TODAY’S KEYNOTE ADDRESS AT THE AIDS 2018 CONFERENCE HIGHLIGHTS THE SIGNIFICANCE OF OUR MONOCLONAL ANTIBODY TO A CURE FOR HIV
Welcome to all of our new investors.
In his keynote address today to the 18,000 attendants from 180 countries at the AIDS 2018 International Conference, Dr. Anthony Fauci emphasized our long held view that long-lasting control of HIV infection without antiretroviral therapy (ART) is a feasible goal and that one primary approach to such a therapy can be expected to be found in the use of broadly neutralizing HIV antibodies (bNAbs).
Of course, we have preached this for years and our findings, in conjunction with previous tests explains why.
Dr. Fauci is head of the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). His lecture today was titled, “Durable Control of HIV Infection in the Absence of Antiretroviral Therapy: Opportunities and Challenges.” In his presentation, Dr. Fauci recognized that one promising approach to what would be an effective cure of HIV is:
- Use of broadly neutralizing HIV antibodies (bNAbs) that can stop nearly all strains of HIV from infecting the human cells providing a continual interventions for long-lasting, retroviral-free remission.
- He recognized that a combination of two or three broadly neutralizing HIV antibodies may provide the answer, in a manner akin to combination antiretroviral therapy.
How does Dr. Fauci’s words apply to our technology?
Our Clone 3 monoclonal antibody is broadly neutralizing.
This means that the site on the HIV virus to which our Clone 3 antibody binds is highly conserved, namely this particular virus structure exits in virtually all strains of the HIV virus.
Specifically, an analysis of the amino-acid surface composition of the 4,556 clinical HIV viral isolates (strains) recorded in the U.S. Government’s National Laboratory HIV Database (which maps the amino-acid topography of the clinical HIV viral isolates) reveals that 3,510 HIV clinical viral isolates (strains) have an exact match for the minimal essential “core” epitope (KLIC) to which our Clone 3 antibody binds. Another 956 of the clinical HIV isolates have a conservative match to Clone 3 epitope to which Clone 3 would bind.
Thus, 4,466 (3,510 + 956) clinical HIV isolates (98% of the total known) have an amino-acid sequence (epitope) that would be bound by our Clone 3 antibody, leaving only 2% of HIV isolates that do not have an identical or conserved epitope that is capable of being bound by our Clone 3 antibody. This is the definition of a broadly neutralizing monoclonal antibody. For more specifics, see http://www.bioclonetics.com/effectiveness.html.
Thus, the Company's Clone 3 therapy can be expected to be effective against 98% of all HIV isolates found around the world and is clearly a broadly neutralizing monoclonal antibody.
Why is it important that a neutralizing antibody be broadly neutralizing?
If an anti-HIV antibody does not have broad effect, it means that the antibody is targeting a portion of the virus that will mutate and while it might be effective initially, the virus “mutates around the antibody”. This is called “virus escape” – a euphemism used by big pharma to report (without clearly admitting) that their antibody will not work in the real world.
Has there ever been a big pharm who has spent millions of dollars on an antibody that faced “virus escape”?
Yes, several. One example is the antibody VRC01 produced and tested by Vaccine Research Center in conjunction with the National Institute of Health (NIH). In their studies of use of the anti-HIV antibody VRC01, it was found that patients treated experienced viral rebound (virus escape) shortly after suspension of the administration. https://www.nejm.org/doi/full/10.1056/NEJMoa1608243. Thus, there is a need for a broadly neutralizing antibodies having the potential for a therapeutic cure without allowing “virus escape”.
Because our monoclonal antibody targets a portion of the virus that does not change, mutations of the virus will still contain the core KLIC epitope to which our antibody binds. Significant testing demonstrates the basis for this expectation. Specifically, in in vitro tests conducted in five independent laboratories, CLONE 3 has been tested against 43 clinical HIV isolates (strains) of the virus. CLONE 3 demonstrated that it successfully neutralizes 41 of them – thus neutralizing 95% of those against which it was tested.
These results were the product of testing in the following 5 independent laboratories:
1. University of California, San Francisco, CA, USA (Jay Levy, M.D.)
2. University of South Florida, Tampa, FL, USA (Kenneth Ugen, Ph.D.)
3. Polymun Scientific, GmbH, Vienna, AUSTRIA, (Hermann Katinger, Ph.D.)
4. Duke University, Durham, NC, USA (David Montefiori, Ph.D.)
5. Dana Farber Cancer Institute (DFCI), Harvard
Medical School, Boston, MA, USA, (Ruth Ruprecht, M.D., Ph.D.)
As recently reported, we have created recombinants of the parent antibody, a form required by the FDA for use in clinical trials and patient therapy. These recombinants have demonstrated much stronger binding to HIV gp41, indicating that their neutralization capability is expected to be more potent than the parent antibody.
We are awaiting testing of the recombinants in the PBMC-based neutralization assay tests. These tests involve use of live HIV isolates and thus the tests require significant preparation and lead time. This testing will be conducted by Texas Biomedical Research Institute (https://www.txbiomed.org/), San Antonio, Texas.
A Second Therapy is Also Now Being Created.
From our technology, we have also just initiated a separate and highly complementary therapeutic approach to treating HIV.
The first recombinant antibody form (call the IgG antibody structure) is our product #1. This IgG antibody form of our antibody protects against HIV replication within the human blood circulatory system. In other words, this form of the antibody (the IgG antibody structure) prevents the virus from replicating in the human body – a step critical to providing an HIV cure.
As a second and complimentary therapy, we are also creating another functional antibody category called "IgA antibody” that can be used against HIV – a product #2. This IgA antibody is expected to be completed in the next few weeks and will also be tested against a fully panel of HIV isolates. IgA antibodies protect against HIV infections that occur at mucosal surfaces, specifically, for example, vaginal, anal and oral mucosal surfaces of the human body. HIV exposure at the mucosal surfaces accounts for the majority of HIV infections which occur upon initial contact with the HIV virus.
This therapy will expectedly provide a protective immunological defense against initial exposure to HIV virus at mucosal surfaces, such as occurs in the passage of the virus from mother to child through maternal breast feeding or other body to body contact.
We will report these results as soon as they are available.