. It is like finding a needle in a haystack and retrieving the needle; you must identify the immutable sites on the virus and then create and characterize fully human monoclonal antibodies that target those sites. The process described here will be our focus, and for a reason, that success has already been achieved with regard to the production of broadly neutralizing antibodies directed against the HIV virus, we expect success will likewise be achieved in the production of broadly neutralizing human monoclonal antibodies directed against the CoronaVirus.
CEOCFO: I realize your brother is the medical person behind the Company, but what led you to take on this role. You have been a practicing attorney for many years. Why this challenge now?
Mr. Cotropia:
Obviously, it is very rewarding to hope that we will produce something that will be so meaningful to so many people. Our initial focus has been on HIV, a still devastating disease that is very much still with us and certainly more so in other counties. That is because, in the U.S., the focus is on HIV; because most U.S. citizens who contract HIV can afford $20,000 a year, through insurance or otherwise, and be treated. Unfortunately, many of those who have taken antiretroviral for thirty years or less have to suffer side effects caused by the current therapy, so there are a great reward and a great challenge in the hope that we can produce something that is better. We see a better therapy and a therapy that can be produced inexpensively for all, and particularly for the 60% and the 36 million people who have no access to currently available antiretroviral therapy. In many countries, like the U.S., this situation no longer makes the headlines in the news. For us, we recognize the need for better therapy.
Now, we turn to the CoronaVirus, and that is something that is on the front page of the U.S. and world news. We definitely have taken note of that. How do you address it? The antibodies that are being produced by other pharma companies may very well have initial beneficial effects. However, a solution requires more than one antibody to be effective. If their antibody targets a site that mutates, and that is what has happened to every other monoclonal antibody produced by the NIH and big pharma in their attempts to treat HIV, it is ultimately not going to be effective. The virus will mutate around it. Therefore, what worked, perhaps, for President Trump, will not necessarily work for you or me in the future. Consequently, as the virus mutates over and over again—in order to be therapeutically successful—you have to target a site that is immutable.
We also note that even those who have been fully vaccinated against the Coronavirus have now contracted the virus. This means that going forward; there will be a continuing need for therapeutics that will treat those that contract the virus. Additionally, experts, such as Dr. Paul Offit, MD, Director of the Vaccine Education Center at Children's Hospital in Philadelphia, have stated that even though successful vaccines have been developed and deployed, we can expect the CoronaVirus to be with continuously into the future, with a resurgence year to year. Thus, therapeutics to treat the virus will be necessary for the future.
We do know that our identified initial target on the CoronaVirus is significantly different from the targets of the antibodies produced by Regeneron and Eli Lily. Thus, with a combination of our proposed broadly neutralizing anti-CoronaVirus antibodies, the administration of a “cocktail” of several antibodies could be expected to produce a more significant neutralizing effect.
If you look back to the history of HIV, the NIH, with Vaccine Research Center, and all the other companies that the NIH has supported, they all attempted for forty years to produce an effective anti-HIV monoclonal antibody and the ones that they produced, VRC01 and VRC02, to name just a few, failed in years-long testing because of what is called “virus escape.” Virus escape is a euphemism for the fact that the virus mutated around what they spent decades trying to produce. Hence, there is a challenge to develop a successful therapy. To answer your question more directly, it is the challenge, and more than that, it is the hope of having a successful therapeutic that drives us. Also, at Enzolytics, we also have a therapeutic which will, we expect, be synergistic with our monoclonal antibodies. It is a peptide that binds to the virus and provides a clinically tested therapeutic effect, which will be examined in combination with our monoclonal antibodies. Again, this combination hopefully will be synergistic and provide a therapeutic that will be highly effective.
CEOCFO: What is your funding position? Development and eventually commercialization are very expensive.
Mr. Cotropia:
Yes, that is a very relevant question. We will be securing long-term financing for advancing our technology. We have begun the process of producing variants of our existing anti-HIV monoclonal antibodies and identifying the target site on the CoronaVirus for producing multiple antibodies against that virus. We have extended our lab capabilities on the Texas A&M University campus at its Institute for Pre-clinical Studies, where we will be producing both additional monoclonal antibodies against HIV and the against the CoronaVirus. For HIV, we will be combining the anti-HIV neutralizing antibodies with the anti-HIV peptide—which is also immunomodulating—that has been previously clinically tested by Enzolytics to have a beneficial effect in HIV patients. The funding we arrange will take us through that development which will include animal trials to be followed by human clinical trials of these therapeutics.
Success in these steps will bring the necessary funding for success. Demonstrating positive results will translate into the necessary funding due to the dire need for these therapies. As I mentioned, there is not going to be one bullet that fends off either the HIV virus or the CoronaVirus. It will be necessary to have more than one. We welcome Eli Lilly and Regeneron in their initial antibody production, and that success is all to be rewarded and celebrated. However, as we have seen in the past with HIV, it is going to be very difficult to completely control the CoronaVirus and all of its mutated forms. Success will require multiple therapeutics, and we know that monoclonal antibodies will certainly be in the picture and in the front line of successful treatments.
Another important aspect of our technology is that identification of a neutralizable binding site on the virus can lead to the creation of a vaccine – one that would be of a different format from the current mRNA vaccines now being produced. Specifically, the vaccine would be based on the known broadly neutralizing antibody and the highly conserved binding site to produce an active immunization that would not comprise nor incorporate an immunization process using nucleic acid constructs. In this process, an active protective immunization would use the neutralizable binding site on the virus as a subunit peptide vaccine. The use of peptide sub-unit immunogens in active immunization obviates the concerns for weak humoral immune response, theoretical risks of insertional mutagenesis, and provocation of an autoimmune response; in other words, concerns associated with immune response outcomes that are related to DNA and mRNA vaccination.
Therefore, different vaccines may be produced in very different ways, some of which hopefully will be very effective and very safe as to their long-term effect on the human body. A safe vaccine can be expected based on a subunit peptide vaccine formulation using the neutralizable bind site on the virus in its development.
CEOCFO: There are so many new ideas, especially around COVID. Why does Enzolytics’s approach stand out?
Mr. Cotropia:
We have a patented anti-HIV peptide, ITV-1, that has been tested in clinical studies. It is now being advanced through the next certification stage in preparation for patient application.
As a complementary treatment for HIV, we have created monoclonal antibodies for treating HIV. These antibodies can accurately be identified as being “fully human,” broadly neutralizing monoclonal antibodies in that the starting point is from human “immune-B cells,” providing the basis for the production of the antibodies. Antibodies created in this way retain the original natural antibody affinity and specificity and have a lower risk of immunogenicity when used as a therapeutic. They will provide broad-spectrum coverage against viral variants with increased potency and stability as a single-domain camelid molecule. Our technology then further stands out in that we are able to identify conserved, immutable sites on the targeted virus, and we have the ability to specifically create monoclonal antibodies that target these identified sites. The whole process is, in our view, a perfect approach to producing therapeutics that are safe and effective and that address and overcome the effect of virus mutation - all the while being able to be produced inexpensively, so they may be provided throughout the world.