BioClonetics offering is now closed and is no longer accepting investments.

INVEST IN BIOCLONETICS TODAY!

Developing a Cure for HIV

This Reg CF offering is made available through StartEngine Capital, LLC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
BioClonetics

$255,600.00 Raised

REASONS TO INVEST

ABOUT

HEADQUARTERS

1756 Bison Meadow Lane
Heath, TX 75032
VALUATION

$15M

TEAM

Charles S. Cotropia
Charles S. Cotropia
CEO/President/Director

Charles Cotropia is a co-founder and CEO/President of BioClonetics. He holds a JD degree from Cornell University and a Bachelor of Science Degree in Aerospace Engineering from the Univ. of Texas- Austin. Charles worked as a stress analysis engineer at Lockheed Aircraft before attending Law School at Cornell Univ., Ithaca-NY. After graduating from Cornell Law School, Charles began his 44 year legal career in Dallas, Texas serving clients in the intellectual property law field. For 18 years, he served as a partner in the firm Sidley Austin LLP, an international law firm, where he represented clients in intellectual property law and related matters in the fields of biotech, aerospace, oil and gas exploration, electronics, software and related fields. His legal career spans 44 years of practice where he managed client matters in numerous technologies involving patenting, licensing and enforcing intellectual property rights. His practice included representing Fortune 500, as well as mid to small, companies and individual inventors and entrepreneurs. He has drafted and prosecuted over 800 patents in the US and foreign countries and has litigated intellectual property cases in Federal and State Courts. In addition, Charles also served as Vice-President of BioClonetics from 2009 until 2017. before becoming President of the Company.

Joseph P. Cotropia
Joseph P. Cotropia
Chief Science Officer/Vice-President/Director

Dr. Cotropia is a co-founder and CSO of BioClonetics. He received his Medical Degree from the Southwestern Medical School Dallas and completed his residency at Southwestern. Prior to attending medical school, he obtained a B.S. Degree in Chemistry from the Univ. of Texas-Austin and a Masters in Science Degree in Physiological Chemistry from the Univ. of Wisconsin-Madison. He has over 45 years of experience in medical research and practice. In these 45 years, Dr. Cotropia has had extensive training in both clinical research and academic medicine environments, and has been involved primarily in the immunological aspects of health care at local, state and national levels. He has been a researcher and reviewer of pre-clinical biologic protocols at the United States Food and Drug Administration [FDA] and from this work at the FDA is knowledgeable in all of the aspects of federal regulatory controls regarding investigation of new drugs and licensing of biological products. Dr. Cotropia invented a proprietary methodology for producing fully human IgG1 monoclonal antibodies for treating infectious diseases with non-toxic passive immunotherapy. From this methodology, the Company has created proprietary cell lines that produce fully human monoclonal antibodies that target and neutralize HIV. Such methodology is applicable to the production of monoclonal antibodies against other human, as well as animal, infectious diseases. Dr. Cotropia served as President of BioClonetics from 2009 until 2017 and is now CSO of the Company.

Gaurav Chandra
Gaurav Chandra
Chief Operating Officer Research and Development

Dr. Chandra obtained his medical degree from Kasturba Medical College, Manipal, India and conducted his surgery residency at Montefiore Albert Einstein College of Medicine, Bronx, New York. He holds a Masters Degree in Business Administration from the Univ. of Colorado-Denver. He has served as a Senior Research Assistant/Clinical Fellow Clinical Islet Cell Transplantation and Cell Biology at Joslin Diabetes Center (Mass General Hospital/Brigham Woman’s Hospital) working on Human Islet Transplantation as part of an initiative to develop cures for Diabetes. He is presently a Consultant Surgeon in the Department of Burn Surgery, Red Cross Children’s Hospital Cape Town, South Africa. In addition to now serving as the COO and Vice President of BioClonetics (2015-present), he is also the CEO of GlobeMD (2014-present). Through partnering with global hospitals and healthcare providers, GlobeMD is the first ever comprehensive digital marketplace for medical tourists. Dr. Chandra is also the CEO and Chairman of United International Diagnostics and United International Health Solutions (Hospitals) (2014-2016). As CEO of United International Diagnostics, he guided the launch and successful establishment of a multi-million dollar Diagnostic Center Network in India that provides a complete Diagnostic Solution to Hospitals and Medical Institutions, leading a company of 100+ employees to success. Dr. Chandra has also served in the past 3 years as CEO of Chemokind Inc. (2015-2016), a company that incorporates therapeutic strategies inspired by biological design. In the past 3 years, Dr. Chandra has also served as CEO of Advanced Medical Information Technology (2013-2014), a company providing mobile health platforms that simplifies healthcare management for patients and physicians.

Paul D. Fellegy

Paul D. Fellegy

Chief Financial Officer/Secretary/Treasure/Director

Paul Fellegy is the Chief Financial Officer of BioClonetics. Paul received his Bachelor of Arts Degree in Zoology and Animal Biology from Drew University. He also holds a graduate Fellowship from Jagiellonian University and has completed graduate computer course work at Boston University. He has 25 years of financial operations and audit experience in the banking and financial services industries in Boston, Massachusetts market. Paul began his career with Shawmut Bank, later acquired by Bank of America. Following this experience, Paul went on to a consulting career with the mutual funds clients in Boston including Fidelity Investments, Putman Investments, John Hancock and Commonwealth Bank and Trust, among other organizations providing services to the financial industry.

Ellen S. Vitetta, Ph.D.

Ellen S. Vitetta, Ph.D.

Scientific Advisory Board

Director of the Cancer Immunobiology Center at the University of Texas Southwestern Medical Center in Dallas. American Association of Immunologists Lifetime Achievement Award (2007); Texas Women’s Hall of Fame Award (2007)

Yvonne J. Bryson, M.D.

Yvonne J. Bryson, M.D.

Scientific Advisory Board

Professor of Pediatrics and Chief, Division of Pediatric Infectious Diseases, David Geffen School of Medicine, Mattel Children's Hospital at UCLA, Marian Davies Children Center at LA, California.

Dalila B. Corry, M.D.

Dalila B. Corry, M.D.

Scientific Advisory Board

Professor of Clinical Medicine, Chief, Division of Nephrology, David Geffen School of Medicine at UCLA, Los Angeles, California.

TERMS

BioClonetics
Overview
INTEREST RATE
2.0%
MATURITY DATE
Nov 30, 2020
VALUATION CAP
$15M
AMOUNT RAISED
$255,600.00
Breakdown
MIN INVESTMENT
$400.00
DISCOUNT RATE
CONVERSION TRIGGER
$1,500,000.00
OFFERING TYPE
Convertible Notes
TYPE OF EQUITY

INVESTMENT OPPORTUNITY

Convertible Note 

Note converts to Common Stock when the company raises $1,500,000 in qualified equity financing

Maturity Date: 11/30/2020

$15M valuation cap

2% annual interest rate*

*Annual Interest Rate subject to adjustment 10% bonus for StartEngine shareholders. See 10% Bonus below

30% Discount

Maximum ($683,234) of Convertible Notes

Minimum ($10,000) of Convertible Notes

Company
BioClonetics Immunotherapeutics, Inc.
 

Corporate Address
1756 Bison Meadow Lane, Heath, Texas  75032
 

Description of Business
BioClonetics is developing a cure for HIV using fully human monoclonal antibodies.
 

Type of Security Offered
Convertible Note
 
Minimum Investment Amount (per investor) 
$400









What is a Convertible Note?

A convertible note offers you the right to receive shares of Common Stock in BioClonetics. The number of shares you will receive in the future will be determined at the next equity round in which BioClonetics raises at least $1,500,000 in qualified equity financing. The highest conversion price per share is set based on a $15,000,000 company valuation cap or if less, then you will receive a 30% discount on the price the new investors are purchasing.  You also receive 2% interest per year added to your investment. When the maturity date is reached, if the note has not converted then you are entitled to either receive your investment and interest back from the company or convert into stock.

Perks

All investors - Frequent updates on our technology progress

$1,000+ Your place on the Official Founders Page of the website - Exclusive content and frequent company updates - Access to the investors only BioClonetics Founder Group on Facebook

$5,000+ Twice yearly update through call from the COO - Your place on the Official Founders Page of the website - Access to the investors only BioClonetics Founder Group on Facebook

*All perks occur after the offering is completed.

The 10% Bonus for StartEngine Shareholders (This bonus period is concluded as of 5:30PM PT on January 5, 2018)

BioClonetics Immunotherapeutics, Inc. will offer a 10% bonus on the annual interest rate for all investments that are committed by StartEngine Crowdfunding Inc. shareholders (with ≥ $1,000 invested in the StartEngine Reg A+ campaign) within 24 hours of this offering going live.

StartEngine shareholders who have invested $1,000+ in the StartEngine Reg A+ campaign will receive a 10% increase in the annual interest rate on Convertible Promissory Notes in this Offering if they invest within a 24-hour window of their campaign launch date.  For example, if invest in the first 24 hours, your annual interest rate will be 2.2% instead of 2%.   

This 10% Bonus is only valid for one year from the time StartEngine Crowdfunding Inc. investors receive their countersigned StartEngine Crowdfunding Inc. subscription agreement.

Irregular Use of Proceeds

The Company might incur Irregular Use of Proceeds that may include but are not limited to the following over $10,000: Vendor payments and salary made to one's self, a friend or relative; any expense labeled "Administration Expenses" that is not strictly for administrative purposes; any expense labeled "Travel and Entertainment"; any expense that is for the purposes of inter-company debt or back payments.

PRESS

Article Image
The Groundbreaking Antibody Taking A Step Closer to a Cure for HIV

Although there have been many advancements in treatments that help slow the virus's growth and allow patients to remain relatively healthy for several years, the world continues its relentless pursuit of the cure to HIV. At BioClonetics Immunotherapeutics, we're one step closer to ending that search

Article Image
The Future of Clone 3

To put it simply, Dr. Cotropia created a human cell line producing a specific human antibody that targets a genetic sequence on the surface of HIV’s outer envelope. When tested in 5 separate lab, this antibody demonstrated that it neutralized over 95% of those HIV stains against which it was tested.

ALL UPDATES

10.03.19

Progress in the 3rd Quarter 2019

PROGRESS IS ONGOING

Dear Investors and Supporters,

We have had a very productive third quarter in 2019 and I would like to summarize that progress here. As always, this progress has been made possible by your support and we are most appreciative of your partnership with us.

As we have earlier 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). From the parent antibody, we have prepared the required recombinant antibodies, required by the FDA for use in patient therapy, and initial tests have been conducted at the Institute of Tropical Medicine, University of Antwerp, Belgium.

From these tests results, the effectiveness of our recombinant antibody as compared to all other anti-HIV monoclonal antibodies thus far produced by pharma and the NIH, our recombinant tested at 2.6 times more effective than the best no. 1 antibody – VRC01 – and 6 times more effective than the no. 2 next best anti-HIV monoclonal antibody – VRC01 – (both produced by Vaccine Research Center, in conjunction with the NIH). We are conducting additional tests on our recombinant antibodies at The Scripps Institute in California and at Responsive BioServices in Georgia.

We have filed an NIH/STTR grant application seeking funding to complete these additional tests and to conduct animal trials at the California National Primate Research Center in Davis, California.

In our grant application, we gratefully received letters of support and participation from each of the following institutions with whom we will be working:

• The Scripps Research Institute, La Jolla, CA

• STC Biologics, Cambridge, MA

• Responsive Bioservices, Smyrna, GA

• California National Primate Research Center, Davis, CA

We have also been invited to file an application for the NIH grant proposal for “Development and evaluation of vaccines relevant to HIV and other infectious diseases for infants, children, and pregnant/breastfeeding women”. The reason for our optimism for the use of our monoclonal to identify a successful vaccine immunogen is the necessity that a vaccine produce an antibody in the body that targets a binding site of the virus that does not mutate. Of all the known anti-HIV monoclonal antibodies produced by pharma to date, we are not aware of any, other than ours, that targets a site that is as immutable as the targeted site to which our antibody binds. Our antibody targets a site that exists in 98%, either directly or conservatively, of the over 5000 different strains of the virus now known – with more strains coming into exits each day.

Specifically, millions of dollars have been and are being invested in the anti-HIV monoclonal antibody known as VRC01 (produced by Vaccine Research Center in conjunction with the NIH) even though tests show that it targets a site on the virus that mutates – resulting in “virus escape”. See https://www.nejm.org/doi/full/10.1056/NEJMoa1608243. Any successful vaccine or therapy must target a site on the virus that is immutable – otherwise the virus simply mutates around the therapy.

We are working diligently to make progress, and we extend our sincere appreciation for your support.

Best regards,

Charles Cotropia

CEO

BioClonetics Immunotherapeutics, Inc.

07.13.19

BioClonetics Update July 1,3 2019

Dear Investors and Supporters,

We have had a very productive second quarter in 2019 and I can summarize the current progress as follows:

We have completed the production of additional recombinants of our anti-HIV monoclonal antibodies and are conducting additional testing prior to embarking on animal trials.

Testing these promising recombinant anti-HIV monoclonal antibodies are ongoing at Responsive BioServices in Smyrna, Georgia and we are working together with Scripps Research Institute in California where our antibodies have been accepted for efficacy testing.

These tests are preparatory to animal trials. We are current making plans and have proposals from two renown animal trial institutions in California and Texas.

We have also engaged a grant writing consulting group to assist us in the submission of NIH and SBIR grant applications for additional funding to support our progress. With our new data, we are encouraged by the prospect of successful grant funding. Grant funding is naturally optimum as it is funding that does not have to be repaid and thus does not dilute (but only increases) your value in our company.

We hope to have progress on all of these fronts this quarter and will keep you apprised of developments. We again thank you for your support - which has made our progress possible.

Best regards,

Charles

Charles Cotropia

BioClonetics

03.31.19

BioClonetics Update - First Quarter 2019 Progress

To Our Investors and Supporters,

We are pleased to provide this end of first quarter report for 2019. We are reminded how fortunate we have been to have investors and supporters such as you. Your support has made possible the great progress we have made and we thank you for your support and partnership.

Because this report may seem overly lengthy and technical, let me give you the bottom-line latest results first.

In testing completed on our recombinant form of our parent anti-HIV monoclonal antibody, the recombinant antibody performed significantly better than the parent antibody. Specifically, our newly produced recombinant form of the antibody reached a 93.2% neutralization (as compared to an 80% neutralization achieved by the parent antibody) while requiring only 1/16th of the concentration required by the parent. The recombinant required only 0.05 µg/ml of antibody to reach 93.2% neutralization as compared to the parent antibody requiring 0.8 µg/ml (16 times more) to achieve an 80% neutralization rate.

These tests were conducted on a single HIV virus isolate (SF162) – a laboratory HIV isolate (strain of virus) known to be very difficult to neutralize. Additional testing is planned and will now be conducted on a greater number of HIV isolates.

Let me recap our developments that have led to this latest data.

Our parent Clone 3 anti-HIV antibody has been successfully tested in five international laboratories where it conclusively neutralized 95% of the HIV isolate strains against which it was tested. http://www.bioclonetics.com/validation.html.

Our Clone 3 antibody is very unique in broad-spectrum coverage – it neutralizes all HIV clades across the world and the targeted epitope – the “Achilles heel” to which our antibody binds resulting in neutralization – is highly conserved and has remained present in the over 6000 HIV isolates that have become known over the past 15 years. The epitope of the Clone 3 antibody has remained present (has not mutated) and is 98% conserved – over the past 15 years (2003 through 2019), as recorded in the Los Alamos National Laboratory HIV Database for amino acid sequencing for primary HIV clinical isolates gp41 amino acid sequence 601-KLIC-604. From this data, it can be seen that 78% of the over 6000 isolates contain the absolute amino acid core epitope for Clone 3 Antibody [= KLIC] and 20% contain conservative substitutions of amino acids within the epitope range 601 through 604. This fact is shown here https://www.hiv.lanl.gov/cgi-bin/QUICK_ALIGNv2/convent.cgi?seq_input=epitope%09KLIC&nucpro=pro

A successful antibody must be “broadly neutralizing” – meaning it must neutralize HIV virus strains by binding to a site on the viruses that does not mutate. If an antibody initially neutralizes the virus by binding only to a site that mutates, the virus simply “escapes” around the antibody and the antibody will ultimately not be successful in controlling the HIV virus. This “virus escape” has rendered other monoclonal antibodies unsuccessful.

As an example, a most recent candidate was the antibody VRC01 produced and tested by Vaccine Research Center in conjunction with the National Institute of Health (NIH). In 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. Also see, K.J. Bar, New England Journal of Medicine, 9 November 2016 (“Viral rebound after 4 weeks and 5.6 weeks).

Another example is the broadly neutralizing antibodies (bNAbs) 3BNC117 and 10-1074 currently in NIH clinical trials. These antibodies fail to bind to an immutable site on the virus – and thus used by themselves or in their combination, will not provide a successful treatment of HIV. Specifically, for mAb 3BNC117, virus escape is documented in the reference Viraemia Suppressed in HIV-1-infected Humans by Broadly Neutralizing Antibody 3BNC117, Marina Caskey, et al., Nature, Vol 522, pp 487 (June 25, 2015); https://www.ncbi.nlm.nih.gov/pubmed/25855300.

As to the monoclonal antibody 10-1074, the reference in Nature Medicine (volume 23, no. 2 February 2017 page 185) entitled “Antibody 10-1074 suppresses viremia in HIV-1-infected individuals” reveals the virus escape that is experienced when used in tests. Careful analysis of the binding site of this mAb reveals that there will be from 19% to 39% virus escape in use of this antibody.

These antibodies will have to be combined with a broadly neutralizing antibody such as our Clone 3 – which binds to an immutable, linear epitope site on the virus – for them to be successful in the real world.

Because – as is usual – the parent antibody producing cell line does not produce a sufficient quantity of antibody to treat the millions of individuals infected with HIV, a “recombinant form” of the antibody (using a fast-producing cell line) had to be produced and then tested. With your support, we successfully produced several recombinants of the parent – each with a slightly difference amino acid sequence composition.

We have now completed the first tests of these recombinants and more testing is under way.

What did this initial testing reveal?

First let me note that the tests were conducted against a lab HIV isolate – a strain identified as SF231 – an HIV strain known to be very resistant to neutralization.

In prior testing of the parent Clone 3 antibody against this isolate SF231, to achieve 80% neutralization required a concentration of 0.8 µg/ml of the parent antibody.

In the tests just completed of the recombinant form of our antibody, to achieve a 93.2% neutralization, only a concentration of 0.05 µg/ml of the antibody was required – a 16-fold improvement over the parent antibody.

More tests are being conducted and will be conducted on many more HIV viral isolates. As noted above, the parent antibody was tested in 5 international labs against 43 isolates, where it fully neutralized over 95% of those tested. We expect a similar or better result from the recombinant form of our antibody. We hope to accumulate more data to solidify interest by an appropriate pharma partner to conduct animal trials and then clinical trials.

We expect that in animal and then clinical trials, our antibody will perform better than the results in these in vitro (test tube) tests and expectedly will perform better those antibodies being studied by others – again because our antibody binds to the virus at an immutable site that exists of 98% of all strains of the HIV virus. This is a characteristic of our antibody that we believe sets it apart from others.

We will keep you informed of our progress. And we thank you again for your support.

Best regards,

Charles

Charles Cotropia

CEO BioClonetics Immunotherapeutics, Inc.

12.29.18

BioClonetics Update - Agenda for the new year

Dear Investors and Supporters,

As we approach the end of 2018, we are reminded how fortunate we have been to have investors and supporters such as you. Your support has allowed us to made great strides as we move into 2019. Thank you for your support and partnership. And we wish you peace, joy and prosperity throughout the coming year!

Our recombinant anti-HIV monoclonal antibodies were successfully produced in 2018 at Genscript Biotech and are in testing against a full panel of HIV isolates at two labs – the University of Antwerp, Institute of Tropical Medicine (https://www.itg.be/), Antwerp, Belgium and at the Texas BioMedical Research Institute (https://www.txbiomed.org/) in San Antonio, Texas.

We have obtained a proposal and protocol for animal trials and plan to later test the recombinants in macaques at the Keeling Center for Comparative Medicine at M.D. Anderson in Bastrop, Texas. Such tests do require a substantial investment and we are conferencing with several potential supporters to obtain the necessary funding.

Our recombinant antibody is also being scheduled for testing in combination with other HIV therapies in the lab of the Italian National Center for Aids Research (CNAIDS) at Istituto Superiore Di Sanità, Rome, Italy. The expectation in such tests is to combine our antibody with other non-antibody therapies to attach to and thereby neutralize the virus in combination. These tests are now being scheduled.

We are continuing our dialogue with potential pharma partners. In addition to using our anti-HIV monoclonal antibodies to address HIV, potential pharma partners are interested in how our technology can address infectious disease other than HIV.

Specifically, our technology can be applied to address diseases like HTLV-1 and HTLV-2 – diseases which effect 20 million people around the world? HTLV-1 and HTLV-2 viral agents cause an increase in white blood T-cell lymphocyte counts leading to leukemia cancer. Here is how our technology can be used to address this cause of cancer.

  • HTLV-1 and HTLV-2 symptoms arise from retroviruses with a similar infection mechanism as HIV-1 - which causes AIDS. HTLV-1 and HTLV-2 can be addressed by implementation of our technology that we have used to create our anti-HIV Clone 3 monoclonal antibody.
  • The same result that we have achieved with HIV through the creation of an anti-HIV antibody can be expected to be achieved against HTLV-1 and HTLV-2 that cause human T-cell leukemias.

To achieve the same result that we have achieved with HIV through the creation of an anti-HIV antibodies, one must know how to successfully target the HTLV-1 and HTLV-2 viral agents that cause human T-cell leukemias. Specific structures within the HTLV-1 and HTLV-2 molecular sequence must be targeted to achieve effective control of these viral agents.

  • Importantly, the cancerous process caused by the HTLV-1 and HTLV-2 is analogous to HIV-1 which causes the diminution of white blood cell count by a lymphocytic process that occurs after viral infection of human cells.
  • Just as our Clone 3 antibody prevents HIV from fusing with normal human cells (preventing infection), the same can be achieved by producing the correct antibody that will target HTLV-1 and HTLV-2.

The significant point here is that we have the knowledge and methodology necessary to successfully target HTLV-1 and HTLV-2. And we hope to work with a pharma partner to address this cancer.

We will keep you updated. And we thank you for your continued support.

Best regards,

Charles

Charles Cotropia

BioClonetics

11.01.18

Our Campaign is Ending in 1 Day

Our Campaign is Ending in 1 Day

Dear Investors and Supporters,

Before I share a final summarizing update, I want to first extend a most sincere thanks to all of our investors and followers. You have truly made our progress possible and we will continue to work tirelessly to assure that we are worthy of your support and that our technology fulfills the promise that it offers.

Our campaign ends in 1 day - November 2, 2018. We will not be extending our campaign and thus we ask that those that have considered reinvesting, please do so on or before November 2nd – and pass the word onto your friends.

There are so many things happening, it is hard to give a final report. I have been accused (by those helping me with these reports) of saying too much in these updates. But there is a lot to say and a lot to convey – after all, our progress has been great and gives hope in light of the devastation caused by the HIV pandemic – a disease that takes the lives of 400 children every day - and 4000 adults each day. With that level of loss, it is hard for me to simply capsulize what we are doing because the goal of an effective therapeutic cure (which can reach those who currently have no treatment) cannot be adequately conveyed in a short summary.

Our strength lies in the fact that we have two distinct areas of technology. First, we have a fully human, and effective, anti-HIV monoclonal antibody - called Clone 3 - and second, we have a proprietary methodology for producing fully human monoclonal antibodies against numerous infectious diseases. Our methodology is superior because it can be used to identify – not just antibodies - but highly effective, neutralizing antibodies.

As we have reported, the parent antibody has demonstrated its effectiveness in 5 separate labs where it neutralized 95% of the HIV isolates against which it was tested. We have now produced recombinant forms of the parent antibody and they are being tested in two labs - University of Antwerp, Institute of Tropical Medicine, Antwerp, Belgium and Texas BioMedical Research Institute, San Antonio, Texas. We have this past week, starting plans for macaque trials at the Michale E. Keeling Center for Comparative Medicine and Research at M.D. Anderson, Bastrop, Texas.

Regarding the methodology, in addition to producing our anti-HIV monoclonal antibody, we have proof of concept in use of the method to generate monoclonal antibodies against Rabies, Influenza A, Influenza B, Tetanus and Diphtheria. The methodology can be used for so many more diseases, both those that effect humans and those that kill animals.

The recombinant forms of the parent antibody were generated for us (with your investment!) by Genscript (www.genscript.com) and we have worked with this superior lab for years. We are now in discussions with Genscript about a partnering or licensing arrangement. As these discussions continue, we are not limiting our search for a biopharma partner to one company. We have had interest by big pharma and have had discussions with Johnson & Johnson and Gilead. To identify the correct partner, we have this week engaged with several highly experienced consultants in the field of identifying and negotiating technology licenses and acquisitions.

As we proceed with negotiations, a partner, licensee or an acquiring company may be interested in some or all of our technology. Each piece has significant value. Our primary interest is in partnering with a pharma company to assure that the full scope of our technology is implemented.

We will keep you up to date on our progress. And we sincerely thank you for all your support.

Kind regards,

Charles

Charles Cotropia

CEO BioClonetics Immunotherapeutics, Inc.

www.bioclonetics.com

10.30.18

Our Campaign Ends November 2

For all of our supporters who have come on board since August 1, your investment will be processed when our campaign closes on November 2, if it was not previously processed. Be on the lookout for an email that will give you the details as to when your investment will be actually  processed for funding to our company.

We again express our appreciation for your confidence and support.

Best regards,

Charles

CEO BioClonetics

10.25.18

Our Campaign Ends in 1 Week

Our Campaign Ends in 1 Week

Dear Investors and Supporters,

Our discussions to partner with a large international biotech are progressing.  Genscript (https://www.genscript.com/), an internationally recognized pharma, has expressed an interest in more than one of our technologies. There is remarkable potential that could flow from a partnership with this entity. Combining our technology with their expertise, scientists and lab facilities can only lead to remarkable successes.

Before I share more about that progress, let me first extend my sincere appreciation to all of our new and existing investors and our supporters. Your support has made the difference. However, our StartEngine campaign will end in 1 week on November 2, 2018. We will not be extending our campaign and so ask that those that have considered reinvesting, please do so before November 2nd – and pass the word onto your friends.

For those who have indicated an intent to invest but have thus far not completed the process, we ask that you do that now – before our campaign closes.

We have worked with Genscript for years and their expertise is unmatched by any with whom we have been associated.  Our most recent developments have been made in conjunction with them. We have multiple separate major areas of technology to offer them and the synergy between our technology and their scientists and facilities would result is success on many fronts. Our technologies in which they are interested include:

1) Our existing anti-HIV monoclonal antibody Clone 3.

2) The methodology for creating fully human monoclonal antibodies against numerous other infectious diseases.

3) The methodology for creating fully human monoclonal antibodies against animal infectious diseases.

Let me also list the ongoing testing we are completing as we negotiate with this potential pharma partner.

  • Testing of our recombinant antibodies is now underway at (1) the University of Antwerp, Institute of Tropical Medicine, Antwerp, Belgium and (2) Texas BioMedical Research Institute, San Antonio, Texas.
  • These tests are being conducted against multiple HIV strains to prove efficacy of our recently produced recombinant antibodies.

Additionally,

  • Our antibodies are also being tested in combination with other HIV therapies in the labs of Dr. Seth Pincus at Montana State University, Bozeman, Mountain.
  • Just this week, we signed agreements with the Italian National Center for Aids Research (CNAIDS) at Istituto Superiore Di Sanità, in Rome, Italy for combined testing our antibody with an anti-HIV vaccine produced there.

Both of these labs requested our antibody to be combined with their distinctively different HIV therapies. The expectation is that a combined therapy will offer a greater probability of success in completely defeating the HIV virus – a virus that big pharma has failed to adequately address and failed to conquer over many decades.

We will keep you informed.

If you have considered investing but have not yet done so, please do so now.

Best regards,

Charles Cotropia

CEO

BioClonetics Immunotherapeutics, Inc.

10.18.18

OUR CAMPAIGN ENDS IN 14 DAYS

OUR CAMPAIGN ENDS IN 14 DAYS

Dear Investors and Supporters,

We have very promising news regarding our plans to partner with a large Biopharma company to license our proprietary methodology for producing fully human monoclonal antibodies against other infectious diseases. In this update, I want to share this news.

Let me first extend my sincere appreciation to all of our investors and supporters. Your support has made our progress possible. However, our campaign on www.startengine.com/bioclonetics will end in 2 weeks on November 2, 2018. We will not be extending our campaign and thus ask that those who have considered investing, please do so before this deadline – and pass the word to your friends. For those who have begun the investment process, we ask that you conclude that process on www.startengine.com.

OUR EFFORTS TO PARTNER WITH A MAJOR BIOPHARMA COMPANY ARE PROGRESSING

As we have reported, tests of our fully human monoclonal antibody in 5 separate international laboratories have demonstrated that our anti-HIV monoclonal antibody fully neutralizes over 95% of the multiple HIV isolates (strains) against which it was tested.

The recombinant forms of the parent antibody (necessary for animal and clinical trials) have been produced and are currently being tested for efficacy in 2 world class laboratories, at Texas BioMedical Research Institute, San Antonio, Texas and the University of Antwerp, Institute of Tropical Medicine, Antwerp, Belgium.

To produce these recombinant forms of our antibodies, we have worked closely with a large Biopharma entity that is a leader in multiple areas of pharmaceutical development. In a conference with this entity yesterday, they have expressed an interest and we are discussing partnering to share the method for producing fully human monoclonal antibodies – a method that can be used (and has been successfully used by us) to produce fully human monoclonal antibodies against numerous infectious diseases. This prospective partner’s interest is due to the fact that our methodology for producing fully human (not mouse-based) monoclonal antibodies can be used not only to produce neutralizing antibodies against HIV but can similarly be used to product fully human monoclonal antibodies against many other infectious diseases. We have already proven proof of concept in producing fully human monoclonal antibodies against:

- Rabies

- Influenza A

- Influenza B

- Tetanus

- Diphtheria

The process can likewise be used to produced fully human monoclonal antibodies against other infectious diseases, such as:

- IV-2

- Anthrax

- Smallpox

- H1N1 Influenza

- h (+) auto-immune disease

- HTLV1 & HTLV2 Leukemia

- Herpes Simplex I & II

- onic Fatigue Syndrome

The method can similarly be used to produce animal-specific monoclonal antibodies for animal viruses such as:

- Asian and African Elephant Herpes

- Primate Herpes

- American Bison Brucellosis

- Australian Koala HIV and Chlamydia

- Feline Immunodeficiency Virus

- African Lion Drug-Resistant Tuberculosis

Given the breath of scope and reach of our proprietary methodology, this large Biopharma company is interested in and we intend to move forward aggressively with a program of development with this company using our methodology.

Look for great progress on this front in the near future.

Best regards,

Charles

Charles Cotropia

CEO BioClonetics Immunotherapeutics, Inc.

10.02.18

PROGRESS BEING MADE

PROGRESS BEING MADE

Dear Investors and Followers,

Let me first extend my sincere appreciation to all of our new investors as well as all of our existing investors.

Testing of our recombinant antibodies are now underway at 2 world class laboratories, (1) Texas BioMedical Research Institute, Dan Antonio, Texas and (2) University of Antwerp, Institute of Tropical Medicine, Antwerp, Belgium. These tests are being conducted on our recently produced recombinant antibodies.

To recap our current status, the parent Clone 3 anti-HIV antibody has been successfully tested in five international laboratories where it conclusively neutralized 95% of the HIV isolate strains against which it was tested.

The recombinant form of the antibody has been produced from the parent antibody, a form of the antibody necessary for proceeding to animal and then clinical trials.

As mentioned, the testing of the recombinant antibodies is now underway at two laboratories. The testing system being used is one where the recombinants are tested against multiple, live HIV viruses, called a PBMC based assay test system. Most, if not all, big Pharma companies do not use this more sophisticated PBMC based assay test which tests antibodies against live viruses. This system is not used due to its complexity, higher costs and time required by the method. Unfortunately, for those researchers using the substituted, less expensive, rapid fluoresce test, the results are not, in our view, a valid indication of whether a tested antibody will succeed in the real world. In other words, the test system used by big Pharma is not against actual HIV virus strains but rather against man-made targets that supposedly “are equivalent” to the real-world virus. We are not willing to use such shortcut procedures as we find them to produce erroneous results.

Our testing in the two labs we be in the more accurate and costlier PBMC based assay test system – a test system that takes several months to complete. But the tests are against live HIV virus strains which produce a valid indication of efficacy.

Thereafter, the antibodies will be ready for animal trials.

In a conversation this week with Johnson & Johnson, a company focused on HIV therapy, our technology was well received and recognized as being significant and the data persuasive. However, Johnson and Johnson indicated that it would need to see results in animal trials before it would be in a position to buy-in to the technology.

We are actively, very actively pursuing a pharma partner who does not require the completion of animal trails before partnering in our technological development. As we attempt to identify such partner, we are proceeding to make plans for animal trials at one of several macaque trial centers including Southwest National Primate Research Center, in San Antonio, Texas (http://snprc.org/primates/macaques/) and Keeling Center for Comparative Medicine, MD Anderson Cancer Center. (http://www.kccmr.org/).

As we have reported, there are several efforts by others to develop anti-HIV monoclonal antibodies and we welcome their research advancements. As we have reported before, a combination of neutralizing antibodies may well be necessary to completely defeat HIV. A combined therapy is the norm in many if not most cases, including treating cancer and many many other diseases. As to these other attempts to identify a successful anti-HIV antibody, for an antibody to effective in the real world, it must have at least these qualities:

It must be capable of being produced in quality (have stability once produced) and quantity sufficient amounts for patient application.

It must bind to an immutable site on the virus (otherwise the virus will escape around it).

It must interrupt an essential step in the infectious process as a result of its binding to the virus (it must be neutralizing).

Those antibodies produced thus far have not succeed in each of these requirements.  Ours does.

As to those monoclonal antibodies now being or recently considered, a most recent candidate was the antibody VRC01 produced and tested by Vaccine Research Center in conjunction with the National Institute of Health (NIH).  In 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. Also see, K.J. Bar, New England Journal of Medicine, 9 November 2016 (“Viral rebound after 4 weeks and 5.6 weeks).

 Another example is the broadly neutralizing antibodies (bNAbs) 3BNC117 and 10-1074 currently in NIH clinical trials. These antibodies fail to bind to an immutable site on the virus – and thus used by themselves or in their combination, will not provide a successful treatment of HIV. Specifically, for mAb 3BNC117, virus escape is documented in the reference Viraemia Suppressed in HIV-1-infected Humans by Broadly Neutralizing Antibody 3BNC117, Marina Caskey, et al., Nature, Vol 522, pp 487 (June 25, 2015); https://www.ncbi.nlm.nih.gov/pubmed/25855300.

As to the monoclonal antibody (mAb) 10-1074, the reference in Nature Medicine (volume 23, no. 2 February 2017 page 185) entitled “Antibody 10-1074 suppresses viremia in HIV-1-infected individuals” reveals the virus escape that is experienced when used in tests. Careful analysis of the binding site of this mAb reveals that there will be from 19% to 39% virus escape in use of this antibody.

These antibodies will have to be combined with a broadly neutralizing antibody such as our Clone 3 that binds to an immutable, linear epitope site on the virus for them to be successful in the real world. We are facing a real-world attack by HIV. We must recognize that an antibody that the virus can defeat is not sufficient.  

We firmly believe that our recombinant testing and then animal trials of our antibodies will produce the necessary evidence for a pharma partner to fully embrace them.

Best regards,

Charles

CEO

Charles Cotropia

CEO BioClonetics

09.21.18

HOW DOES OUR MONOCLONAL ANTIBODIES COMPARE TO THOSE OF BIG PHARMA NOW BEING TESTED?

How Does Our Monoclonal Antibodies Compare to Those of Big Pharma Now Being Tested?

A good question – which each investor and each party to this search for a cure for HIV should ask.

Here is the answer.

Our technology is significant because it is a critical component to other unsuccessful monoclonal anti-HIV antibodies now being tested and developed.  Specifically, those monoclonal antibodies being tested by the industry, referenced below, have been shown to face “virus escape” and thus will fail by themselves in providing a therapeutics cure for HIV. The investments made will be lost without combining those antibodies with one – like ours – that binds to an immutable site on the virus.

Please consider these points and share them with others that you know.

  • It is widely recognized that a combination of neutralizing monoclonal antibodies will be necessary to defeat the virus. I respectfully refer you to the keynote address by Dr. Anthony Fauci, head of NIAID, at the 2018 AIDS conference in Amsterdam. In his address, entitled “Durable Control of HIV Infection in the Absence of Antiretroviral Therapy: Opportunities and Challenges,” Dr. Fauci pointed out the well accept axiom that a successful approach to creating an effective cure of HIV will require:
    • 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, and
    • That a combination of two or three broadly neutralizing HIV antibodies may provide the answer, in a manner akin to combination antiretroviral therapy.
  • The monoclonal antibodies examined by others, and now the subject of examination, have failed because they bind to variable sites on the virus. 
  • 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. Also see, K.J. Bar, New England Journal of Medicine, 9 November 2016 (“Viral rebound after 4 weeks and 5.6 weeks). Notice that the NIH is apparently not pursuing the VRC01 mAb. It is clear why – it faced “virus escape”.

 A most current example is the NIH clinical trial of what it calls “two highly potent, HIV-specific, broadly neutralizing antibodies (bNAbs) — 3BNC117 and 10-1074.” https://www.nih.gov/news-events/news-releases/nih-launches-study-test-combination-antibody-treatment-hiv-infection.

  • What is not clearly pointed out in the NIH news is that these mAbs fail to bind to an immutable site on the virus – and thus used by themselves or in their combination, will not provide a successful treatment of HIV.
  • Specifically, for mAb 3BNC117, virus escape is documented in the reference Viraemia Suppressed in HIV-1-infected Humans by Broadly Neutralizing Antibody 3BNC117, Marina Caskey, et al., Nature, Vol 522, pp 487 (June 25, 2015); https://www.ncbi.nlm.nih.gov/pubmed/25855300.
  • As to the mAb 10-1074, the attached reference in Nature Medicine (volume 23, no. 2 February 2017 page 185) entitled “Antibody 10-1074 suppresses viremia in HIV-1-infected individuals” reveals the virus escape that is experienced when used in tests. In fact, careful analysis of the binding site of the mAb reveals that there will be from 19% to 39% virus escape in use of this mAb.

Thus, to be successful, it will be critical to combine additional broadly neutralizing antibodies that bind to an immutable site – otherwise, the combinations now being examined will fail.

  • Our Clone 3 antibody binds to an immutable site and neutralized the virus.
  • 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, our Company's Clone 3 mAb can be expected to be effective against 98% of all HIV isolates found around the world and is clearly a broadly neutralizing monoclonal antibody.
  • The other mAbs referenced fail in this analysis.
  • Tests of our mAb have been conducted in 5 international labs where it neutralized (at IC90) 41 or 43 isolates (over 95%) against which it was tested.
  • These results were achieved 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.)
  • Tests of the recombinant form of our parent Clone 3 antibody - a form of the mAb necessary for clinical and then human trials - are now being conducted at University of Antwerp, Institute of Tropical Medicine (https://www.itg.be/), Antwerp, Belgium and Texas BioMedical Research Institute (https://www.txbiomed.org/) in San Antonio, Texas.

In view of these facts, we ask that you share this information with others who want to see a successful therapy for HIV.

Charles

Charles Cotropia

CEO/President

BioClonetics Immunotherapeutics, Inc.

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