OUR PROGRESS CONTINUES

To all of our new and current investors, we thank you for your continued support.

Our funding campaign is set to end in 60 days and we plan to conclude our fundraising effort at that time. We ask that you share our technology and story with friends and acquaintances as I am sure they will have the same interest in our program as you. Everything described here is made possible by the support of investors like you and the support of those you know.

Let me update you on the several programs we have ongoing:

Our monoclonal anti-HIV antibody development.

As we have reported, our parent anti-HIV monoclonal antibody has been tested against multiple HIV viral isolates (strains of the virus) and has been shown to neutralize these virus strains. These results can be viewed on our website at - http://www.bioclonetics.com/validation.html.

We have produced recombinants of this parent antibody (necessary for animal and clinical trials) and are in the process of testing these recombinants against multiple isolates (strains) of the virus. These recombinants are being scheduled for testing at the Texas BioMedical Research Institute (https://www.txbiomed.org/) in San Antonio, Texas. Thereafter, the antibodies will be tested in macaques at the Southwest National Primate Research Center, also in San Antonio, Texas (http://snprc.org/primates/macaques/). Our recombinants are also scheduled to be tested for efficacy at the University of Antwerp, Institute of Tropical Medicine (https://www.itg.be/), Antwerp, Belgium.

Why haven’t these tests been completed?

The required test method for confirming the efficacy of these recombinant forms of our antibody (to assure that they are as effective against HIV as the parent antibody) requires a very specialized test method (called the PBMC based assay test) conducted using live multiple HIV isolates (strains of the virus). As you can appreciate, this requires a very specialized lab and protocol using a process that takes several months to complete.  For this reason, we have engaged 2 labs to independently complete these necessary tests, one in Texas (https://www.txbiomed.org/) and one in Antwerp, Belgium (https://www.itg.be/). We have also requested another lab in Milan, Italy (also known for its expertise in conducting these tests) to provide a proposal for testing. These test results will be completed before the end of this year. We wish this could be completed sooner but this is the necessary timetable required.

A more rapid (and cheaper) test is used by some researchers – called the rapid fluorescent assay method [TZM-bl cells]. However, this procedure performs the test using pseudo viruses, not actual HIV viruses and is known to fail to provide a true reading as to efficacy. This fact of non-concordance between the TZM-bl rapid throughput test method and the test method we are using, called the PBMC-based in vitro neutralization test, is well documented dating back to 2008 (Polonis, et al., Virology 375, pp. 315–320 (2008)).

 Why many researchers would use a test known to not produce a valid result is hard to believe as there is no rational reason for using such a test if it produces an erroneous result. Could this be part of the reason why further meaningful progress has not been made over these many years?

Patenting our technology.

We have just filed a comprehensive additional patent on the technology for using our recombinant monoclonal antibodies to treat HIV. This application covers the precise multiple recombinant antibody configurations that have been created (and their equivalents). This additional application is being filed in the U.S. with foreign country applications to follow.

Complimentary therapy to our monoclonal antibody.

As a second and complimentary therapy, we have now created another functional antibody category called "IgA antibody” that can be used against HIV. 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.

Just this week, our lab completed production of this IgA antibody form and initial tests of its ability to bind to the gp 41 structure of the HIV virus have been positive. Our development of this additional technology is continuing.

An additional strategy is now also being pursued. 

Recall that combination therapy always offers a potential for a superior and more complete control of any infectious disease and few if any diseases are more difficult to control than the HIV virus. As an additional approach to controlling and eliminating the HIV virus from the human body, we are cooperating with a University research lab to use our antibody to deliver cell-killing drugs or radionuclides or toxins to the virus to eliminate persistent reservoirs of HIV infection. 

Let me explain this approach.

Our Clone 3 antibody, has been shown to neutralize (render incapable of replicating) the virus by itself. But, an additional strategy is to deliver further controlling drugs or radionuclides or toxins to the virus to provide additional effective control. In non-medical terms, the approach is to deliver a “hand grenade” to the virus to destroy it. To be effective, a delivery system must effectively deliver the “grenade” to the HIV virus – and deliver it to a site on the virus that is always present in all of the 5000+ various strains of the virus now known to exist.

This is what we know our antibody is capable of doing and why it is valuable. In this therapy, the control drug or radionuclides or toxins are attached to our antibody – which we know binds to the virus and which we know binds to the virus at a site that exists in virtually all of 5000+ strains of the virus now known.

In such an approach, it is critical to use an antibody that binds to the HIV virus at a site that will always be present – even as the HIV virus “mutates” (changes its amino acid structure). It is well known that the virus readily mutates but we also know that all the mutation variants of the virus continue to contain the “binding site” to which our antibody binds. You can see the invariant site to which our antibody binds as shown on our website at http://www.bioclonetics.com/effectiveness.html. Our antibody’s binding site exists in 98% of all 5000+ HIV virus strains now know.

This is just a further use of our technology for developing an effective control and neutralization of the virus. We are encouraged by this current effort.

We greatly appreciate your being a part of all of these efforts. Stay tuned for further updates and results.  Share our technology with those you know.

Best regards,

Charles Cotropia

BioClonetics

A FURTHER ADDITIONAL USE OF OUR MONOCLONAL ANTIBODY BEING TESTED

To all of our new and current investors, we thank you for your continued support and want to report an additional strategy making use of our technology to control and eliminate the HIV virus.

As we have reported, we have 2 strategies ongoing:

• Our parent antibody has been tested against multiple HIV viral isolates (strains of the virus) and has been shown to neutralize these virus strains. We have produced recombinants of this parent antibody (necessary for animal and clinical trials) and are in the process of testing the recombinants against multiple isolates (strains) of the virus.
• As a second and complimentary therapy, we are also creating another functional antibody category called "IgA antibody” that can be used against HIV. 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.

An additional 3rd strategy is now also being pursued. 

• Recall that combination therapy always offers a potential for a superior and more complete control any infectious disease and few if any are more difficult to control that the HIV virus. As an additional approach to controlling and eliminating the HIV virus from the human body, we are cooperating with a University research lab to use our antibody to deliver cell-killing drugs or radionuclides or toxins to the virus to eliminate persistent reservoirs of HIV infection. 

Let me explain this approach.

• Our Clone 3 antibody, can – we expect – neutralize (render incapable of replicating) the virus by itself. But, an additional strategy is to deliver further controlling drugs or radionuclides or toxins to the virus to provide additional effective control. In non-medical terms, the approach is to deliver a “hang grenade” to the virus to destroy it. To be effective, a delivery system must effectively deliver the “grenade” to the HIV virus – and delivery it to a site on the virus that is always present in all of the 5000+ various strains of the virus now know.
• This is what our antibody is capable of doing and why it is valuable. In this therapy, the control drug or radionuclides or toxins are attached to our antibody – which we know binds to the virus and which we know binds to the virus at a site that exists in virtually all of 5000+ strains of the virus now known.

In such an approach, it is critical to use an antibody that binds to the HIV virus at a site that will always be present – even as the HIV virus “mutates” (changes its amino acid structure). It is well known that the virus readily mutates but we also know that all the mutation variants of the virus continue to contain the “binding site” to which our antibody binds. You can see the invariant site to which our antibody binds as shown on our website at http://www.bioclonetics.com/effectiveness.html. Our antibody’s binding site exists in 98% of all 5000+ HIV virus strains now know.

This is just a further use of our technology for developing an effective control and neutralizing effect of the virus. We are encouraged by this current effort. We greatly appreciate your being a part of it.

Best regards,

Charles Cotropia

BioClonetics

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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.)

Current Update

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.

Best regards,

Charles Cotropia

CEO BioClonetics

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We are making great progress in validating our anti-HIV monoclonal antibody technology. We urge all of our followers and prospective investors to join us in the advancement of our technology. Your investment makes our ultimate success possible.

As we have reported, our parent monoclonal antibody has been previously tested in 5 international labs and shown to effectively neutralize multiple HIV isolates (strains of the virus) (http://www.bioclonetics.com/validation.html). We have prepared the required recombinant antibodies, required by the FDA for use in patient therapy, from the parent antibody and are in the process of testing these recombinants to demonstrate that they are equally as effectiveness as the parent antibody.

In the initial tests of our parent antibody, the antibody was tested by the 5 labs using the most strenuous and sophisticated test system – known as a PBMC-based neutralization assay test. In such test, an antibody is tested against live HIV viruses. The use of this test methodology is significant in that we are confident that it is far more reliable than other “rapid tests” methodologies (such as the TZM.bl assay test) that have been designed to provide quick results but results that do not have concordance with the more direct and sophisticated PBMC-based neutralization assay test. Such rapid tests can be conducted quickly and less expensively but because the test does not measure the effectiveness against real world HIV viral strains - but rather uses pseudo viruses – they do not represent the real world presented by actual HIV viral strains.

Others do use such tests – since they are less time consuming and less expensive – but it is clear that testing against a pseudo virus is not the same as testing against actual HIV viral isolates. And those using these lesser tests have not provided a successful therapy.

Identifying labs with the expertise and sophistication to conduct the more sophisticated PBMC-based neutralization tests is a challenge – in large part because of the extra complexity introduced by the necessity of using live HIV virus in conducting the tests. We have the benefit of the partnering with Texas Biomedical Research Institute who has expertise in conducting PBMC-based assay testing. Plans are now being made for using such methodology to tests the 6 recombinant antibodies we have produced.

Additionally, just this week, we have engaged a second West coast lab with the specialized capability of performing PBMC-based assay testing. We have engaged this lab to test our recombinant antibodies against 10 different HIV isolates (strains of the virus). These tests, combined with those expected from Teas BioMedical, will provide an accurate evaluation of how our antibody will function in actual clinical trials and patient therapy.

Your investment makes these tests possible.

A Second Therapy is Also Now Being Created.

Using our technology, we have also just initiated a separate and highly complementary therapeutic approach to treating HIV.

As we have described, from the parent antibody, a first recombinant antibody form (call the IgG antibody structure) has been created. And as just described, these recombinants are scheduled to be tested in PBMC-based assays against HIV isolates (strains of the virus) in 2 separate labs.

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.

But, there is another functional antibody category called "IgA antibody” that can be used against HIV. 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.

Procedures are now available for creating this IgA structure from our existing IgG structure (this is called a "class-switch"). We have today initiated the process for creating this IgA structure by "class switching". This process uses currently available biotechnological methodology – starting with our now known recombinant IgG antibody structure and producing the IgA structure – resulting in an additional protective structural class of antibodies. 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.

Our lab is now producing this second line of defense. Preparation of this IgA structure is in progress as you read this update.

Your investment makes this second line of defense possible.

We thank you for your support. It makes our progress possible.

Best regards,

Charles

Charles Cotropia

CEO BioClonetics

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To all New and Existing Investors and to our Followers,

We extend our sincere appreciation and welcome to all of our new investors. We have had many new investors join us recently and we thank each of you for your confidence in our technology.

Many have also indicated an intention to invest. If you have done so but have not finalized your investment, we ask that you do so while our campaign is still ongoing. If you are asked by Startengine to re-confirm your investment, please do so as your support makes our progress possible.

We have made great progress this week. Importantly, additional recombinant antibodies have been created and were yesterday delivered to our research partner the Texas BioMedical Research Institute (https://www.txbiomed.org/) in San Antonio, Texas, for testing. Texas BioMedical will test these recombinants against a full panel of HIV isolates (strains of the virus) to confirm their effectiveness in neutralizing the HIV virus. As you can appreciate, such testing can only be completed in a highly specialized laboratory and will take some time to complete.

For those that are new to our team, let me back up and give me a bit of background leading to where we are today. As our existing investors know, we have previously produced a fully human monoclonal anti-HIV antibody and have successfully tested this parent antibody in 5 separate international labs where it neutralized (at IC 90) 95% of primary HIV isolates - from HIV clades A, B, C, E and F - against which it was tested. These tests were conducted at University of California, San Francisco, CA, USA (Jay Levy, M.D.); University of South Florida, Tampa, FL, USA (Kenneth Ugen, Ph.D.); Polymun Scientific, GmbH, Vienna, AUSTRIA, (Hermann Katinger, Ph.D.); Duke University, Durham, NC, USA (David Montefiori, Ph.D.); Dana Farber Cancer Institute (DFCI), Harvard Medical School, Boston, MA, USA, (Ruth Ruprecht, M.D., Ph.D.). These results can be viewed on our website at - http://www.bioclonetics.com/validation.html.

We have now produced recombinant forms of the antibody – this is the form that is necessary for use in patient therapy and thus they must be tested before reaching clinical trials.

Six distinctive recombinants have been produced for testing.  These are each slight variants which will provide an increased likelihood of identifying the most effective therapeutic. Additionally, Texas BioMedical is associated with the animal trial facility at the Southwest National Primate Research Center, also in San Antonio, Texas (http://snprc.org/primates/macaques/) and animal trials using our recombinant antibodies will be conducted there.

We are also preparing additional patent applications covering the original created recombinants and newly created variant recombinants that have just been produced.

We are looking further into the future by having discussions with pharmaceutical companies (both in the U.S. and in foreign countries) who we expect to interest in partnering with us to take our technology into clinical trials.

Your support and investment has made all this possible and we extend our thanks to you for joining us in this journey. Although progress in this field does take time, we are aligning ourselves with those capable of reaching our goal of providing a successful therapy against HIV.

Thanks again for your support.

Best regards,

Charles

Charles Cotropia

CEO

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Update to all of our investors and followers,

We wholeheartedly welcome all of our new investors. Thank you for your investment and support. This report will bring you up-to-date.

Our crowdfunding efforts on www.startengine.com/bioclonetics will end in 24 days on July 2. We ask that any investor who have not finalizing his or her investment, please do so. Your support makes our progress possible. We also ask that you consider sharing our technology with friends and acquaintances. We believe they will have the same interest in our efforts as you do.

Within the last week, we have completed the production of 3 additional recombinants of our parent antibody which will now be tested for efficacy with the original 3 recently prepared recombinants.

As you will recall, our parent antibody has been successfully tested in 5 international laboratories where it demonstrated the ability to neutralize (at IC 90) 95% of primary HIV isolates - from HIV clades A, B, C, E and F - against which it was tested. These tests were conducted at University of California, San Francisco, CA, USA (Jay Levy, M.D.); University of South Florida, Tampa, FL, USA (Kenneth Ugen, Ph.D.); Polymun Scientific, GmbH, Vienna, AUSTRIA, (Hermann Katinger, Ph.D.); Duke University, Durham, NC, USA (David Montefiori, Ph.D.); Dana Farber Cancer Institute (DFCI), Harvard Medical School, Boston, MA, USA, (Ruth Ruprecht, M.D., Ph.D.). These results can be viewed on our website at - http://www.bioclonetics.com/validation.html.

Recombinants of the parent antibody are required by the FDA for use in clinical trials and then patient therapy.  We have previously produced 3 recombinants of the parent and now have produced 3 additional recombinants.  These new recombinants are slight variations of the previously completed recombinants. Each of the now 6 recombinants are scheduled for testing at the Texas Biomedical Research Institute (https://www.txbiomed.org/).

We are fortunate to have the assistance of this world-renowned Institute to complete the testing of these recombinants.

Why have we produced additional recombinants?

Let me use this analogy. Assume you are the CEO of The Coca-Cola company. Your technical staff suggest that the formula for the “original Coke” product can be improved. Indeed, your team sets out to produce “New Coke” and supply it to the market. You are aware that your original formula is a success - in fact, over the company’s 126-year existence, you have sold billions upon billions of Coke products. When “New Coke” is introduced, you find that there are benefits to both “New Coke” and to “Classic Coke”. The formulation is ever so slightly different but each has its strong points. Note that only you can produce “New Coke” as you have the secret formula unknown to your competitors.

In our case, we have the complete amino acid sequence that programs for our monoclonal antibody. The parent monoclonal is composed of a sequence of 1346 amino acids that program for the antibody. These amino acids can be visualized as a long string-like pearl necklace that make up the antibody. From this formulation of 1346 amino acids, “recombinants” can be produced (as are required by the FDA for patient therapy) and by changing any one of the 1346 amino acids, a new recombinant is formed.

We don’t know how The Coca Cola Company decided which ingredient to change to produce “New Coke”.  We do know where along the 1346 amino acid sequence of our antibody changes can improve efficacy. The Coca Cola Company probably knew the same.

Each of the 6 recombinants will now be tested.  We could end up with both a “Classic Coke” and “New Coke” for use in patient therapy.

Given that our crowdfunding effort will conclude on July 2, we ask that you consider finalizing your investment if you have not done so.  We also ask that you consider sharing our technology with friends and acquaintances. We believe they will have the same interest in our technology and our efforts as you have.

Best regards,

Charles

Charles Cotropia

CEO BioClonetics

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One of our followers posed the following insightful and significant question.  We believe the question and our answer will be of interest to all of our investors and followers:

Question: 

Can you address, with excruciating clarity, whether your work is focused on viral suppression (management) or an actual cure? As someone who is HIV+ and who has followed research in this field for years, we are constantly hearing of 'breakthroughs,' but almost every one is focused on suppression to undetectable levels (which of course, is wonderful!), but there seems to be a 'gap' when it comes to actually finding a CURE that will render an HIV positive person 100% cleared of the virus.

Answer:

First, there is an important and critical difference between the way antibodies work as compared to the way chemotherapy (antiretrovirals (ARVs) – the current treatment for HIV) works in the body. Both have a place but they significantly differ in the following way.

CHEMOTHERAPY (ANTIRETROVIRAL THERAPY) FOLLOWS THE FIRST ORDER PHARMACOKINETICS

Chemotherapy (antiretroviral therapy) follows First Order Pharmacokinetics meaning it offers at best a fractional kill of the viral burden leaving a percentage of the virus remaining after each cycle of antiretroviral therapy. If the chemotherapy provides a 90% kill, there will always be 10% of the virus remaining. Thus, even though therapy is repeated, there will always be a residual virus remaining - although diminishing, it will always be present. Moreover, if the virus mutates in a way to escape the effectiveness of the chemotherapy, the chemotherapy will never completely rid the body of the virus. Consider this example - assume you have deadly bacteria on your lab work bench (or for that matter on your kitchen floor) and you use a chemical that you know will be 90% effective against the bacteria. When you use it, you leave 10% of the bacteria alive and it reproduces to re-infect the area. No matter how many times you use the chemical, you always leave 10% alive and while you diminish the bacteria, it will always remain.

Thus, ARVs can never produce a zero-virus load in the body, since a fraction (e.g., 10%) of the virus burden remains as a result after each cycle of ARV treatment.

IMMUOTHERAPY (ANTIBODY THERAPY) FOLLOWS ZERO ORDER PHARMACOKINETICS

Monoclonal antibody therapy is immunotherapy, which operated under a different mechanism than antiretroviral therapy.  Specifically, immunotherapy follows Zero Order Pharmacokinetics – meaning that it can theoretically achieve a 100% neutralization of the virus. As a result, monoclonal antibody therapy can eradicate all (100%) of HIV present while ARVs only remove a fraction of the virus. Again, back to my analogy – assume your lab workbench contains deadly bacteria – if you can remove all of the bacteria (100%), then there are no remaining remnants to continue to infect the area.

In summary, monoclonal antibody therapy follows Zero Order Pharmacokinetics – meaning that it can theoretically neutralization 100% of the virus.  Antiretroviral therapy follows First Order Pharmacokinetics - meaning it achieves--at best--only a fractional log viral kill. Thus, ARVs do not offer the prospect of a cure.

This is not to say that the two therapies may not someday be used hand and glove – meaning chemotherapy could be used to reduce the viral load and immunotherapy (monoclonal antibodies) used to clean out the residual viral load.

Now, let’s look one step further.

Not every monoclonal antibody will be successful. Specifically, a monoclonal antibody that attacks the virus at a site on the virus that mutates will ultimately be evaded by the virus.  For example, the monoclonal antibody VRC01, produced by Vaccine Research Center, was found to delay but not prevent HIV rebound after antiretroviral treatment interruption. http://www.aidsmap.com/VRC01-antibody-delays-but-does-not-prevent-HIV-rebound-after-antiretroviral-treatment-interruption/page/3047632/.  Other attempts such as use of CRISPR/Cas9, have not been successful.  While this therapy suppresses the virus, the same process that inactivates the deadly virus may also enable it to escape the treatment. http://www.the-scientist.com/?articles.view/articleNo/45757/title/How-HIV-Can-Escape-an-Experimental-CRISPR-Therapy/.

Thus, for a monoclonal antibody therapy to have conclusive effect, it must target an immutable (non-varying) site on the virus – otherwise the virus “escapes” around it. Our antibody targets an immutable site on the virus (located on the part of the virus known as “gp 41”) and has been shown to fully neutralize the virus (all clades and groups) in in vitro tests conducted in 5 international labs (University of California, San Francisco, CA, USA (Jay Levy, M.D.); University of South Florida, Tampa, FL, USA (Kenneth Ugen, Ph.D.); Polymun Scientific, GmbH, Vienna, Austria, (Hermann Katinger, Ph.D.); Duke University, Durham, NC, USA (David Montefiori, Ph.D.) and Dana Farber Cancer Institute (DFCI), Harvard Medical School, Boston, MA, USA, (Ruth Ruprecht, M.D., Ph.D.).  (http://www.bioclonetics.com/validation.html) These tests also demonstrated that the antibody is effective against all clades and groups found around the world. http://www.bioclonetics.com/effectiveness.html. 

 We trust that this explanation provides some insight why we believe that application of monoclonal antibodies will be critical to successfully addressing the HIV pandemic.

To all New and Existing Investors,

We extend our sincere appreciation and welcome to all of our new investors. Your confidence in our technology is sincerely appreciated and fully recognized. Please share this updated information about our technology with your friends and acquaintances as their interest may be the same as yours.

We have made great progress this week. Importantly, we have completed the necessary formal agreements leading to the arrangement with the Texas BioMedical Research Institute (https://www.txbiomed.org/) in San Antonio, Texas, a world class institution, for the testing of the recombinant antibodies that have just been produced. Texas BioMedical will test our recombinants against a full panel of HIV isolates (strains of the virus) to confirm their effectiveness in neutralizing the HIV virus. As you can appreciate, such testing can only be completed in a highly specialized laboratory.

For those that are new to our team, let me back up and give me a bit of background leading to where we are today. As our existing investors know, we have previously produced a fully human monoclonal anti-HIV antibody and have successfully tested this parent antibody in 5 separate international labs where it neutralized (at IC 90) 95% of primary HIV isolates - from HIV clades A, B, C, E and F - against which it was tested. These tests were conducted at University of California, San Francisco, CA, USA (Jay Levy, M.D.); University of South Florida, Tampa, FL, USA (Kenneth Ugen, Ph.D.); Polymun Scientific, GmbH, Vienna, AUSTRIA, (Hermann Katinger, Ph.D.); Duke University, Durham, NC, USA (David Montefiori, Ph.D.); Dana Farber Cancer Institute (DFCI), Harvard Medical School, Boston, MA, USA, (Ruth Ruprecht, M.D., Ph.D.). These results can be viewed on our website at - http://www.bioclonetics.com/validation.html.

We have now produced recombinant forms of the antibody which are necessary for use in patient therapy.

This week, we completed agreements for testing these antibody recombinants against a full panel of HIV isolates to confirm that they have the same efficacy against the HIV virus as the parent antibody. These tests will be conducted at the Texas BioMedical Research Institute (https://www.txbiomed.org/) in San Antonio, Texas. A review of the credentials of Texas BioMedical will reveal the value of having our monoclonal antibodies tested at this renown institution. Additionally, Texas BioMedical is associated with the animal trial facility at the Southwest National Primate Research Center, also in San Antonio, Texas (http://snprc.org/primates/macaques/). After testing our recombinant antibodies against HIV isolates (strains of the virus), animal trials will then be available to us through this relationship.

We have also begun the preparation of additional patent applications covering the newly created recombinants and additional recombinants (variations of the parent antibody) that are also currently being produced.

We are looking further into the future by having discussions with pharmaceutical companies (both in the U.S. and in foreign countries) who we expect to interest in partnering with us to take our technology into clinical trials.

Your support and investment has made all this possible and we extend our thanks to you for joining us in this journey. Although progress in this field can and will be challenging, we are aligning ourselves with those capable of reaching our goal of providing a successfully therapy against HIV.

Thanks again for your support.

Best regards,

Charles

Charles Cotropia

CEO

[The following is an automated notice from the StartEngine team].

Hello!

As you might know, BioClonetics has exceeded its minimum funding goal. When a company reaches its minimum on StartEngine, it's about to begin withdrawing funds. If you invested in BioClonetics be on the lookout for an email that describes more about the disbursement process.

This campaign will continue to accept investments until its indicated closing date.

Thanks for funding the future.

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Welcome and thanks to all our new investors.  We are making great progress with the support of all existing and new investors and ask that you each share our funding effort and technology with friends and acquaintances. Our thanks go out to each of you as we know the decision to invest is not an easy one and takes sacrifice, commitment and trust.

Since my last update, we have now arranged for the testing of our recombinant antibodies which have been recently produced.

I can explain the importance of recombinant antibody production in this way. As mentioned in early reports, we have previously demonstrated that our anti-HIV monoclonal antibody, produced by the parent cell line, fully neutralizes over 95% of all strains of the HIV virus against which it was tested in 5 separate international labs – the test results are shown on our website at http://www.bioclonetics.com/validation.html. Because the parent antibody (as is usual) does not produce sufficient quantities of our antibody for patient therapy, the antibody has been reconfigured using a fast-producing CHO cell line to provide the pharmaceutical form for further testing and patient therapy. Having produced this recombinant form, it will now be tested to confirm its effectiveness leading to animal and then clinical trials.

Now that the recombinant form of the antibody has been produced, we are moving forward with addition patent applications to cover these newly identified configurations and their function. We expect to be able to fully patent these and additional developments.  My 43 years as a practicing patent attorney should be of value to us in this effort.

We are now arranging for the testing of the newly produced recombinants against a panel of HIV isolates.  These tests are being carried out at a renowned research institute.

Once efficacy is demonstrated in these “in vitro” tests, we will move to animal trials. A well-known primate research facility will be available to us for this critical testing. Also, Serum Institute of India (www.seruminstitute.com) has expressed an interest in facilitating testing.

So, you can see we are moving forward - all with your help. Share this news with friends. And look for future updates on our Facebook “investors only page” which can be accessed at: https://www.facebook.com/groups/122827755072109

We appreciate the confidence and support shown by each of you and look forward to sharing our progress as we move forward.

Best regards,

Charles Cotropia

CEO / BioClonetics

To our Investors and Followers:

At the request of prospective investors and given the success of our campaign and the support that has been shown by existing investors, our campaign will be open for an additional 60 days so that new investors can become part of our mission. This will allow more individuals to invest in our technology and will allow us to progress more rapidly in our development.

This extension of our campaign may require certain of our investors to reconfirm their investments. For those who will need to reconfirm, Startengine will send a notice of this requirement. We sincerely hope all our current investors reconfirm and continue to be a part of our mission.  Also, please consider sharing our story and technology with friends and acquaintances.

The additional funds raised will be applied toward the continued development of our anti-HIV monoclonal antibody. As I have reported, we have previously demonstrated that our monoclonal antibody fully neutralizes over 95% of all strains of the HIV virus against which it was tested in 5 separate international labs – the test results are shown on our website at http://www.bioclonetics.com/validation.html.

We are encouraged now more than ever in that we have successfully produced the recombinant form of the antibody – the form necessary for ultimate use in patient therapy – and are scheduling confirmation testing against a full panel of live HIV virus strains (isolates). We are working with a superbly qualified institution where these “in vitro” tests will be conducted. Preparation of additional variations of our antibody (variations of the parent antibody in recombinant form) are also under production at this moment and these will likewise be tested for efficacy. 

Once efficacy is demonstrated in these tests, we will move to animal trials. A well-known primate research facility will be available to us for this critical testing.

So, you can see we are moving forward – all with your help. Share this news with friends. And look for future updates on our Facebook “investors only page” which can be accessed at: https://www.facebook.com/groups/122827755072109

We appreciate the confidence and support shown by each of you and look forward to sharing our progress as we move forward.

Best regards,

Charles Cotropia

CEO/BioClonetics

Hello! Recently, a change was made to the BioClonetics offering. Here's an excerpt describing the specifics of that change:

BioClonetics Immunotherapeutics, Inc. has extended their campaign and updated their financials.

When live offerings undergo changes like these on StartEngine, the SEC requires that certain investments be reconfirmed. If your investment requires reconfirmation, you will be contacted by StartEngine via email with further instructions.

Our campaign closes in 6 days!  It has been a great success and we extend our most heartfelt thanks to all those who have invested in our technology and vision.

We have been supported by over 250 investors and have greatly surpassed our initial goal.  Our thanks go out to each of you as we know the decision to invest is not an easy one and takes sacrifice, commitment and trust. 

Let me outline where we are and where we are headed - all with your support. Do consider sharing our story and commitment with your friends and acquaintances.

As you know, we have previously demonstrated that our anti-HIV monoclonal antibody fully neutralizes over 95% of all strains of the HIV virus against which it was tested in 5 separate international labs – the test results are shown on our website at http://www.bioclonetics.com/validation.html. Because the parent antibody (as is usual) does not produce sufficient quantities of our antibody for patient therapy, the antibody had to be reconfigured using a fast-producing CHO cell line to provide the pharmaceutical form for further testing and patient therapy. This requires producing the antibody in a recombinant form. This form of the antibody is made from the molecular sequence of the parent antibody and is required by the FDA for use in patient application. Our work in this regard has been with three world class labs – GenScript (www.genscript.com), STC Biologics (www.stcbiologics.com) and Rapid Novo (www.rapidnovor.com).  Your investment made possible confirming the identity of the 1346 amino acids that compose our antibody.  Can you image trying to precisely identify the 1346 ingredients in a recipe not having any of them initially?  Well, this was done and makes possible this next step.

From this sequence, our lab has now produced 11 separate recombinants, each based on the amino acid sequence of the parent antibody, each slightly different in structure so as to cover all potential variations of the parent and to identify the more potent. In results recently received, of these 11 recombinants produced, 3 of the recombinants demonstrate the required successful binding to the HIV virus – meaning that these 3 will be our candidates for the next step in our development – namely testing of these recombinants against live HIV isolates ((“in vitro” tests against strains of the virus). Additional recombinant variants are also now being produced and will also be tested for efficacy.  These are of s slightly different form and can be made into different therapies to protect against infection by the virus.

We are now arranging for these tests against a panel of HIV isolates at an almost century old world-renowned research institute.  Agreements in place preclude me being more specific but this recent development (within the last week) is most encouraging to us.

Once efficacy is demonstrated in these “in vitro” tests, we will move to animal trials. A well known primate research facility will be available to us for this critical testing. Also, Serum Institute of India (www.seruminstitute.com) has expressed an interest in facilitating testing.

So, you can see we are moving forward - all with your help.  Share this news with friends.  And look for future updates on our Facebook “investors only page” which can be accessed at: https://www.facebook.com/groups/122827755072109

We appreciate the confidence and support shown by each of you and look forward to sharing our progress as we move forward.

Best regards,

Charles Cotropia

 CEO BioClonetics

A Progress Report of Success

To Our Investors and Followers:

In our last update, we reported that we were producing the necessary recombinant form of our anti-HIV monoclonal antibody.  We can now report that we have achieved the results hoped for in this developmental step.

As background, we are progressing toward preclinical trial using our anti-HIV monoclonal antibody. We have previously demonstrated that our antibody (Clone 3) fully neutralizes over 95% of all strains of the virus against which it was tested in 5 separate international labs. The labs in which these tests were completed and their results are shown on our website at http://www.bioclonetics.com/validation.html.

As we have also mentioned in the past, because the parent antibody (as is usual) does not produce sufficient quantities of our antibody for patient therapy, the antibody must be reconfigured using a fast-producing CHO cell line to provide the pharmaceutical form for further testing and patient therapy. This requires producing the antibody in a recombinant form. This form of the antibody is made from the molecular sequence of the parent antibody and is required by the FDA for use in patient application.

As progress from our last report, our labs have now produced 11 separate recombinants, each based on the amino acid sequence of the parent antibody, each slightly different in structure so as to cover all potential variations of the parent. Of these 11, 3 of the recombinants demonstrate the required successful binding to the HIV virus – meaning that these 3 will be our candidates for the next step in our development – namely testing of these recombinants against live HIV isolates (strains of the virus). 

Recall that the parent antibody fully neutralized 95% of all isolates against which it was tested in 5 separate labs. We hope to duplicate or improve on these results using the recombinant form of our antibody.  From there, once efficacy is demonstrated in these “in vitro” tests, we will move to animal trials, leading to clinical trials.

We have several labs with whom we will be working to complete these tests against HIV isolates and have entered into Confidentiality Agreements setting the stage for such testing.

We will keep you updated on our progress. Our fundraising campaign is continuing at www.startengine.com/bioclonetics. Please consider sharing our story and technology at www.startengine.com/bioclonetics with your friends and colleagues. Funds are needed to conduct our further develop - which we are now completing. Your spreading the word will assist us in completing our mission of developing our anti-HIV monoclonal antibody and finding a cure for HIV.

Our Facebook investor page may also be accessed where we periodically post updates of our progress. Find it here: https://www.facebook.com/groups/122827755072109

We appreciate the confidence and support shown by each investor and look forward to sharing our progress as it occurs.

We will stay in touch.

Best regards,

Charles Cotropia

CEO / BioClonetics

To our investors and followers:

As our investors have been notified, we have taken a distribution of funds and at that time made amendments to our campaign.  In these amendments, we have increased our minimum investment (for new investors) from$100 to $400.  We believe the new level is reasonable in view of our objectives. We also amended the description in our convertible note to clarify that conversion of your investment to stock would be to "common stock" (adding the word "common") which is the same class of stock owned by all founders and principals of the company.

These amendments do require certain investors (who will be contacted by Startengine) to re-confirm their investment and we encourage those investors to re-confirm and continue to be a part of our team.  We ask those following our campaign to consider an investment – as our campaign must close April 30.  We expect to have results from the production of the recombinant form of our antibody (now being produced) in the very near term and we are arranging for validation testing at the Univ. of California San Francisco. These results will be significant.

 We will be sharing the results of our development as soon as they are available.  Stay tuned.

 Best regards,

Charles Cotropia

CEO

BioClonetics

Hello! Recently, a change was made to the BioClonetics offering. Here's an excerpt describing the specifics of that change:

BioClonetics Immunotherapeutics, Inc. is extending their offering, adjusting their minimum purchase price, and updating the terms of their convertible note.

When live offerings undergo changes like these on StartEngine, the SEC requires that certain investments be reconfirmed. If your investment requires reconfirmation, you will be contacted by StartEngine via email with further instructions.

Monoclonal Antibodies Provide the Promise of an HIV Cure

The first verified case of human immunodeficiency virus (HIV) occurred almost 60 years ago. Scientists and researchers have been debating about treatments for almost 40 years.

Yet the disease remains a global and public health issue. More than 36 million live with HIV – almost 2 million of those are children.

https://www.avert.org/sites/default/files/styles/responsive_articlecustom_user_desktop_1x/public/Global%20stats%20infographic%2001_Final.jpg?itok=nYz29rD9&timestamp=1503500159.

Almost 2 million new cases of HIV were diagnosed in 2016, the latest year data was reported.  One million people died -- 120,000 of the deaths were children. While these statistics show improvement over prior years across the 69 countries affected by the disease over prior years, UNAIDS has warned progress in stopping transmission is not occurring rapidly enough to meet global targets. Global resources targeting HIV and AIDs have plateaued, with 2016’s $19 billion dollars investment by low-to-middle income countries only 5% higher than the prior year. 

About 57% of those with an HIV diagnosis are receiving antiretroviral therapy (ARV), taking medications that don’t kill or cure the virus. The combination of medicines prevents the growth of the virus.  

https://www.avert.org/sites/default/files/styles/responsive_articlecustom_user_desktop_1x/public/Number%20of%20people%20and%20treatment_updated%20August2017_for%20website.png?itok=fu1VRZI4&timestamp=1503495559

HIV’s Threat to the Immune System

Understanding how genetic engineering holds promise for a cure for HIV starts with an overview of the challenge this virus presents to the human immune system.

When bacteria, viruses or chemicals enter the human body, its immune system goes to war. Bacterial or viral invaders, called antigens, are first met by ‘helper’ T cells. Once called into action, the helper T cells stimulate B cells. These B cells create customized antibodies (or immunoglobulins) that attach or bind to the antigen. The antibody ‘scouts’ have a critical role, since they ‘mark’ specific antigens as enemies to the system. Now the immune system’s ‘killer’ T cells know how to recognize the antigens that must be attacked and destroyed. This process helps the body eliminate the invaders and return to peaceful, normal function.

HIV targets and kills the ‘helper’ T cells, cutting the connection to B cells and stalling the critical process of antibody production. The result? The immune system is unable to identify antigens, ‘killer’ T cells can’t find invaders, and the immune system’s ability to protect is compromised.

Latest HIV Drugs Continue to Focus on Slowing Virus Growth

The most recent FDA-approved medicine is called Biktarvy -- it’s a combination antiretroviral drug with three medications:

• Bictegravir is an integrase inhibitor. Integrase is an HIV enzyme essential for viral replication. The integrase inhibitor prevents HIV from pasting its DNA into T-cells.
• Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI). A reverse transcriptase is another HIV enzyme -- this one copies RNA back to DNA, like a car driving the wrong way on a one-way street. Reverse transcriptase allows the virus to insert its DNA to the host cell's DNA, forcing the cell to make more of the virus. Reverse transcriptase inhibitors prevent the HIV virus from replicating itself.
• Tenofovir alafenamide (TAF) is a reverse transcriptase inhibitor (NRTI) sold only as a combination drug. Compared to other NRTIs, TAF has been shown to have fewer adverse effects on kidney function and bone density.

Biktarvy must be taken daily. Its audience? Adults who have never taken HIV medication before or those with HIV less than 50 copies / mL of the virus who need to replace their current regimen.

Test results showed a reduced HIV viral load in most patients with no one discontinuing trial due to adverse side effects or renal failure. But the drug warns of the possibility of lactic acid buildup in the blood (lactic acidosis) and severe liver problems.

While test results are favorable, Biktarvy remains daily regimen with a risk of liver damage and is an adult-only solution.

Better news is needed.

Genetically Engineered Monoclonal Antibodies Opened the Door

More than 40 years ago, biomedical researchers found a way to fuse a B cell that was creating customized antibodies with an immortal B cell – one that would continue to divide and grow – resulting in a cell that could target a specific invader and have a long cell life.  Their discovery, monoclonal antibodies, has fueled disease research.

The first monoclonal antibodies were created with animal cells, making them less compatible with human immune systems. A solution must be fully humanized to prevent patient rejection.  And since HIV can also compromise the effectiveness of vital ‘killer’ T cells, the most effective monoclonal antibody must be able to stop the HIV virus cells from reproducing.

BioClonetics’ Solution 

Through many years of research and development, the BioClonetics research team created a cell line that produces a fully human monoclonal antibody, the Clone 3 antibody that binds to the HIV virus. Importantly, tests in the international research institutes of Harvard Medical School, Duke University, University of California San Francisco, University of South Florida and Polymun Scientific show that Clone 3 neutralizes over 95% of primary HIV strains (isolates) against which it has been tested.

More significant, however, is the fact that the target site on the HIV virus to which the Clone 3 antibody binds is immutable – in other words, the binding site is always present from virus strain to virus strain. Today, there are more than 6000 strains of the HIV virus worldwide and it is critical that an antibody target a site that is immutable (always present).  Otherwise, the antibody will fail to have a sustained ability to defeat the virus.  In the case of the Clone 3 antibody, the target site exists (either directly or by way of conservative amino acid substitutions) in 98% of the 6000 strains currently known.

This success rate far outpaces current FDA approved treatments, and the company is quickly moving forward to complete additional testing and seeking support to launch animal trials this year.

https://d19j0qt0x55bap.cloudfront.net/production/startups/bioclonetics/campaign/images/mobile_screen_shot_2017-09-26_at_12_01_36_pm.jpg

Why BioClonetics’ Clone 3 Antibody is the right solution.

BioClonetics’ Clone 3 Antibody provides the following advantages over current HIV medications:

• Clone 3 is a fully human monoclonal antibody (preventing rejection) targeting and neutralizing HIV.
• Clone 3 is non-toxic.
• Clone 3 has been shown to be 100% effective against over 95% of all strains and viral subtypes of HIV-1 against which it has been tested.
• Once validated as a therapy for those who have HIV, knowledge of the binding site of Clone 3 to the virus makes possible a prophylactic vaccine to prevent uninfected populations from contracting the HIV virus.

The net result is a solution that is safer, will provide a much-needed immunotherapeutic cure rather than a lifelong treatment, and at a cost substantially lower than current medical therapies.

Response from medical and scientific communities has been positive.

I am very happy and excited to see the development of this monoclonal antibody move ahead. Combination neutralizing monoclonal antibody treatment of HIV+ mothers and their infants offers a potential alternative to the current nevirapine regimen which has some significant problems in creating drug resistant virus variants and could also be used in combination with newer proposed interventions such as tenofovir. Clone 3, in combination with other neutralizing monoclonal antibodies, offers the potential for safely protecting infants from infection from a broad range of primary HIV-1 isolates, and I look forward to being involved in its clinical evaluation.          

Yvonne J. Bryson

Chief, Division of Pediatric Infectious Diseases,

David Geffen School Of Medicine at UCLA

BioClonetics' immunologic proposal is of significant importance in the development of immunotherapy for HIV patients worldwide. Demonstration of neutralization of primary clinical HIV isolates in vitro is critical to the ultimate step of in vivo application of monoclonal anti-HIV antibody to be effectively utilized in passive immunotherapy. I offer my strongest endorsement for your proposal.                                      Chuanhai Cao, Ph.D.

Associate Professor, University of South Florida

Despite effective anti-HIV retrovirals, clearance of HIV-1 remains a critical global health issue. We are excited to be part of your strong interdisciplinary team and you have our full support for successful advancement of your technology.                                                                          Magdalena Leszczyniecka, Ph.D., MBA                                                               CEO and President, STC Biologics, Inc.

BioClonetics is currently seeking funding to complete development of the Clone 3 antibody for pre-clinical trials within the next 12 months.  Join us and invest in this lifesaving technology.

This question has been asked and I would like to provide the explanation – hopefully in a way that can be understood by all.

For HIV to replicate and be infectious, it must bind to the human CD4 cell at two receptor sites on the human cell, namely:

(1) Binding to a primary human CD4 receptor initially (where the part of the virus known as gp120 binds to the human cell), and then also

(2) Binding to a 2nd human cell co-receptors CXCR4 and/or CCR5 (where the part of the virus known as gp41 attaches to human cell).

The Clone 3 Antibody interrupts the binding of the virus to the human CD4 cells by blocking its binding to this 2nd co-receptor on the human CD4 cell surface. The second co-receptor may be CCR5 and the CXCR4 depending on the virus but in either event, Clone 3 block this binding. By blocking this binding, the HIV infection process is arrested.

The life cycle of the HIV virus begins with attachment of the virus to the human CD4 T cell, the primary receptor and then to two separate surface co- receptors on the human T-cell.

Binding to these receptors then induces a conformational change in the structure of the virus leading to fusion with the human cell. Fusion results in the release of the viral genome of the virus into the human cell.

The way Clone 3 works is that it prevents this second binding step and thus the virus is prevented from replicated in the body.

As you can appreciate, a successful cure for HIV will require the precise mechanism that will prevent the virus from entering the Human cell and thereby prevent its replication. We know that this is what our monoclonal antibody is capable of doing and we are moving forward to further prove it.

Share our technology with friends and acquaintances – at www.startengine.com/bioclonetics.

Many thanks to our investors and followers.

BioClonetics Immunotherapeutics, Inc.

To our investors and followers:

You will be receiving a notice that we are withdrawing some of the funds raised in our Startengine Crowdfunding Campaign.  This will report how your investment funds will be used.

Please note however that our campaign is continuing and we ask that you share our campaign with friends and acquaintances who would have an interest in our goal of providing a cure for HIV.

As we have mentioned, we are progressing toward preclinical trial using our anti-HIV monoclonal antibody. We have previously demonstrated that our antibody (Clone 3) neutralizes over 95% of all strains of the virus against which it was tested in 5 separate international labs. The results of these tests are shown on our website at http://www.bioclonetics.com/validation.html.

The creation of the recombinant forms of the antibody in now underway. This form of the antibody is make from the molecular sequence of the parent antibody and is required by the FDA for use in patient application.  Thus, this step must be achieved as we move toward pre-clinical and then clinical trials.

In this current effort, we are producing 11 separate recombinants, each slightly different in structure so as to cover all potential variations of our parent antibody. This increases significantly the potential outcome such that more than one – or perhaps several – will demonstrate efficacy.

This effort is now under way. We have the benefit of 3 world class laboratories, located in New England, Canada and China working on this production.

Once produced, this recombinant will be tested against numerous strains of the HIV virus to confirm the effectiveness as being equal to that of the parent antibody. We are arranging for the testing of the recombinants at the University of California at San Francisco.

We will keep you updated on our progress. Our fundraising campaign is continuing at www.startengine.com/bioclonetics. Do consider sharing our story and technology at www.startengine.com/bioclonetics with your friends and colleagues. This will assist us in completing our mission of finding a cure for HIV.

Our Facebook investor page may also be accessed where we will be periodically posting updates of our progress. Find it here: https://www.facebook.com/groups/122827755072109

We will stay in touch.

Best regards,

Charles Cotropia

CEO / BioClonetics

[The following is an automated notice from the StartEngine team].

Hello!

As you might know, BioClonetics has exceeded its minimum funding goal. When a company reaches its minimum on StartEngine, it's about to begin withdrawing funds. If you invested in BioClonetics be on the lookout for an email that describes more about the disbursement process.

This campaign will continue to accept investments until its indicated closing date.

Thanks for funding the future.

-StartEngine

HIV excels at evading the immune system by hiding out in certain immune cells, referred to as viral reservoirs. The virus can be suppressed to very low levels with antiretroviral therapy, but quickly rebounds to high levels if a person stops taking medications as prescribed.

Researcher have for some time considered strategies for targeting these viral reservoirs but without success. Recent tests in animal trials conducted by the NIH support the expectation that broadly neutralizing antibody treatment can target these viral reservoirs. https://www.sciencedirect.com/science/article/pii/S0092867414009933

In these NIH tests, after receiving a course of antiretroviral therapy for their HIV-like infection, half of a group of monkeys infused with a broadly neutralizing antibody to HIV paired with an immune stimulatory compound suppressed the virus for over six months without additional treatment, according to NIAID-supported scientists. The researchers concluded that the therapy may have targeted the viral reservoir—populations of long-lived, latently infected cells that harbor the virus, and from where the virus rebounds when suppressive therapy is discontinued. The new findings support the importance of using broadly neutralizing antibodies to achieve sustained, drug-free viral remission in people living with HIV. Researchers discussed these results in their March 2018 press conference at the 25th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

Our monoclonal antibody (Clone 3) is just such a broadly neutralizing antibody. In tests of Clone 3 in 5 independent laboratories, Clone 3 neutralize over 95% of the 45 HIV isolates against which it was tested. Moreover, Clone 3 binds to the HIV virus (resulting in neutralization) at a site that is immutable – namely a site that is found in 98% (directly or at conserved substitution sites) of the over 6000 strains of the virus now known – meaning that it is indeed a “broadly neutralizing monoclonal antibody”.  These recent finding are most encouraging and support our expectation of the efficacy that can be expected from our monoclonal antibody.

As a status update, the recombinant form of our antibody is now being produced.  This process is time consuming and highly technical but is scheduled for completion in the next 8 weeks.  As soon as completed, the recombinant form of the antibody (which is necessary for animal and clinical trials) will be first tested against HIV strains of the virus to confirm efficacy equal to that of the parent antibody.

We appreciate the confidence and support shown by each investor and look forward to sharing our progress as it occurs.  Please consider sharing our technology and story with those you know.

BioClonetics

To our investors and followers:

We are progressing in the development of our anti-HIV monoclonal antibody ( Clone 3) that has been demonstrated through testing in 5 international labs to neutralize numerous strains of the HIV virus. The results of these tests demonstrating the neutralizing capability against many different strains of the virus are shown on our website at http://www.bioclonetics.com/validation.html.

The creation of the recombinant forms of the antibody in now underway – this form of the antibody is required by the FDA for use in animal trials and then clinical trials. Once produced, this recombinant will be tested against numerous strains of the HIV virus followed by the required animal and clinical trials. This effort will take a short period of time but we will keep you updated as we proceed. Thereafter, binding studies will be completed to determine which of the several recombinants (and perhaps all) effectively bind to HIV isolates (strains of the virus).

To prepare the recombinant for testing, we have substantially identified the entire molecule sequence necessary for the recombinant preparation. We know our antibody consist of 1346 amino acids and have now confirmed substantially all of the sequence.

Rather than proceed to produce a single recombinant, we will be producing 11 separate recombinants, each slightly different so as to cover all possible variations. This improves the potential outcome such that more than one – or perhaps several or all – will demonstrate efficacy.

We have the benefit of having 2 world class laboratories working for us on this program. Additionally, a third lab has also been engaged. 

Thereafter, the recombinants will be tested against a full panel of HIV isolates to determine the neutralizing capability of  the varied recombinant antibodies.

Technology has significantly advanced during the past few years. The cost to complete the steps we are now taking was excessive just a few years ago but due to advancements in technology, we are able to complete these sophisticated steps with a much smaller investment. Your investments make this possible and we are making progress now at a pace that would not have been possible just a few years ago.

We will keep you updated on our progress. Our fundraising campaign is continuing at www.startengine.com/bioclonetics. Do consider sharing our story and technology at www.startengine.com/bioclonetics with your friends and colleagues. This will assist us in completing our mission of finding a cure for HIV.

Our Facebook investor page is may also be accessed where we will be periodically posting updates of our progress.  Find it here: https://www.facebook.com/groups/122827755072109

We will stay in touch.

Best regards,

Charles Cotropia
CEO - BioClonetics Immunotherapeutics, Inc.

We have received the following questions from an investor and believe our answers will be of interest to all investors.  Thus, we are sharing them here.

Hi Prakask,

Thank you for your insightful questions. We can address them in this way.

1. Can you substantiate your claim that your monoclonal antibody binds to an “immutable” site on the virus?

Our Response: We have established the site on the virus to which our monoclonal binds AND the U.S. Government Los Alamos National Laboratories Viral Database has published the HIV sequences of over 5000 HIV isolates. By comparing the two, it is revealed that the binding site to which our monoclonal binds exists in 98% of those isolates known (either directly or including conservative substitutions) AND as more HIV sequences have been added to the database over numerous years, this 98% has maintained constant. (See http://www.bioclonetics.com/effectiveness.html).

Which gene?

Our Response: HIV gp41

2. What is the virus neutralization titer for your antibody?

Our Response: Clone 3 Antibody is a broadly neutralizing human monoclonal anti-HIV gp41 antibody, neutralizing across Groups M, N, and O; and Clades A, B, C, E, and F. The broad neutralization capacity of the Clone 3 Antibody—when tested against 41/43 [95%] primary clinical isolates of HIV1-1 in standardized in vitro PBMC-based neutralization assays by 5 international laboratories—was demonstrated at an Inhibitory Concentration [IC90] using <30 micrograms/ml, for a geometric mean of 5 micrograms/ml. (See http://www.bioclonetics.com/validation.html).

3. Will it work on long-term non-progressors (LTNP)?

Our Response: Yes.

4. Is the assay enzymatic (RT) or antigenic, like p24?

Our Response: Both assays have been utilized to determine neutralization capacity: enzymatic RT and antigenic p24; concordance between two assays is 1:1

5. What is the specificity (ability to differentiate from close homologs) & kM for binding?

Our Response: Clone 3 Antibody binds to the minimal core epitope and homologous peptides with conservative amino acid substitution; and Clone 3-like Antibody binds to HIV1 gp41 transmembrane protein with amino acid substitution within the core epitope. kM has not been determined.

6. Is your technology patented?

 Our Response: We have multiple patent applications pending and more in preparation. None are yet published and, as you can appreciate, there is no benefit prior to commercialization to issuance of a patent recognizing that a patent term is 20 years. Additionally, our methodology for producing monoclonal antibodies is proprietary and although subject to a pending patent application (unpublished) we will be making a decision regarding the issuance of patents on such methodology as opposed to protecting the methodology relying on trade secret rights – which have an unlimited life.

Dear Investors and all Startengine followers,

To all investors and those following us, we welcome your partnership.  Please consider sharing our campaign with your friends and acquaintances as they will likely have the same interest as you.

As we have reported, we are continuing the development of our monoclonal antibody (called Clone 3) that has been demonstrated through testing in 5 international labs to neutralize numerous strains of the HIV virus. The results of these tests demonstrating the neutralizing capability against many different strains of the virus are shown on our website at http://www.bioclonetics.com/validation.html.

We have today initiated the production the recombinant form of the antibody – which is required by the FDA for use in animal trials and then clinical trials. Once produced, this recombinant will be tested against numerous strains of the HIV virus followed by the required animal and clinical trials.

To prepare the recombinant for testing, we have substantially identified the entire molecule sequence necessary for the recombinant preparation. We know our antibody consist of 1346 amino acids and have now confirmed substantially all of the sequence.

Rather than proceed to produce a single recombinant, we will be producing 10 separate recombinants, each slightly different so as to cover all possible variations. This improves the potential outcome such that more than one – or perhaps several – will demonstrate efficacy.

We have the benefit of having 2 world class laboratories working for us on this program. Additionally, a third lab has also been engaged. This additional lab in under contract to the supporting Institute interested in our technology and thus the confirming work performed by this lab will be at no expense to us.  This is a great plus for us and our investors. This further demonstrates the support our technology is receiving from big pharma’s leading institutions.

Further, technology has significantly advanced during the past few years.  The cost to complete the steps we are now taking were excessive just a few years ago but due to advancements in technology, we are able to complete these sophisticated steps with much smaller investments.  Your investments make this possible and we are making progress now at a pace that would not have been possible just a few years ago.

 Further, we are continuing to engage with a world renowned institute whose primary focus on producing an anti-HIV vaccine and an effective treatment for HIV.  This relationship will be significant as be complete more confirming data as to efficacy of our monoclonal antibody.

We will keep you updated on our progress.  Do consider sharing our story and technology with your friends and colleagues.

Best regards,
Charles Cotropia
CEO - BioClonetics Immunotherapeutics, Inc.

Dear Investor and all Startengine followers,

Our fundraise is off to a great start – having surpassed our initial goal in the first few days.  Our sincere thanks go out to all those who have invested in our cause. As to those who are following us, we welcome your interest and hope you decide to join us as an investor in the future. Please also share our campaign with your friends and acquaintances as they will be as interested as you.

Funds from our fundraising will be used in the development of our anti-HIV recombinant antibody that is now being produced from our parent antibody. Here is the status of that effort.

As we have reported, we are continuing the development of our monoclonal antibody (called Clone 3) that has been demonstrated through testing in 5 international labs to neutralize numerous strains of the HIV virus. The results of these tests demonstrating the neutralizing capability against many different strains of the virus are shown on our website at http://www.bioclonetics.com/validation.html.

We are now producing the recombinant form of the antibody – which is required by the FDA for use in patient therapy. Once produced, this recombinant will be tested against numerous strains of the HIV virus and then its efficacy confirmed in tests in animal and clinical trials.

To prepare the recombinant for testing, we must identify the molecule sequence necessary for the recombinant preparation. We know our antibody consist of 1346 amino acids. In my last report, we had a consensus sequence for all but 27 of these 1346. In the most recent round of analysis, we have reduced this number to less than half of these 27. Analysis to establish the identity of the remainder is currently underway at the facilities of Genscript (www.genscript.com) in its New Jersey and Shanghai China laboratories. The results of this analysis will be available later this month.

Once the resulting data is analyzed and we are confident of a consensus sequence, the recombinant form of our antibody will be produced and then tested against HIV isolates to confirm effectiveness. Alternatively, we also have the option of producing numerous recombinants with differing sequences in an effort to identify the most potent.

Additionally, we are in discussions with a global non-profit organization whose sole focus in on the development of a treatment and vaccine against HIV. Our monoclonal is one of a few under consideration. This is a promising opportunity and will be fully explored in the New Year.

Stay in touch with us and please consider sharing our campaign with others.

Best wishes,
Charles Cotropia
CEO - BioClonetics Immunotherapeutics, Inc.